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97–182 PDF 2015

HEARING TO REVIEW THE DEVELOPMENT OF 

THE 2015 DIETARY GUIDELINES FOR 

AMERICANS 

HEARING 

BEFORE THE

COMMITTEE ON AGRICULTURE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

OCTOBER 7, 2015 

Serial No. 114–29 

( 

Printed for the use of the Committee on Agriculture 

agriculture.house.gov 

COMMITTEE ON AGRICULTURE 

K. MICHAEL CONAWAY, Texas, Chairman 

RANDY NEUGEBAUER, Texas, 

Vice Chairman 

BOB GOODLATTE, Virginia 

FRANK D. LUCAS, Oklahoma 

STEVE KING, Iowa 

MIKE ROGERS, Alabama 

GLENN THOMPSON, Pennsylvania 

BOB GIBBS, Ohio 

AUSTIN SCOTT, Georgia 

ERIC A. ‘‘RICK’’ CRAWFORD, Arkansas 

SCOTT DESJARLAIS, Tennessee 

CHRISTOPHER P. GIBSON, New York 

VICKY HARTZLER, Missouri 

DAN BENISHEK, Michigan 

JEFF DENHAM, California 

DOUG LAMALFA, California 

RODNEY DAVIS, Illinois 

TED S. YOHO, Florida 

JACKIE WALORSKI, Indiana 

RICK W. ALLEN, Georgia 

MIKE BOST, Illinois 

DAVID ROUZER, North Carolina 

RALPH LEE ABRAHAM, Louisiana 

JOHN R. MOOLENAAR, Michigan 

DAN NEWHOUSE, Washington 

TRENT KELLY, Mississippi 

COLLIN C. PETERSON, Minnesota, Ranking 

Minority Member 

DAVID SCOTT, Georgia 

JIM COSTA, California 

TIMOTHY J. WALZ, Minnesota 

MARCIA L. FUDGE, Ohio 

JAMES P. MCGOVERN, Massachusetts 

SUZAN K. DELBENE, Washington 

FILEMON VELA, Texas 

MICHELLE LUJAN GRISHAM, New Mexico 

ANN M. KUSTER, New Hampshire 

RICHARD M. NOLAN, Minnesota 

CHERI BUSTOS, Illinois 

SEAN PATRICK MALONEY, New York 

ANN KIRKPATRICK, Arizona 

PETE AGUILAR, California 

STACEY E. PLASKETT, Virgin Islands 

ALMA S. ADAMS, North Carolina 

GWEN GRAHAM, Florida 

BRAD ASHFORD, Nebraska 

SCOTT C. GRAVES, Staff Director 

ROBERT L. LAREW, Minority Staff Director 

(II) 

(III) 

* American Bakers Association; American Institute of Baking International Grain Foods Foundation; Independent Bakers Association; National Association of Wheat Growers; National Pasta 

Association; North American Millers’ Association; Retail Bakers of America; USA Rice Federation; Wheat Foods Council. 

C O N T E N T S 

Page 

Conaway, Hon. K. Michael, a Representative in Congress from Texas, opening 

statement .............................................................................................................. 1 

Prepared statement .......................................................................................... 3 

Hartzler, Hon. Vicky, a Representative in Congress from Missouri, submitted 

report ..................................................................................................................... 61 

Lujan Grisham, Hon. Michelle, a Representative in Congress from New Mexico, submitted statements .................................................................................... 70 

McGovern, Hon. James P., a Representative in Congress from Massachusetts, 

submitted article .................................................................................................. 70 

Peterson, Hon. Collin C., a Representative in Congress from Minnesota, opening statement ........................................................................................................ 4 

Submitted article .............................................................................................. 55 

WITNESSES

Burwell, Hon. Sylvia M., Secretary, U.S. Department of Health and Human 

Services, Washington, D.C. ................................................................................. 5 

Prepared statement .......................................................................................... 6 

Submitted joint questions ................................................................................ 127 

Submitted questions ......................................................................................... 139 

Vilsack, Hon. Thomas ‘‘Tom’’ J., Secretary, U.S. Department of Agriculture, 

Washington, D.C. ................................................................................................. 8 

Prepared statement .......................................................................................... 9 

Submitted joint questions ................................................................................ 127 

Submitted questions ......................................................................................... 139 

SUBMITTED MATERIAL

Archer, Ph.D., M.S., Edward, NIH/NIDDK Research Fellow, Nutrition Obesity 

Research Center, University of Alabama at Birmingham, submitted statement ...................................................................................................................... 73 

Campagna, Shannon, Director, Federal Government Affairs, Mars, Incorporated, submitted letter ..................................................................................... 102 

Schoenfeld, M.S., R.D., Pamela, Executive Director; Adele Hite, M.P.H., R.D., 

Public Policy Advisor, Healthy Nation Coalition, submitted letter ................. 106 

Teicholz, Nina, Author, The Big Fat Surprise: Why Butter, Meat and Cheese 

Belong in a Healthy Diet, submitted statement ................................................ 110 

Wilcox, Kristin Pearson, Vice President of Government Relations, International Bottled Water Association, submitted letter ....................................... 117 

Grain Chain,* submitted letter .............................................................................. 119 

(1) 

HEARING TO REVIEW THE DEVELOPMENT OF 

THE 2015 DIETARY GUIDELINES FOR 

AMERICANS 

WEDNESDAY, OCTOBER 7, 2015 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON AGRICULTURE, 

Washington, D.C. 

The Committee met, pursuant to call, at 8:59 a.m., in Room 1300 

of the Longworth House Office Building, Hon. K. Michael Conaway 

[Chairman of the Committee] presiding. 

Members present: Representatives Conaway, Neugebauer, Lucas, 

King, Rogers, Thompson, Gibbs, Austin Scott of Georgia, Crawford, 

DesJarlais, Gibson, Hartzler, Benishek, LaMalfa, Davis, Yoho, 

Allen, Rouzer, Abraham, Moolenaar, Newhouse, Kelly, Peterson, 

David Scott of Georgia, Costa, Walz, Fudge, McGovern, DelBene, 

Kuster, Nolan, Maloney, Kirkpatrick, Aguilar, Plaskett, Adams, 

Graham, and Ashford. 

Staff present: Anne DeCesaro, Callie McAdams, Haley Graves, 

John Goldberg, Mary Nowak, Mollie Wilken, Scott C. Graves, 

Stephanie Addison, Faisal Siddiqui, Lisa Shelton, Liz Friedlander, 

Mary Knigge, Mike Stranz, and Nicole Scott. 

OPENING STATEMENT OF HON. K. MICHAEL CONAWAY, A 

REPRESENTATIVE IN CONGRESS FROM TEXAS 

The CHAIRMAN. Well, good morning. Let us go ahead and get 

started. Mr. Kelly, would you open us with a prayer, please? 

Mr. KELLY. Dear Heavenly Father, we just ask that you bless 

this Committee. We ask that you bless this government. We ask 

that you bless all those who lead this great nation. Dear Lord, we 

just ask that everything we do honor and please you. In Jesus’s 

name I pray, amen. 

The CHAIRMAN. Thank you, Trent. This hearing of the Committee 

of Agriculture regarding the review of the development of the 2015 

Dietary Guidelines for Americans, will come to order. I want to 

thank our witnesses for being here this morning. It is no small feat 

to get the Secretaries of two of the most important agencies of government to come sit at the same table at the same time, and so 

I thank you, Secretary Vilsack, Secretary Burwell, for making this 

happen. We certainly appreciate it. 

We are joined today by the Secretary of Agriculture and the Secretary of Health and Human Services to discuss development of an 

important document: The 2015 Dietary Guidelines for Americans. It 

is not this Committee’s intention to legislate specific recommendaVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 P:\DOCS\114-29\97182.TXT BRIAN
2 

tions or guidelines, however we will demand that the guidelines be 

developed in a transparent and objective manner. The DGA is not 

only a recommendation to the American people on how to make 

healthy food purchasing decisions to live a healthy lifestyle, but it 

also forms the basis of Federal nutrition policy, education, outreach 

efforts used by consumers, industry, nutrition educators, and 

health care professionals. 

It is essential that the guidance that comes out of this process 

can be trusted by the American people. To achieve this, it must be 

based on sound, consistent, and irrefutable science. The DGA is 

Congressionally mandated under the National Nutrition Monitoring and Related Research Act of 1990. According to the Act, the 

DGA shall contain nutritional and dietary information and guidelines for the general public, shall be ‘‘based on the preponderance 

of the scientific and medical knowledge current at the time the report is prepared’’, and ‘‘shall be promoted by each Federal agency 

in carrying out any Federal food, nutrition, or health program’’. Ensuring a sound development process is important because it is extremely difficult to reverse or change public policy once implemented without causing consumer confusion. At a time when consumers are already subjected to conflicting, and often contradictory, 

nutrition and health information, staying within the scope of the 

intent of the law by providing the public with science-based realistic and achievable information is more likely to improve public 

health outcomes. 

The process of the 2015 DGA began in 2012, when Secretary 

Vilsack and Secretary Burwell’s predecessor, Secretary Sebelius, 

created, and then appointed, the 15 members to the Dietary Guidelines Advisory Committee. Though this committee is not specifically authorized, it was chartered under the Federal Advisory Committee Act, which requires that the advice rendered by the Committee be ‘‘objective and accessible to the public’’ by formalizing the 

process for ‘‘establishing, operating, overseeing, and terminating’’ 

the committees. This makes the committee solely responsible to 

USDA and HHS, who are then responsible for continually reviewing the committee’s performance and process compliance, which include activities as detailed as approving all of the meeting agendas. 

It is therefore the responsibility of USDA and HHS to maintain 

control over the scope and methods used by DGAC. 

I personally weighed in with both of you, as have many of my 

colleagues, about our concerns with the process of developing the 

guidelines. I raised concerns about the committee’s report shortly 

after its release, and called on you to extend the public comment 

period, which you did, and I appreciate that very much. USDA and 

HHS received over 29,000 public comments to the committee’s report, many of which were developed by nutritionists and other experts in the study of human health. Included in their submitted 

comments, available for public viewing on DGA’s website, were scientific studies and other evidence that observers assert had been 

ignored by the committee. As a result, I repeatedly requested that 

each and every comment be considered by USDA and HHS before 

the final guidelines are published. 

In May the Ranking Member and I sought, in writing, details on 

your plan to review the more than 29,000 comments, and to make 

3 

sure that they were viewed properly. You response to us on that 

plan, though, was less than sufficient, so I look forward to hearing 

more today on this matter. 

Uncertainty in the process leads to concern about whether the 

committee’s recommendations will maintain the scientific integrity 

necessary to be actionable by Americans. It is my hope that as 

USDA and HHS review of the 2015 recommendations, that in that 

review they are mindful of the process failures that lie squarely between each of the recommendations. It is imperative to hear assurances from each of you that Americans were ultimately presented 

with the best and most reliable information for making healthy 

food and beverage choices. 

Again, thank you, Secretary Vilsack and Secretary Burwell for 

being with us today, and I look forward to our conversation. 

[The prepared statement of Mr. Conaway follows:] 

PREPARED STATEMENT OF HON. K. MICHAEL CONAWAY, A REPRESENTATIVE IN

CONGRESS FROM TEXAS

I want to welcome our distinguished witnesses to today’s hearing and thank them 

for taking the time to be with us. We are joined by both the Secretary of Agriculture 

and the Secretary of Health and Human Services to discuss the development of an 

important document: The 2015 Dietary Guidelines for Americans (DGA). 

It is not this Committee’s intention to legislate specific recommendations or guidelines; however we will demand that the guidelines be developed in a transparent 

and objective manner. 

The DGA is not only a recommendation to the American people on how to make 

healthy food purchasing decisions in order to live a healthy lifestyle, but it also 

forms the basis of Federal nutrition policy, education, and outreach efforts used by 

consumers, industry, nutrition educators, and health professionals. It is essential 

that the guidance that comes out of this process can be trusted by the American 

people. To achieve this, it must be based on sound, consistent, and irrefutable 

science. 

The DGA is Congressionally mandated under the National Nutrition Monitoring 

and Related Research Act of 1990. According to the Act, the DGA shall contain nutritional and dietary information and guidelines for the general public; shall be 

‘‘based on the preponderance of the scientific and medical knowledge current at the 

time the report is prepared’’; and ‘‘shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program.’’ 

Ensuring a sound development process is important because it is extremely difficult to reverse or change public policy, once implemented, without causing consumer confusion. At a time when consumers are already subjected to conflicting and 

often contradictory nutrition and health information, staying within scope of the intent of the law by providing the public with science-based, realistic and achievable 

information is more likely to contribute to improved public health outcomes. 

The process for the 2015 DGA began in 2012, when Secretary Vilsack and Secretary Burwell’s predecessor, Secretary Sebelius, created and then appointed fifteen 

members to the Dietary Guidelines Advisory Committee (DGAC). Though the DGAC 

is not specifically authorized, all advisory committees must be charted under the 

Federal Advisory Committee Act which requires that the advice rendered by the 

committee be ‘‘objective and accessible to the public’’ by formalizing the process for 

‘‘establishing, operating, overseeing, and terminating’’ the committees. This makes 

the DGAC solely accountable to USDA and HHS, who are then responsible for continually reviewing the DGAC’s performance and process compliance, which included 

activities as detailed as approving all DGAC meeting agendas. It was therefore the 

responsibility of USDA and HHS to maintain control over the scope and methods 

used by DGAC. 

I have personally weighed in with you both, as have many of my colleagues, about 

my concerns with the process of developing the Dietary Guidelines. I raised concerns 

about the DGAC report shortly after its release and called on you to extend the public comment period, which you did. 

As we are all aware of by now, USDA and HHS received over 29,000 public comments to the DGAC report, many of which were developed by nutritionists and other 

experts in the study of human health. Included in their submitted comments, availVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00007 Fmt 6633 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
4 

able for public viewing on the DGA’s website, were scientific studies and other evidence that observers assert had been ignored by the DGAC. As a result, I repeatedly 

requested that each and every comment be considered by USDA and HHS before 

the final Dietary Guidelines are published. 

In May, the Ranking Member and I sought, in writing, details on your plan to 

review the more than 29,000 public comments because public comments do matter. 

Your response to us on that plan was less than sufficient so I look forward to hearing more from you today. 

Uncertainty in the process leads to concern about whether the DGAC recommendations will maintain the scientific integrity necessary to be actionable by 

Americans. It is my hope that as USDA and HHS review the 2015 DGAC recommendations, they are mindful of the process failures that lie squarely behind 

each of DGAC’s recommendations. It is imperative to hear assurances from USDA 

and HHS that Americans will ultimately be presented with the best and most reliable information for making healthy food and beverage choices. 

Again, thank you Secretary Vilsack and Secretary Burwell for being here today, 

I look forward to our conversation. 

The CHAIRMAN. Are there any opening comments from the Ranking Member? 

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A 

REPRESENTATIVE IN CONGRESS FROM MINNESOTA 

Mr. PETERSON. Thank you, Mr. Chairman, and I welcome both 

Secretary Burwell and Secretary Vilsack to the Committee, and I 

look forward to your testimony. Given that USDA and HHS are 

still reviewing comments, we are probably getting ahead of ourselves here, but I do hope that today’s testimony can shed more 

light on the process to establish new guidelines, and what they will 

actually mean for our constituents. There has been a strong reaction to the Dietary Guidelines Advisory Committee report. I have 

heard concerns about future sodium targets, difficulties of small 

schools meeting the guidelines, and what this could mean for cranberries and sugar. But these are mostly coming from those who are 

directly impacted, industries, schools, and the medical community. 

We are not really hearing from the public. 

I don’t think the general public is paying much attention. For 

those who are, I think they are very skeptical of the whole process. 

For example, we were once told that butter and eggs were bad for 

you. Now I guess they are okay. According to the Washington Post 

this morning, they were wrong on milk as well, and I don’t know 

how much government subsidized powder we bought because of it. 

So people may be losing confidence in these guidelines. Given the 

public skepticism, maybe we should reconsider why we are doing 

this. Is it because it is something that we have always done? We 

may wish, at first look, to expand on a provision in the 2008 Farm 

Bill that would help us understand more about what people are actually eating, and then go from there. 

I am a little concerned that we have lost sight of what we are 

doing, and we seem to be more focused on ideology and marketing 

food products than providing clear nutrition advice to the general 

public. But I do hope we can have a productive hearing and achieve 

a good outcome. I know you are going to do the best that you can 

breaking through all this noise, and I thank the Secretaries for appearing before us today, and I yield back. 

The CHAIRMAN. I thank the gentleman. I would like to inform my 

colleagues that Ms. Burwell has a hard stop at 11:30. She has an 

5 

international flight to catch. And so, with that, I don’t know who 

wants to go first. Secretary Burwell? 

Secretary BURWELL. I would be happy to, yes. 

The CHAIRMAN. Okay. 

STATEMENT OF HON. SYLVIA M. BURWELL, SECRETARY, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES, 

WASHINGTON, D.C. 

Secretary BURWELL. Good morning. Thank you, Mr. Chairman, 

and Ranking Member Peterson, as well as Members of the Committee, for the opportunity to discuss the Dietary Guidelines. I 

want to begin by thanking the Committee for your interest in the 

Dietary Guidelines, and for your work to support Americans, and 

a healthy agriculture sector. 

One of the most important responsibilities that our government 

is entrusted with is protecting the American public, and that includes empowering them with the tools they need to make educated 

health decisions. Since 1980, families across the nation have looked 

to the Departments of Health and Human Services and Agriculture 

for science-based Dietary Guidelines to serve as a framework for 

nutritious eating and healthy lives. Our guidelines also help lay a 

foundation for preventing diet-related health conditions, like obesity, diabetes, and heart disease. 

As is required by the National Nutrition Monitoring and Related 

Research Act, the Departments update these regulations and 

guidelines every 5 years. The key elements that make up a healthy 

lifestyle remain consistent, fruits and vegetables, grains and lean 

proteins, and limited amounts of saturated fats, added sugars, and 

sodium. We anticipate these will continue to be the building blocks 

of the 2015 guidelines, updated to reflect the latest research in 

science, as well as our current understanding of the connections between food and health. As part of our effort to rely on the best 

science available, we have appointed an independent Advisory 

Committee of nutrition and medical experts and practitioners to inform each addition. The 2015 Advisory Committee evaluated research, and considered comments from the public to develop recommendations included in its finished report. 

It is important to note that the Advisory Committee report is one 

input into the Dietary Guidelines. The guidelines themselves are 

written and reviewed by experts at both of our Departments. In addition to the recommendations of the Advisory Committee, our Department’s experts perform their own extensive review and consideration of public comments. In fact, as was mentioned, we received 

29,000 written comments during the 75 day public comment period. 

As a result, the 2015 Dietary Guidelines will be informed by a review of thousands of scientific papers, and decades of nutrition and 

medical research, as well as input from the public. 

We know that the guidelines are of critical importance to many 

Americans. They contribute to a culture of wellness, and empower 

individuals to better manage their own health, help keep their families healthy, reduce the onset of disease, and reduce the amount 

of money that we spend on healthcare. They also provide guidance 

to public and private programs, and support efforts to help our nation reach its highest standard of health. At HHS, the Dietary 

6 

Guidelines provide a roadmap for the nutrition advice, and services 

that we deliver, such as chronic disease prevention efforts, food assistance programs, and educational initiatives. 

HHS and USDA are working together to finalize the 2015 Dietary Guidelines, which are expected to be completed in December 

of this year. Without a finished product, I am unable to comment 

on the final content of the forthcoming edition at this time. I expect, however, that the new guidelines will continue to emphasize 

the importance of healthy eating habits and individual food choices. 

I want to thank you again for your interest in this topic, as well 

as the feedback that we have received. I know many of you have 

specific questions and concerns, and I want to assure you that we 

are taking your concerns into consideration. And we are working 

hard to answer your questions as thoroughly as we can as we are 

in the process of doing the guidelines. I look forward to continuing 

to work together, and look forward to your questions today. Thank 

you. 

[The prepared statement of Ms. Burwell follows:] 

PREPARED STATEMENT OF HON. SYLVIA M. BURWELL, SECRETARY, U.S. DEPARTMENT

OF HEALTH AND HUMAN SERVICES, WASHINGTON, D.C. 

Chairman Conaway, Ranking Member Peterson, and Members of the Committee, 

thank you for the opportunity to discuss the Dietary Guidelines for Americans (Dietary Guidelines). 

I want to begin by thanking Members of this Committee for your interest in the 

Dietary Guidelines and, more broadly, for your work to support Americans and a 

healthy agricultural sector. The Dietary Guidelines are a critical science-based initiative drafted by experts at the Departments of Agriculture and Health and Human 

Services that gives Americans advice on building healthy eating patterns that can 

help prevent chronic diseases and promote the health and well-being of our nation. 

I want to emphasize that the focus of the Dietary Guidelines is on preventing dietrelated health conditions, such as obesity, diabetes, and heart disease, rather than 

treating these and other diseases. The Dietary Guidelines are one part of a larger 

effort to help lower disease rates in the United States and give every American the 

tools they need to live healthy and productive lives. 

History 

The Dietary Guidelines are required under the 1990 National Nutrition Monitoring and Related Research Act, which directs the Departments of Health and 

Human Services (HHS) and Agriculture (USDA) to publish a report entitled ‘‘Dietary Guidelines for Americans’’ at least every 5 years. By law, each edition of the 

Dietary Guidelines includes ‘‘nutritional and dietary information and guidelines for 

the general public . . . .’’ The law also states that the Dietary Guidelines should ‘‘be 

promoted by each Federal agency in carrying out any Federal food, nutrition, or 

health program.’’ In our development of these Guidelines, we follow this statute to 

guide the scope of our work. 

Historically, the Key Recommendations of the Dietary Guidelines have not 

changed substantially from one edition to the next. Elements of healthy eating patterns continue to include fruits, vegetables, grains, dairy, and protein-rich foods 

such as lean meats and seafood, and limit components like saturated fats, added 

sugars, and sodium. The guidelines provide a science-based framework for policy 

makers, nutrition educators, and healthcare providers to include nutrition as part 

of an overall prevention strategy for lowering rate of disease. The guidelines also 

help Americans make healthy food choices, enjoy food, and celebrate personal culture through food, all of which are important to Americans. 

Development 

HHS and USDA strive to develop Dietary Guidelines recommendations that are 

based on the strongest available scientific evidence and represent our current understanding of the connections between food and health. One of the ways that we 

achieve this goal is by appointing a Dietary Guidelines Advisory Committee (Advisory Committee). The Advisory Committee is an independent group of experts and 

practitioners in the fields of nutrition and medicine that is voluntary and solely adVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
7 

visory, and although their work informs the government’s work, they are not directly involved in the Departments’ development of the Dietary Guidelines. It develops a scientific report and recommendations to inform each edition of the Dietary 

Guidelines. The use of an Advisory Committee is a best practice to ensure that the 

Federal Government is obtaining sound, external scientific advice to inform policy 

decisions. Advisory Committees have been used to inform the development of the 

Dietary Guidelines since the 1985 edition. 

The 2015 Advisory Committee used state-of-the-art standards to develop its scientific recommendations to the Federal Government, which were delivered to HHS 

and USDA in its Advisory Report in February 2015. In addition to drawing on the 

expertise of the Committee members, the Advisory Committee also received both 

written and oral public comments over the course of its work. These comments 

helped ensure that the Committee discussed topics and issues of interest to the public and received evidence to consider in the scientific process. 

The work of the Advisory Committee informs HHS and USDA’s development of 

the Dietary Guidelines; however, the Advisory Report is only one component that 

the Departments consider when developing each edition of the guidelines. The 

Guidelines themselves are written and reviewed by the experts at our Departments 

and ultimately by Secretary Vilsack and me. In addition to the Advisory Committee’s report, HHS and USDA consider public comments on the Advisory Report and 

look to Federal agencies with expertise in nutrition to review both the Advisory Report and the draft policy before Secretary Vilsack and I approve it. 

We recognize that the Advisory Report addressed many issues about which nutrition and agricultural stakeholders care deeply. We received over 29,000 written 

comments during the 75 day public comment period on the Advisory Report, as well 

as 73 oral comments during a March 2015 public meeting. This demonstrates public 

interest and concern about information in the Dietary Guidelines. In response to the 

high level of interest and Congressional requests, HHS and USDA extended the 

public comment period by 30 days to accommodate a high volume of public comment 

submissions and ensure we were able to take the public’s input into account. These 

comments have been fully reviewed by staff within our Departments and are being 

considered in the development of the 2015 Dietary Guidelines. While all public comments are reviewed, in order to ensure the Dietary Guidelines are based on sound 

science, the Departments focus heavily on public comments that include scientific 

justification. 

As a result, the 2015 Dietary Guidelines will be informed by a review of thousands 

of scientific papers and decades of nutrition and medical research, as well as significant input from the public. The Guidelines will translate this science into succinct, 

food-based guidance that Americans can rely on for choosing a healthy diet. 

Impact 

The 2015 edition of the Dietary Guidelines will build on this strong scientific foundation to continue to provide guidance to help encourage more healthy food choices 

across our nation. As Members of this Committee know, this issue is of critical importance. We must strive, together, to prevent nutrition-related disease and improve 

the health of American families and communities. 

The Dietary Guidelines are one of numerous important Federal policy initiatives 

that aim to help Americans reach their highest standard of health. For more than 

25 years, over 1⁄2 of our adult population has been overweight or obese. Today, about 1⁄2 of all American adults have one or more preventable chronic diseases, which are 

attributable to several causes, including poor-quality diet and physical activity behaviors. All sectors of society play an integral part in contributing to a culture in 

the United States that champions wellness and empowers all people to achieve their 

highest standard of health. The Dietary Guidelines provide the framework for not 

only the Federal Government but also for other sectors of influence, including other 

policymakers, health professionals, etc. who can apply the Guidelines in a multitude 

of ways with the potential to lower nutrition-related disease rates. 

At HHS, the Dietary Guidelines for Americans provide a roadmap for the nutrition 

advice and services that we deliver to the public through chronic disease prevention 

efforts, food assistance programs, and educational initiatives. Examples include the 

Older Americans Act Nutrition Services Programs and Head Start. The Guidelines 

are also used to inform national disease prevention and health promotion objectives 

related to nutrition and weight status, primarily through Healthy People 2020. 

CDC’s prevention campaigns, NIH’s lifestyle guidance, and FDA’s Nutrition Facts 

Label regulations consider the nutrition information in the Dietary Guidelines. As 

in the past, the 2015 edition of the Dietary Guidelines will help focus our resources 

on efforts that have the greatest positive impact on health outcomes. 

8 

Dietary Guidelines for Americans, 2015 

HHS and USDA are working together to finalize the 2015 Dietary Guidelines, 

which are expected to be completed in December of this year. We will conduct several layers of scientific review prior to preparing a draft for final approval, which 

has not yet occurred. As such, I am unable to comment on the final content of the 

forthcoming edition of the Dietary Guidelines at this time. However, I expect the 

new Dietary Guidelines will continue to focus on food-based recommendations that 

emphasize the importance of consuming a total ‘‘healthy eating pattern’’ over time 

while recognizing the importance of individual choices. 

Closing 

Again, thank you, Chairman Conaway, Ranking Member Peterson, and Members 

of the Committee for this opportunity to discuss the Dietary Guidelines and for your 

interest in this important topic. I am looking forward to continuing our partnership 

so that together we can ensure that every American has access to the building 

blocks of healthy and productive lives. I am happy to answer your questions. 

The CHAIRMAN. Thank you, Secretary. Secretary Vilsack? 

STATEMENT OF HON. THOMAS ‘‘TOM’’ J. VILSACK, SECRETARY, 

U.S. DEPARTMENT OF AGRICULTURE, WASHINGTON, D.C. 

Secretary VILSACK. Thank you, Mr. Chairman, Ranking Member 

Peterson, and all of the Members of this Committee, I want to 

thank the Chairman for the opportunity to be here today, and I 

want to thank my colleague, Sylvia Burwell, for the extraordinary 

work that she and her team have done, in concert with the Department of Agriculture, in getting us to this point today. 

I will tell you that I struggle with the Dietary Guidelines, because it is important for people to understand precisely what they 

are and what they are not. These guidelines are a set of recommendations based on a series of well-informed opinions that create a framework that is designed to encourage and to educate 

Americans about what they can do to increase their chances of preventing chronic diseases. This is not about treating disease. This 

is about trying to prevent chronic diseases. 

As a result, the guidelines that we formulate are, and should be, 

restricted, by law, to nutritional and dietary information. The Advisory Committee report, which Secretary Burwell mentioned, is not 

the guidelines, and sometimes there is confusion about that. The 

report informs our work, but certainly does not, and should not, 

dictate it. Only HHS and USDA can, and should, write the guidelines, based on a variety of inputs. This has been an open and 

transparent process. Questions were posed by and to the Advisory 

Committee. A number of studies, indeed thousands of studies, and 

tens of thousands of pages of documents, were reviewed. Those reviews went through a very strict and gold standard process for determining what is the strongest, best, and most available science. 

Multiple public meetings took place. Information was posted on the 

web, and we indeed received 29,000 comments as a result of the 

extended comment period, of which 8,000 comments are probably 

considered unique. 

I recognize that our process here is to determine the best available science, and, based on that, and the preponderance of that, we 

formulate the guidelines. I believe I have the same goal that Secretary Burwell has, which is to finish our work on time, before the 

end of the year, so that we can use these guidelines, as directed 

by Congress. So I too look forward to your comments and questions, 

9 

and this hearing is an important opportunity for us to educate folks 

about what these guidelines are and what they are not. 

[The prepared statement of Mr. Vilsack follows:] 

PREPARED STATEMENT OF HON. THOMAS ‘‘TOM’’ J. VILSACK, SECRETARY, U.S. 

DEPARTMENT OF AGRICULTURE, WASHINGTON, D.C. 

Chairman Conaway, Ranking Member Peterson, and Members of the Committee, 

thank you for the opportunity to discuss the Dietary Guidelines for Americans with 

you. I know it is important to all of us that the Department of Health and Human 

Services (HHS) and Department of Agriculture (USDA) deliver on our Congressional 

mandate. 

The Dietary Guidelines are focused on promoting health and preventing disease 

by providing food-based recommendations on diet and nutrition. The Guidelines 

form the cornerstone for all Federal nutrition programs. Over the years, they have 

also become an important resource for policy makers, nutrition educators, health 

professionals, and industry. What unites us all is the shared appreciation for the 

importance of nutrition in helping to prevent chronic diseases such as cardiovascular disease, high blood pressure, type 2 diabetes, diet-related cancers, and obesity—and the knowledge that too many Americans suffer from these preventable 

diet-related diseases. 

It is important to note that the Dietary Guidelines are intended to prevent these 

diet-related conditions, not to treat them. The recommendations apply to individuals 

2 years of age and older who are healthy or at increased risk of chronic disease, 

not those with medical conditions or special dietary needs. Dietary recommendations 

for specific populations that suffer from various conditions are likely to differ from 

those recommended by the Dietary Guidelines. 

HHS and USDA currently are working together to develop the eighth edition of 

the Dietary Guidelines, which is scheduled to be released by the end of this calendar 

year. 

Background 

HHS and USDA have jointly published the Dietary Guidelines every 5 years since 

1980, even before it was required by statute. The 1990 National Nutrition Monitoring and Related Research Act now directs HHS and USDA to publish the Dietary 

Guidelines at least every 5 years. The Congressional mandate states that the Dietary Guidelines ‘‘shall contain nutritional and dietary information and guidelines for 

the general public, and shall be promoted by each Federal agency in carrying out 

any Federal food, nutrition, or health program.’’ The law also requires that each edition of the Dietary Guidelines ‘‘shall be based on the preponderance of the scientific 

and medical knowledge which is current at the time the report is prepared.’’ 

Since the 1985 edition of the Dietary Guidelines, the Secretaries of HHS and 

USDA have appointed an external, independent group of experts and practitioners 

in the fields of nutrition and medicine to provide independent, science-based advice 

and recommendations to the Departments as we develop the Dietary Guidelines. 

Each Dietary Guidelines Advisory Committee is compliant with the Federal Advisory Committee Act, serves in a voluntary and advisory role only, and submits a 

report of scientific recommendations to the Federal Government. The Advisory Committee does not develop the Dietary Guidelines; that is the role of HHS and USDA, 

and the recommendations we receive from the Advisory Committee inform our work. 

External Scientific Evidence Review Prior to HHS–USDA Dietary Guidelines Development 

The 2015 Advisory Committee was charged with reviewing the 2010 Dietary 

Guidelines and reviewing the current state of scientific evidence on nutrition and 

health to develop food-based recommendations of public health importance for Americans ages 2 years and older. Their recommendations were outlined in the Scientific 

Report of the Dietary Guidelines Advisory Committee, submitted to HHS and USDA 

in February 2015. 

The Advisory Committee conducted comprehensive and rigorous systematic reviews of scientific evidence on food, nutrition, and health using state-of-the-art 

standards to develop its Scientific Advisory Report. The Committee formulated and 

addressed more than 80 scientific questions using: (1) original systematic reviews 

conducted through USDA’s Nutrition Evidence Library (NEL); (2) existing highquality systematic reviews, meta-analyses, and reports from the scientific community; (3) data analyses; and (4) food pattern modeling analyses. These four apVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00013 Fmt 6633 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
10 

proaches contribute to a comprehensive body of scientific evidence upon which the 

Federal Government can develop policy. 

It is worth noting that systematic reviews were used to examine the majority of 

the scientific evidence in diet and health. Considered the gold standard and standard practice for more than 25 years in the medical field, systematic reviews are relied upon to inform the development of national guidelines for use by research and 

health professionals. The NEL, developed in consultation with leaders in the systematic review community such as the highly respected Cochrane Collaboration, involves a structured, protocol-driven approach to identify, evaluate, summarize, and 

synthesize peer-reviewed scientific literature as a means to answer the scientific 

questions specifically focused on diet and public health. Use of the NEL involves 

thorough searches of all peer-reviewed scientific literature contained in multiple 

electronic databases, and putting the results through pre-determined inclusion/exclusion criteria to focus on those that answer the scientific questions. Because the 

Dietary Guidelines focus on disease prevention, and not treatment, these reviews excluded studies that involved treating disease, such as those in which patients with 

an existing condition followed a therapeutic diet. Of approximately 4,000 manuscripts screened for inclusion, the 2015 Advisory Committee reviewed nearly 300 

studies that met the criteria for the systematic review questions. 

In addition, the Advisory Committee used existing systematic reviews from the 

NEL and external national and international scientific organizations to prevent duplication of efforts and to conserve Federal resources and time. All existing systematic reviews were screened by Federal staff and underwent assessment to ensure the 

proper quality and objectivity. 

Public Participation in the Process 

Public participation in the Dietary Guidelines scientific review process has been 

important and extremely valuable. HHS and USDA issued a public call for nominations of candidates for 2015 Dietary Guidelines Advisory Committee members in the 

fall of 2012. Following a careful and diligent process, members were appointed to 

the Advisory Committee by Secretary Sebelius and me. The Advisory Committee 

proceeded to hold seven public meetings spanning 19 months, which included an opportunity for the public to provide oral testimony. After each public meeting, the 

Committee’s slides and videos were posted for public access on 

DietaryGuidelines.gov, along with a list of all the scientific studies discussed during 

the meetings and the inclusion-exclusion criteria the Committee used. Throughout 

this time, the public was encouraged to submit comments to the Advisory Committee on DietaryGuidelines.gov. These comments ensured that the Committee considered all relevant topics in preparation of the Scientific Advisory Report. 

Once the Advisory Committee submitted its Scientific Advisory Report to Secretary Burwell and me in February 2015, the report was posted on 

DietaryGuidelines.gov for public review and comment. HHS and USDA extended the 

public comment period from 45 days to 75 days; for comparison, the public comment 

period to review the 2010 Advisory Report was 30 days. In addition, the public was 

invited to provide oral testimony to the Federal Government on the Scientific Advisory Report in March 2015. 

Public comments serve as a vital resource to our Departments in drafting the Dietary Guidelines. In addition to the March public meeting for oral testimony, we received more than 29,000 written comments during the 75 day public comment period. Staff from both Departments have reviewed all comments submitted and posted them online at DietaryGuidelines.gov. To ensure the Dietary Guidelines are based 

on the totality of sound science, the Departments’ focus is primarily on public comments with scientific justification. 

HHS–USDA Development of the 2015 Dietary Guidelines for Americans 

In addition to the Advisory Committee’s report and public comments, HHS and 

USDA look to Federal agencies with expertise in nutrition to review both the Scientific Advisory Report and the draft of the Dietary Guidelines for Americans. This 

ensures that the Dietary Guidelines are grounded in the current scientific knowledge and are compliant with existing Federal policies before Secretary Burwell and 

I review and approve it for release and implementation across Federal nutrition programs. 

As a result of this multi-faceted process, the 2015 Dietary Guidelines for Americans will be informed by thousands of scientific papers, decades of nutrition and 

medical research, public comments, and reviews by Federal experts. We will conduct 

several layers of review prior to preparing a draft for final approval, which has not 

yet occurred. However, I can assure you that the 2015 Dietary Guidelines for Americans will be grounded in the preponderance of the best available scientific evidence, 

11 

represent our current understanding of the connections between food and health, 

and integrate the science into succinct, food-based guidance that Americans can rely 

on for choosing a healthy diet. 

The Dietary Guidelines has been referred to as the nutrition backbone of our nation. We take this responsibility very seriously. Again, thank you, Chairman 

Conaway, Ranking Member Peterson, and Members of the Committee for this opportunity to discuss the Dietary Guidelines for Americans. 

The CHAIRMAN. Well, thank you. I got ahead of myself. Let me 

mention that the Chairman requests that other Members submit 

their opening statements for the record. And I rudely failed to introduce Secretary Tom Vilsack, who is the Secretary of the Department of Agriculture, and the Honorable Sylvia Burwell, who is Secretary of Department of Health and Human Services. Two folks 

who needed no introduction, and I didn’t introduce you, I apologize 

for that. The chair would remind Members that they will be recognized for questioning in order of seniority for the Members who 

were here at the start of the hearing. After that, Members will be 

recognized in order of arrival, and I appreciate the Members’ understanding. And I recognize myself for 5 minutes. 

Ms. Burwell, you said in your comments that the guidelines don’t 

change substantially from one set to the next, but yet the Advisory 

Committee reports have gone from 57 pages in 1995 to 571 pages 

for this one. So I am not sure we have gotten ten times better information today than we did at that point in time. 

As I mentioned in my opening statement, the oversight we are 

conducting today is on the development of the guidelines in sight 

of concern for the integrity of the process, and its resulting recommendations. The Federal Advisory Committee Act defines how 

Advisory Committees operate. The law puts special emphasis on 

open meetings, chartering, public involvement and reporting. According to statute, a Federal Advisory Committee shall, among 

other things, require the membership of the Advisory Committee to 

be fairly balanced in terms of the points of view represented and 

the functions to be performed, contain appropriate provisions to assure that the advice and recommendations of the Advisory Committee will not be inappropriately influenced by the appointing authority, or by special interests, but will instead be the result of Advisory Committee’s independent judgment. 

Despite these statutory safeguards, serious questions have been 

raised about the oversight of the overall DGAC process while it was 

ongoing. This has tended to fuel concerns that members of the commission may have been appointed in order to achieve certain policy 

outcomes outside the legitimate purview of the Advisory Committee. I refer specifically to an op-ed published on October 1, 2015 

by former Deputy Secretary Kathleen Merrigan, who currently 

serves as the Executive Director of the Sustainability Institute at 

George Washington University. I note that Secretary Merrigan was 

serving as USDA Deputy Secretary during the time the DGAC was 

chartered and appointed. The suggestion of including sustainability 

and tax issues by the DGAC has been a topic of intense discussion 

for some time. I recognize that you both jointly published a blog 

yesterday acknowledging that sustainability is out of the scope of 

this exercise, and I hope to get some comments from you about tax 

issues as well. I am likewise sure you recognize that the inclusion 

of these issues in this process could have resulted in misguided recVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00015 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
12 

ommendations, which would have ill effects on consumer habits 

and agricultural production. 

The counter to potential bias in the process is the public comment period. The 75 day period was the public’s first real opportunity to review the 571 page document. In your written statement, 

Secretary Burwell, you mentioned that USDA and HHS staff have 

already fully reviewed all the comments. You also mentioned that 

you focused most heavily on those with scientific justification. Help 

us understand, then, what is going on right now. What have you 

done with the studies, such as those evaluating low carbohydrate 

consumption patterns, since the review has been taking place? 

Secretary BURWELL. I think there were a number issues raised, 

and I apologize, I could not hear your final question. 

The CHAIRMAN. What have you been doing? Have you been 

studying the comments, and the report itself. Can you talk to us 

about how you have been evaluating other information, like low 

carbohydrate consumption patterns, as a part of that review? 

Secretary BURWELL. With regard to one issue that you touched 

on earlier that I want to go ahead and address, you asked which 

was the tax issue, and the question of tax policy. I think, like our 

comments yesterday in the blog that Secretary Vilsack and I put 

out about the issue of sustainability, while we haven’t received recommendations from our staff speaking to the specifics of what are 

in the Dietary Guidelines, that is a question of scope, like the sustainability question, and that is not an issue that we would address, on the tax issue, when I address that. 

With regard to the process that we are now going through, and 

how, whether it is the carbohydrate issue, or any of the specific 

issues, what is happening is we received the report of the committee. Our staffs are reviewing that. At the same time, we are reviewing all of the public comments that we have received. In addition to that, we are bringing in the experts from all of our Departments to make sure that they weigh in as we do the consideration. 

And, for us, that includes the Food and Drug Administration, the 

NIH, the Centers for Disease Control, the Office of the Assistant 

Secretary for Health, and many others. So that is the process that 

we are using now, to review what we received, and to put together 

the guidelines. 

The CHAIRMAN. Could the guidelines have things in them that 

weren’t necessarily directly reported in the recommendations from 

the committee? Your own wisdom, your own thoughts, would be reflected in the guidelines as well? 

Secretary BURWELL. In terms of the expert advice of our staffs 

that exist, with regard to the question of studies and pieces of 

work, it is important to reflect what Secretary Vilsack said, which 

is there has been a systemic literature review with regard to the 

studies, and that is part of keeping integrity to the process. With 

regard to our experts who are constantly involved in those issues, 

yes, they will be a part of that process. 

The CHAIRMAN. Thank you. Ranking Member? 

Mr. PETERSON. Thank you, Mr. Chairman. I think you both know 

that sodium not only provides a benefit in making products shelf 

stable, it also improves taste, and is an important food safety component in cheese. Studies have shown that there is insufficient eviVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00016 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
13 

dence to conclude that lowering sodium intake below 2,300 milligrams per day decreases risk of cardiovascular disease, and the Dietary Guidelines Advisory Committee agreed. So why has the committee continued to support further sodium reduction, and is this 

something that you will be able to address in your guidelines? 

Secretary VILSACK. Well, let me take a stab at that. First of all, 

again, we are going to probably respond to a number of questions 

by pointing out these guidelines have not been formulated yet, and 

we can’t comment on the specifics of what the guidelines will be because we haven’t had an opportunity to prepare them and to review them. 

Having said that, the Advisory Committee, basically, they go 

through a process, as Secretary Burwell indicated, of reviewing a 

variety of studies. There, no doubt, were studies that linked prehypertension, hypertension, to sodium consumption. They probably 

looked at the National Academy of Medicine studies, in terms of sodium, and they probably concluded that there was evidence relating to sodium consumption and these chronic diseases, which is 

why they have recommended what they have recommended. 

The reality of this situation is that science changes, and we learn 

more information, and that is why it is important to have a process 

that we have in place to review what the Advisory Committee recommends, then to have public input, to get public comments, to 

have our own staff review studies, based on information they have 

accumulated during the course of the 5 year period since the last 

Dietary Guidelines, and also to refer back to the last set of guidelines, which is a foundation for this set of guidelines. So, Congressman, I can’t comment specifically on why the Advisory Committee 

did what they did because they sort of operate independent. We 

don’t inject ourselves into that process. But we do basically take 

their input into consideration, along with many, many other studies, many, many other opinions, to try to formulate the best set of 

guidelines and framework for the country. 

Mr. PETERSON. Thank you, Secretary. I don’t know if you both 

have seen the Washington Post story today? Secretary Vilsack, I 

guess you have seen it. 

Secretary VILSACK. I have seen it, and several people were mentioned in there. I have read books by those folks in preparation for 

this. This is what has caused my concern about what these guidelines are and what they are not. 

Mr. PETERSON. Well, my concern is that we have had these 

guidelines that have pushed people away from eggs, and butter, 

and milk, and so forth, and then they come back and say, well, we 

were wrong. And so my question is, for both of you, what are we 

going to do to make sure that doesn’t happen in the future? First 

of all, do you agree with this, and second of all, how are we going 

to keep this from happening? Why are we going off on these tangents if we have a process that is so heavily vetted? 

Secretary BURWELL. I would say a couple of things. First, the 

consistency over time for most issues has been there, and it is right 

to point out that, with regard to the issue specifically of dietary 

cholesterol, there has been a change over time. 

I can think of a couple things, to answer your question. First, for 

the most part, things are consistent over time. Second, we need to 

14 

make sure we use the most scientific evidence we can. And there 

has been an evolution and change, and that does get reflected in 

what the Advisory Committee has given us. They no longer will do 

recommendations based on expert opinion. Instead, they will only 

do recommendations based on the science, and that is a change 

that will occur. 

The other thing that is an important thing to reflect is that, in 

some cases, science does change. And in the case of our understanding of blood cholesterol versus dietary cholesterol, there has 

been an evolution in understanding of the difference of those, and 

what they cause. And we want to be prepared to make sure we review in a rigorous way changes that happen. There is not one simple answer to the problem that you raise, but a number of pieces 

of how we can work to get to a place where we have the most consistent science-based advice. 

Secretary VILSACK. And let me just simply add that Congress has 

directed us to take a look at the preponderance of that available 

science, which suggests, which is a term that I am familiar with in 

the practice of law, it suggests that there may be studies on both 

sides of an issue. And it is important and necessary for folks to sort 

of weigh the studies. And one of the challenges of this is to distinguish between one single quality study that is absolutely solid 

versus a bulk of studies over time that may have a slightly different view. 

And this is the challenge here, and it is a reflection of the fact 

that all of this is evolving. You are not going to ever have something that just basically is going to be a fact about this, because 

science evolves. We learn more, we understand more. And I would 

hope that we would be flexible enough to appreciate that, and to 

take that into consideration. 

Mr. PETERSON. Well, I thank both of you for your observations, 

and you have made some points, but I just want you to understand, 

for my constituents, most of them don’t believe this stuff anymore. 

You have lost your credibility with a lot of people, and they are just 

flat out ignoring this stuff. And so that is why I say I wonder why 

we are doing this. From what I am hearing from my constituents, 

Secretary VILSACK. Congressman—— 

Mr. PETERSON.—what it is worth. 

Secretary VILSACK.—can I respond to that for just a second? 

Here is the challenge, though. We take these guidelines, we incorporate them in our website, choosemyplate.gov. We have had over 

290,000,000 hits on choosemyplate.gov. It may very well be that 

there are folks who are concerned about this, but I still think there 

is merit in it, as long as people understand what they are and what 

they are not. They are not a hard and fast set of rules, they are 

a guideline, a set of guidelines, a framework. And they are not 

about treating disease, they are about preventing it. 

The CHAIRMAN. Thank you. Mr. Neugebauer, for 5 minutes. 

Mr. NEUGEBAUER. Thank you, Mr. Chairman. I want to go back 

to something that the Chairman was asking, and I want to make 

sure that we are all on the same page here. So, taxes are off the 

table, as far as consideration in the guidelines, is that correct? 

Secretary BURWELL. With regard to the question of whether 

there be a tax recommendation in our Dietary Guidelines, we do 

15 

not believe that that is something that is in the scope of the work 

that we are doing. 

Mr. NEUGEBAUER. Secretary Vilsack? 

Secretary VILSACK. Well, that is not within the scope. It is not 

dietary, it is not nutrition, and it doesn’t belong in this context. 

There are probably many other ways in which that conversation 

should be taken and should be had. As is the case with sustainability, it doesn’t belong here, it belongs elsewhere. And I am 

happy to have that conversation with folks if they are interested. 

Mr. NEUGEBAUER. So both of you agree, then, sustainability and 

taxes are off the table, as far as these recommendations are concerned? 

Secretary BURWELL. Both are important issues that we believe 

should have conversations, but not in the context of this document. 

Mr. NEUGEBAUER. Thank you. HHS and USDA have always stated that they have looked to appoint members to the DGAC so it 

consists of nationally recognized experts in the fields of nutrition 

and health. As you know, the DGAC is subject to the Federal Advisory Committee Act, which is widely used throughout the Federal 

Government. This Act is designed to ensure that the various Advisory Committees formed over the years are objective and accessible 

to the public. The Act has formalized a process of establishing and 

operating and terminating these advisory bodies. For the 2015 

guidelines, the HHS and the USDA began to solicit nominations for 

the DGAC in 2012. Once selected and appointed, the DGAC was 

composed of academics, including professors, epidemiologists, and 

even a physician-scientist. 

In a departure from prior Dietary Guidelines’ Advisory Committees, nutritionists and food scientists were not selected to serve on 

this DGAC. Understandably, questions regarding the inherent bias 

are being raised by the fact that no food industry scientists were 

included in the DGAC committee. Additionally, after the DGAC 

had officially disbanded, the former Advisory Committee members 

decided to hold a public event, acting in their capacity as DGAC 

members, which they were not, according to the committee’s charter and Federal Advisory Committee Act. 

Based on the charter, it is the DGAC’s responsibility to review 

the science and make recommendations to your Departments, 

which is then developed for final recommendations for the public. 

It is, however, not the responsibility of the DGAC to educate the 

general public on the report that still needed to be considered by 

the HHS and USDA claiming the nutritional recommendations 

were based on Dietary Guidelines. 

Secretary Burwell, what instructions were given the Advisory 

Committee members regarding the FACA and the Advisory Committee’s disbandment? 

Secretary BURWELL. With regard to the specifics of the disbandment, I can get back to you, Congressman, with regard to the direction that was given as to review the science with regard to the 

issues that were in front of them with regard to the Dietary Guidelines, and present a report about that. So, with regard to the question of disbandment, I don’t know what, if any, specific direction 

was given, but the point that you have made, which is this is about 

an Advisory Committee producing a document, an independent 

16 

group of people producing a document, that then is an element in 

the basis of what our decisions will be on the Dietary Guidelines, 

is what their role is. 

Mr. NEUGEBAUER. Well, was their role to then go out and start 

doing a road show on their recommendation? Is that a part of the 

scope of that committee? 

Secretary BURWELL. With regard to what we followed, at least at 

the Department, and what I know about is the fact that, once we 

received the committee’s recommendations, and those became public, that there was a public comment period. That was the part that 

we have both been focused on, and the 29,000 comments that have 

come in from the public. As well as, when we heard from you all 

that you asked for an extension of the public comment, Secretary 

Vilsack and I very quickly agreed that that was something we 

thought was an important thing to do. That is the—— 

Mr. NEUGEBAUER. Well—— 

Secretary BURWELL.—part of the process, in terms of public—— 

Mr. NEUGEBAUER.—the question here is that; first, did they follow the guidelines, and second, what steps were taken to make 

sure that the committee followed the law? And then, from an ethical standpoint, once you have served in your capacity on that Advisory Committee, and made your recommendations, what is your 

responsibility, moving forward? And one of the things we don’t 

want is that this turn into some kind of a profitable situation on 

their behalf because of their participation on that Advisory Committee. 

Secretary BURWELL. With regard to—these are voluntary, nonpaid. They all have to file financial disclosures on an annual basis 

as they go through this process, and so those are all things we 

want to protect against. With regard to the specific question of a 

press briefing, or some kind of briefing, I apologize, I am not familiar with that. As I said, we have focused on the public comments 

and the steps and process that we are following. 

The CHAIRMAN. The gentleman’s time has expired. Mr. Scott, for 

5 minutes. 

Mr. DAVID SCOTT of Georgia. Thank you very much, Mr. Chairman. I am very concerned that you are not using the most relevant, 

basic, and the best science-related information in formulating these 

guidelines. You certainly did not use some of the most recent peerreviewed and published nutrition and diet-related science. It was 

not even considered by the Advisory Committee, and not even included in the evidence-based library to be considered by the Advisory Committee when they were finalizing the report. That is a 

fact. 

And, Mr. Vilsack, you said you were using the best information. 

Your quote was we have the best informed opinions. But if you are 

not using the most recent peer review, that information that is 

there, and your committee has not even agreed to put it into the 

final report. So maybe you all can give me some level of confidence 

that your staffs and you will take into consideration the strong scientific evidence with the final policy document, even though it was 

not included in the evidence-based library throughout the working 

group process? 

17 

Secretary VILSACK. Congressman, can you be specific about 

which study you are talking about? 

Mr. DAVID SCOTT of Georgia. I am talking about the scientific 

study that came out that gave evidence that certain things were 

very important. Let me just give you one example. Let us look at 

the whole issue of the involvement of sugar, and how it is not even 

included. Why, for example, that low calorie sweeteners are not 

being recommended, when the study pointed out that low calorie 

sweeteners could be used to lower weight, to be able to help what 

is called atopocity, and it is not even being used. What is wrong 

with low calorie sweeteners that can be used, and it is not even in 

the report? 

Secretary VILSACK. Congressman, let me try to respond to the 

question as best I can. First of all, when you have a process that 

is every 5 years, you, obviously, are going to have to have, at some 

point in time, a cutoff of what information you consider, because, 

theoretically, the minute before we publish the guidelines, somebody could publish a study, and you would be criticizing us for not 

taking the latest science into consideration. So there has to be a 

cutoff time in terms of consideration. Having said that, over 4,000 

studies were reviewed, 300 manuscripts were reviewed, and they 

went through a gold standard process for evaluating the appropriateness and efficiency of those studies. That it is unfair to the 

committee, and unfair to the process, to suggest that we are not 

looking at the science. We are. Number one. 

Number two, as far as sugars are concerned, look, here is the 

problem. Our children, 15 to 17 percent of what they consume is 

sugar. And so, obviously, we are looking for ways in which we can 

reduce that. And what they were recommending and suggesting is 

that if you are going to have sugared drinks, if you are going to 

have sugar in your diet, you ought to at least look for the most nutritionally dense foods that you possibly can consume for that 

sugar, that you don’t basically use empty calories to obtain it. So 

you could have something like chocolate milk versus a low cal 

drink. You would get more nutrition bang for your sugar buck, if 

you will, out of that process. And that is what they were suggesting. 

Mr. DAVID SCOTT of Georgia. But you are familiar with that report? The Added Sugars Working Group said that moderate, and 

generally consistent, evidence from studies conducted in adults and 

children supports replacing sugar-containing sweeteners with low 

calorie sweeteners to reduce calorie intake, body weight, and 

atopocity. 

So the issue simply is for both of you to be able to explain why 

the DGAC, the Dietary Guidelines for America, would then recommend that consumers not—that is the whole point. You have 

used this evidence, it is pointed to where it could be helpful, but 

then the committee recommends that the consumers not use low 

calorie sweeteners as a tool in the toolbox to reduce added sugars. 

All I am simply saying is that if this report is going to have value 

for the welfare of the American people, and you all say you are 

using the most relevant basic information, then this clearly contradicts that. 

18 

Secretary BURWELL. There are two different things. One is what 

the Advisory Committee has in its report, and the other is what we 

do in the guidelines. And the specifics of that, as we have said, are 

not something we received as recommendations. My understanding 

of what is in the committee report, with regard to the question of 

substitution of the drinks, is that not enough evidence exists one 

way or another to make a recommendation, and that that is where 

the committee left the issue of the specific of the substitution. 

The CHAIRMAN. The gentleman’s time has expired. Mike Rogers, 

5 minutes. 

Mr. ROGERS. Thank you, Mr. Chairman. I thank you all for being 

here. You have both made reference to the fact that you take these 

comment periods seriously, and that you consider these comments 

in your guideline making process. And I take you at your word. 

One particular area of concern to me, though, and producers in my 

district, is in the Dietary Guidelines Advisory Committee recommendations regarding red meat. The current DGAC report 

seemingly recommends that Americans consume less red meat. 

Will your agencies be reviewing studies submitted during the comment period that address the recommendations for red meat, both 

pro and con, and can you tell me more about that? 

Secretary VILSACK. In terms of the issue of red meat, it is fairly 

clear that there is a recognition that lean meat is, and should be, 

part of a healthy diet. The challenge is to understand that, as 

Americans, if we look at the obesity epidemic that we are confronting in this country, that some of us are consuming more calories than we should. And so the recommendation is in relationship 

to the overall consumption of calories. And one way to reduce the 

overall consumption of calories is, obviously, to eat less of certain 

things. And in that category would be red meat, but that is by no 

means the only thing in that category. So I want to be clear 

here—— 

Mr. ROGERS. What I don’t understand. I am sorry, Mr. Vilsack, 

but why would you include in that category red meat? I mean, why 

wouldn’t you just say anything that takes you over a caloric level 

that is unacceptable, you shouldn’t eat? Why would there be a category of things not to eat? 

Secretary VILSACK. Because of the importance of having balance, 

in terms of what you consume, in terms of what a healthy diet consists of. Again, remember what this is. It is a set of guidelines 

which is designed to give you the best chance of reducing cardiovascular, cancer, and chronic diseases. 

Mr. ROGERS. But wouldn’t red meat be part of a—— 

Secretary VILSACK. It is. 

Mr. ROGERS.—list of things that you should eat, as long as you 

eat lean? 

Secretary VILSACK. It is. That is what I am saying. It is. 

Mr. ROGERS. I am sorry, I thought you said that you would put 

it in a list of things not to eat. 

Secretary VILSACK. No. Sir—— 

Mr. ROGERS. Okay. 

Secretary VILSACK.—what I said was, if you are concerned about 

over-consumption of food generally, then obviously you are going to 

19 

suggest that people should eat less of something that they are eating a lot of. That is the key. 

Mr. ROGERS. I agree. 

Secretary VILSACK. To suggest that we are not going to have a 

guideline, it is fair to say, regardless of the fact the guidelines 

aren’t fixed yet, that lean mean is going to be part of a healthy 

diet. There is no question about that, as far as—— 

Secretary BURWELL. Yes. The Advisory Committee’s recommendation on this is exactly the same as 2010. So I think—— 

Mr. ROGERS. Yes. 

Secretary BURWELL.—the Secretary’s comments hold. 

Mr. ROGERS. Okay. 

Secretary BURWELL. The Secretary’s comments are also reflected—I have Fiesta plates, those are what my mother had. Those 

are the plates, those colorful plates, and my mother used those. 

The plates that I have from my mother, and the ones I received for 

my wedding, they are a different size, reflecting the issue that we, 

as a nation, I just think that is a visible thing that people see. My 

mom’s plates, they are smaller, the ones I have from her. The ones 

that I received—and this gets to the issue of the totality that we 

need to work on at the same time that we think about the nutritional content. So we have too much, and we have to get the right 

nutritional content. 

And what everybody wants is an opportunity to be able to have 

guidelines to do that. And that is what the choosemyplate.gov hits 

are about, and everything is about. Being a mother of an 8 and a 

6 year old, and your time in the grocery story, having worked for 

the largest grocer in the country, Wal-Mart. The average time for 

a working mom or dad is, like, 20 minutes. And so your ability to 

get in there, get it done, and try and do it in a way that is healthy 

for your children, you need ease in decision-making. This is step 

one. It is just the guidelines. How it gets translated into other 

things are the next steps. That is what the Secretary’s comment 

about what this is, and what this isn’t, and why we want something that is useful for working families who are just trying to get 

this right for themselves and their children. 

Mr. ROGERS. Great. Thank you both. I yield back. 

The CHAIRMAN. The gentleman yields back. Mr. Walz, for 5 minutes. 

Mr. WALZ. Thank you, Mr. Chairman. And I want to thank both 

of you for being here, for the work you do. And, Secretary Burwell, 

I appreciate that last comment, too, as a father of a young son, and 

someone who, as I often tell my colleagues, I supervised the high 

school lunchroom for 20 years, so you see that side of things, and 

how those school lunches impact. You brought up great points here, 

and this is an important hearing. And articulating what this is and 

what this isn’t is really important. Because, at the heart of this, 

with so much information out there, and Americans are going to 

try and find it, from their uncle’s e-mail to them to Dr. Oz and others, they are looking for the gold standard on what makes a difference in their own lives as they search for this. 

And all we have to do is look at the cost of obesity in the United States, estimated at between $150 and $200 billion per year. This 

is an important subject. We need to help people find the informaVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00023 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
20 

tion. They are busy, there is lots of it. And that is why the questions that are coming up from colleagues about the integrity of 

your suggestions, as many of us saw, and still do believe, as the 

gold standard on how this gets done, and valid concerns about the 

decisions we make here. And, in full disclosure, I have the ninth 

largest agricultural district in America. We produce lots of pork, 

lots of milk, lots of turkeys, and all those things. When we make 

those decisions, they have an economic impact. So the concern is 

valid, it is warranted, but we have a responsibility to move headlong into this to help the American public get it. So, for me, and 

more a statement on this, we are concerned on process, and hearing that. It is important to hear both of you articulate that, and 

it is important for the American public to know that they can trust 

these as guidelines for them, and they are going to make decisions 

for their own family based on them. 

So maybe what I would do is just ask you, what you are hearing 

on this process, do you feel like the concerns you are hearing from 

Members on the totality of the evidence and things, are you comfortable that those are being included when you make your guidelines? You are hearing about Members talking about things that 

aren’t included, specific commodities that aren’t in that? Are you 

comfortable? And maybe, Secretary Burwell, start with you. 

Secretary BURWELL. Yes, that we are including these comments. 

And whether that is the blog that we issued yesterday, we had a 

number of questions about that sustainability issue, or the tax 

issue that we tried to address here today, that we are, across the 

board, hearing and listening. And you can be assured that the 

questions that you all are asking us are the questions that we will 

be asking our teams as the recommendations come forward. It was 

mentioned cranberries, and the issue of something that has high 

nutrient value, and the question of how that interrelates with 

added sugar, and how we think about those issues. Your questions 

become our questions as part of this process. 

And we do believe—I mean, the comments that came in, as the 

Secretary mentioned, there were a number of repeat—8,000 were 

probably singular. There were 19,000 comments on sustainability: 

97 percent of those comments, so we are clear and transparent, 

were positive, and that we should include sustainability as part of 

the Dietary Guidelines. And I say that to make the point that we 

want to hear. We are going to ask the questions, and then, based 

on what the Dietary Guidelines are, and the scientific evidence, 

that is how we will go about making the decisions. 

Secretary VILSACK. I would only add that the debate that we are 

having here, and the debate that is taking place outside of this 

room, is a reflection of people’s interest in where their food comes 

from, how it is produced, who is producing it, who is benefiting 

from it. And that is a healthy debate—— 

Mr. WALZ. Yes. 

Secretary VILSACK.—for us to have, in the right context. 

Mr. WALZ. Yes. 

Secretary VILSACK. It is a healthy debate for us to have in the 

context of developing a farm bill. It is a healthy debate for us to 

have in the context of conservation, in the local and regional food 

system effort. All of those are avenues and vehicles for having that 

21 

conversation, and we are having that conversation, and we should 

have that conversation. This, however, is about dietary and nutrition, and that is what we are going to focus on as we develop these 

guidelines. 

Mr. WALZ. Well, I very much appreciate that point of view. I am 

not going to miss this opportunity, with my last 40 seconds, Mr. 

Chairman. Mr. Secretary, again, off topic, but I am going to use it. 

The effect of sequestration on ARC and PLC. I am going to ask, 

if my folks are out there, if you could help me. 

Secretary VILSACK. It will be a 6.8 percent reduction—— 

Mr. WALZ. Okay. 

Secretary VILSACK.—across the board, regardless of when they 

came into the FSA office, or when they basically—— 

Mr. WALZ. So what they are hearing is true, there will be a reduction—— 

Secretary VILSACK. Yes. 

Mr. WALZ.—to them? 

Secretary VILSACK. Unless something happens with the sequester. 

Mr. WALZ. Very good. I yield back. Thank you. 

The CHAIRMAN. The gentleman yields back. Mr. Gibbs, for 5 minutes. 

Mr. GIBBS. Thank you, Mr. Chairman. I have to tell you, hearing 

the Ranking Member’s, Mr. Peterson’s, comments that I agree with 

about everything he said. Why are we doing all this, if it is really 

necessary. And I make the comment that there is a lot of information out there to consumers. You have the medical associations, the 

cancer, heart. There are all kinds out there. I am encouraged to 

hear you say that the process—to make sure that the tax, sustainability issues aren’t part of this, because they shouldn’t be. 

I guess my only demand, demand, would be that you use common sense, and say, moderation, people out there can make a lot 

of decisions on their own. There is a lot of information out there, 

and these guidelines should just be common sense things, that if 

you have a weight problem, you need to lower your calorie intake. 

So that is just my comment. I wonder if you know how much—I 

won’t even bother to ask how much all this process costs, but I can 

just imagine. 

But, Secretary Vilsack, what I want to ask you, these guidelines 

are supposed to be guidelines. And how does that have an affect 

on the school lunch program? Because we have seen the school 

lunch program be turned on its head, and there have been all kinds 

of reports of certain school districts that want to get out of the program, and there are guidelines—part of that effect of determining 

what is happening in the school lunch program? 

Secretary VILSACK. Well, the school lunch program is, obviously, 

focused on compliance with the Healthy Hunger Free Kids Act, 

which passed Congress in 2010. And in that, Congress directed us 

to do a better job, in terms of the quality and nutritional value of 

those meals. More fruits and vegetables, more whole grains, more 

low fat dairy, and less fat, sugar, and sodium, and we are compliant with that. And, in fact, 95 percent of school districts have been 

certified as following the standards. Surveys of children, surveys of 

school administrators, surveys of parents, and surveys of the public 

22 

all indicate strong support for what we are doing. And we are helping school districts that are struggling through a series of programs—for success, where we are seeing struggling schools linked 

up with succeeding schools, and we are finding a good success for 

that program as well. 

So the Dietary Guidelines help to inform, as they do with some 

of the other nutrition programs, as they do with the Department 

of Defense, in developing what they are going to serve our military. 

These Dietary Guidelines help to inform the process. 

Mr. GIBBS. Okay. Because I am just really concerned what is 

happening in the school lunch program. I am hearing issues out 

there that kids aren’t eating, their food is going to waste. There are 

things, when I was a kid, that I wouldn’t eat that I eat—I love to 

eat today, so there are different behaviors—— 

Secretary VILSACK. I can say a couple things about that. Number 

one, there are several studies, University of Connecticut, Harvard 

Public Health School, that suggest that food waste is not as significant as it has been reported, and, in fact, is no greater than it was 

prior to the new guidelines. Number two, it is a matter of time. 

There is some research to suggest that if kids are given more time 

to eat there is less food waste. And the timing of the meal, in terms 

of whether it is before or after recess, may also impact that. 

And then, finally, I had an interesting conversation with the 

President of Tufts yesterday, they did away with food trays at 

Tufts, and what they have found is that that has reduced significantly the amount of food waste, because kids came in with a tray, 

and they feel like they have to fill up the tray, as opposed to a 

plate. And they fill up the plate, they get satisfied, they don’t go 

back for seconds, there is less food waste. So there is a lot of opportunity here for us, as a nation, to reduce food waste, but I don’t 

think it is a reflection, or an indication, of the new school—— 

Mr. GIBBS. When USDA’s working on the school lunch program 

and stuff, is there much discussion about physical activity? That is 

probably—maybe more so than what they are—I—especially in 

kids. 

Secretary VILSACK. Well, we have over 6,000 schools that have 

now been certified under the U.S. Healthier School Challenge, 

which is an effort on our part to encourage both calories in and calories out. And we reward and acknowledge school districts that are 

doing a good job of balancing nutrition and exercise. We also have 

an interesting relationship with the Dairy Association, and the 

NFL, on their Fuel Up to Play 60—— 

Mr. GIBBS. Okay. 

Secretary VILSACK.—program. So there is an—— 

Mr. GIBBS. Okay. 

Secretary VILSACK.—emphasis on exercise. 

Mr. GIBBS. Secretary, your comment about sustainability, and all 

the comments you had, I guess my only comment would be something that gets a little weighted by certain agendas, by certain organizations, we saw this in the waters of the United States. We saw 

a lot of comments that came in, and obviously that was orchestrated, and there are agendas out there, just so you are aware of 

that, and some of those comments are sometimes subject to how 

credible they really are. I yield back. 

23 

The CHAIRMAN. The gentleman yields back. Ms. Fudge, 5 minutes. 

Ms. FUDGE. Thank you very much, Mr. Chairman, and I thank 

you both for being here this morning. On August 24 the Center for 

Nutrition Policy and Promotion issued a Federal Register Notice 

asking for input as to how to better inform the public about the 

2015 Dietary Guidelines. I think that is a great idea, because so 

many Americans really do not understand, and are confused, about 

the guidelines, and the dietary patterns. So tell me how you are 

planning your messaging around the guidelines, and if you have 

any just straightforward suggestions as to how Americans can improve their eating habits? 

Secretary VILSACK. Well, we take the guidelines and incorporate 

it into our choosemyplate.gov initiative, which Secretary Burwell 

referred to it earlier. It is an opportunity for us to visually give 

people an idea of what a healthy plate looks like. The 

choosemyplate.gov website, which I mentioned before, is also part 

of our effort to try to do outreach. We also have a super tracker 

program that if you are struggling with weight—I have it on my 

iPhone—it basically gives you daily updates on—and suggestions 

on how you might be able to control your weight, tips on substituting foods and so forth so that you have a healthier, balanced 

diet. So there are a series of ways in which we incorporate the information from the guidelines in our educational materials, which 

we then disseminate through a variety of mechanisms, social 

media, and legacy media. 

Ms. FUDGE. Thank you. How many American households do you 

believe are at risk for food insecurity, and how can the 2015 DGA 

address the critical needs of our most vulnerable populations? 

Secretary VILSACK. Well, I can tell you our focus has been, obviously, on children, and there are 15.8 million children who live in 

food insecure homes. That number is down, which is good news. 

We, obviously, still have work to do. There are a variety of ways 

in which we can provide help and assistance. Some of the obvious 

ways are the SNAP program, and expansion of summer feeding, 

weekend feeding programs during the school year. There is an opportunity for us to also work with day care facilities and child care 

facilities to ensure that youngsters in those facilities get decent 

snacks. 

And we mentioned the school lunch program. Unfortunately, a 

lot of kids today get 1⁄2 or at least 1⁄3, and in some cases all of the 

calories they consume in schools. So, to the extent that we can do 

a good job of not only providing school meals, school breakfast and 

school lunch, but also after school snacks through our snack program, these are all a variety of ways in which we can try to provide 

help. 

The last thing I would say is that we are also trying to find creative ways for SNAP families to extend their SNAP dollar by giving 

them tips on how they might be able to use fruits and vegetables 

effectively in recipes. We are also making access to farmers’ markets more available. Over 6,200 farmers’ markets today, that is a 

dramatic increase in the number, now have the EBT cards that 

allow SNAP beneficiaries to access farmer’s markets. 

24 

Ms. FUDGE. Which, by the way, works very, very effectively. I 

have it in my district, so I thank you for that. 

Last, tell me how important it is to maintain the 5 year cycle for 

the Dietary Guidelines, so that Americans really do get the benefit 

of the current science for diet and health. 

Secretary BURWELL. I think we think that the 5 year review is 

a very important part of doing many of the things that we are 

being asked to do, which is make sure that we have the most up 

to date science, and make sure that we are listening to the public, 

because it is a formalized process that we do hear from the public, 

and there are those opportunities. While it is in statute, and that 

is a big part of why we do it, I think we would agree that it is important to have points in time where you do the work, and settle, 

and do the analysis, and the listening. And so I think we think 

that updating it on a regular basis, on a 5 year cycle, is important. 

Secretary VILSACK. I agree. 

Ms. FUDGE. Thank you very much, Mr. Chairman. I yield back. 

The CHAIRMAN. The gentlelady yields back. Mr. Scott, 5 minutes, 

Austin Scott. 

Mr. AUSTIN SCOTT of Georgia. Thank you, Mr. Chairman. Madam 

Secretary, Mr. Secretary, thank you for being here. As we talk 

about the reports, the credibility of the report is arguably the most 

important thing. It doesn’t matter how much time and money went 

into it, if we have a credibility gap, we have a problem. There were 

certainly some questions about the fact that Ms. Mylett was from 

the private sector now. I have read her re ́sume ́: 30 years at one of 

the major institutions, certainly qualified in every way, shape, and 

form from her academic career to be there. But there are questions 

about the fact that she is now a member of the private sector, 

chairing the committee. 

Historically, we have not allowed industry representatives on the 

panel. And I recognize that she doesn’t represent, for example, the 

cattle industry or the corn industry, because we would believe that 

there would be the assumption—whether true or not, there would 

be the assumption that there would be bias in the opinions of people who represented a certain industry on the panel. When I see 

issues like tax on sodas and other things being recommended, it 

seems to me that ideology is taking precedence over science, and 

that creates a tremendous credibility gap as well. 

And I would just ask, as we go forward, how do we make sure 

that we don’t have that credibility gap in the report? Because the 

CDC and the others do use this information to send out recommendations to the American public. And if the Nutrition Evidence Library is not being used, how do we guarantee the credibility of the report? 

Secretary BURWELL. Do you want to speak to the nutrition library—— 

Secretary VILSACK. Yes, go ahead. 

Secretary BURWELL.—and I will speak with regard to the credibility, that is a very important element of the trust of what we 

have in front of us, and that is why we are having the conversation. In the places where we can provide clarity, we do, as well as 

providing clarity—and that is a little bit of—some of our follow-up 

questions about, there is a scientific approach to what documents 

25 

are included, how they are included. That is the standard of scientific research. The gold standard is used. I have checked even 

with our economists, had them come in and look at it. 

Mr. AUSTIN SCOTT of Georgia. Can I—— 

Secretary BURWELL. So clearing—— 

Mr. AUSTIN SCOTT of Georgia.—ask you a question there? If the 

standard is scientific research, how do recommendations for tax on 

sodas get into the report? 

Secretary BURWELL. It is important to reflect that in the Advisory Committee’s report that there wasn’t a recommendation. It 

was an articulation that some used policy, and so I don’t think 

there were recommendations. They did not make recommendations. 

But with regard to the issue that has been raised, when we get to 

the Dietary Guidelines, how we take what we are given, that is one 

input, and use it will be an important part of establishing a process 

that people believe in. 

Mr. AUSTIN SCOTT of Georgia. I am down to a minute, so I would 

like to hear what Secretary Vilsack has to say, but I would suggest 

that, when you see those things in the report, and whether it is a 

jump to conclusion or not, there is a belief, then, that the people 

on the committee entered with a bias in some way, shape, or form, 

and we are searching for the science to back up what they already 

believe to be true, instead of using the best available science. 

Whether it is true or not, we can debate that there is a credibility 

gap from those things working their way into the report. 

Secretary VILSACK. Congressman, I would like just simply to, 

again, emphasize there is a fundamental difference between the 

Advisory Committee’s report and the guidelines. And there is confusion out there. For some reason, people seem to think that the 

report equals the guidelines. It does not. It is one aspect of information that will be taken into consideration, relative to the dietary 

and nutrition guidelines that we have to put together, number one. 

Number two, the Nutrition Evidence Library was used, and there 

is an extensive process that is involved in accumulating information and putting it through a filter, if you will, of—— 

Mr. AUSTIN SCOTT of Georgia. Secretary Vilsack, I am down to 

30 seconds, but it was used for 30 percent, at least the reports, that 

a tremendous number of things were not taken from that library. 

This is a text I received from a dad yesterday, and he is saying 

that their school can’t sell candy bars, which they used to do to 

help pay for a kids’ trip, and that they are being told from our local 

school system that that comes from the Federal Government—— 

Secretary VILSACK. That is not—— 

Mr. AUSTIN SCOTT of Georgia.—that they can’t sell candy bars to 

raise money. Is that—— 

Secretary VILSACK. That is not true. Folks can sell outside of 

school, which is what these candy deals are. Outside of school, 

there is no prohibition. There are exceptions and waivers that can 

be granted. Oftentimes it is not the Federal law that is in place. 

It can be a state law that is that, or it could be—— 

Mr. AUSTIN SCOTT of Georgia. I don’t think we would have that 

in—— 

Secretary VILSACK. Well, that may be the case. Well, then folks 

are mistaken about that. 

26 

Mr. AUSTIN SCOTT of Georgia. Thank you, sir, for clearing that 

up. 

The CHAIRMAN. The gentleman’s time has expired. Mr. McGovern, 5 minutes. 

Mr. MCGOVERN. Thank you, and, Secretary Vilsack and Secretary Burwell, thank you for being with us today, and thank you 

both for your respective agencies’ work on the Dietary Guidelines 

Advisory Committee’s report. I know that this is no simple undertaking, and I appreciate the fact that it takes and requires months 

and months of scientific analysis and consideration of thousands of 

stakeholder comments, and thoughtful collaboration among committee members and agency staff. And I want to say that I appreciate the process that the Advisory Committee went through. It is 

a solid process, one that was open, and included, as you mentioned, 

many opportunities for the public to weigh in. 

And it is also important, to kind of put all this in perspective 

here, my colleagues understand, that, in this country today, one in 

three school-age children and adolescents is overweight or has obesity. And more than one in three American adults suffers from cardiovascular disease and diabetes. Clearly we can do better. When 

I look at what we are all talking about here today, this is an attempt for us to get it better. And if people aren’t interested in the 

well-being of our citizenry, and all they are interested in is the bottom line, they should be very supportive of what you are talking 

about here today, because, at the end of the day, healthier people 

mean lower healthcare costs. So we all benefit here. 

You mentioned earlier the HHS blog yesterday, where the issues 

of sustainability were taken off the table for inclusion in the final 

guidelines. And I get that is the case, and I respect your decision, 

but this is an important issue, and you both have acknowledged 

that. Sustainability, somehow, in this Congress is a dirty word. I 

don’t quite get it, but it is important, and we ought to be talking 

about sustainability when we are talking about issues of diet and 

food security. And I do think that it is important that at least we 

start this conversation about this issue in the context of Dietary 

Guidelines. 

I also appreciate that both your testimonies do a good job of emphasizing the importance of nutrition on disease prevention, and 

putting these recommendations into context. In Congress we ought 

to be focusing more on prevention as a way to reduce healthcare 

costs and improve overall well-being and economic productivity. We 

should be highlighting what the science says on good nutrition for 

our kids and for our families. 

I have an op-ed here today that was in today’s Hill newspaper, 

penned by the Presidents of the American Academy of Pediatrics 

and the American Medical Association. It is entitled, Physician’s 

Perspective, Keep Politics Out of Dietary Guidelines, and I would 

like to insert that in the record. In it they talk about the importance of Dietary Guidelines, and the soundness of science used to 

inform them. The issue was raised that sometimes science changes. 

Everything changes. We know more today than we knew yesterday. 

Our research techniques have improved over the last 10, 20, 30 

years. So when we learn the latest science, then we need to make 

the necessary adjustments. 

27 

[The information referred to is located on p. 70.] 

But, as you know, some of the biggest critics of these guidelines 

are from industries that produce the least healthy foods, and from 

special interests with questionable credentials. I was reading about 

some billionaire from Texas who is a former Enron executive who 

is funding some initiatives to try to raise questions about what you 

are doing. I don’t know what Enron knows about Dietary Guidelines, but, nonetheless, there are powerful special interests out 

there trying to raise issues of credibility, trying to question science. 

And so I just would conclude by saying I encourage you to keep, 

first and foremost, the health and well-being of our kids and our 

citizenry in the forefront as you move forward. And maybe, in my 

last minute, can you explain to me if we all improved our diets, 

what would be the impact on the rates and costs of diabetes, and 

heart disease, and obesity? Secretary Burwell? 

Secretary BURWELL. When I examined both Medicaid and Medicare costs over the 10 year period, and as a trustee, as one goes 

out over periods of time, both heart disease, something that we 

know about how to do—and diabetes are two very, very large cost 

drivers for us as a nation. And they are cost drivers because those 

are both conditions that continue over an extended period of time, 

and especially as we have a population that lives longer, which is 

a good thing. 

But the idea that these are costs that are controllable—and I 

would also say that in my engagement with the private-sector, and 

CEOs of companies—and I am sure you all hear this in your districts. They talk about wellness a lot. And the reason they are so 

deeply focused on this issue, and want to engage with us as a Department on the issue, is because they are putting initiatives in 

place because they are starting to see. And I was just actually with 

NAM this week, the National Association of Manufacturers, and 

had one of the CEOs who says she has done it now for almost 10 

years, and she has the analytics to show it. Those are analytics 

companies can make decisions on. We want to see those to see if 

they are worthy enough for us to make decisions on the taxpayers’ 

money. 

So it is across the board in both the public-sector spending and 

the private-sector spending on these health issues, and diabetes 

and heart disease are two of the leading costs that we have, both 

publicly and privately. 

The CHAIRMAN. The gentleman’s time has expired. I would ask 

my colleagues’ indulgence, Secretary Burwell has a hard stop at 

11:30, and, given the apparent interest everyone has in getting 

these, I would ask for colleagues’ unanimous consent to go to 4 

minutes for questioning so that we give a chance for everybody to 

get here to make that happen. So, without objection, we will go to 

4 minutes from this point forward. So, Mr. Crawford, for 4 minutes. 

Mr. CRAWFORD. Thank you, Mr. Chairman. Kind of keeping on 

that subject, a lot of attention has been paid to the Dietary Guidelines, and the fact that they are guidelines, they are not rules. Am 

I correct in that? 

Secretary BURWELL. Yes. They are guidelines—— 

Mr. CRAWFORD. Okay. 

28 

Secretary BURWELL.—that then are used as a basis for programmatic and policy decisions. 

Mr. CRAWFORD. Okay. So they actually are used pretty hard and 

fast on rulemaking, then, correct? 

Secretary BURWELL. It depends on which program. So, for instance, school lunch programs in our area—the Administration for 

Community Living—— 

Mr. CRAWFORD. Yes. 

Secretary BURWELL.—in terms of Meals on Wheels and those 

types of programs, they are used, and they are applied in different 

settings in different ways. 

Mr. CRAWFORD. We have heard a lot of talk about the school 

lunch program, and it seems that—and I know that my colleague 

mentioned he had gotten a text just in the last few minutes, and 

I have gotten phone call, after phone call, after phone call once the 

new school lunch program was implemented fully in 2012, but 

there has been very little attention paid to how we roll this out and 

apply it rigidly to the SNAP program. 

And so it seems like using the argument that, well, we can be 

proactive, and we can sort of help to regulate the kind of food that 

people eat that we can control, the Secretary mentioned Department of Defense, and meals that our soldiers, sailors, airmen, Marines receive. We mentioned the school nutrition program, meals 

that our students receive, but we are not talking about actively engaging in how we do a better job in administering the SNAP program with respect to the sugary drinks that are often purchased, 

and all the other things that are bad, according to these guidelines. 

So why aren’t we doing a better job of actually going in and 

proactively engaging in rules that help us do a better job on dietary 

structure, as it applies to the SNAP program? 

Secretary VILSACK. Well, first of all, we are trying to address 

through a variety of mechanisms. The farm bill provided for the 

Food Nutrition and Security Initiative, which is designed to provide 

assistance and help for SNAP families to purchase more fruits and 

vegetables and alike. The expansion of access to farmers’ markets 

is also giving them that opportunity. We are looking at a—we had 

a data-based, research-based program at Holyoke, Massachusetts 

for 2 years to determine what would actually provide direction for 

SNAP families, in terms of purchasing nutritious food, making nutritious choices. What we found was that incentives work. 

Also, there is a fairly serious technology challenge, in terms of 

trying to prohibit people from using SNAP for certain products. 

Mr. CRAWFORD. Okay, let me stop you right there, Mr. Secretary, 

because I know that our travel card will deny a purchase. If you 

try to fill up your car on official business with your travel card, and 

then put a Snickers on there, it will decline that purchase. 

Secretary VILSACK. Well—— 

Mr. CRAWFORD. So I know the technology exists that we can do 

a better job in administering what the SNAP card can be used for. 

Secretary VILSACK. There are 300,000 different products that are 

sold in grocery stores across the United States. 

Mr. CRAWFORD. Right. We ought to identify the ones that aren’t 

allowed. 

29 

Secretary VILSACK. Well, here is the problem. You want to do 

sugared drinks? Does that include apple juice, 100 percent apple 

juice? Do you want to permit that? 

Mr. CRAWFORD. But that is my question, why are we not addressing that—— 

Secretary VILSACK. Well, I am asking, do you want to exclude 

that? Because—— 

Mr. CRAWFORD. No, I am asking you because we are not marking 

up a bill here. I am trying to get feedback from you on why the 

Dietary Guidelines are not more rigidly utilized in the—— 

Secretary VILSACK. They—— 

Mr. CRAWFORD.—SNAP program, they are in the school nutrition 

program. 

Secretary VILSACK. They are used in the SNAP program, in 

terms of providing guidance and direction to SNAP families in 

terms of how they can extend their SNAP dollar, where they can 

buy fruits and vegetables, how they might be able to use recipes. 

Mr. CRAWFORD. And you mentioned incentives. What kind of incentives are being used to incentivize people to make those smarter 

choices? 

Secretary VILSACK. Well, the Food Insecurity Initiative is providing resources to a number of groups that are providing cash incentives. So when a person goes to a farmers’ market, and they buy 

$5 worth of tomatoes, they actually will be able to buy $10 because 

of the additional incentive. So they get more bang for their buck. 

It is also an opportunity for associations involved to provide sales, 

to provide promotions, to provide recipes. There are a whole series 

of programs. We will be happy to provide you a list of all the grants 

that have been made under that initiative, and what actually is 

being done. I think that might be helpful to you. 

Mr. CRAWFORD. Thank you, I appreciate it. I yield back. 

The CHAIRMAN. The gentleman’s time—Mr. Aguilar, 5 minutes— 

4 minutes, excuse me. 

Mr. AGUILAR. Thank you, Mr. Chairman, and thank you both to 

the Secretaries for being here. I wanted to expand a little bit on 

that discussion. I participated, and I mentioned it to my colleagues 

before, in the SNAP challenge earlier this year. And the biggest 

piece that struck me was there was an end in sight, when I went 

through this challenge, but it was the budgetary constraints on 

healthy eating. And, Mr. Secretary, you were just talking about 

those programs, and the success that you are seeing there, and I 

hope that we can continue to grow those programs. 

And I understand that, within the Dietary Guidelines, both 

USDA and HHS also plan to release marketing materials. And, Mr. 

Secretary, you talked about choosemyplate.gov as an example, 

showing folks how to live on a low budget and a balanced diet. In 

the Advisory Committee report it is mentioned that the best food 

patterns of healthy living include the healthy U.S. style pattern, 

the healthy Mediterranean style pattern, and the healthy vegetarian pattern. Do you know approximately how much it would cost 

to afford each of these lifestyles per week, and could you expand 

a little bit on the programs that educate low-income families on 

healthy purchases like the food insecurity program? 

30 

Secretary VILSACK. Well, the guidelines help to inform a series 

of meal patterns, and it goes from the high end to the low end. And 

the Thrifty Food Plan basically is the plan—I don’t know the specific dollar amount. Obviously, it depends on the choices that people make, Congressman. But we need to sort of dispel the myth 

that healthy eating necessarily has to be more expensive. And here 

is why people think that. If you take a portion of potato chips and 

a portion of broccoli, in the past, the way we judge the value of that 

was by looking at 100 calories’ worth of potato chips, and 100 calories’ worth of broccoli. Well, 100 calories’ worth of potato chips 

would be about three potato chips. One hundred calories’ worth of 

broccoli would probably fill 1⁄2 this room. Obviously that is going 

to be more expensive. But what we ought to be doing is looking at 

portion sizes, because people eat more than three potato chips, and 

they don’t eat 1⁄2 a room full of broccoli. 

When you look at portion sizes, fruits and vegetables become affordable, number one. Number two, if you look at recipes, the use 

of canned and frozen vegetables and fruits also is an opportunity— 

there are ways in which we can stretch dollars, and so part of our 

education initiative is to provide people with the recipes and the 

information that will allow them to use fruits and vegetables more 

effectively, to understand that it doesn’t necessarily have to be 

more expensive. 

And then also the incentive programs that we have, where we 

work with foundations to encourage farmers’ market purchases by 

incenting those, the food and nutrition incentives that allow grocery stores to offer additional bonus points, if you will, for SNAP 

families to purchase fruits and vegetables. I mean, there are a wide 

variety of things. And we are also working with food banks to make 

sure that the areas of opportunity that they have to help struggling 

families also includes more healthy choices. So there are a wide variety of steps and ways in which we are attempting to make a difference. 

Mr. AGUILAR. I would love to see how we can stretch to become 

healthier. But, I would say, it was incredibly tough, Mr. Secretary, 

my wife and I, $66, on the SNAP challenge, to include healthy portions and to manage our portions. I ate peanut butter and jelly 

every day for at least one meal because we were trying to have a 

couple salads for the week. 

Secretary VILSACK. The SNAP program, as everyone knows, is a 

Supplemental Nutrition Assistance Program. It is not designed, 

and not engineered, and not funded to be the be-all and end-all for 

a family—— 

Mr. AGUILAR. But for countless Americans it is. 

Secretary VILSACK. Well, I understand that, but that is why we 

work with food banks, that is why we work with foundations, that 

is why we work with shelters, that is why we work with other avenues. That is why we have the school lunch and school breakfast 

programs that are expanding. That is why we have after school efforts, why we have a summer feeding program, to try to supplement and to—— 

Mr. AGUILAR. And I look forward to working with you to carry 

out the mission of those programs—— 

31 

The CHAIRMAN. The gentleman’s time has expired. Mr. 

DesJarlais, 4 minutes. 

Mr. DESJARLAIS. Thank you. Thank you both for being here. Secretary Burwell, I can count on one finger the number of times that 

a sitting secretary has reached out to all the Members of a Committee prior to the hearing to ask if they had any concerns, and 

so thank you for that. I appreciate you doing that. I know that is 

time consuming, but very thoughtful. 

Historically, the Dietary Guidelines for Americans policy document, which you say will be released in December, have not made 

suggestions about specific ingredients of commodities, yet that 

hasn’t prevented the Advisory Committee from taking a look at aggregate consumption by the U.S. population, and potential health 

risks of ingredients such as low calorie sweetener aspartame. Aspartame is one of the most widely studied food additives in the history of the FDA, and its approval came after more than a decade 

of review through an affirmative food additive petition. FDA has 

asserted, and re-asserted, the safety of aspartame, yet DGAC used 

a dubious process to call into question its safety, citing extremely 

weak science against the backdrop of decades of research that 

shows otherwise. And now we are calling for more research, in 

spite of the fact that FDA spent over a decade studying this ingredient’s safety, and concluded there is no increased risk of cancer 

from aspartame consumption. 

During your inter-agency review of the guidelines, are you consulting with the FDA on recommendations after they spent years 

reviewing the science? 

Secretary BURWELL. Yes, FDA is a part of the process at HHS. 

And, with regard to the issue of the safety of aspartame—and there 

are basically five products that FDA has said in given contents are 

fine and safe. And so, yes, FDA is a part of the HHS process. 

Mr. DESJARLAIS. How did the inter-agencies review ultimately 

impact the final recommendations? 

Secretary BURWELL. The inter-agency review is an extremely important part of the process. Both the Secretary and I have indicated that the input of the Advisory Committee is something that 

we are reviewing, but our own experts across our Departments, not 

just FDA for us, but CDC and NIH as well. The whole Department 

is a part of this process. It comes together, reviews everything together, and that is what forms the recommendations that we will 

receive from our Departments collectively together. 

Mr. DESJARLAIS. Okay. Additionally, DGAC recommends replacing sugared beverages with water or low fat milk only. However, 

for the guidelines to be effective to most Americans, we need to be 

able to meet them in the middle and offer guidelines that are realistic, not idealistic. In your final recommendations, how do you intend to balance dietary ideals that are realistic and achievable for 

most Americans? 

Secretary BURWELL. With regard to that question, getting ahead 

of where the recommendations are from our staff, I wouldn’t be 

able to comment on the specifics. But we do look for a balanced approach and an evidence-based approach. With regard to where we 

have the evidence about issues of—when we say balanced, it is also 

about this issue the Secretary raised of nutritional value. And so, 

32 

when you are trying to have a set number of calories, and you have 

to get in certain numbers of nutrition, how you can get that puzzle 

to fit together is an important part of what we will think about as 

we put together the final guideline. 

Mr. DESJARLAIS. Okay. Thank you, Secretary. Secretary Vilsack, 

at the December meeting, before the final Advisory Committee recommendations were voted upon, the committee got in a discussion 

about the definitions of red versus lean versus processed meat. At 

the end of the discussion they decided to remove lean meat from 

the healthy dietary pattern, even though the scientific data in their 

own report was not changed, and the same, as the 2010 Dietary 

Guidelines, which recognized lean meat as a nutrient-dense food, 

and nutrient-dense foods were encouraged to increase. 

It is important for the Dietary Guidelines to have a strong scientific background, peer reviewed and published research to give 

Americans clear advice on their diets and health. Can you please 

give me the assurances that you have both taken into account to 

ensure strong scientific evidence is the foundation for the 2015 

guidelines? 

Secretary VILSACK. I can, and I can also suggest—it is my understanding, and maybe I am wrong about this, that the report basically is fairly consistent with the recommendation that was made 

in the 2010 guidelines with reference to lean meat. I would be surprised if our final conclusion is not to include that as part of a 

healthy diet. 

Mr. DESJARLAIS. Thank you, sir. 

The CHAIRMAN. Mr. Costa, 5 minutes. 

Mr. COSTA. Four minutes, I got it. Thank both Secretaries for 

your efforts in reaching out. I do appreciate that, and to the degree 

that we collaborate on a greater basis, we all do a better job. 

A lot of discussion this morning has been talking about the process in these guidelines, and I do appreciate your emphasizing that 

they are guidelines, as a part of a total work product. And I guess 

I would like to get your take, both of you, on how we measure success. Clearly we all believe, or I hope it is not in debate, that part 

of healthy Americans is a healthy diet, and it is part of preventative health care. As our mothers told us a long time ago, an ounce 

of prevention is worth a pound of cure. So how do we measure success in terms of the incredible changes that have been taking place 

in American’s dietary habits over decades, and this effort to use 

these guidelines as a means to provide better diets so that we have 

healthier lifestyles? Have you thought about that in this process? 

Secretary BURWELL. So—— 

Mr. COSTA. I mean, we are asking you the questions. How can 

we make this process better? 

Secretary BURWELL. When we think about success, first, the 

guidelines themselves being a quality product. We need to start 

with that, and that is a lot of the conversation that we are having 

today, about an evidence-based and quality product. The second 

thing is how the guidelines get used in an appropriate fashion, in 

terms of people understanding what they are and—— 

Mr. COSTA. Do you think we are making progress along those 

lines? 

Secretary BURWELL. I think it—— 

33 

Mr. COSTA. There is a lot of advertising out there that tries to, 

especially among young people, skew their eating habits. 

Secretary BURWELL. Yes, and so that comes to the third, which 

is the knowledge has to be activated so that people are acting and 

behaving. And those are all places where we believe that we, as a 

nation, can improve. And we can improve it both at a population 

health level, and then we improve it in the ways that we use it in 

the programs. And whether that is the programs at USDA, or the 

programs at HHS, in terms of applying them. And CDC, and its 

work in population health, is another place that I believe we can 

make progress. 

Mr. COSTA. Secretary Vilsack, you have been at this for 7 years. 

Secretary VILSACK. Congressman—— 

Mr. COSTA. How do you measure success? 

Secretary VILSACK. I would only add to what Secretary Burwell 

said, is that one way, potentially, of looking at this is to take a look 

at the healthy eating index that we have, which is a 100 point system. And currently today the average American is about 57. We 

have seen improvement over the last couple of years. That is good, 

but obviously—I don’t know what your mother said about 57 out 

of 100, but my mother wasn’t satisfied with that. 

Mr. COSTA. No. 

Secretary VILSACK. So it is important for us—— 

Mr. COSTA. Not good. 

Secretary VILSACK.—to continue. That is one index. That is one 

way of measuring. Another way is to measure whether or not we 

are making headway on obesity. I am pleased by the fact that, at 

least among young children, we are beginning to see some indication of a plateauing, and potentially maybe even a slight decline in 

obesity rates. That is good news. But we still have work to do. 

And in terms of improving the process, I would say that this debate is healthy because it allows people to understand what these 

recommendations are, and what they aren’t. And there is a misunderstanding between a prevention orientation, which is what 

these guidelines are, versus a treatment orientation, a lot of the 

criticisms often are because you aren’t dealing with certain diets 

that would be helpful in dealing with obesity. And so maybe there 

is a way which we could potentially expand, or create an avenue, 

for that kind of treatment discussion to take place. 

Mr. COSTA. Okay. I have other questions regarding GMO labeling, and biotech traits as it relates to that, and I will submit that 

for the record, because there is no time. I guess, just a final comment, and it is getting back to good habits. When I grew up, it was 

a few years ago, but 8 ounces was considered a regular thing, and 

a 12 ounces was really considered big. And then I remember we 

were all floored by 16 ounces. Today, you see 24 ounces. It is a 

large part of the problem, just sizes and amounts as it relates to 

obesity, and how we combat against obesity. That is a comment. 

The CHAIRMAN. The gentleman’s time has expired. Mrs. Hartzler, 

4 minutes. 

Mrs. HARTZLER. Thank you, Mr. Chairman. Thank you, Secretaries. I really appreciate the work that you are doing, as a former 

family consumer sciences teacher who taught nutrition for many 

years. It is very, very important, and very important to be scienceVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00037 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
34 

based. I am very encouraged to hear that you are going to make 

sure that it is that, and doesn’t include sustainability, tax policies, 

other issues. 

I wanted to focus on the Nutrition Evidence Library. We have 

heard much about it, with even the USDA officials describing it as 

the gold standard. But I have heard concerns that the Nutrition 

Evidence Library has ignored a large credible and growing body of 

peer-reviewed science on low carb diets, as it contradicts the evidence from previous guidelines. So can you elaborate on how scientific studies are added to the Nutrition Evidence Library, and 

what can be done to ensure that cutting edge research in nutrition 

science is considered? 

Secretary VILSACK. Well, there are four approaches as it relates 

to the library. There are original systematic reviews, there are existing reports, there are new reports that are funneled in from a 

variety of different locations. There is a review of what the typical 

diet of an American might be. Food pattern modeling is also included. So there is a broad array of things that are included in this 

effort. 

The issue of low carb diets raises the point that I just made with 

Representative Costa. I think that is ultimately in the context of 

how do you treat a particular condition, obesity, for example? It 

may very well be that a low carb diet, or a high protein diet, might 

be a way in which a physician would prescribe for an obese individual to deal with obesity. That is not what these guidelines are 

about. These guidelines are about preventing that circumstance to 

begin with. 

There isn’t an avenue within the guidelines today for that treatment discussion, and that is why there is a lot of confusion about 

all of this, and why there is a lot of angst about it, because some 

people are looking at the guidelines as treating all health issues, 

and we are looking at what the law requires us to do, and that 

is—— 

Mrs. HARTZLER. Sure. 

Secretary VILSACK.—focus on dietary and nutritional guidelines 

relative to prevention. 

Mrs. HARTZLER. Now, some people point out that 52 percent of 

U.S. adults are pre-diabetic, and they allege that a low carb diet 

helps prevent people becoming pre-diabetic, so it is actually—— 

Secretary VILSACK. So in that—— 

Mrs. HARTZLER.—would be helpful to include that. 

Secretary VILSACK. So in that circumstance you have competing 

studies, which is why it is important to understand this is really 

about well-informed opinion. I wish there were scientific facts, but 

the reality is stuff changes, right? Stuff changes. And the key here 

is taking a look at the preponderance, the greater weight of the evidence, and trying to make a judgment based on the greater weight 

of the evidence. If you have one study on one side, and you have 

15 studies on another side, the preponderance of the evidence may 

be on this side, with the 15 studies. 

And that is a challenge, and that is why we do this every 5 

years, to give an opportunity for that quality study to be further 

enhanced so that, 5 years from now, maybe there are 15 studies 

on this side, and 15 studies on this side. 

35 

Mrs. HARTZLER. In the guidelines—— 

Secretary VILSACK. It is an evolving process. 

Mrs. HARTZLER. In the guidelines, are there any disclaimers 

mentioned in there that say for certain populations, this might not 

be true, or for certain populations this might be helpful? Do you 

include that, or do you just pick one and say, this is it? 

Secretary VILSACK. It isn’t so much that. It is a caveat that these 

are recommendations focused on prevention. They are guidelines. 

They are not saying, ‘‘You shall do this.’’ They are recommendations and suggestions that you should do this. And that, sort of an 

indirect way—— 

Mrs. HARTZLER. Yes. 

Secretary VILSACK. We obviously haven’t crafted the guidelines 

yet, so I don’t know whether or not they will be caveats as—— 

Mrs. HARTZLER. Yes, is there any population—I mean, there has 

to be differences, perhaps, for different populations—— 

Secretary VILSACK. Well, there are—— 

Mrs. HARTZLER.—the guidelines may not be one size fits all, or 

do you present it as everybody—this is for—— 

Secretary VILSACK. It is a general guideline. It is a general set 

of recommendations. It is—I mean, in theory, you could have 317 

million different guidelines—— 

Mrs. HARTZLER. Yes. 

Secretary VILSACK.—because we are all slightly different, in 

slightly different circumstances. So you have to create kind of a 

wide berth here, but within that wide berth, this is what we are 

recommending. If you are interested in a healthy diet, if you are 

interested in reducing the risk of diabetes and cardiovascular, this 

is a course that you might want to consider. Obviously, people are 

going to make choices and decisions based on what is best for 

them. 

The CHAIRMAN. The gentlelady’s time has expired. Ms. Plaskett, 

for 4 minutes. 

Ms. PLASKETT. Yes, thank you, Mr. Chairman, and good morning 

to you both. Thank you so much for your time today. I was just 

looking at the volume of comments that you had received, the 

29,000 comments after the report came out. Can you explain how 

you are going to, and will you be able to, meet the timeframe that 

you have for an evaluation of all of those responses to be able to 

issue that report, the guidelines? 

Secretary BURWELL. Yes. Our staffs have gone through all of the 

comments. One of the things that is helpful, in a sense, is that a 

large percentage of them actually were form letters. So, as the Secretary reflected, only about 8,000 were individual. Not only, but 

that is less than 29,000—— 

Ms. PLASKETT. Yes. 

Secretary BURWELL.—in terms of our ability to get through. And 

the Secretary and I are both working very hard with our teams to 

meet the deadline of this year. 

Ms. PLASKETT. Okay, great. And I guess my other question is related to moderate alcohol intake. And, looking at the guidelines 

that were issued in 2010, I noted in the 2015 Committee Statement 

that it confirmed the conclusions from 2010. Do we think that that 

36 

is going to remain the same, or what is considered moderation? 

Will that change as well? 

Secretary BURWELL. So, as you appropriately reflect, the Advisory Committee has the identical recommendations from the 2010 

report. While we are not going to comment on specifics, it is important—— 

Ms. PLASKETT. Yes. 

Secretary BURWELL.—to reflect that there was no change. 

Ms. PLASKETT. Okay. 

Secretary VILSACK. After this hearing, I may be consulting that 

guideline. 

Secretary BURWELL. The FDA would say he meets age requirements. 

Ms. PLASKETT. And that is two for males, right? 

Secretary VILSACK. Good enough. 

Ms. PLASKETT. Well, I just want to thank you all for the tremendous work you have done. This is really important to the American 

people. I am just echoing my colleagues’ discussions about proportion sizes, and the need for healthy diets, particularly in communities in which there may be a dearth of fresh foods that are available to them as well. 

And also, let us not forget, in terms of obesity, the thing we 

haven’t talked about, which is not just your diet, but exercise as 

well, which is something that Americans have been woefully lacking for our young people for some time now. So thanks very much. 

I yield the balance of my—— 

The CHAIRMAN. The gentlelady yields back, and I don’t think the 

Secretary—after 5 o’clock, did you? Mr. Rouzer, 4 minutes. 

Ms. PLASKETT. It will be 5 o’clock somewhere. 

Mr. ROUZER. Thank you, Mr. Chairman, Secretary Vilsack, Secretary Burwell. Thank you both for being here today. I appreciate 

it very much, because this is an incredibly important issue, and I 

am looking at this from a very macro perspective. We have close 

to a $20 trillion debt. Medicare and Medicaid, which you referenced 

a little earlier, is such a huge component of that debt because the 

vast majority of our budget is mandatory spending. Medicare and 

Medicaid are a huge component of mandatory spending. 

And so you consider the obesity issue that we are facing, and you 

mentioned obesity and heart disease as two major components that 

drive the cost of Medicare and Medicaid. All that gets back to what 

we consume. And back to my time, when I was in K through 12, 

versus the schools that I go in today, when I look at the student 

population, I do not recall, at least, when I was growing up, the 

number of overweight kids that are in school that you have today. 

And I visit all kinds of schools all across my district, and I would 

say 1⁄3 of them are clearly overweight. And some of them are really 

young, I mean exceptionally young. And some of them I know their 

parents, I knew their grandparents, and obesity was not an issue 

in the family until this generation. And so that leads me to think 

that clearly something has changed in our society over the last 20 

years, in particular, and I look at it from the perspective of that 

you have different movements out there influencing public policy. 

In the Dietary Guideline Advisory Committee, there is the statement in there that says common characteristics of dietary patterns 

37 

associated with positive health outcomes include lower consumption of red meats. 

It was mentioned earlier about caloric diet, trying to maintain a 

certain number of calories. Well, not all calories are the same. I 

would suggest, just from a common sense perspective, 2,000 calories of beef versus 2,000 calories of donuts are very different. Your 

body reacts to it very different. Your body takes the carbohydrate 

and turns it into sugar, and that often goes straight to the belly. 

Whereas consumption of protein, same calorie amount, the body 

treats it very differently. In fact, if you go and have a blood test 

done, they measure protein level in your blood, which suggests that 

obviously protein is a key component to a healthy lifestyle. 

So my main point that I want to drive home this morning is that 

it is very, very important to understand that there is a difference, 

not all calories are the same. And, from a public policy standpoint, 

perhaps maybe we have gotten too smart for our own good. I recognize science has improved dramatically, but mankind has survived 

for many a thousand a year on red meat, whole milk. In fact, I remember growing up when there was a report that came out that 

said apple juice was bad for you, and then they came out and said, 

actually, no, we are wrong. Eggs, bacon. I remember growing up 

where they said, ‘‘May contribute to high cholesterol and heart disease.’’ 

I want to make sure that we get back to common sense, and that 

we do what is right for future generations, because—not only for 

the health standpoint, but that translates directly in terms of the 

public policy decisions we have to make as it relates to our budget. 

Finishing it up here, I want to ask both of you—— 

The CHAIRMAN. You can’t ask anything at this point. We are 

going to have to keep going. Ms.—— 

Mr. ROUZER. No problem. 

The CHAIRMAN.—DelBene, 4 minutes. 

Ms. DELBENE. Thank you, Mr. Chairman, and thank you both for 

being here and for your time today. First I wanted to ask you about 

dairy. As you know, it has been a distinct food group in the past, 

and, according to the report, dairy products contribute many essential nutrients, Vitamin D, calcium, magnesium, iron, Vitamin A, riboflavin. And yet, since 2010, one percent flavored milks haven’t 

been allowed in schools, and we also know that dairy consumption 

has dropped in girls ages 4 to 8. And so I just had a couple questions: how do we continue to make sure students have access to appealing and nutritious dairy products, and do you expect that dairy 

would remain its own food group, going forward? 

Secretary VILSACK. Well, I don’t want to assume what we are 

going to do, in terms of the guidance, but I will tell you that one 

of the things that we have done is to work yogurt into the school 

lunch program. And we are also taking a look at the issue of milk, 

relative to school meals. So that is in the process, not in the context of the guidelines, but in the context of our efforts to try to encourage healthier choices at schools. 

Ms. DELBENE. Yes. 

Secretary VILSACK. I don’t think there is any question that dairy 

is an important component. It is going to be recognized, and should 

be recognized. 

38 

Ms. DELBENE. And, kind of on a different note, given that we 

have regional, cultural, socioeconomic diversity throughout the 

country, how will the Dietary Guidelines meet the challenges of 

being relevant, accessible, achievable for all Americans, knowing 

that, folks have different backgrounds, cultural backgrounds, that 

may impact the types of foods that they are eating? 

Secretary BURWELL. I think that many of the programs that the 

Secretary has spoken about, in terms of how you put those out, it 

is about having information that is simple enough that you can use 

it in your own cultural context, and then it is about a number of 

the programs, in terms of how the information moves. Not just the 

guidelines themselves, but then the programmatic piece that follows on. So it is the step beyond the guidelines. Having guidelines 

that are clear and simple enough that can be applied across context 

is the first step, but then it is how those guidelines are then implemented. 

Secretary VILSACK. Right. Our work at USDA with Native American populations, is a good example of where we are trying to work 

to reflect the traditions and culture of Native Americans and Indians to make sure that their dietary choices are a wide enough 

range that they can meet their cultural and traditional needs. 

So there is a greater sensitivity, and that is the challenge for us 

in the future, which is to understand those differences, and to try 

to figure out creative ways from recipes, and from direction and instruction, to reflect those differences without necessarily getting to 

a circumstance where we have to move away from the purpose of 

these guidelines, which is a—sort of a general recommendation. 

Ms. DELBENE. Thanks. I guess it is also, then, important to understand what the messaging might be, going forward, and how different folks will understand and be able to learn about the guidelines as well. 

Secretary VILSACK. Well, there will be an extensive effort at both 

Departments, but certainly at USDA we will be using all of the 

tools that we currently have, which have been pretty effective. The 

choosemyplate.gov has been one of the more effective efforts on the 

part of USDA. We are going to refresh that, obviously, the 

choosemyplate.gov, the super tracker, the SNAP education and nutrition information that we provide to SNAP families, the work 

that we will continue to do on menus with school lunch personnel. 

There are a variety of ways in which we can incorporate and assist 

folks in trying to follow these recommendations. 

Ms. DELBENE. Thank you both again for being here, and I yield 

back, Mr. Chairman. 

The CHAIRMAN. The gentlelady yields back time. I need to apologize, Mr. Rouzer. I was brusque and rude. I should have simply 

said your time has expired. So, David, please accept my apologies. 

Mr. ROUZER. No problem, Mr. Chairman. 

The CHAIRMAN. Mr. Kelly, 4 minutes. 

Mr. KELLY. Thank you, Mr. Chairman. Thank you, witnesses. 

The Dietary Guidelines for Americans have been published every 5 

years since 1980. We are concerned that the public at large has lost 

faith in the process to develop the Dietary Guidelines, which will 

ultimately decrease the adherence to them, with potentially costly 

effects on public health. In the military, in my service, we often say 

39 

you can have an SOP, standard operating procedure, but if your 

units and your soldiers don’t know them and use them, you don’t 

have an SOP. It is the same thing with guidelines. 

Before coming to Congress I was a prosecutor, and I understand 

that two people can look at a problem and come to a different solution. And, Secretary Vilsack, during your process you talked many 

times about the preponderance of evidence, but as a prosecutor, I 

didn’t get by with that standard, because the things that I was 

doing were so important that I had to prove beyond a reasonable 

doubt my case. 

Because for different things and different priorities, the importance of them, sometimes we have to use a different standard of 

evidence, and I would say maybe a preponderance of the evidence 

for scientific evidence is not the right standard. Maybe it is clear 

and convincing evidence. Or maybe it is beyond a reasonable doubt 

that, when we have science, that we hold them to a standard that 

makes sure that the end result is something that we have a good 

belief that it will be viable, and it will be the right answer. Although we won’t always be correct, if we raise the standard, maybe 

we will be correct more often. 

Secretary VILSACK. Congressman—— 

Mr. KELLY. Further—if I can finish—there have always been disagreements about this, and there always will be, about what the 

science is. I just say, sometimes we may want to look at the standards. But over 1,350 percent increase in public comments, it raises 

some concern with me that people don’t have faith in the system. 

So, to both of you, I just ask you, what can we do? Because it 

doesn’t matter how good the standards are, and it does not matter 

if we are doing the right things, if the public doesn’t have trust 

that it is the right thing, we have to build that trust. And, Secretary Vilsack or Secretary Burwell, what would you do to make 

sure that our public believes that the standards of the guidelines 

that we are putting forward are the true and correct ones? Thank 

you. 

Secretary VILSACK. Congressman, first of all, the preponderance 

of the evidence standard is a Congressional mandate, so we have 

to follow the Congressional mandate. So if you all believe that it 

should be a higher standard, that is obviously your call, and whatever your call is, we will follow it. Second, despite the fact that we 

had 29,000 comments, we have also had 290,000,000 hits on our 

choosemyplate.gov website, which would suggest to me that people 

are following these guidelines, they are interested in these guidelines, and they haven’t necessarily lost confidence in them. So that 

is another data point that I think is important to take into consideration. 

And I see this as a positive thing. Maybe I am looking at this 

wrong, but the more public input that you have, the better the decision-making can be. And we are obviously going to take all this 

information into consideration, as we should, and there are a variety of input focuses on all of this, and hopefully we are going to 

come up with the best guidelines that continue to have the faith 

and confidence in the American—— 

Secretary BURWELL. And I would just add, even as we implement 

the statute in preponderance, that, as you appropriately indicate, 

40 

there are different levels of evidence, and it is related to your colleague’s earlier comment about aren’t there different populations 

that are affected in different ways? And the evidence that we look 

at, and whether that is on the issue of sodium, and what that recommendation will be, and what we did last time, it does look at 

different places, where there is more evidence or less evidence. And 

that is something that is important to do, and we do follow statute. 

But we hear your point—— 

Mr. KELLY. Thank you. 

Secretary BURWELL.—and the scientific review actually—when 

we get our—— 

Mr. KELLY. If I can just—I have 10 seconds. If I can have one 

further point? I just think it is just important, that the citizens 

want to know that we are not using science to justify ideology, that 

it is the other way around. Thank you, and I yield back, Mr. Chairman. 

The CHAIRMAN. The gentleman’s time has expired. Mr. Davis, 4 

minutes. 

Mr. DAVIS. Thank you, Mr. Chairman. Thank you, Secretary 

Burwell. It was great to speak with you last week, and thanks for 

being here and talking about this very important subject. Secretary 

Vilsack, I know you are probably going to be surprised by this, but 

I am not going to ask you about the school lunch today. It has been 

discussed already, so I will skip over that. But I do have some concerns. 

My most serious concern today is what I see as a lack of evidence 

to show that the recommended dietary patterns proposed by the 

DGA have been based on any evidence on children. According to 

the citations in some previous advisory reports for recommendations, the recommended diet has been tested almost exclusively on 

middle-aged men, and women, whose nutritional needs, obviously, 

are very different from young people and growing children. 

In particular, I am concerned because young children need certain vitamins and minerals, obviously, in order to grow and develop. We are talking about where, in previous reports, the expert 

report states that the recommended dietary patterns do not meet 

sufficiency goals for potassium, Vitamin D, Vitamin E, choline, and 

that Vitamin A sufficiency may be marginal. These are essential 

basic nutrients for growth and health in children, and as a dad of 

a freshman in high school, and a coach, these are things that concern me on a regular basis too. 

At the same time, the DGAC appear to be deficient in their role 

in developing nutritional guidance to meet the basic nutritional 

sufficiency for children to grow and be healthy. They were expanding their review of what has been referred to as the dining out 

topic. Specifically, the fast food category was broadened to capture 

other types of dining out venues, including, like, quick serve, casual, formal restaurants, and grocery store take-out. 

And, given today’s busy lifestyle, and really, when you look at 

restaurants, they have offered a lot more healthy choice than what 

we saw just a decade ago. And, with that, I am kind of disappointed, and others are disappointed, that restaurants seem to 

be singled out, even though they are doing their best to offer 

healthier options to customers, and that concerns me. And I just 

41 

find it difficult to understand that location in which we would eat, 

without any other consideration, automatically impacts the quality 

or nutritional value of the food served. And I certainly understand 

that some restaurants may serve better food than others, but that 

is the consumer that can make that final decision on that too. 

So, Secretary Burwell, wouldn’t you agree that the nutrient content of food is more important than where the food is purchased, 

and that, rather than directing people away from dining out, 

maybe we should focus on helping to educate them on their nutritional choices? 

Secretary BURWELL. So, with regard to the issue of children, and 

the amount of research and evidence that we have in that space, 

even as we are preparing to complete where we are now, the conversation—my team actually brought up the issue of children yesterday, as we look to making sure we have appropriate evidence for 

a number of the things that you are talking about for the next set. 

Because, what you are appropriately reflecting is the research 

doesn’t exist because it is on older, so we need to get started on 

that now. So with regard to the issue of, do we need to understand 

this better, we don’t have the facts yet. We don’t have a science 

base, but if we start now, we will for the next. 

With regard to the question—— 

Mr. DAVIS. Great. 

Secretary BURWELL.—the dining out—— 

Mr. DAVIS. And I appreciate that. 

Secretary BURWELL.—the dining out question, right now 30 percent of your calories, for Americans, are consumed outside the 

home. And with regard to how we think about making sure 

that—— 

Mr. DAVIS. What percentage? 

Secretary BURWELL. Thirty percent. So when that is happening, 

what we need to focus on, with regard to this issue, is making sure 

people have appropriate information. That is what we want to do, 

is make sure that people have appropriate information to make the 

choices. As you reflect, it is up to people to make their own choices 

in that context. And that is where we touch on that issue. And, 

again, always separating the Advisory Committee’s work with the 

work that we are doing. 

Mr. DAVIS. Well, thank you again both. My time has expired. 

The CHAIRMAN. The gentleman’s time has expired. Mr. Benishek, 

4 minutes. 

Mr. BENISHEK. Thank you, Mr. Chairman. Thank you both for 

being here today. I want to follow up on a few of the thoughts that 

Representative Hartzler had. As a physician, I have been involved 

in peer-reviewed science in my training, and in my career, and I 

am a little bit concerned about some of the things you guys have 

said here. You brought up the fact that the AMA brought out that 

52 percent of Americans are pre-diabetic, or diabetic, and yet, the 

dietary recommendations, as I understand it, are not really appropriate for that. There are too much carbohydrates. These people 

have a carbohydrate intolerance, and there are more carbohydrates 

in the diet that you are recommending than is really appropriate 

for that. And you mentioned that this would be a treatment, but 

42 

this is really not a treatment. This is a preventative problem, and 

I think that you have to address that more. 

Those are my comments, but one of the questions that I had is, 

how are the studies taken, how do you determine what studies to 

base your science on? I have evidence that this evidence library included some trials, while excluding several other larger trials, some 

of which were funded by the NIH. I don’t know why all the studies 

aren’t included in the data. How does that not lead me to believe 

that there is a pre-determined result that has been looked for? 

Secretary VILSACK. Well, the process starts with a series of questions that are formulated, and then information is accumulated, 

and it goes through a process of evaluation. 

Mr. BENISHEK. Is the NIH involved in this process? 

Secretary VILSACK. Well, it is involved in the sense that the NIH 

helps to fund studies that—— 

Mr. BENISHEK. I know, but I mean they are not involved as interagency review of how the studies are picked? 

Secretary BURWELL. I think there are two different processes. 

There are three. One is the library of materials that people use, 

and that is housed at USDA. I think the second is—— 

Mr. BENISHEK. So is stuff excluded from that library? Who makes 

the choice of what goes in the library? 

Secretary VILSACK. Well, there is a process that the folks at the 

National—— 

Mr. BENISHEK. That is what I am asking. Is the NIH involved 

in that process? I mean, I am just surprised that NIH funded studies, some of which were larger than the studies that you rely on 

for your data, contradictory studies, funded by the NIH, are not included in the data. So I am just kind of wondering why. 

Secretary VILSACK. If you can give me specific—— 

Mr. BENISHEK. Well, yes, I can do that. 

Secretary VILSACK. Yes, I will be able to provide you a specific 

answer as to why that particular study, or series of studies, were 

not included, or perhaps they were, and we are having a—— 

Mr. BENISHEK. Well, my understanding is they are not. That 

is—— 

Secretary VILSACK. Well—— 

Mr. BENISHEK.—why I am concerned, because that is leading to 

my question, and some of your comments suggested that diabetes, 

and pre-diabetes, and obesity are major problems in this country. 

And, because of the cut down on the fat portion of the diet, we are 

recommending more carbohydrates. Well, this is a—that is exactly 

the problem that pre-diabetics and diabetics have, is not being able 

to respond to carbohydrates. So, I mean, for the majority of the 

people, 52 percent of the people being pre-diabetic, this is the 

wrong diet to recommend. 

So when you say it is a general diet, well, that is great, but then 

shouldn’t it be the caveats that Mrs. Hartzler mentioned? This is 

pretty serious stuff here, somebody else mentioned, when we were 

kids, people aren’t as fat back when we were kids, and we are eating more fat. And, frankly, it is not an exercise thing, as far as I 

can see, because I am experienced with it. If you eat a lot, you can 

exercise it all off. You have to get it right. 

The CHAIRMAN. The gentleman’s time has expired. 

43 

Mr. BENISHEK. I am sorry. I did go on, but—— 

Secretary VILSACK. Mr. Chairman, if I could just have 30 seconds. I would say that the NEL website will provide you the information as to why certain studies weren’t selected, but if you get us 

specific information, Congressman, we will be happy to provide you 

specific answers to specific studies. 

The CHAIRMAN. All right. Mr. Allen, for 4 minutes. 

Mr. ALLEN. Yes, and I will just follow up on that question, as far 

as the NEL was concerned, and as far as the Dietary Guidelines 

Advisory Committee did not use the NEL for more than 70 percent 

of their research questions, why was the NEL not used in these 

guidelines? 

Secretary BURWELL. For certain issues, like food pattern analysis, that they needed to do to understand what we actually are 

eating, an issue that has been brought up a number of times in 

this hearing, that is not information that would be available there, 

and they need to turn to other sources for that information to understand what is it actually Americans are eating? The sources for 

that are different. I think there were some other issues. 

The reason it is not all there is if the question—if that is not 

where the source of information can come from, there are certain 

data analytics, and there are also places where systemic reviews 

have already been done on the issues, and while they do their own 

systemic review, they at least consider the other systemic reviews. 

And so I don’t think those are counted in that percentage. But, Secretary, since that is housed at—— 

Secretary VILSACK. Well, the only other thing I would say is that 

the review process goes through a series of mechanisms to try to 

provide an understanding of what the best science is, the best 

available science is, and the least biased science is. And it is a series of things, the Cochran Collaboration, the Academy of Nutrition 

and Dietetics, the Aging for Healthcare Research and Quality, the 

Data Quality—all consistent with the Data Quality Act. So that is 

the other parameter that we have to work under, is that the Congress has given us direction, under the Data Quality Act, as to how 

this is to be managed. 

Mr. ALLEN. Well, the NEL is basically science-based. There is 

very little ideology there. They go by exact science. And I didn’t 

quite understand why you—still don’t understand why you are not 

using them as a—more of a resource in these guidelines. 

Secretary VILSACK. They are used—— 

Secretary BURWELL. Extensively. 

Mr. ALLEN. Extensively. 

Secretary BURWELL. It is only when a question can’t be answered—one of the issues is certain of the data analytics around 

what everyone is eating right now are different sources, is my understanding of why the Advisory Committee didn’t use it. That is 

the kind of—— 

Mr. ALLEN. So they didn’t have the information on more than 70 

percent of the research? 

Secretary BURWELL. I think there are a number of other places 

that the Advisory Committee has to turn to other things, and they 

do that. 

44 

Mr. ALLEN. Regarding sodium, obviously, there are some of us 

that retain fluid, and there are others who do not retain fluid. Sodium, back in my athletic career, I took salt pills, and I had a hard 

time retaining fluid. Of course, now it is the opposite, I am on a 

low sodium diet. All this stuff is very personal. It depends strictly 

on your DNA, and that sort of thing. In my opinion, it is very dangerous to set forth guidelines when everybody has a different DNA, 

and at different ages you have different requirements. And, of 

course, we already talked about it doesn’t apply necessarily as 

much to children. 

And the mistrust here is that this one size fits all thing. Because, 

folks are getting a lot of bad information in our SNAP program. 

They are really not getting good information, and then the consequences are this epidemic of diabetes that we have, particularly 

in Georgia, with folks who do not know how their diet works, and 

how it fits. Is there any way to get this more locally based, rather 

than Washington top down? 

Secretary BURWELL. We want to get it to the place where it is 

useful, and I think that is a big part of the conversation. With regard to the issues like sodium, we do take care to not put something—a standard that—it is the standard for everyone, not the 

standard for individuals. And then, this is about how one implements, in terms of—if it is the standard—but if you have a certain 

disease condition, then we need to figure out how we, in a public 

health setting, and other settings, can provide the right information for you. Because the IOM has said 2,300 milligrams of salt, 

but perhaps right now, for you, in your current state, that is not 

actually accurate. 

Mr. ALLEN. Yes. I am less than 1,000. And I yield back, Mr. 

Chairman. 

The CHAIRMAN. The gentleman’s time has expired. 

Secretary BURWELL. So we have to make sure, even though we 

set at 2,300, that we can have a forum in which we can communicate, so you know where to turn, together with your physician. 

The CHAIRMAN. Mr. Moolenaar, for 4 minutes. 

Mr. MOOLENAAR. Thank you, Mr. Chairman, and Secretary 

Vilsack, and Secretary Burwell. Thank you for being with us, and 

my apologies for my voice. It still hasn’t gotten better since yesterday. I wanted to mention just a couple of themes that I have heard, 

especially you, Secretary Vilsack, stating today is that you don’t 

want to assume what we will do with the guidelines. You don’t 

want to pre-determine what the outcome will be. Is that a fair assessment? 

Secretary VILSACK. The process hasn’t been completed yet. 

Mr. MOOLENAAR. Okay. And then one of the other themes I 

heard you say was that the more public input you have, the better 

decisions we will have. Is that a fair statement? 

Secretary VILSACK. Yes. 

Mr. MOOLENAAR. Okay. Well, one of the concerns I have about 

the process that you are currently following, my understanding is 

you have the Dietary Guidelines that are based on the expert report from the Advisory Committee, and then that is translated by 

you and your staff into—or your Department into actual guidelines. 

Is that—— 

45 

Secretary VILSACK. That is one aspect of it, Congressman. It is 

not the only thing that we rely on or look at. It is one piece of a 

large puzzle. 

Mr. MOOLENAAR. Okay. Well, the concern is, and I know that we 

have had a comment period to date, and it seems that right now 

the process only allows for the American people to comment after 

the committee releases its report, but does not allow for public comment after USDA and HHS release the final Dietary Guidelines. 

And I appreciate that you did extend the 60 day public comment 

period by an additional 15 days following the release of the report 

this spring, but, as you can tell from the hearing today, there is 

still considerable criticism of the report. 

And there is a provision in the Fiscal Year 2016 agricultural appropriations legislation that, if enacted, requires a 90 day comment 

period after the Dietary Guidelines are formally released. And this 

process seems more in line with the Administrative Procedures Act, 

which long pre-dates the current process you are using for the Dietary Guidelines. And considering the fact that more than 29,000 

comments were submitted on this report, while only 2,000 were received on the 2010 report, it really shows that there is a great deal 

of interest in this by the public, and it seems to me that the public 

should have a final opportunity to comment on this report before 

it is finalized. And I guess my question is would you agree to give 

the American people another comment period, given the fact that 

the 2015 committee report generated the most comments in the 

history of the guidelines? 

Secretary VILSACK. Well, first of all, I would point out that there 

were a number of places where the public could have input in this 

process before even the public comment period. As the dietary advisory group was meeting, there were a series of public meetings, opportunities for people to have input, and the like. There has also 

been continued opportunity to have input in the process. The challenge I have, Congressman, is when does the process—you have to 

have a finality to it. You have to have a stopping point to it, and— 

in order for us to be able to factor into the various other decisions 

we have to make that are in some places based on the guidelines. 

So I am concerned about how long you extend this process. 

Mr. MOOLENAAR. Well, yes, but—— 

Secretary VILSACK. And the last thing I would say is the public 

does have a way of commenting on this, and that is that they could 

decide not to follow them. They could decide to be critical of them 

once they are proposed. So, I mean, there is an ongoing debate and 

conversation about this. 

Mr. MOOLENAAR. I guess—— 

Secretary VILSACK. It never ends. 

Mr. MOOLENAAR.—my concern is, right from the start you made 

the comment, and I appreciated it, that you didn’t want to prejudge what the guidelines will be. It is not a complete process. You 

are taking in feedback now. But the reality is that once you publish 

those guidelines, those are the guidelines, and there is no avenue 

for the public to have input on that. And I think that is—— 

Secretary VILSACK. Well, I would disagree with that, in the sense 

that there have already been several places where they have had 

input, and they can continue to have input. They continue to reVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00049 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
46 

spond to the 2010 guidelines, which are part of the foundation and 

the information that we take into consideration. So it is an ongoing 

education process. I don’t think it ever stops. Now, there may not 

be a formalized period of time, but it never stops. 

Mr. MOOLENAAR. Well—— 

The CHAIRMAN. The gentleman’s time has expired. 

Mr. MOOLENAAR. Thank you, Mr. Chairman. 

The CHAIRMAN. Mr. King, 4 minutes. 

Mr. KING. Thank you, Mr. Chairman. Thanks to the witnesses 

for testifying today. A few questions still come to mind, after all 

this discussion that we have had here. And the first one that I 

have is that when I look at data on the students that are overweight or obese, have we had any evidence that of which direction 

their weight has gone? I ask first Ms. Burwell. Do we have any indication on whether this program is reducing the obesity of our 

children in school, or whether it might be working against us? 

Secretary BURWELL. So with regard to the specifics of programs 

in schools, I would—— 

Mr. KING. The lunch program, yes. 

Secretary BURWELL.—defer to my colleague, Secretary Vilsack, in 

terms of those programs. What we do know is that in younger children we are starting to see overarching across the board, not just 

from a programmatic school base, but we are starting to see the 

numbers go in the right direction. With regard to the specifics of 

school programs, I would defer—— 

Mr. KING. Well—— 

Secretary BURWELL.—to Secretary Vilsack. 

Mr. KING. And I was actually prepared to redirect that question 

after your response, so thanks for pointing that out. I would say 

this information, Mr. Secretary, according to the Centers for Disease Control, we saw the obesity rate of high school students by 

nine percent in the 4 years prior to the Healthy and Hunger Free 

Kids Act’s implementation, and, in the 4 years after, that the obesity rate increased by 16 percent. Have you seen any data like that 

from the Centers for Disease Control, and does that cause you to 

wonder what the result of that might be? 

Secretary VILSACK. Congressman, I would be happy to take a 

look at that information to better understand it, but there is no 

question in my mind this is not a situation where we are going to 

see fundamental change in a year. It is going to be a generational 

process. And I am convinced that, from a generational process, we 

are going to see progress. And Secretary Burwell’s correct, that we 

have begun to see progress, particularly among younger children. 

Mr. KING. Let me just ask you another one. This data says the 

opposite. It says the obesity rate of high school students had reduced by—we just picked the 4 years since it has been implemented and went to the 4 years prior, so it was the longest period 

of time that we could have that would have balance, 4 years before, 

4 years after. In the 4 years before, obesity rates went down nine 

percent, according to CDC, and the 4 years after obesity rates for 

high school students went up 16 percent, according to the CDC. 

Now, I don’t know how to explain that, because what I am getting back from my constituents, and across this country, is more 

and more complaints about not enough food for these kids. And I 

47 

would ask, Mr. Secretary, we are all very well aware of those complaints, especially as this was implemented in the fall of 2014. Now 

we are well into the school year of 2015. Are those complaints 

going up or down, in comparison to the year earlier? 

Secretary VILSACK. They have gone down. In fact, some school 

districts that left the program have come back into the program. 

Mr. KING. Well, I am glad to hear that, and how is that program 

doing in Rhode Island that was spawned by the waste, and do you 

have any measure on the waste of the food that has been—the program in Rhode Island that I am referring to is aptly named—it is 

at North Smithfield, Rhode Island, where they are feeding 3,000 

pigs with the waste from the school, essentially an industry that 

is created. And I still get a lot of complaints on hungry kids. 

Secretary VILSACK. So—— 

Mr. KING. I am concerned. Is there any question, and then is 

there evidence that our students, K through 12, are getting overweight because of school lunch program, or are they eating that 

food somewhere else that is making them overweight? Was there 

ever any evidence that indicated it came from the school lunch? 

Secretary VILSACK. Congressman, in terms of food waste, there 

is the Rudd study at the University of Connecticut. There is the 

Harvard Public Health school study. There is a study at Berkeley, 

University of California Berkeley, suggesting that kids are eating 

more fruits and vegetables, no more food waste, and, in fact, are 

eating more of their entre ́es than before. So I don’t think there is 

documentary evidence. There may be anecdotal evidence from 

school to school, and we are, obviously, focused on the food waste 

issue. I am sorry, the—your second question? 

Mr. KING. Were they ever getting overweight on school lunch? 

Was there ever any evidence prior to 2010? 

Secretary VILSACK. Well, that is sort of an interesting question. 

It could be answered yes and no. Yes, because it was part of the 

overall caloric intake that a young person was taking, and if they 

were taking more calories than they should, then everything that 

they ate in that particular day, in a sense, contributed. But if you 

are asking whether or not the number of calories consumed in a 

school meal, if we fit it within the standard, it shouldn’t contribute 

to obesity. 

Mr. KING. Either before after—— 

Secretary VILSACK. Especially—— 

Mr. KING.—2010? 

Secretary VILSACK. Especially if we are reducing the fat, sodium, 

and sugar, as we are. 

Mr. KING. I am out of time, I regret. Thank you, Secretaries. 

The CHAIRMAN. The gentleman’s time has expired. 

Secretary VILSACK. Thank you, Mr. Chairman. 

The CHAIRMAN. Mr. Newhouse, for 4 minutes. 

Mr. NEWHOUSE. Thank you, Mr. Chairman, and thank you, Mr. 

Secretary, and Madam Secretary, for being here with us this morning. I appreciate your time. I have a couple observations, but also 

some requests, and a question or two, and I will try to get through 

in 4 minutes. I have spoken with a lot of impacted constituents, 

and also through my own review. It seems clear that this Dietary 

Guidelines Advisory Committee went outside the scope of their 

48 

mandate in developing the recommendations for the report, including policy recommendations from taxes to local restaurant zoning, 

to food labeling, and sustainability policy. According to the underlying statute, that was the sole product of this committee back in 

1990, each such report shall contain nutritional and dietary information and guidelines for the general public. 

Secretary Vilsack, back in March, the Wall Street Journal reported you saying, ‘‘I read the actual law, and what I read was that 

our job ultimately is to formulate dietary and nutrition guidelines, 

and I emphasize dietary and nutrition because that is what the law 

says. It is my responsibility to follow the law.’’ Sustainable diets 

are an appropriate debate to have, you said, however there are forums and places for that to take place. And I was pleased to hear 

your comments, but what concerns me is the lack of evidence to 

suggest that neither of the agencies exercised any effort to instruct 

the Advisory Committee on their scope, or mandate. 

When you, Secretary Vilsack, and Secretary Burwell, your predecessor established the committee, you did so under the Federal Advisory Committee Act. This Act is designed to ensure that advice 

by the various Advisory Committees formed over the years is objective, and accessible to the public. The Act has formalized a process 

for establishing, operating, overseeing, and terminating these advisory bodies across government. The DGAC members are not full 

time employees, and rely very heavily on agency staff to carry out 

their duties. 

To be clear, when I review portions of the report, such as the Advisory Committee’s conflict statements on encouraging lower meat 

consumption, but then higher meat consumption for the Mediterranean diet, or when I can see the Advisory Committee’s recommendations on added sugars versus natural sugar, or use a 

lower scientific threshold than groups like the Institute of Medicine 

have used to reach their conclusions, I worry greatly about the 

process, and the guidance and oversight that they have been given. 

So it would be helpful for you to provide the Committee evidence 

in writing to confirm that your agencies did, in fact, make attempts 

to oversee the Advisory Committee once it became clear they were 

delving to areas of public policy. In response I would like to see evidence that your agencies provided instructions to the committee 

during their assembly to ensure they were staying focused on the 

right guidance, and not straying into policy matters outside their 

scope or mandate. And, likewise, I would like to receive documented evidence of the instructions agencies provided to the committee on the public law to help them understand their report must 

be based on the preponderance of scientific and medical knowledge 

that is current at the time of publication. 

And, finally, I would like to welcome your comments on any advice you could give future secretaries as to future Advisory Committees, and how they could stay focused on their charter, and 

produce a recommendation that really stays coloring with in the 

lines. So I would appreciate a response. Thank you. 

Secretary VILSACK. We will certainly provide a response to your 

questions, Congressman, as we are bound to do, and would be 

happy to do that in writing. 

49 

My advice to future secretaries will be to continue the process of 

educating people about what these recommendations are and what 

they are not, and the distinction between the report and the guidelines. There seems to—again, I have said this several times today, 

there seems to be a misunderstanding upon some folks that the report equals the guidelines, and that is not the case. The report is 

one aspect of our consideration, one aspect of the data, or the information, that is used to formulate these guidelines. 

And, to me, this debate has been helpful, I hope, in getting a better understanding of precisely what the recommendations are. And 

the discussion we have had today is also healthy, as it relates to 

what is the purpose of these guidelines? Is it focused on prevention, 

or is it focused on treatment, or should it be focused on both? I 

think that is a healthy discussion. 

The CHAIRMAN. The gentleman’s time has expired. Mr. Thompson, 4 minutes. 

Mr. THOMPSON. Thank you, Mr. Chairman. Thank you, both Secretaries. I really, really appreciate you being here. My first question actually is very specific. It is an area I care a lot about. So 

my question is, why do Americans, especially children over the age 

of 4, continue to fall short of the Dietary Guidelines’ recommended 

servings of milk, and its nine essential nutrients and vitamins, and 

what can we do to remove policies that are hindering milk consumption, or promote policies that could enhance milk consumption? 

Secretary VILSACK. We can, basically we are taking a look at 

those issues right now, Congressman, and that is the goal here, is 

that, as we learn more, as we understand more, as we re-learn lessons of long ago, that is obviously going to change the direction and 

focus. That is the whole purpose, and the whole reason why we do 

this every 5 years, is it is an evolving process. 

Mr. THOMPSON. Yes. 

Secretary VILSACK. And as our information evolves, our policies 

will evolve. And we are taking a look at the issue of milk, and taking a look at ways in which milk can be introduced into diets in 

a variety of different ways, dairy products. 

Mr. THOMPSON. And we worked together on that, and I appreciate those efforts. I want to know, how much of a factor do you 

think that it is that we publish these guidelines once every 5 years, 

and as you said, 5 minutes before you are ready to publish it, there 

is new evidence that probably is contrary to what you are publishing. And I am assuming, correct me if I am wrong, that the rate 

of research within nutrition is significant. Which is a really good 

thing, so the fact is, as soon as you publish these guidelines, to 

some extent they are inaccurate, and the longer they are there 

until the next 5 years, the more inaccurate they are. But when you 

publish them, doesn’t that influence the markets? 

I would argue—I would think, I am not going to argue, but I 

would think that when it comes to milk, the fact that at one point 

the guidelines discouraged milk took all the flavor out of it, because 

somehow fat was bad for you. And I know the science today shows 

contrary to that. But you take the fat, you take the taste out, and 

that somehow these guidelines that we do every 5 years, that are 

never really totally accurate, and increasingly more inaccurate toVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00053 Fmt 6633 Sfmt 6601 P:\DOCS\114-29\97182.TXT BRIAN
50 

wards the end of the 5 years, increases the impacts on the ag commodity markets. 

My question for you, given the fact that these were under—I may 

be wrong—President Carter, so it would be late 1970s when it was 

originated, are Americans healthier or less healthy since the guidelines have been published, and therefore, are these, in some way, 

haven’t these guidelines somewhat failed? We are talking about increasing obesity. The Pentagon is more concerned than ever about 

having access to kids that would be able to serve in the military. 

Have these guidelines really been successful, given disease, and 

chronic illnesses, and conditions? And that is not to be a criticism, 

because my second question is, then, how do we use these in a way 

that they could be successful? Because they don’t seem like they 

are accomplishing the objective, as you two have very well articulated today. 

Secretary BURWELL. So we do want to—and I think the issue of 

obesity is one that has a number of different elements. And the 

physical activity guidelines, which are something that Congress 

mandated—— 

Mr. THOMPSON. As a former rehabilitation guy, I am all in on 

that. I agree, yes. 

Secretary BURWELL. So that is another piece that I think that we 

need to focus on, and we need to make sure that these things are 

being used. I think you are right to reflect. The question is, what 

is the critical path issue, and what is the counterfactual? That is 

the other thing that we all can’t answer. We are on the wrong trajectory, but would the—— 

Mr. THOMPSON. Yes. 

Secretary BURWELL.—trajectory have been worse, and then second—— 

Mr. THOMPSON. Sure. Well—— 

Secretary BURWELL.—what is the—— 

Mr. THOMPSON.—let me make a suggestion, and get a response 

in the few seconds I have left. It seems like once every 5 years this 

doesn’t work because it changes. And, in fact, it can negatively impact ag commodities, which is irresponsible, to tell people not to eat 

certain things when the next round of research says that you want 

to eat more of it. Shouldn’t we do something, in this day and age, 

with technology that would just share the best research with folks? 

A place where people can go to get the best possible information 

in terms of eating, and knowing that that changes all the time? 

Once every 5 years, I don’t think this is effective. Sorry, Chairman. 

Secretary VILSACK. Honestly, this discussion suggests that there 

is some extraordinarily bright line on science, that over here there 

is the real science, and then over here, there is not the real—the 

science is evolving. It is—— 

Mr. THOMPSON. That is my point. 

Secretary VILSACK. And so—— 

Mr. THOMPSON. That is what science does. 

Secretary VILSACK. It does. So you have to have general guidelines that provide some parameters. 

Mr. THOMPSON. Well, do we have static guidelines once every 5 

years, or do we have—— 

51 

Secretary VILSACK. Well, you could theoretically go through this 

process every year, but I don’t know that that would be particularly 

helpful. 

Mr. THOMPSON. No. 

Secretary VILSACK. I think a 5 year period is good. Obviously, it 

gets better informed. And this issue of obesity is far more complex 

than just simply saying, because we have these guidelines, that 

somehow we have become an obese nation. It has to do with the 

fact that an average kid spends 7 hours in front of a screen every 

day. I mean, that is part of it, right? It is portion size, that is part 

of it. It is a variety of factors. I suppose if every American followed 

the guidelines it might be a different situation. But we don’t. 

The CHAIRMAN. The gentleman’s time has expired. 

Secretary VILSACK. Doesn’t mean we shouldn’t have them. 

Mr. THOMPSON. Yes. 

The CHAIRMAN. Mr. LaMalfa, for 4 minutes. 

Mr. LAMALFA. Thank you, Mr. Chairman, and both Secretaries, 

thank you for being here today. Ms. Burwell, let me follow up on 

what Mr. Thompson was saying on that as well, we have been 

hearing, ever since I was a kid, eggs are bad, so my grandparents 

had a lot of powdered eggs, because of their age, and factors like 

that. And it turns out eggs are okay later. Then you hear beef, red 

meat, and then we have high protein diets are supposed to help 

you lose weight. Somebody I was talking to just over the weekend, 

a constituent, they lost weight, but they are staying away from 

fruit, because fruit has sugar in it. Well, I mean, how are people 

supposed to really know when the ideals are changing all the time, 

the guidelines? 

So, I guess following up on the 5 year thought, is it good to have 

a hard and fast 5 year timeline of changing the Dietary Guidelines, 

or should it be less frequent, more frequent, or does it need to be 

even more—kind of change what you know to change, and have 

the—and leave the rest alone? What do you think of that? 

Secretary BURWELL. I think that the Congress, in making a 

choice on 5 years, probably made a good choice. And the reason for 

that is, while we heard from some of your colleagues about extending the period—I think that this took 18 months for the Advisory 

Committee to do its work, then you had an additional 75 days of 

the period of comment for us to receive comments on that, and then 

you have the period for us to review and get it out. And so when 

you add that up, and you think about that timetable, if you tried 

to shrink that, the question is, would you have relevant—— 

Mr. LAMALFA. Well, I guess what I am looking at is maybe you 

have most of the guidelines are going to be consistent for a long 

time. When you have school books, for example, it seems like they 

throw out the whole school book. You are buying a new one where 

maybe most of that math lesson is fine, so maybe you are just 

changing the elements in there, since it is electronic, and not doing 

something every 5 years. 

So let me follow that up with should there be a legislative change 

that we should produce that would help this process? 

Secretary BURWELL. I don’t know that there should, and actually, 

we are like the school books, in that most of this is consistent. You 

reflected on, in terms of where there are changes, the things that 

52 

there are key recommendations on have been relatively consistent 

over the period since the 1980s, in terms of the importance of fruits 

and vegetables, the importance of a balanced approach that provides nutrition that is fewer calories than the nation currently consumes. 

In several select areas, it is fair to appropriately reflect the 

science has changed, but the dominant picture is a very similar picture over the periods of time. And so I also think it is important 

to distinguish between the Dietary Guidelines and what is happening in our popular culture with regard to different diets that 

are proposed by different people in different ways. Distinguishing 

that is also an important element, and this gets to what are the 

guidelines, and what are they not? 

Mr. LAMALFA. Certainly, there is a lot of overlap, a lot of different messages being sent. The Dietary Guidelines, though, they 

can be seen by people as confusing, or difficult to follow. Do you 

think the 2015 Guidelines will be more straightforward, giving people a little more straightforward ideas of how to follow this pattern 

for what they need? Is the 2015 going to be an improvement over 

that? 

Secretary BURWELL. We will, obviously, work to make things as 

simple as we can. But the real way that people interact with these 

things is actually in their implementation in programs. And whether that is the topic we have talked about in school lunch, or another topic we haven’t touched as much on, which is the labeling 

issues. And that is how most people interact with what the Dietary 

Guidelines are, in terms of how they get their advice about what 

they are going to eat, and that sort of thing. 

Mr. LAMALFA. Well, let me ask, then, since most of the efforts 

say to follow or be consistent with the guidelines, what does follow 

the DGA mean to you, Madam Secretary? 

Secretary BURWELL. What it means to me is that there are these 

guidelines, and when we apply those from a perspective of the Federal Government to certain of our programs, that they are the basis 

that we think about promoting the programs. And whether that is 

our Meals on Wheels program, or, as we think about our Million 

Hearts initiative at CDC to try and reduce by a million the number 

of people with heart attacks, that an important element of that is 

understanding what the Dietary Guidelines say. 

Mr. LAMALFA. Thank you. You have had a very difficult job the 

last year or so, so thanks for coming. 

The CHAIRMAN. The gentleman’s time has—— 

Secretary BURWELL. Thank you. 

The CHAIRMAN.—expired. And before we adjourn, David Scott, 

any comments you have from the Ranking Member? 

Mr. DAVID SCOTT of Georgia. Yes. Well, thank you very much, 

Mr. Chairman. First thing I want to say is how much we appreciate both of you Cabinet officials coming before us at the same 

time. That is a rarity, and we really appreciate it. 

Agriculture is indeed our most important industry. It is the food 

we eat, it is the water we drink. It is our survival. And you do get 

the feeling from this Committee of how important this is. And I 

hope that what we have discussed today, that you all will take 

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53 

cause this is the single most important industry in the world, our 

agriculture. My hope is that you will take back and understand— 

even go back and review a bit. 

Secretary Vilsack, you hit the nail on the head when you stated 

that they sit there before the screen. That is exactly right. When 

you and I were coming along, folks would say, Daddy or Mama, can 

I go out to the playground? That is a phrase we don’t even hear 

now. I am going upstairs, or I am going downstairs, I am going in 

the room, and get on the Internet, sit before that screen hour after 

hour. And that is why it is so important now that we use our 

science to make up for that. 

And that is why I hope that you will take my suggestions to go 

back, and look, and make sure we are using the strong scientific 

evidence. And if there are things like the low calorie sweeteners, 

where the study has already shown that it will lower obesity, go 

back and review, and explain why you don’t use that. Or maybe 

you go back and you look at, and you say, you know what, I think 

we can use this and make a difference. And that is why, Mr. Chairman, this has been an extraordinary and very important hearing, 

and I thank you for calling it. 

The CHAIRMAN. Well, I thank the gentleman. I also want to 

thank our witnesses. This is a big deal, to get both of you at the 

table at the same time. I appreciate that. The emphasis today was 

on the process, and restoring trust. 

And, Ms. Burwell, your testimony said that the guidelines don’t 

change much from issue to issue. Is that a bias that, if I am a scientist, and I have a body of work that comes to certain conclusions, 

and I am going to be hard bent to change my conclusion against 

new evidence? That is going to be an issue that is there. Hopefully 

the next time you will be asked are the guidelines themselves contributing to the problem? For example, the emphasis on carbohydrates over the last 20 years, and the impact that has had on 

these issues that we are talking about, whether it is obesity, or diabetes, or other things. Do we have anybody who is going to live 

these guidelines for 5 years so we could see what it did to them? 

I know you guys try to gather that information, because the guidelines are important. They are voluntary for me. I am going to go 

have lunch here in a little bit, and I will decide for myself. They 

are not voluntary, though, when they get woven into school lunch 

programs, and SNAP, and everything else. They become the law of 

the land in many instances, so it is important that we get these 

right. 

And I appreciate both of your comments this morning about limiting the criticisms about sustainability and taxes. You laid those 

to rest. Thank you so very much for that, for the emphasis on staying within the scope that was supposed to be there. I appreciate 

that. And I really also appreciate your work on trying to clarify 

that these are guidelines, and that the report was one thing. You 

have work to be done between now and December to make that 

happen. The idea that perhaps a proposed rule might have some 

value. I understand time and that getting it finished is an important process as well. I appreciate that both of you came today, and 

the comments that were made from my colleagues. 

54 

Under the rules of the Committee, the record of today’s hearing 

will remain open for 10 calendar days to receive additional material and supplementary written responses from the witnesses to 

any questions posed by a Member. This hearing of the Committee 

on Agriculture is adjourned. 

[Whereupon, at 11:25 a.m., the Committee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

55 

SUBMITTED ARTICLE BY HON. COLLIN C. PETERSON, A REPRESENTATIVE IN CONGRESS

FROM MINNESOTA

THE WASHINGTON POST

Wonkblog 

For decades, the government steered millions away from whole milk. Was 

that wrong? 

By Peter Whoriskey October 6 

The United States Government once considered butter and margarine as 

one of seven food groups to consume daily. Look back at other advice that 

unfortunately is no longer a part of the USDA’s Dietary Guidelines. (Jayne 

W. Orenstein/The Washington Post) 

Video hyperlink: http://wapo.st/1VEwNVl. 

U.S. Dietary Guidelines have long recommended that people steer clear of whole 

milk, and for decades, Americans have obeyed. Whole milk sales shrunk. It was 

banned from school lunch programs. Purchases of low-fat dairy climbed. 

‘‘Replace whole milk and full-fat milk products with fat-free or low-fat choices,’’ 

says the Dietary Guidelines for Americans, the Federal Government’s influential advice book, citing the role of dairy fat in heart disease. 

Whether this massive shift in eating habits has made anyone healthier is an open 

question among scientists, however. In fact, research published in recent years indicates that the opposite might be true: millions might have been better off had they 

stuck with whole milk. 

Scientists who tallied diet and health records for several thousand patients over 

10 years found, for example, that contrary to the government advice, people who 

consumed more milk fat had lower incidence of heart disease. 

By warning people against full-fat dairy foods, the United States is ‘‘losing a huge 

opportunity for the prevention of disease,’’ said Marcia Otto, an assistant professor 

of epidemiology at the University of Texas and the lead author of large studies published in 2012 and 2013, which were funded by government and academic institutions, not the industry. ‘‘What we have learned over the last decade is that certain 

foods that are high in fat seem to be beneficial.’’ 

Over Decades, Consumers Spurned Whole Milk 

For decades, public health authorities have advised Americans to switch away 

from whole milk, and they have obeyed. The chart shows sales of milk in millions 

of pounds. 


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* Editor’s note: this is an interactive graphic that was embed in the article. To access the 

interactive functionality go to http://www.washingtonpost.com/news/wonkblog/wp/2015/10/ 

06/for-decades-the-government-steered-millions-away-from-whole-milk-was-that-wrong/. 

Source: USDA/The Washington Post.* 

This year, as the ‘‘Dietary Guidelines for Americans’’ undergoes one of its periodic 

updates, the Federal bureaucrats writing them must confront what may be the most 

controversial and weighty question in all of nutrition: does the consumption of socalled saturated fats—the ones characteristic of meat and dairy products—contribute to heart disease? 

It is, without doubt, an important question. Heart disease is the leading cause of 

mortality in the United States, and the Federal Government has long blamed saturated fats. 

[Whole milk is okay. Butter and eggs too. What’s next—bacon? 

(https://www.washingtonpost.com/news/speaking-of-science/wp/2015/10/ 

07/whole-milk-is-okay-butter-and-eggs-too-whats-next-bacon/)]. 

But the idea that spurning saturated fat will, by itself, make people healthier has 

never been fully proven, and in recent years repeated clinical trials and large-scale 

observational studies have produced evidence to the contrary. 

After all the decades of research, it is possible that the key lesson on fats is twofold. Cutting saturated fats from diets, and replacing them with carbohydrates, as 

is often done, likely will not reduce heart disease risk. But cutting saturated fats 

and replacing them with unsaturated fats—the type of fats characteristic of fish, 

nuts and vegetable oils—might. 

This shift in understanding has led to accusations that the Dietary Guidelines 

harmed those people who for years avoided fats—as instructed—and loaded up excessively on the carbohydrates in foods such as breads, cookies and cakes that were 

marketed as ‘‘low fat.’’ 

It also has raised questions about the scientific foundations of the government’s 

diet advice: To what extent did the Federal Government, and the diet scientists they 

relied upon, go wrong? When the evidence is incomplete on a dietary question, 

should the government refrain from making recommendations? 

The dietary science has drawn the skepticism of some on Capitol Hill. On 

Wednesday, a House Committee will air concerns regarding the evidence for the 

guidelines with Agriculture Secretary Tom Vilsack and Health and Human Services 

Secretary Sylvia Burwell. 

[Read: Could 95 percent of the world’s people be wrong about 

salt? (http://www.washingtonpost.com/news/wonkblog/wp/2015/05/26/ 

could-95-percent-of-the-worlds-people-be-wrong-about-salt/)]. 

The Dietary Guidelines have stepped back slightly from their blanket advice to reduce saturated fats, adding the caveat that saturated fats ought to be replaced with 

unsaturated fats. But Dariush Mozaffarian, a cardiologist, epidemiologist, and dean 

of the Friedman School of Nutrition Science & Policy at Tufts University said that 

in his view the Dietary Guidelines have yet to retreat far enough from the idea that 


11429003.eps
57 

saturated fat is a dietary evil, and their suspicion of whole milk is a good example. 

Judging a particular food solely on how much fat it contains, he said, can too easily 

blind people to its other benefits. 

‘‘If we are going to make recommendations to the public about what to eat, we 

should be pretty darn sure they’re right and won’t cause harm,’’ Mozaffarian said. 

‘‘There’s no evidence that the reduction of saturated fats should be a priority.’’ 

Some, including representatives of the American Heart Association, disagree. In 

their view, the evidence for the dangers of saturated fats arises from these two 

ideas: Consuming saturated fats raises levels of so-called ‘‘bad’’ cholesterol in the 

blood, and higher levels of ‘‘bad’’ cholesterol, in turn, raise risks of heart disease. 

[Related—USDA: We will not steer people away from meat to protect the environment (https://www.washingtonpost.com/news/ 

wonkblog/wp/2015/10/06/usda-we-will-not-steer-people-away-from-meatto-protect-the-environment/)]. 

In support of their position, they point to the trials of statin drugs, which show 

that the drugs lower ‘‘bad’’ cholesterol levels and lower risks of heart disease. 

There is a ‘‘mountain of evidence’’ explaining how consumption of saturated fats 

raises the risk of heart disease, said Penny Kris-Etherton, a Nutrition Professor at 

Penn State University and a former member of the Dietary Guidelines Advisory 

Committee. 

How We Die 

Heart disease is the leading cause of death in the U.S. and health authorities 

have long blamed its prevalence, at least in part, on our consumption of fatty foods. 

The Case Against Saturated Fats Begins 

Over the long tortured course of fat research, it certainly seemed at times that 

there was strong evidence in the case against saturated fats. 

The history of the fat warning is usually traced to the work of Ancel Keys, a scientist at the University of Minnesota, whose study of heart disease in the 1950s 

startled the medical world. 

Keys examined fat consumption and rates of heart disease in various countries. 

In places where people eat lots of fat, he found high levels of heart disease. One 

of his famous charts, from 1953, showed that in the United States, where close to 

40 percent of the diet came from fat, people suffered a disproportionate number of 

heart disease deaths. People in Japan and Italy, by contrast, consumed less fat and 

died of heart disease less often. 

58 

Degenerative Heart Disease 

1948–49, Men 

FIG. 2. Mortality from degenerative heart disease (Categories 93 and 94 

in the Revision of 1938, categories 420 and 422 in the Revision of 1948, 

International List. National vital statistics from official sources. Fat calories as percentage of total calories calculated from national food balance 

data for 1949 supplied by the Nutrition Division, Food and Agriculture Organization of the United Nations. 

In 1953, scientist Ancel Keys linked national fat consumption to heart 

disease. 

From the Keys, A., Atherosclerosis: A problem in newer public health. 

1953. JOURNAL OF MOUNT SINAI HOSPITAL 20: 118–39. 

In 1953, scientist Ancel Keys linked national fat consumption to heart disease. 

To Keys, the data offered proof that Americans could improve their health by reducing the fats in their diets. 

‘‘It is now abundantly clear that degenerative heart disease is not an inevitable 

consequence of aging,’’ he wrote in the 1953 medical journal article. 

More evidence was coming. In the 1960s, several clinical trials—from Oslo, Los 

Angeles, Finland, London and Minnesota—put his suspicion to the test. Three of the 

five suggested that he was right. 

The Oslo study, for example, studied 412 men who’d previously had a heart attack. Half were given a special diet that was low in saturated fat; the other half 

was allowed to eat their usual diet, which was richer in saturated and trans fats. 

The special diet seemed to work: After 5 years, 64 subjects on the special diet had 

a relapse of heart disease, while of those eating their regular diet, 90 people did. 

Public health authorities, including those in the United States, were soon recommending that people reduce their consumption of saturated fats—meat, eggs and 

dairy—as a means of lowering heart disease risks. 


11429004.eps
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The idea became a part of U.S. official advice in 1977, when the U.S. Dietary 

Goals, a forerunner of the Dietary Guidelines, embraced the position. 

How a Hypothesis Became Dogma 

But even as a Senate committee was developing the Dietary Goals, some experts 

were lamenting that the case against saturated fats, though thinly supported, was 

being presented as if it were a sure thing. 

‘‘The vibrant certainty of scientists claiming to be authorities on these matters is 

disturbing,’’ George V. Mann, a biochemist at Vanderbilt’s medical school wrote in 

the New England Journal of Medicine. 

Ambitious scientists and food companies, he said, had ‘‘transformed [a] fragile hypothesis into treatment dogma.’’ 

Indeed, the subsequent 40 years of science have proven that, if nothing else, the 

warning against saturated fats was simplistic. 

By itself, cutting saturated fats appears to do little to reduce heart disease. Several evidence reviews—essentially summing up years of research—have found no 

link. 

‘‘There is no significant evidence for concluding that dietary saturated fat is associated with an increased risk of coronary heart disease,’’ said one published in 2010 

in the American Journal of Clinical Nutrition. 

‘‘Current evidence does not clearly support’’ guidelines linking saturated fat and 

heart disease, according to a review of experiments and observational studies published in the Annals of Internal Medicine. 

‘‘Saturated fats are not associated’’ with mortality, heart disease, strokes or type 

2 diabetes, a major review in the British Medical Journal reported in July. 

One of the most noted experiments on fats was the Women’s Health Initiative, 

which involved more than 48,000 older women. Some had counseling to eat less fat 

and more vegetables and fruits; others continued, more or less, with their normal 

diets. Subjects in the diet group cut their saturated fat intake from 13 percent of 

their diet to ten percent, as well as their consumption of other fats. Their levels of 

‘‘bad’’ cholesterol dropped. Yet when it came to heart disease, researchers found no 

significant difference between the two groups. 

To many critics, the trouble with the fat warning was not merely academic. 

The ‘‘campaign to reduce fat in the diet has had some pretty disastrous consequences,’’ Walter Willett, dean of the nutrition department at the Harvard School 

of Public Health has said. ‘‘With more fat-free products than ever, Americans got 

fatter.’’ 

Best-sellers such as ‘‘Good Calories, Bad Calories’’ by Gary Taubes and ‘‘Big Fat 

Surprise’’ by Nina Teicholz went further in their critique of the government position. 

‘‘There’s a large body of scientific literature to show that a high-carb diet, as recommended by the Dietary Guidelines for Americans, provokes a number of heartdisease risk factors,’’ said Teicholz, whose critique of the guidelines appears in a recent issue of the British Medical Journal. 

The Case Weakens 

For the bureaucrats writing the forthcoming Dietary Guidelines, the shifting evidence against saturated fats may be a lesson, experts said: there were weaknesses 

in each of the three lines of evidence used. 

First, there were those studies by Keys showing that a country’s fat consumption 

was linked to its rate of heart disease. After Keys’ paper appeared, scientists began 

adding other countries to his graph, and when they did, the pattern suggesting a 

link between fat consumption and heart disease became less distinct. 

More importantly, by the very nature of his research, Keys’ data could only show 

that saturated fat consumption was associated with heart disease, not that consuming saturated fat caused heart disease. That’s because his study was ‘‘observational’’—that is, it was based on merely observing subjects rather than randomly assigning them to high-fat and low-fat diets. It was possible, in other words, that some 

unaccounted factor caused the varying rates of heart disease. 

The second line of evidence in the case against saturated fats came from those 

controlled experiments in the 1960s—in Oslo, Finland and Los Angeles. These suggested that subjects who consumed less saturated fat suffered less from heart disease. 

As further scientific review showed, none of the experiments was perfectly designed to assess the danger of saturated fats, and the results in some cases were 

modest. Moreover, the diets showing a benefit were not just low in saturated fats, 

they were also high in unsaturated fats—the ones common in fish, nuts and vegetable oil. 

60 

Indeed, these trials, along with more recent studies, have led many scientists to 

conclude that merely cutting back on saturated fats provides no benefit, but replacing them with unsaturated fats does. By contrast, cutting back on saturated fats 

and eating breads and cookies instead won’t help. 

‘‘We have strong evidence that replacing saturated fats with carbohydrates has no 

effect on cardiovascular disease,’’ said Alice Lichtenstein, a Tufts University nutritionist who served this year on the Dietary Guidelines advisory panel. 

No More ‘‘Blanket Recommendations’’ 

Even so, the advisory panel has continued to tout the benefits of limiting saturated fat to ten percent of the diet, and of swapping whole milk for fat-free. 

In doing so, the panel is relying on the third piece of the argument against saturated fats, which is that two-step chain of logic: that saturated fats raise the levels 

of ‘‘bad’’ cholesterol in the blood, and that higher levels of ‘‘bad’’ cholesterol in turn 

raise the risks of heart disease. 

Scientists generally agree on the premises of that argument. The trouble, according to critics, is that connecting the two and drawing the conclusion that saturated 

fats lead to heart disease is a vast oversimplification, for a handful of reasons. 

First, while consumption of saturated fats tends to raise levels of ‘‘bad’’ cholesterol 

in the blood, they also tend to raise the levels of ‘‘good’’ cholesterol levels, too, and 

that may have compensating effects. 

Second, saturated fatty acids come in chains of carbon of varying lengths, and 

each one differs in its effects on heart disease risks. Some molecules appear to raise 

the amount of ‘‘bad’’ cholesterol in the bloodstream, while other longer chains appear to have no appreciable effect. 

And it gets even more complicated. It turns out that ‘‘bad’’ cholesterol comes in 

two forms. One consists of particles that are smaller and denser and these appear 

to be strongly linked to heart disease; the other type of ‘‘bad’’ cholesterol consists 

of lighter, fluffier particles that appear to have lesser effects on heart disease. Saturated fats do raise the levels of ‘‘bad’’ cholesterol, but seem to produce mainly the 

lighter, fluffier and less dangerous particles. 

As a result of such complexity, as well as the ways in which food sources vary 

in their health effects, ‘‘blanket recommendations to reduce total saturated fats may 

not be appropriate,’’ according to the most recent Annual Review of Nutrition, an 

academic publication that provides summaries of the latest research. 

So What About Whole Milk? 

While nutrition advice is often presented in terms of ‘‘macronutrients’’—fats, proteins, carbohydrates—foods may be more than the sum of their scientific parts. 

Milk is a good example. 

Repeated research on milk, not funded by the industry but by public institutions, 

has provided evidence that the fats in milk are, for some reason, different. 

In 2013, New Zealand researchers led by Jocelyne R. Benatar collected the results 

of nine randomized controlled trials on dairy products. In tallying the tests on 702 

subjects, researchers could detect no significant connection between consuming more 

dairy fat and levels of ‘‘bad’’ cholesterol. (Four of the nine studies included in the 

tally were funded by the industry. Those results were consistent with those of the 

trials funded by government entities.) 

The same year, Otto and Mozaffarian, then both at the Harvard School of Public 

Health, conducted another study on the effects of milk. Their study sought to address a key weakness in the previous research. 

One of the flaws of nutrition studies is that they rely on people to accurately recall what they’ve eaten over the course of a year. Those recollections are vulnerable 

to inaccuracy, especially for dairy fats which can be found in small amounts in 

many different foods. This inaccuracy may be one of the reasons studies have yielded contrary results on the link between milk and heart disease. 

To improve estimates, Otto and Mozaffarian used a blood sample for each of more 

than 2,800 U.S. adults. Using the blood sample, they could detect how much dairy 

fats each had consumed. And over the 8 year follow up period, those who had consumed the most dairy fat were far less likely to develop heart disease compared to 

those who had consumed the least. 

The advocates of whole milk allow that it has more calories than its low fat cousins, and for some, that might be reason to avoid it. But the traditional case against 

whole milk—based on the risk of heart disease—has frayed enough now that many 

argue the Dietary Guidelines should yield to the new findings. 

‘‘There is no scientific basis for current dietary advice regarding dairy,’’ Benatar 

said. ‘‘Fears [about whole milk] are not supported by evidence. The message that 

61 

it is okay to have whole fat food, including whole fat milk, is slowly seeping into 

consciousness. But there is always a lag between evidence and changes in attitude.’’ 

Peter Whoriskey is a staff writer for The Washington Post handling investigations of financial and economic topics. You can email him at 

peter.whoriskey@washpost.com. 

SUBMITTED REPORT BY HON. VICKY HARTZLER, A REPRESENTATIVE IN CONGRESS

FROM MISSOURI

Scientific Integrity in Policymaking 

A White Paper authored by Joanne L. Slavin, Ph.D., R.D. 

Executive Summary 

A scientific white paper was commissioned by a coalition of food and agriculture 

trade associations to examine the use of scientific research in U.S. food and nutrition policymaking efforts, including the Dietary Guidelines for Americans (DGA). 

The white paper, authored by Joanne Slavin, Ph.D., R.D., was published in Nutrition Journal (Attachment). Following is an executive summary of the white paper’s 

main findings and recommendations. 

Rationale 

The current Administration, Federal agencies and regulators are increasingly 

looking to policy and systems-change interventions to improve public health in 

America. The process by which Federal agencies and policymakers consult scientific 

research in developing proposed regulations and policies varies and greatly impacts 

the nature of the ultimate recommendations. Because of the profound effect that 

many of these policies have on consumers, the food environment, Federal nutrition 

assistance programs and subsequent policy and regulatory recommendations, it is 

imperative that only the strongest, best available evidence is used to inform and set 

policy. 

White Paper Objectives 

1. Describe the current U.S. food and nutrition policy environment. 

2. Examine how science is used in Federal food and nutrition policymaking efforts, using the Dietary Guidelines for Americans (DGA) as an example. 

3. Describe strong versus weak science as well as what types of studies are most 

appropriate for use in policymaking. 

4. Discuss the potential effects and consequences of making policy recommendations in the absence of scientific consensus or agreement. 

5. Make recommendations to support the present and ongoing development of 

science-based policy likely to positively impact public health. 

Barriers to Setting Evidence-Based Policy 

• Scientific studies are used by all agencies to set nutrition policy. Yet, consistent 

guidelines for how to identify, evaluate, and translate research into policy recommendations do not exist. This can lead to national dietary guidance based 

on research studies with varying degrees of methodological strength and applicability. 

• Nutrition is a constantly evolving science and much of our available knowledge 

and thus dietary recommendations are based on observational data or research 

that is of a weaker quality. It is critical that study methodology is carefully considered and applied to our interpretation of nutrition science. Limitations of 

such data are often underappreciated by nutrition scientists and policymakers. 

• The DGA serve as the cornerstone for all Federal nutrition education and program activities, including but not limited to nutrition labeling campaigns, 

Healthy People objectives, and nutrition assistance programs including the Supplemental Nutrition Assistance Program (SNAP) and the National School Lunch 

Program (NSLP). The Dietary Guidelines Advisory Committee (DGAC) is the review committee responsible for formulating and publishing recommendations 

that lead to the development of the DGA policy document. 

» The nutrition and health topics investigated, as well as the evidence review, 

interpretation, and grading processes are at the discretion of DGAC members. 

» Final DGAC recommendations will be provided to the Secretaries of the Department of Health and Human Services and USDA by the end of 2014/early 

62 

* Correspondence: jslavin@umn.edu, Department of Food Science and Nutrition, University of 

Minnesota, 1334, Eckles Avenue, St. Paul, Minneapolis, MN 55108, USA. 

©2015 Slavin.; licensee BioMed Central. This is an Open Access article distributed under the 

terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/ 

4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the 

original work is properly credited. The Creative Commons Public Domain Dedication waiver 

(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in 

this article, unless otherwise stated. 

2015. The content of the ultimate DGA policy document is at the discretion 

of both agencies. 

• It is extremely difficult to reverse or change public policy, once enacted, without 

causing consumer confusion. Inaccurate and conflicting dietary guidance messages are detrimental to consumer understanding of nutrition and the ability 

to build healthy diets. At a time when consumers are already subjected to an 

overabundance of nutrition and health information, providing the public with 

science-based, realistic and achievable information is more likely to contribute 

to improved public health outcomes. 

Recommendations 

• It is imperative that food and nutrition policies reflect, and do not get ahead 

of the strongest available scientific evidence. It is unlikely we will ever have 

RCT data available to answer most nutrition questions, but we should rely on 

our strongest designs. We must demand stronger scientific standards from appointed committee members who serve on authoritative IOM and DGAC panels. 

• A universal system that grades evidence quality would help achieve consistency 

in science interpretation and use across all nutrition policies and regulations. 

Grading schemes should be vetted and approved by authoritative bodies, so that 

findings and recommendations are supported across a wide array of credible 

groups. 

• Food and nutrition policy must be a cooperative effort of scientists from universities, the government, commodity groups and food companies. Dietary guidance 

that is produced in such a collaborative system will more likely be translatable 

and realistic for the general public. 

• When policy recommendations are developed by committees, such as the DGAC, 

those committees should be comprised of a balanced and well-rounded set of 

perspectives and expertise. A scientific nutrition committee should not only include experts in nutrition, biochemistry, physiology, epidemiology and statistics, 

but also food science, food production and processing, food policy and behavior. 

This would ensure that the ultimate recommendations adequately reflect our 

entire food system and food environment. 

• Policies should reflect what is practical and likely to have the greatest impact 

on the general population. Simple, flexible and straightforward messages that 

are rooted in the best available evidence are likely to be most effective. 

Joanne Slavin is a Professor in the Department of Food Science and Nutrition at the University of Minnesota, St. Paul. She is a Science Communicator for the Institute of Food Technologists and served as a member of the 

2010 Dietary Guidelines Advisory Committee (DGAC). 

ATTACHMENT

Slavin NUTRITION JOURNAL (2015) 14:15 * 

The Challenges of Nutrition Policymaking 

DOI 10.1186/s12937–015–0001–8 

Review, Open Access 

Joanne L. Slavin 

Abstract 

In my over 3 decades of work in the field of food and nutrition, I have participated 

in many efforts that seek new policy initiatives in the hopes that these programs 

can curb rates of obesity and chronic disease and help consumers make healthier 

dietary choices. Because of the profound effect that many of these policies have on 

consumers, the food environment, Federal nutrition assistance programs and subsequent policy and regulatory recommendations, it is imperative that only the strongest, best available evidence is used to set policy. This review evaluates methods by 

which current nutrition policies use scientific research as well as provides recVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00066 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
63 

ommendations for how best to ensure future nutrition policies are truly sciencebased and likely to have a meaningful impact on public health. Specifically, this review will: 

• Describe the current food and nutrition policy environment in the U.S. 

• Examine how science is used in Federal food and nutrition policymaking efforts, 

using the Dietary Guidelines for Americans (DGA) as an example. 

• Describe strong versus weak science as well as what types of studies are most 

appropriate for use in policymaking. 

• Discuss the potential effects and consequences of making policy recommendations in the absence of scientific consensus or agreement. 

• Make recommendations to support the present and ongoing development of 

science-based policy likely to positively impact public health. 

Keywords: Dietary guidance, Nutrition policy, Evidence based review, Sodium, 

Added sugars 

Introduction 

The U.S. food and nutrition policy and regulatory environment is highly active. 

The current Administration, Federal agencies and regulators are increasingly looking to policy and systems-change interventions to improve public health in America. 

For example, within the last 5 years, Federal and state/local governments have instituted significant changes to the school food environment [1], proposed state and 

local initiatives to tax and/or ban certain foods and beverages [2], and published proposed rules to significantly change nutrition labeling regulations [3]. Additionally, 

the 2015 Dietary Guidelines Advisory Committee (DGAC) [4] is presently meeting 

and will issue the 2015 DGAC report in the coming year. 

The process by which Federal agencies and policymakers consult scientific research in developing proposed regulations and policies varies, and greatly impacts 

the nature of the ultimate recommendations. An investigation into this process 

would yield important understanding about how science is used to set policy and 

what impact this process is likely to have on consumers. 

Review 

How Science Is Used in Policymaking 

Science is used by all agencies to set nutrition policy. Yet, guidelines for how to 

identify, evaluate, and translate scientific research into policy recommendations 

vary among agencies. Policymakers generally rely on published research and consensus reports by scientific authorities and government bodies; however the manner 

in which research findings and report conclusions are interpreted and applied can 

differ from one initiative to the next. Government agencies have outlined their approach for evaluation of scientific studies to be used in decision-making. For example, NIH uses the AHRQ system [5] and FDA has an accepted system of systematic 

review for health claims [6]. Because there is not a universally accepted evidencegrading scheme, conclusions are based on research studies with varying degrees of 

methodological strength and applicability. The fact that nutrition research produces 

constantly evolving scientific findings further complicates the development of objective, evidence-based policy recommendations. 

One example of a U.S. scientific authority with significant influence is the Institute of Medicine (IOM). The IOM is one of the premier authoritative bodies that 

conducts health-related research and promulgates health and nutrition recommendations for policymaking purposes. IOM reports are frequently commissioned 

by government agencies for topics where policy and/or regulatory interest exists but 

research gaps remain. Some recent examples include sodium [7] and front-of-package labeling [8]. Once IOM recommendations are published, they are often used as 

scientific basis for proposed regulations and nutrition guidance. IOM recommendations aim to reflect our most current scientific understanding and usually precede 

the actual setting of policy to ensure any action is evidence-based. However, the 

IOM is challenged to keep pace with advances in our understanding of nutrition. 

For example, the IOM completes the Dietary Reference Intake (DRI) reports, 

which are considered the most reliable sources of nutrient recommendations—they 

inform the very basis of our current nutrition understanding. The DRIs are summarized in the 2006 volume [9] and are an update to the Dietary Recommended Allowances (RDA) that have been published since 1941. While DRI reports for certain nutrients have been updated recently (vitamin D and calcium were updated in 2011), 

other DRI reports have not been updated since 1997–1998. This means that the 

body of research that has been completed for a number of nutrients within the last 

15+ years is not accounted for in our current IOM DRI report conclusions. 

64 

Researchers and policymakers also rely heavily on the National Health and Nutrition Examination Survey (NHANES), an ongoing group of studies designed to assess 

the health and nutritional status of adults and children in the United States. These 

studies are based on self-reporting; they consist of 24 hour dietary recalls completed 

through individual surveys. NHANES also collects biological data and 

anthropometrical data with mobile units. NHANES information is a valuable resource on changes in nutrient intake and health status of a cross-sectional group 

of U.S. consumers. 

Critics suggest the data are flawed because of biases that accompany self-reporting measures [10]. As one might expect, survey respondents have a tendency to 

under-report their caloric intake or over-report the amount of more nutritious foods 

they consume and under-report the amount of less nutritious foods they consume. 

Archer, et al. [11] reported that 67% of women and 59% of men who participated 

in NHANES provided caloric intake responses that were not physiologically plausible. They calculated physiologically credible energy intake values as the ratio of 

reported energy intake to estimated basal metabolic rate and subtracted estimated 

total energy expenditure to create disparity values. The greatest mean disparity values were ¥716 kcal/day and ¥856 kcal/day for obese men and women, respectively. 

The limitations of our nutritional data are generally not acknowledged in scientific 

reports or consensus statements. And yet, NHANES is cited by virtually every government agency involved in health and nutrition as an accurate representation of 

Americans’ eating habits. 

These examples raise important questions about the data that U.S. nutrition policymakers have available to them. How confident can we be that Federal dietary 

guidance is evidence-based when our foundational measures are outdated and significantly limited? What controls can be put in place to ensure that policies and regulations are likely to have demonstrated, positive public health impact? 

The Dietary Guidelines Advisory Committee 

Another highly influential scientific authority is the Dietary Guidelines Advisory 

Committee (DGAC), the appointed review committee responsible for formulating and 

publishing (in the form of a comprehensive report) an evidence-based review that 

provides scientific support for the Dietary Guidelines for Americans (DGA) policy 

document. The DGA are statutorily mandated (Section 301 of Public Law 101–445 

(7 U.S.C. 5341, the National Nutrition Monitoring and Related Research Act of 

1990, Title III)) and are a collaborative effort between the Department of Health 

and Human Services (HHS) and Department of Agriculture (USDA); the DGA have 

been published every 5 years since 1980. The DGA aim to provide ‘‘sound advice 

for making food and physical activity choices that promote good health, a healthy 

weight, and help prevent disease for Americans ages 2 years and over, including 

Americans at increased risk of chronic disease’’ [12]. DGA recommendations serve 

as the cornerstone for all Federal nutrition education and program activities, including but not limited to nutrition labeling campaigns by the Food and Drug Administration (FDA) and USDA Food Safety and Inspection Service (FSIS), the Office of 

Disease Prevention and Health Promotion (ODPHP) Healthy People objectives, and 

USDA Food and Nutrition Service nutrition assistance programs including the Supplemental Nutrition Assistance Program (SNAP) and the National School Lunch 

Program (NSLP). As a result, DGA reach and impact are extensive. 

The 2015 DGA process is underway, with the current DGAC holding meetings to 

share their evidence review process and findings with the general public. According 

to the 2015 DGAC charter, the Committee’s official responsibilities are to ‘‘examine 

the current Dietary Guidelines for Americans, take into consideration new scientific 

evidence and current resource documents, and then develop a report to be submitted 

to the Secretaries that outlines its science-based recommendations and rationale 

which will serve as a basis for developing the eighth edition of Dietary Guidelines 

for Americans’’ [12]. 

The DGAC is governed by Federal Advisory Committee Act (FACA) guidelines and 

an official charter and charge [13]. While the freedom exists to explore food and nutrition topics that the DGAC deems important and scientifically relevant, the charge 

explicitly states that ‘‘DGAC responsibilities include providing authorship for this 

report; however, responsibilities do not include translating the recommendations 

into policy or into communication and outreach documents or programs’’ [13]. In 

other words, DGAC recommendations should be scientific in nature and not indicative of policy direction. 

The DGAC Evidence Review Process 

The DGAC process to identify, review, and evaluate available nutrition research 

for a variety of topics is complex and time-intensive. Typically, DGAC members are 

65 

divided into subcommittees to address specific research areas based on topic importance and DGAC member expertise. In 2010, the DGAC consisted of thirteen scientists with expertise in nutrition, physical activity, food behavior and nutrition 

through the lifecycle. There were eight subcommittees focusing on the following dietary issues: (1) alcohol; (2) carbohydrate; (3) energy balance and weight maintenance; (4) fatty acids and cholesterol; (5) food safety and technology; (6) nutrient 

adequacy; (7) protein; and, (8) sodium, potassium and water. As a member of the 

2010 DGAC, the author of this paper served as chair of the carbohydrate and protein subcommittees and also as a member of the energy balance and the nutrient 

adequacy subcommittees. 

The 2015 DGAC is organized somewhat differently, with fourteen scientists serving on five subcommittees: (1) Food and Nutrient Intakes, and Health: (2) Current 

Status and Trends; Dietary Patterns, Foods and Nutrients, and Health Outcomes; 

(3) Diet and Physical Activity Behavior Change; (4) Food and Physical Activity Environments; and (5) Food Sustainability and Safety. There are separate working 

groups for sodium, added sugar, saturated fat and physical activity. The 2015 Committee is also using expert consultants to inform its evidence reviews. 

One of the first steps in the DGAC evidence review process is to develop research 

questions regarding the relationship between diet and health outcomes, including 

disease risk or health benefits (e.g., what is the relationship between dietary fiber 

intake and specific health outcomes). These questions should reflect the research 

gaps identified by the previous DGAC, as well as areas of nutrition where there is 

new, influential evidence since the previous edition of the DGA. Once the research 

questions have been agreed upon, the DGAC, in concert with USDA Nutrition Evidence Library (NEL) staff, gathers the relevant available studies. 

The research studies are then closely examined and evaluated based on strength 

of study design as well as relevance of outcomes. In past years, the DGAC used the 

NEL evidence-based review process [14], a strict hierarchy of evidence and rigorous 

grading process. For each question addressed in the 2010 evidence-based report, the 

DGAC developed precise search criteria, inclusion and exclusion criteria for all of 

the studies, including the range of dates searched, and made this information available on the USDA DGA portal [14]. Such detailed process and transparency in the 

NEL evidence-based approach minimizes bias and therefore adds credibility to the 

findings. However, the scientific review method ultimately used by the DGAC is at 

the Committee’s discretion—for example, at the time of this paper’s completion, the 

2015 DGAC has decided to use the NEL process to answer some research questions, 

but not others. This permitted subjectivity and variability increases the potential for 

less rigorous studies to be used to inform DGAC recommendations. 

Once the DGAC has determined which studies to examine for each research question, evidence conclusion statements are written. Within the NEL system, the conclusions drawn can be deemed as strong, moderate, limited, or lacking data to support them. There may also be strong evidence of no relationship. For example, 

strong evidence was found of no relationship between glycemic index and disease 

outcomes in the 2010 DGAC review [15]. Agreeing on the strength of the relationship is always difficult, as for each question, different types of studies with a variety 

of outcomes have been published. A closer examination of study methodology will 

help further illustrate this point. 

The DGAC process is transparent and open to input from scientists and consumers. The 2015 DGAC will hold seven public meetings with public comments accepted throughout the process. Although the final DGAC report is not released, the 

committee regularly updates their progress on reviewing scientific questions at the 

public meetings. 

Research Methodology: What Makes a Strong vs. Weak Study 

The evidence-based medicine (EBM) hierarchy ranks research design in the following order of strength (from highest to lowest): systematic reviews of randomizedcontrolled trials (RCT), RCT, prospective cohort studies, case control studies, crosssectional studies, case series/case reports and editorials/expert opinions. RCT are 

the strongest study designs for determining cause and effect between a dietary exposure and a health outcome [16]. Following RCT are prospective cohort studies, 

where a group or cohort of subjects is studied over time. Food frequency instruments 

are often used to collect dietary information before any diagnosis of disease, making 

these studies more reliable than cross-sectional studies where diet and outcome 

measures are assessed simultaneously. Historically, in the case of DGAC reviews, 

no case-control studies, animal research, or in vitro studies have been considered 

due to their relative weakness and because their findings cannot prove cause and 

effect in humans. Typically cross-sectional studies are only included in DGAC reviews if no stronger prospective studies are available. 

66 

Following this reasoning, food and nutrition policies would be best served if only 

the strongest types of evidence—perhaps RCT alone—informed their development. 

However, this is an unrealistic ideal as not all diet and health outcome relationships 

can be practically or ethically evaluated using RCT. For example, it is difficult to 

carry out blind food treatments in dietary studies (subjects know they are consuming an apple versus apple juice). However, such trials can work with nutrients, 

as nutrients can be added to food or drinks without the knowledge of the participants or investigators (the double-blind mechanism). 

Further, all RCT data are not created equal. RCT generally use biomarkers as 

outcome measures rather than disease incidence due to the length of time it takes 

healthy people to manifest disease symptoms. Biomarker data can be extrapolated 

to infer relationships regarding population health without adequately accounting for 

weaknesses in the relationship between the biomarker and the disease state. Ultimately, this can result in a strong study methodology being misapplied and used 

to make assumptions that are not actually supported by the research. For example, 

RCT are clear that sodium intake or excretion is directly related to blood pressure, 

yet prospective cohort studies show that too low sodium intakes actually increase 

risk of cardiovascular disease (CVD). Thus, at low levels of sodium consumption, 

blood pressure does not account for all of the CVD risks. Biomarker data fail to tell 

the complete story. 

In reality, many dietary recommendations are supported by evidence primarily 

from observational data, particularly those from prospective, cohort studies. Nutrition scientists and policymakers often under-appreciate limitations of such data. 

Some of the limitations of observational evidence for diet-disease relationships include imprecise exposure measures, collinearity among dietary exposures, displacement/substitution effects, healthy/unhealthy consumer bias, and residual confounding. Maki, et al. [16] recommend greater caution in making dietary recommendations for which RCT evidence of clinical event reduction after dietary intervention is not available. 

For these reasons and because nutrition science is complex and changeable, it is 

critical that study methodology is carefully considered and applied to our interpretation of nutrition science. Ideally, observational data would be validated by stronger 

research methods before being used to inform policy. While observational research 

may be valuable to our understanding of nutrition and health, its limitations must 

be acknowledged. Consider the 2015 DGAC investigation into sustainable dietary 

patterns. This field of research is arguably in its infancy—in fact, there is no scientific consensus for even a definition of sustainability [17]. Any sustainability-related recommendations in the 2015 DGAC report should be preliminary at best, recognizing the need for additional, rigorous research to validate initial findings. Without these underlying studies in place, it would be premature for HHS and USDA 

to use sustainability recommendations to inform nutrition guidance in the 2015 

DGA policy document. 

Consequences of Non-Evidence-Based Policy 

We don’t have to travel very far back in time to witness examples of dietary guidance recommendations that were made prematurely and are now challenged as 

more research is introduced. Our understanding of fats has evolved considerably, 

with dietary recommendations now emphasizing healthy consumption of 

monounsaturated and polyunsaturated fats, proving that healthier dietary patterns 

include, rather than exclude, foods higher in fat content. 

More recently, it could be argued that the 2010 DGA sodium intake recommendation was made in the absence of scientific consensus. The policy document recommends that individuals over 51 years old, African Americans or those with hypertension, diabetes, or chronic kidney disease reduce their daily sodium intake to 

1,500 milligrams. This applies to about 1⁄2 the U.S. population, including children 

and the majority of adults. 

Since then, the IOM published its Sodium Intake in Populations: Assessment of 

Evidence report. Findings stated that recent studies ‘‘support current efforts to reduce excessive sodium intake in order to lower risk of heart disease and stroke. 

However, the evidence on health outcomes is not consistent with efforts that encourage lowering of dietary sodium in the general population to 1,500 mg/day. Further 

research may shed more light on the association between lower—1,500 to 2,300 

mg—levels of sodium and health outcomes’’ [7]. 

The 2010 DGA recommendations are now inconsistent with our most recent scientific understanding of sodium and health. As noted, this conflict could have been 

avoided if the DGA policy document had withheld such extreme guidance until more 

rigorous studies were fielded, reviewed, and published. Recent papers in the New 

67 

England Journal of Medicine cast further doubt on our low sodium recommendations for the general public [18]. 

The sodium example is important because of the aforementioned impact of DGA 

recommendations on other food and nutrition policies. The Final Rule for the Nutrition Standards in the National School Lunch and School Breakfast Programs [1] 

states that schools must ‘‘reduce the sodium content of meals gradually over a 10 

year period through two intermediate sodium targets of 2 and 4 years post implementation’’. Now that schools have begun to implement the new regulations, these 

severe sodium reductions are proving difficult, costly, and may reduce student participation rates [19]. These consequences are especially concerning considering the 

underlying recommendation may not accurately reflect the current evidence base. 

Inaccurate and conflicting dietary guidance messages are also detrimental to consumers’ understanding of nutrition and their ability to build healthy diets. At a time 

when consumers are already subjected to an over-abundance of nutrition and health 

information, government agencies should be held accountable for developing policies 

and regulations that are rooted in strong science, and are realistic and achievable 

for the majority of the population. In the case of sodium, not only is there insufficient evidence to link highly restrictive sodium intakes to improved health outcomes, but encouraging the general public to reduce intakes from the estimated current average of 3,400 mg/day to 1,500 mg/day is self-defeating and unachievable 

[20]. 

Another example can be seen in the use of the 2010 DGAC review to support the 

FDA proposal to mandate added sugars labeling on the Nutrition Facts panel [3]. 

Added sugars have become the current nutrition ‘‘watch out’’, believed by some to 

uniquely contribute to obesity and other adverse health outcomes. However, the majority of scientific evidence shows that all sugars (added or intrinsic) provide 4 

kcalories/gram just like any other digestible carbohydrate and are no more likely to 

cause weight gain or negative health outcomes than other calorie sources [21]. In 

fact, even the proposed rule acknowledges this fact: 

‘‘U.S. consensus reports have determined that inadequate evidence exists to 

support the direct contribution of added sugars to obesity or heart disease. Specifically, although it is recognized that sugar-sweetened beverages increase adiposity (body fat) in children (Ref. 30), neither the 2010 DGA nor the IOM 

macronutrient report concluded that added sugars consumption from all dietary 

sources, in itself, increases obesity. In fact, the 2010 DGA states that added 

sugars do not contribute to weight gain more than any other source of calories . . .’’ [3]. 

FDA states that the basis for this proposed labeling requirement is the 2010 DGA 

recommendation to reduce intakes of added sugars to assist consumers in maintaining healthy dietary practices. The DGA rationale is that lower intakes of added sugars will result in decreased calorie intakes and increased nutrient density of individual diets, not reduced risk of adverse health outcomes. Specifically, the 2010 

DGAC energy balance subcommittee investigated sugar-sweetened beverage intakes 

and found that ‘‘strong evidence shows that children who consume more sugarsweetened beverages have greater adiposity (body fat) compared to those with a 

lower intake’’ [15]. However, a closer look at the evidence review shows that only 

12 of the 19 studies (which included crosssectional studies) found a positive association between sugar-sweetened beverage intakes and adiposity in all or a subsample 

of population studies. It is difficult to see how the subcommittee concluded this to 

be ‘‘strong’’ evidence. 

Furthermore, it is unclear why FDA proposed mandatory added sugars labeling 

in the absence of consumer research to demonstrate whether the change will in fact 

influence consumer understanding and purchasing behavior. The proposed rules 

even preceded the agency’s own study. Existing consumer research suggests that 

consumers already find aspects of the current nutrition label confusing [22]. In addition, public misunderstanding about added sugars abounds. Some consumers believe 

added sugars do cause unique adverse health outcomes compared to other sugars 

and even contain more calories that intrinsic sugars [22]. Even if the intention behind the proposed rule is to steer consumers away from purchasing non-nutrient 

dense foods and beverages that contain added sugars, current available research 

suggests they will do this for the wrong reasons. This proposal stands to perpetuate 

misleading beliefs about nutrition and lead to more consumer confusion. 

It is extremely difficult to reverse or change public policy, once enacted, without 

causing consumer confusion. There are few mechanisms available to regulators and 

policymakers to make adjustments that reflect new science and understanding. Furthermore, nutrition policy recommendations, once adopted, appear frequently in the 

media and online. Reversing consumer misunderstanding about nutrition is an inVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00071 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
68 

credibly difficult task; providing the public with accurate, realistic and achievable 

information first would go a long way in improving our understanding of nutrition 

and health, and ultimately contributing to improved public health outcomes. 

Conclusions 

It is imperative that food and nutrition policies reflect, and do not get ahead of 

the strongest available scientific evidence. It is unlikely we will ever have RCT data 

available to answer most nutrition questions, but we should rely on our strongest 

designs, including prospective cohort studies. We should not accept cross-sectional 

studies as influential drivers of policy development. We must demand stronger scientific standards from our appointed committee members who serve on advisory 

IOM and DGAC panels. 

A transparent system that grades evidence quality would help achieve consistency 

in science interpretation and use across nutrition policies and regulations. Grading 

schemes should be vetted and discussed by experts across the wide expertise needed 

in dietary guidance, including nutritionists, dietitians, food scientists, physicians, 

applied economists, and food processors so that findings and recommendations could 

be supported across a wide array of credible groups. This would also help ensure 

that the dietary guidance messages consumers are receiving are factual and consistent. 

When policy recommendations are developed by committees, such as the DGAC, 

those committees should be comprised of a balanced and well-rounded set of perspectives and expertise. Ideally a scientific nutrition committee would not only include experts in nutrition, biochemistry, physiology, epidemiology and statistics, but 

also food science, food production and processing, food policy and behavior. This 

combination of skills would ensure that the ultimate recommendations adequately 

reflect our entire food system and food environment. 

Scientists who understand how we ‘‘learn’’ about nutrition must be included, even 

if they have worked on research supported by commodity groups or food companies. 

The IOM process considers bias of individual committee members and whether they 

have taken such strong public stands on issues that it is not possible for them to 

move to another position based on the deliberations of the committee. Any linkages 

to the food industry are criticized, yet there seems to be little concern about committee members who are closely linked to professional groups, such as American 

Heart Association or other advocacy groups. Improvements to our food system and 

public health can only be realized if we work together, respecting the strengths of 

all parties. Nutrition advice that is produced in such a collaborative system will 

more likely be translatable and realistic for the general public. 

Policies should reflect what is practical and likely to have the most impact on the 

general population. Simple, flexible and straightforward messages that are rooted 

in the best available evidence are likely to be most effective. For example, the majority of Americans are unlikely to be interested in or able to prioritize building sustainable diets, shop at farmers markets, or avoid processed foods, which provide nutrition and convenience for individuals with less access to full-service grocery stores 

and fresh produce. 

I would finally suggest that the U.S. Government consider elongating the DGA 

publication schedule. The DRI reports and nutrition labeling regulations are not updated every 5 years; instead they are reexamined when there is a sufficient level 

of new research to warrant a change. Without new science to review, the DGAC may 

choose to focus on fads and trends instead of updating the scientific data for the 

core areas of dietary guidance. As every DGAC wants to be bold and set new direction, nutrition science would support that first we must do no harm with our dietary 

guidance. Moderation and variety must be kept front and center, as well as an appreciation that a teenage active boy may need two or three times more calories than 

an elderly man or young child. A suggestion that all Americans should reduce sodium intakes is not sound and is potentially dangerous. Targeting certain foods and 

beverages, including chocolate milk, processed meats, added sugars, and even the 

noble potato as villains in the nutrition wars is not a science-based strategy and 

may need to be countered on the political front if appointed scientific review committees continue to take this approach. 

As described by Schneeman [6], science is necessary for developing effective food 

regulation and policy, but it is not sufficient. The interface between nutrition and 

public health must include food science and agriculture. Food technology can help 

all consumers, including those of lower socioeconomic status, have access to safe, nutritious foods that science has found to be linked to improved health outcomes. 

Abbreviations 

69 

HHS: Department of Health and Human Services; USDA: Department of Agriculture; DGAC: Dietary Guidelines Advisory Committee; DGA: Dietary Guidelines for Americans; DRI: Dietary reference intakes; EBM: Evidence-based medicine; FACA: Federal Advisory Committee Act; FDA: Food and Drug Administration; IOM: Institute of Medicine; LDL: Low-density lipoprotein; NHANES: 

National Health and Nutrition Examination Survey; NSLP: National School Lunch Program; ODPHP: Office of Disease Prevention 

and Health Promotion; RCT: Randomized-controlled trials; SNAP: Supplemental Nutrition Assistance Program; FSIS: USDA Food 

Safety and Inspection Service; NEL: USDA Nutrition Evidence Library. 

Competing Interests 

In the past 5 years Dr. Slavin has received research grants from Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle, General Mills, Inc., USA Pears and American Pulse Association. In the past 5 years Dr. Slavin has received speaking fees from food companies and commodity groups with interests in

processed foods, dairy products, meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr. Slavin has participated in scientific panels and advisory boards that are funded by food companies, ingredient companies, commodity groups, scientific societies, 

and trade groups. She holds a third interest in the Slavin Sisters LLC, a 119 acre farm in Southern Wisconsin. 

Author information 

Joanne Slavin, Ph.D., R.D., is a Professor in the Department of Food Science and Nutrition, University of Minnesota, St. Paul. 

She is a Science Communicator for the Institute of Food Technologists and served as a member of the 2010 Dietary Guidelines Advisory Committee (DGAC). 

Acknowledgements 

The author thanks Sarah Levy, M.P.H., R.D., for her support in the development of this paper, which includes assistance with 

outline development and revision of drafts. Ms. Levy is a Vice President with FoodMinds LLC, a food and nutrition affairs company 

that represents a range of food, nutrition, and wellness organizations. During this paper’s development, she worked for 

FleishmanHillard, a global communications agency that represents the Corn Refiners Association. 

This paper was funded by an unrestricted grant from the following organizations: Corn Refiners Association, Grocery Manufacturers Association, International Dairy Foods Association, American Beverage Association, National Confectioners Association, and 

American Meat Institute. 

Received: 13 September 2014 Accepted: 20 January 2015. 

Published online: 07 February 2015. 

References 

1. Nutrition Standards in the National School Lunch and School Breakfast Program, Food and Nutrition Service (FNS), USDA. 

Final Rule. FEDERAL REGISTER Vol. 77, No 17, January 26, 2012. 

2. Taber D.R., Chriqui J.F., Vuillaume R., Chaloupka F.J. How state taxes and policies targeting soda consumption modify the association between school vending machines and student dietary behaviours: A cross-sectional analysis. PLOS ONE 9(8):e98249. 

doi:10.1371/journal.pone.0098249. 

3. ‘‘Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Proposed Rule.’’ 21 CFR 101 (3 March 2014), pp. 

11904–11905. Available online: http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04387.pdf. 

4. ‘‘Establishment of the 2015 Dietary Guidelines Advisory Committee; Notice;’’ 78 Federal Register 24 (5 February 2013), pp. 

8147–8148. Available online: http://health.gov/dietaryguidelines/2015.asp#resources. 

5. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov. 

6. Schneeman B. Linking science and policy. NUTR. TODAY. 2014;49:167–73. 

7. Institute of Medicine. Sodium intake in populations: assessment of evidence. Washington, D.C.: National Academies Press; 

2013. 

8. Front-of-Package Nutrition Rating Systems and Symbols. Promoting Healthier Choices. Committee on Examination of Front-ofPackage Nutrition Rating Systems and Symbols (Phase II), Food and Nutrition Board, Wartella E.A., Lichtenstein A.H., Yaktine A., 

Nathan R., eds. Institute of Medicine, The National Academies Press, Washington, D.C. 

9. National Research Council. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington D.C.: The 

National Academies Press; 2006. 

10. Schoeller D.A., Thomas D., Archer E., Heymsfield S.B., Blair S.N., Goran M.J., Hill J.O., Atkinson R.L., Corley B.E., Foreyt 

J., Dhurandhar N.V., Krol J.G., Hall K.D., Hansen B.C., Heitmann B.L., Ravussin E, Allison D.B. Self-report-based estimates of energy intake offer an inadequate basis for scientific conclusions. AM. J. CLIN. NUTR. doi:10.3945/ajcn.113.062125. 

11. Archer E., Hand G.A., Blair S.N. Validity of U.S. nutritional surveillance: National Health and Nutrition Examination survey 

caloric energy intake data: 1971–2010. PLOS ONE. 2013;8(10):e75532. 

12. Dietary Guidelines for Americans, 2010. Available online: http://www.health.gov/dietaryguidelines/dga2010/ 

DietaryGuidelines2010.pdf. 

13. Charter of the 2015 Dietary Guidelines Advisory Committee. Approved January 9, 2013. Available online: http:// 

www.health.gov/dietaryguidelines/dgac2015-charter-final.pdf. 

14. USDA Nutrition Evidence Library, 2010 Dietary Guidelines process. http://www.nel.gov/category.cfm?cid=21. 

15. Dietary Guidelines Advisory Committee. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for 

Americans, 2010. To the Secretary of Agriculture and the Secretary of Health and Human Services, U.S. Department of Agriculture. Washington, D.C.: Agricultural Research Service; 2010. 

16. Maki K.C., Slavin J.L., Rains T.M., Kris-Etherton P.M. Limitations of observationalevidence: implications for evidence-based 

dietary recommendations. ADV. NUTR. 2014; 5:7–15. 

17. Johnston J.L., Fanzo J.C., Cogill B. Understanding sustainable diets: a descriptive analysis of the determinants and processes 

that influence diets and their impact on health, food security, and environmental sustainability. ADV. NUTR. 2014; 5:418–29. 

18. Oparil S. Low sodium intake—Cardiovascular health benefit or risk? NEW ENG. J. MED. 2014; 371:677–9. 

19. Protect School Meal Programs. School Nutrition Association PolicyResources, July 2014. Available online: https:// 

schoolnutrition.org/uploadedFiles/Legislation_and_Policy/SNA_Policy_Resources/July2014-Protect%20School%20Meal%20 

Programs.pdf. 

20. Maillot M., Monsivais P., Drewnowski A. Food pattern modeling shows that the 2010 Dietary Guidelines for sodium and potassium cannot be met simultaneously. NUTR. RES. 2013;33:188–94. 

21. Hess J., Latuilippe M.E., Ayoob K., Slavin J. The confusing world of dietary sugars: definitions, intakes, food sources and 

international dietary recommendations. FOOD FUNCT. 2012; 3:477–86. 

22. Consumer Investigation into Nutrition Facts Panels and Sugars Labeling: Topline Report of Findings. Consumer research conducted by Turner Research Network and supported by the IFIC Foundation. Available online: http://www.foodinsight.org/sugarslabeling-nutrition-panels. 

Submit your next manuscript to BioMed Central and take full advantage of: 

• Convenient online submission. 

• Thorough peer review. 

• No space constraints or color figure charges. 

• Immediate publication on acceptance. 

• Inclusion in PubMed, CAS, Scopus and Google Scholar. 

• Research which is freely available for redistribution. 

Submit your manuscript at www.biomedcentral.com/submit. 

70 

SUBMITTED ARTICLE BY HON. JAMES P. MCGOVERN, A REPRESENTATIVE IN CONGRESS

FROM MASSACHUSETTS

THE HILL

October 07, 2015, 06:30 a.m. 

Physician Perspective: Keep Politics Out of Dietary Guidelines 

By Sandra G. Hassink, M.D., F.A.A.P. and Steven J. Stack, M.D. 

The process by which the Federal Government provides the best available dietary 

advice to millions of Americans is under attack on Capitol Hill. As physicians and 

leaders of professional medical organizations, we are compelled to speak out. 

Physicians routinely provide patients with guidance on how to stay healthy. We 

rely on the best available scientific evidence to make these recommendations, and 

fortunately, we have had the Dietary Guidelines for Americans to turn to. Unfortunately, that could all change; there are unprecedented attacks taking place in Congress right now that threaten the scientific integrity of the guidelines. 

Every 5 years, the guidelines are updated and published as America’s authority 

for nutrition advice. Important legislation, the Healthy, Hunger-Free Kids Act of 

2010, called for school meals to conform to these guidelines, which makes sense: 

since children typically consume up to 1⁄2 of their daily calories in school, we have 

an obligation to ensure those meals are healthy and nutritious. 

At a time when nearly one in three school-age children and adolescents is overweight or has obesity and more than one in three American adults suffer from cardiovascular disease and diabetes, science, not politics, should drive the Federal Government’s efforts to revise the guidelines. And indeed, the guidelines themselves are 

informed by an expert committee made up of scientists, doctors and nutritionists 

who are nominated by their peers and selected by the Federal Government after a 

rigorous vetting process. They evaluate the evidence and provide independent advice 

to the U.S. Government in the form of Dietary Guidelines. 

This process takes years, and is intentionally removed from the political process. 

And yet, it is currently under threat on Capitol Hill: Language pending in multiple 

spending bills would hinder the Federal Government’s ability to provide the best 

available advice to millions of children and adults on healthy diets and lifestyles. 

If enacted, efforts to reduce consumption of added sugars in order to lower the risk 

of cardiovascular disease, type 2 diabetes and dental caries would be stymied. Interventions to reduce screen time and increase physical activity in children and adults 

would be disrupted. 

What’s more, the language would limit dietary information or guidelines that can 

be included in the 2015 Dietary Guidelines for Americans only to those with a 

‘‘strong’’ evidence rating, which means it is completely free from study design concerns or disagreements between findings. As any nutrition scientist or dietician will 

tell you, nutrition research is exceptionally difficult to perform. Meals are so complex and varied that establishing an individual’s true pattern requires meticulous 

diet tracking; population-level data is easier to obtain but less specific. In addition, 

there is an unlimited amount of factors that influence health, including physical activity, chemical exposure, and co-morbid health issues. A ‘‘strong’’ rating is only 

given if virtually every study on a topic agrees. As this rarely happens in science, 

the Dietary Guidelines for Americans have historically relied on both strong and 

moderate evidence to make key recommendations. 

Our patients deserve nutrition guidance that is free of political interference. The 

2015 Dietary Guidelines for Americans will play a crucial role in the lives of millions 

of children and adults. Nutrition and physical activity are integral to a healthy population, and it’s essential that doctors are able to continue to advise our patients 

based on what the evidence recommends. Congress should support, not derail, what 

the science shows and keep the politics out of the guidelines. 

Hassink, is president of the American Academy of Pediatrics. Stack is 

president of the American Medical Association. 

SUBMITTED STATEMENTS BY HON. MICHELLE LUJAN GRISHAM, A REPRESENTATIVE IN

CONGRESS FROM NEW MEXICO

STATEMENT OF ACADEMY OF NUTRITION AND DIETETICS; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN COLLEGE OF CARDIOLOGY; AMERICAN DENTAL ASSOCIATION; 

AMERICAN MEDICAL ASSOCIATION

As the science leaders of the Academy of Nutrition and Dietetics, American Academy of Pediatrics, American College of Cardiology, American Dental Association and 

71 

the American Medical Association, we are writing to clear up possible misunderstandings regarding scientific evidence and the 2015 Dietary Guidelines for Ameri- cans. We are concerned that the proposed language in the House’s Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies 

(section 734) and Departments of Labor, Health and Human Services and Education 

and Related Agencies, (section 232) Fiscal Year 2016 Appropriations Bills is an overreach regarding the intention of evidence-based science. 

(1) Each revision to any nutritional or dietary information or guideline contained in the 2010 edition of the Dietary Guidelines for Americans 

and any new nutritional or dietary information or guideline to be included in the eighth edition of the Dietary Guidelines for Americans— 

(A) shall be based on scientific evidence that has been rated 

‘‘Grade I: Strong’’ by the grading rubric developed by the Nutrition 

Evidence Library of the Department of Agriculture; 

The Academy of Nutrition and Dietetics’ Evidence Analysis Library was 

established in 2004. The Nutrition Evidence Library was launched in July 2008 

by the Department of Agriculture’s Center for Nutrition Policy and Promotion and 

mirrors the Academy’s EAL but specializes in systematic reviews to inform 

Federal nutrition-related policies and programs. The NEL conducts systematic 

reviews on food and nutrition-related topics by using a rigorous, transparent and 

reproducible methodology to support Federal nutrition policies and programs. 

This process includes developing a specific research question on diet and 

health, developing a corresponding search plan for literature review designed to answer the research question, extracting data from existing literature as directed by the search plan, developing a conclusion statement 

to answer the question and grading the strength of evidence supporting 

the conclusion. A conclusion can be graded Strong, Moderate, Limited or 

Grade Not Assignable. 

The strong rating is reserved for bodies of evidence completely free from 

study design concerns or disagreements between findings. The nature of 

science and statistics is such that a small number of contrary findings is 

expected and a preponderance of evidence can overcome limitations of individual studies. Therefore, recommendations with a moderate rating, 

which indicates a sizable body of well-designed research with which the 

committee had no more than minor doubts, are more than sufficient to inform the Dietary Guidelines for Americans. 

The exclusion of recommendations with a moderate rating would strike several 

uncontested truths from the record available to USDA, including the relationships 

between sugar and cavities and between a sedentary lifestyle and obesity. Additionally, the current language would bar USDA and HHS from supporting two recommendations derived from emerging science that are vital to the health of Americans: the use of school-based nutrition and exercise programs to prevent obesity and 

the reduction of added sugar intake to prevent heart disease. Obesity and heart disease are deadly and costly burdens to the nation and Americans deserve access to 

the knowledge of every effective tool to combat them. 

Nutrition focused systematic reviews, unlike pharmaceutical research, use a 

plethora of methodology, not just randomize clinical trials. The reason for a paucity 

of randomized clinical trials in nutrition literature is multifactorial but basically 

people must eat to survive and thus pure control groups are difficult. Fortunately, 

many new research methods are becoming acceptable to study key research questions relating to the health of the public. Unfortunately, many of these have yet to 

be utilized to fill the current large gaps in human nutrition research. Currently, the 

published food and nutrition research, which has been funded by the government, 

foundation and industry is a mixture of clinical trials, observational trials and cohort and case studies the latter of which do not receive as high of a grade value 

as randomized clinical trials. Thus, if the United States is to continue to guide the 

American population on healthy eating choices to prevent disease and have optimal 

health we must accept conclusion statements that are less than Grade 1 while futuristically funding rigorously designed food and nutrition studies in a variety of 

populations to fill the prevalent nutrition research gaps. 

The DGAC’s scientific conclusions and HHS/USDA’s final development of the Dietary Guidelines use more than one question or source of evidence, such as NEL systematic reviews. The DGAC considered seven questions examining the relationship 

between dietary patterns and health outcomes, including cancer, type 2 diabetes and 

cardiovascular disease. The DGAC also reviewed evidence using a process known as 

72 

food pattern modeling to describe the combination of foods and drinks a person 

should consume to meet nutrient needs and the impact on chronic disease. The final 

Dietary Guidelines consider all this information. 

Nutrition is an evolving science and a lack of evidence or limited evidence for one 

specific question does not mean that there is not strong evidence to support guidance. DGA recommendations have historically been made drawing upon both 

‘‘Strong’’ and ‘‘Moderate’’ strength evidence. The Dietary Guidelines are developed 

based on the preponderance of the strongest available evidence. Limited or Moderate evidence for one health outcome could greatly limit the ability to provide guidance on dietary patterns when the evidence may be Strong for other health outcomes. Using the cutoff of ‘‘Strong’’ will significantly limit the ability to develop recommendations across the Dietary Guidelines. 

The 2010 Dietary Guidelines for Americans were based on the strongest evidence 

available, not just the evidence that was identified as Grade 1: Strong. Making a 

change for 2015 would create an inconsistency between recommendations in the 

2010 DGAs, some of which are supported by ‘‘Moderate’’ evidence. 

We ask that the House’s Departments of Agriculture, Rural Development, Food 

and Drug Administration and Related Agencies (section 734) and Departments of 

Labor, Health and Human Services and Education and Related Agencies, (section 

232) Fiscal Year 2016 Appropriations Bills not be included in the final spending 

package for Fiscal Year 2016. 

We would be glad to discuss this request further. Please feel free to connect Alison 

Steiber, Ph.D., R.D.N., Chief Science Officer for the Academy of Nutrition and Dietetics, with your questions. (asteiber@eatright.org). 

Thank you for your consideration. 

Respectfully, 

Academy of Nutrition and Dietetics; 

American Academy of Pediatrics; 

American College of Cardiology; 

American Dental Association; 

American Medical Association. 

STATEMENT OF ACADEMY OF NUTRITION AND DIETETICS; AMERICAN SOCIETY FOR

NUTRITION

As the food and nutrition leaders representing the of the Academy of Nutrition and Dietetics and the American Society for Nutrition, we ask for 

your support of the 2015 Dietary Guidelines process to continue without interference by Congress. We are concerned that the proposed language in 

the House’s Departments of Agriculture, Rural Development, Food and 

Drug Administration and Related Agencies (section 734) and Departments 

of Labor, Health and Human Services and Education and Related Agencies,(section 232) Fiscal Year 2016 Appropriations Bills will halt the 

progress of this important nutrition policy that could improve public 

health. 

The Dietary Guidelines for Americans are founded in evidence-based 

science and should be insulated as much as possible from political influences. The Nutrition Evidence Library (NEL) was launched in July 2008 by the Department of Agriculture’s Center for Nutrition Policy and Promotion. The NEL was 

built as an outgrowth from the Academy of Nutrition and Dietetics’ Evidence 

Analysis Library (EAL), developed in 2004. The NEL mirrors the Academy’s 

EAL but specializes in systematic reviews to inform Federal nutrition-related policies and programs. The NEL conducts systematic reviews on food and 

nutrition-related topics by using a rigorous, transparent and reproducible methodology to support Federal nutrition policies and programs. This process includes: 

• Developing specific research questions on diet and health. 

• Developing corresponding search plans for literature review designed 

to answer the research questions. 

• Extracting data from existing literature as directed by the search 

plans. 

• Developing conclusion statements to answer each question and grading 

the strength of evidence supporting the conclusion. 

A conclusion can be graded Strong, Moderate, Limited or Grade Not Assignable. The Strong rating is reserved for bodies of evidence completely 

free from study design concerns or disagreements between findings, which 

is rare. Science and statistics expect a small number of contrary findings 

73 

and it is the ‘‘preponderance of evidence’’ that can overcome limitations of 

individual studies. As a result, recommendations with a Moderate rating, 

which indicates a sizable body of well-designed research with which the 

Dietary Guidelines Advisory Committee (DGAC) had no more than minor 

doubts, are more than sufficient to develop the Dietary Guidelines for 

Americans. The exclusion of recommendations with a Moderate rating 

would eliminate several uncontested truths from the record available to 

USDA and HHS and interfere with helping Americans consume a healthy 

diet. 

Nutrition-focused systematic reviews draw on several types of methodologies, not just randomized clinical trials. The reason for this lack of 

randomized clinical trials in nutrition is multi-faceted, but, most important, people must eat to survive and pure control groups are ethically difficult. Large clinical trials are also very costly and take many years to complete. Fortunately, new research methods are becoming acceptable to study 

key research questions relating to the health of the population, which will hopefully 

enhance nutrition related research. Currently, the published food and nutrition research, which has been funded by government, foundations and industry, is a mixture of randomized controlled trials and observational studies which include prospective cohort and case-control studies. The NEL and the DGAC utilized only randomized controlled trials and prospective cohorts and did not consider results from 

case-control studies due to the potential for bias or weaker designs such as case reports or ecological studies. If we are to continue to guide the American population 

on healthy eating choices to prevent disease and have optimal health, we must accept recommendations that are rated less than Strong. The DGAC’s scientific conclusions and HHS/USDA’s final development of the Dietary Guidelines use more than 

one question or source of evidence, such as NEL systematic reviews. The DGAC also 

conducted de novo data analysis using data from our national nutrition surveillance 

system (the National Health and Nutrition Examination Survey, NHANES) and reviewed evidence using a process known as food pattern modeling, which is used to 

describe the combination of foods and drinks a person should consume to meet nutrient needs without exceeding calorie intake to maximize health benefits and reduce risk of diet-related chronic disease. The final Dietary Guidelines for Americans 

will consider all this information. 

Nutrition, like all sciences, evolves with new research and information. A lack of 

evidence or limited evidence for one specific question does not mean that there is 

not strong evidence to support guidance. The Dietary Guidelines will continue to be 

developed on the preponderance of the strongest available evidence available at the 

time. Limited or Moderate evidence for one health outcome could greatly limit the 

ability to provide guidance on dietary patterns when the evidence may be Strong 

for other health outcomes. Using the cutoff of ‘‘Strong’’ will significantly limit the 

ability to develop recommendations across the Dietary Guidelines and could therefore undermine advances in improving public health. 

We ask that the House’s Departments of Agriculture, Rural Development, Food 

and Drug Administration and Related Agencies (section 734) and Departments of 

Labor, Health and Human Services and Education and Related Agencies, (section 

232) Fiscal Year 2016 Appropriations Bills not be included in the final spending 

package for Fiscal Year 2016 based on their current language regarding the Dietary 

Guidelines for Americans. 

We would be glad to discuss this request further. Please feel free to connect Alison 

Steiber Ph.D., R.D.N., Chief Science Officer of the Academy of Nutrition and Dietetics, at asteiber@eatright.org or Mary Pat Raimondi, Vice President at 

mraimondi@eatright.org with your questions. 

Thank you for your consideration. 

Respectfully, 

Academy of Nutrition and Dietetics; 

American Society for Nutrition. 

SUBMITTED STATEMENT BY EDWARD ARCHER, PH.D., M.S., NIH/NIDDK RESEARCH

FELLOW, NUTRITION OBESITY RESEARCH CENTER, UNIVERSITY OF ALABAMA AT

BIRMINGHAM

Thank you Chairman Conaway, Ranking Member Peterson, and Members of the 

Committee for the opportunity to submit this statement for the record to the Committee on Agriculture, United States House of Representatives. My name is Dr. Edward Archer and I am currently an NIH/NIDDK Research Fellow at the Nutrition 

74 

1 Exhibit A.* 

* Editor’s note: this document is retained in Committee file. 2 Exhibit B (Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and, Carl J. Lavie, M.D., The Inadmissibility of What We Eat in America and NHANES Dietary Data in NUTRITION AND OBESITY

RESEARCH and the Scientific Formulation of National Dietary Guidelines, MAYO CLIN. PROC., 

90(7): 911–926 (July 2015), also available at http://dx.doi.org/10.1016/j.mayocp.2015.04.009 

(last accessed Oct. 19, 2015). 3 Id. at 911 (emphasis added). 4 Id. 

5 Id. at 914 (emphasis added). ‘‘Incompatible with life’’ means the survey respondent could 

notsurvive on the amount of food and beverages he or she reported consuming. 6 Id. at 911 (emphasis added). 7 Id. (emphasis added). 8 Id. (emphasis added). 9 Chairman K. Michael Conaway, U.S. House of Rep. Comm. on Agric., Full Committee—Public Hearing: 2015 Dietary Guidelines for Americans (Oct. 7, 2015), Videotape at 00.01.05– 

Obesity Research Center, University of Alabama at Birmingham. I hold multiple 

graduate degrees including a Doctorate and two Masters of Science degrees with extensive training in physiology, psychology, nutrition, exercise science, and epidemiology. I have conducted extensive research, lectured, and published scientific papers 

in peer-reviewed journals regarding obesity, nutrition, and physical activity, particularly as they relate to the Dietary Guidelines published jointly by the United States 

Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA). My curriculum vitae is attached.1

I am submitting this Statement for the Record because my research and a recent 

scientific paper of mine published in the July 2015 issue of Mayo Clinical Proceedings directly address the subject matter of this hearing, namely, the biased, unscientific methods used by USDA and HHS to collect the dietary data that have informed dietary and nutritional guidelines over the past 40 years. My paper, entitled 

The Inadmissibility of What We Eat in America and NHANES Dietary Data in NUTRITION AND OBESITY RESEARCH and the Scientific Formulation of National Dietary 

Guidelines,2 outlines the lack of valid scientific evidence for and consequent confusion in Federal dietary guidance. 

As this paper explains, ‘‘[t]he Scientific Report of the 2015 Dietary Guidelines Advisory Committee was primarily informed by memory-based dietary assessment 

methods (M–BMs) (e.g., interviews and surveys). The reliance on M–BMs to inform 

dietary policy continues despite decades of unequivocal evidence that M–BM data 

bear little relation to actual energy and nutrient consumption. Data from M–BMs 

are defended as valid and valuable despite no empirical support and no examination 

of the foundational assumptions regarding the validity of human memory and retrospective recall in dietary assessment. We assert that uncritical faith in the validity and value of M–BMs has wasted substantial resources and constitutes 

the greatest impediment to scientific progress in obesity and nutrition research.’’ 3

The evidence is conclusive in this regard: ‘‘M–BMs are fundamentally and fatally 

flawed owing to well-established scientific facts and analytic truths.’’ 4 This is so for 

the following reasons: 

• M–BM produce data that are ‘‘physiologically implausible’’ and often ‘‘incompatible with life.’’ 5

• ‘‘[T]he assumption that human memory can provide accurate or precise reproductions of past ingestive behavior is indisputably false.’’ 6

• ‘‘[T]he subjective (i.e., not publicly accessible) mental phenomena (i.e., memories) from which M–BM data are derived cannot be independently observed, 

quantified, or falsified; as such, these data are pseudoscientific and inadmissible in scientific research.’’ 7

• ‘‘Given the overwhelming evidence in support of our position, we conclude that 

M–BM data cannot be used to inform national Dietary Guidelines and that 

the continued funding of M–BMs constitutes an unscientific and major 

misuse of research resources.’’ 8

The results of the research reported in my paper demonstrate that the dietary 

data collected by the USDA and HHS via the National Health and Nutrition Examination Survey (NHANES) and analyzed by the 2015 Dietary Guidelines Advisory 

Committee (DGAC) were derived from fatally flawed, unscientific methods. As such, 

the USDA and HHS data are meaningless numbers, not scientific evidence. 

This finding is critical because, as Chairman Conaway correctly stated, dietary 

guidance should be ‘‘based on sound, consistent and irrefutable science.’’ 9 I assert 

75 

00.01.08 (emphasis added) (‘‘Hearing Videotape’’), available at https://www.youtube.com/ 

watch?v=x6DNns4oFao&feature=youtu.be (last accessed Oct. 19, 2015). 10 Ex. B at 914 (emphasis added). 11See supra note 9. 12 Hon. Sylvia Burwell, Sec’y, U.S. Dep’t of Health & Human Servs., Hearing Videotape 

at01.52.34–01.52.36 (emphasis added). 13 Ex. B at 914 (emphasis added). 14See supra note 12. 15 Hon. Tom Vilsack, Sec’y, U.S. Dep’t of Agric., Hearing Videotape at 01.21.32– 

01.21.34(emphasis added). 16 Ex. B at 914 (emphasis added). 17See supra note 15 at 00.12.26–00.12.30 (emphasis added). 18 Id. at 01.53.12–01.53.17 (emphasis added). 19Statement by Thomas J. Vilsack, Sec’y of Agric., U.S. House of Rep. Committee on 

Agric.(Oct. 7, 2015) at 5. 20See, e.g., Exhibit C (Archer E., Hand G.A., Blair S.N., Validity of U.S. Nutritional Surveillance: National Health and Nutrition Examination Survey Caloric Energy Intake Data, 1971– 

2010, PLOS ONE (2013), at 8(10):e76632), available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0076632 (last accessed Oct. 19, 2015). 21Pub. L. No. 106–554, H.R. 5658 (Treasury and Gen. Gov’t Appropriation Act for Fiscal Year 

2001, § 515 Appendix C, 114 Stat. 2763A–153 (2000) (effective Oct. 1, 2002). 

* The document referred to is retained in Committee file. 

* From the Office of Energetics, Nutrition Obesity Research Center, University of Alabama at 

Birmingham, Birmingham (E.A., G.P.); and Department of Cardiovascular Diseases, John 

Continued 

that because the NHANES dietary data are ‘‘incompatible with life’’ 10 and are 

therefore not representative of what Americans actually eat, it is clear that these 

data are unequivocally not ‘‘sound, consistent and irrefutable science.’’ 11

Importantly, the testimony and written statements of The Honorable Tom 

Vilsack, Secretary, United States Department of Agriculture, and The Honorable 

Sylvia Burwell, Secretary, United States Department of Health and Human Services, do not bear up under scientific review. For example, Secretary Burwell’s testimony that food pattern analyses allowed the DGAC to understand ‘‘what is it actually Americans are eating . . .’’ 12 is patently false. All food pattern analyses in the 

DGAC report were based on dietary data that are ‘‘incompatible with life.’’ 13 Food 

pattern analyses based on physiologically implausible data cannot be representative 

of ‘‘what is it actually Americans are eating.’’ 14

Secretary Vilsack testified ‘‘we should take a look at the Healthy Eating Index.’’ 15

The Healthy Eating Index estimates are derived from the physiologically implausible NHANES dietary data. It should be obvious that a valid Healthy Eating Index 

cannot be created from dietary data that are ‘‘incompatible with life.’’ 16

Secretary Vilsack also testified the DGAC review process produces the ‘‘strongest, 

best . . . available science’’ 17 and the ‘‘best science . . . best available science . . . 

and least biased science’’ 18 and wrote ‘‘the 2015 Dietary Guidelines for Americans 

will be grounded in the preponderance of the best available scientific evidence.’’ 19

These statements are patently false. Data from scientific papers demonstrating 

the implausible nature of both M–BM and the NHANES dietary data 20 were excluded from the 2015 DGAC’s report, and have been excluded from all previous 

DGAC reports. The decades-long exclusion of contrary data is in violation of 

the Data Quality Act,21 and is indicative of the bias and scientific misconduct (i.e., omission of data) of the DGAC. 

Sincerely, 

EDWARD ARCHER, PH.D., M.S. 

EXHIBIT A * 

EXHIBIT B

The Inadmissibility of What We Eat in America and NHANES Dietary Data 

in Nutrition and Obesity Research and the Scientific Formulation of National Dietary Guidelines 

MAYO CLINIC PROCEEDINGS

Article in Press≥Special Article 

Mayo Clin Proc. n XXX 2015;nn(n):1–16 n http://dx.doi.org/10.1016/ 

j.mayocp.2015.04.009 ■ www.mayoclinicproceedings.org ■ 2015 Mayo Foundation for Medical Education and Research.* 


11429012.eps
76 

Ochsner Heart and Vascular Institute, Ochsner Clinical School the University of Queensland 

School of Medicine, New Orleans, LA (C.J.L.). 

Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and Carl J. Lavie, M.D. 

Abstract 

The Scientific Report of the 2015 Dietary Guidelines Advisory Committee was primarily informed by memory-based dietary assessment methods (M–BMs) (e.g., interviews and surveys). The reliance on M–BMs to inform dietary policy continues despite decades of unequivocal evidence that M–BM data bear little relation to actual 

energy and nutrient consumption. Data from M–BMs are defended as valid and valuable despite no empirical support and no examination of the foundational assumptions regarding the validity of human memory and retrospective recall in dietary assessment. We assert that uncritical faith in the validity and value of M–BMs has 

wasted substantial resources and constitutes the greatest impediment to scientific 

progress in obesity and nutrition research. Herein, we present evidence that M–BMs 

are fundamentally and fatally flawed owing to well-established scientific facts and 

analytic truths. First, the assumption that human memory can provide accurate or 

precise reproductions of past ingestive behavior is indisputably false. Second, M– 

BMs require participants to submit to protocols that mimic procedures known to induce false recall. Third, the subjective (i.e., not publicly accessible) mental phenomena (i.e., memories) from which M–BM data are derived cannot be independently observed, quantified, or falsified; as such, these data are pseudoscientific and 

inadmissible in scientific research. Fourth, the failure to objectively measure physical activity in analyses renders inferences regarding diet-health relationships 

equivocal. Given the overwhelming evidence in support of our position, we conclude 

that M–BM data cannot be used to inform national Dietary Guidelines and that the 

continued funding of M–BMs constitutes an unscientific and major misuse of research resources. 

©2015 Mayo Foundation for Medical Education and Research ■ Mayo 

Clin Proc. 2015;nn(n):1–16. 

When the facts change, I change my mind. 

What do you do, sir? 

JOHN MAYNARD KEYNES 1, p. 19

Success, Failure, and Confusion in Nutrition Research 

During the past century, our nation’s food supply and the nutritional status of 

Americans have improved to a level unparalleled in human history.2–3 Although this 

reality may be contrary to the popular belief that our modern diet is inherently inadequate, the data are clear. In the early 20th century, nutritional diseases such 

as pellagra, beriberi, rickets, and goiter were substantial public health challenges. 

In the United States alone, pellagra (a disease of niacin deficiency) claimed more 

than 100,000 lives and severely affected more than three million people.4 Yet in 

2013, the Centers for Disease Control and Prevention’s Second National Report on 

Biochemical Indicators of Diet and Nutrition reported that nearly ‘‘80% of Americans (aged ≥6 y) were not at risk of deficiencies in any of the 7 vitamins’’ 4, p. 938

examined via biomarkers (i.e., vitamins A, B6, B12, C, D, E, and folate; emphasis 

added).2 In addition, approximately 90% of women of childbearing age (12–49 years) 

were not at risk for iron deficiency, and folate levels have increased by approximately 50% since the previous national report.2, 5 As such, most of the U.S. population is not at risk for nutritional deficiencies, and neither do they have nutritional 

deficienciesand associated diseases. 

Given these important improvements in diet-related health and recent work demonstrating that nongenetic evolution is the predominant driver of the diseases of excess (e.g., obesity and type 2 diabetes mellitus),6–8 it can be posited that diet is no 

longer a major risk factor for disease for most Americans. If accurate, this hypothesis suggests that the billions of research dollars targeted for diet and nutrition-related health research are misdirected.9–10 Nevertheless, despite the important dietary milestones of the past century and the substantial increases in Federal funding 

during the past 2 decades,9–10 research into human nutrition has been increasingly 

criticized.11–13 The genesis of these criticisms is the appalling track record of highly 

publicized nutrition claims derived from epidemiologic studies (e.g., see the studies 

by Stampfer, et al.14 and Rimm, et al.15) that consistently failed to be supported 

when tested using objective study designs. 11, 16 Young and Karr examined 17 more 

than 50 nutritional claims from observational studies for a variety of dietary patterns and nutrient supplementation and found that ‘‘100% of the observational 

claims failed to replicate’’ p. 117 and that five claims were statistically significant ‘‘in 

77 

the opposite direction.’’ p. 117 These outcomes and others 18–21 suggest that as often 

as not, when epidemiologic nutrition claims are tested against objective research 

methods, the results are either inconclusive or indicative of a contrary outcome. 

A Failed Research Paradigm 

Epidemiologic studies suggest that almost any nutrient can be associated with a 

myriad of outcomes,11, 22 as observed in Schoenfeld and Ioannidis’ article, ‘‘Is Everything We Eat Associated With Cancer?’’ 22, p. 117 With persistent cycles of specious 

nutrition claims in the media, it is not surprising that the public is confused and 

incredulous.23 Insofar as the provision of clear and consistent Dietary Guidelines for 

the consuming public is a goal of nutrition epidemiology, it has failed in decisively 

answering the simple question, ‘‘What should we eat?’’ 24 Nowhere is this fact more 

evident than the shifting sands of opinion on the relative risks of fat, salt, cholesterol, and sugar.25–30 Five decades of controversy surrounding basic Dietary Guidelines and nutrition recommendations is a public acknowledgement of a failed research paradigm. The striking incongruence between the improvements in the nutritional status of the U.S. population2, 5 and the current state of confusion, controversy, and clinical failure of epidemiologic nutrition research could not be clearer 

and necessitates an examination of the validity and value of epidemiologic nutrition 

research. 

Purpose of this Review 

Memory-based dietary assessment methods (M–BMs) (e.g., interviews, questionnaires, and surveys 31–32) are the dominant data collection protocols in national nutrition surveillance 33 and government-funded epidemiologic nutrition 34 and obesity 33 research. Importantly, M–BM data are used to inform national nutritional 

policy and Dietary Guidelines.30 The recent Scientific Report of the 2015 Dietary 

Guidelines Advisory Committee (DGAC) stated explicitly that most of the DGAC 

data analyses used the M–BMs of the National Health and Nutrition Examination 

Survey (NHANES) dietary component, What We Eat in America (WWEIA).30 Although decades of unequivocal evidence demonstrate that the indirect, proxy estimates derived from M–BMs bear little relation to actual energy or nutrient consumption,13, 33, 35–45 the underlying assumptions regarding the validity of human 

memory and recall in dietary assessment have not been questioned. To the contrary, 

M–BM data are vigorously defended as valid and inherently valuable despite no empirical support for those assertions.46 Although the relationship between two different constructs may be expected to be weak, the trivial relationships between the 

proxy estimates (i.e., self-reported energy intake [EI] and nutrient intake) and their 

referents (i.e., actual EI and nutrient intake) are unacceptable. We assert that the 

explanatory and predictive failure of epidemiologic nutrition research is explained 

by its reliance on M–BMs, and, as such, the uncritical faith in the validity and value 

of M–BMs has wasted significant resources and constitutes the single greatest impediment to actual scientific progress in the fields of obesity and nutrition research. 

The purpose of this review is to survey the explanatory and predictive failure of 

nutrition epidemiology in general,11, 17 with a focus on the WWEIA–NHANES 

data,33 and argue that these failures are due to the reliance on M–BMs. First, we 

present evidence that the anecdotally derived proxy data produced by M–BMs bear 

little relation to actual EI or nutrient consumption.13, 33, 35–45 Second, we provide 

interdisciplinary evidence that human memory is an amalgam of constructive and 

reconstructive processes 47–52 (e.g., imagination 53) that render the archival model of 

human memory 54 and the naı ̈ve assumption that recall provides literal, accurate, 

or precise reproductions of past events indisputably false.50, 52, 55–58 Third, M–BMs 

require respondents to undergo protocols 59 and perform behaviors 31 that mimic procedures known to induce false recall.50, 52, 53, 60, 61 Fourth, the subjective (i.e., private, not publicly accessible) mental phenomena (i.e., memories) from which M–BM 

data are derived are not subject to independent observation, quantification, falsification, or verification; as such, M–BM data are pseudoscientific and inadmissible in 

scientific research.62–66 Fifth, the failure to accurately and objectively measure and 

control for physical activity (PA), cardiorespiratory fitness (CRF), and other obvious 

confounders annuls inferences regarding diet-health relationships. 

The M–BMs of Nutrition Epidemiology 

Self-Reported Dietary Intake 

The primary methods of data collection for nutrition epidemiologic research (e.g., 

the WWEIA–NHANES) are M–BMs (e.g., 24 hour dietary recalls [24HRs] and food 

frequency questionnaires [FFQs] 31–33). For clarity, these methods do not directly or 

objectively measure EI or nutrient intake, and neither do they directly or objectively 

measure food and beverage consumption. The actual data derived from M–BMs are 

78 

the a priori numeric values from nutrient databases that are assigned by researchers to the participants’ reports of their memories of past eating and drinking behaviors. In other words, nutrition researchers designate numeric values to whatever the 

respondents are willing or able to recall about what they think (or would like the 

researcher to think 67) he or she consumed during the study period. Given the indirect, pseudoquantitative (i.e., number-generating 68) nature of M–BMs and the fact 

that the respondents’ reports of their memories are subject to intentional and unintentional distorting factors (e.g., perceptual, encoding, and retrieval errors; 69 social 

desirability; 42 false memories; 55 and omissions 48, 49, 70), it is not surprising that 

most conclusions drawn from these number-generating protocols have not been supported when subjected to rigorous objective examination.11, 17

The Implausibility of M–BMs in Dietary Assessment 

It is the natural tendency of the ignorant to believe what is not true. In 

order to overcome that tendency it is not sufficient to exhibit the true; it is 

also necessary to expose and denounce the false. 

H.L. MENCKEN 71, p. 124

Research into M–BMs reports a wide range of EIs that are not physiologically 

plausible (i.e., incompatible with survival) and that do not accurately quantify the 

foods and nutrients consumed.11, 33, 35, 38–40, 42 Recently, we used multiple methods 

to ascertain the validity and plausibility of the NHANES and WWEIA–NHANES EI 

data from 1971 to 2010 33 and found that they had such severe systematic biases 

as to render them fatally flawed. Given that ‘‘[a] cross the 39 year history of the 

NHANES, [self-reported energy intake] data on the majority of respondents (67.3% 

of women and 58.7% of men) were not physiologically plausible’’ 33 (Figure), we concluded that these data are not valid for any inferences regarding EI and the etiology 

of the obesity epidemic. A recent editorial in the British Medical Journal concurred 

and stated that the NHANES dietary data are ‘‘incompatible with life.’’ 11, p. 7

In a previous report,33 we used two objective, physiologically based methods to determine misreporting: (1) Goldberg cutoff values 44, 45, 72 (i.e., reported EI [rEI] divided by basal metabolic rate [BMR]) and (2) the disparity between the Institute of 

Medicine total energy expenditure (TEE) equations 73 and rEI via NHANES MBMs. 

The two methods were in close agreement, demonstrating significant misreporting. 

The cutoff values we used (i.e., rEI/BMR <1.35 and >2.40) were more generous than 

the rEI/BMR cutoff value of 1.50 suggested by Goldberg et al.45 when using a single 

24HR, and the BMR is ‘‘predicted from the Schofield equations’’ with a sample size 

of 300 or greater.45, p. 577 Given the reduced sensitivity of the cutoff values, we captured far fewer under-reporters. As reported, when using the proposed cutoff value 

of 1.50, under-reporting increased to more than 70% for the entire NHANES sample 

and to approximately 77% and 85% for obese men and women, respectively. We also 

reported the large and significant disparity between rEI and the Institute of Medicine TEE: ¥467 and ¥554 kcal/d (>17% and 30%) for obese men and women, respectively. In addition to under-reporting, there was significant overreporting in all 

of the subpopulations (e.g., normal, overweight, and obese men and women). One 

important caveat with the use of cutoff values is that the term plausible reporter 

is not synonymous with accurate reporter. Participants with high levels of PA may 

substantially underreport yet still be considered plausible reporters. 

79 

Figure 

Percentage of implausible reporters by body mass index (BMI) for U.S. 

women aged 20 to 74 years in the National Health and Nutrition Examination Survey (NHANES) (1971–2010). Physiologically implausible values 

were determined via the following equation: (reported energy intake/basal 

metabolic rate) ≤1.35. Implausible values may be considered ‘‘incompatible 

with life.’’ 11, p. 7

Given these results, we ask four questions, (1) What is the value of WWEIA– 

NHANES M–BM data if 70% to 80% of obese women’s self-reported EI is physiologically implausible and, therefore, incompatible with life (Figure)? (2) Given the extant objective data on the nutrition-related health status of Americans,2 why does 

the DGAC rely on the subjective M–BM data? 30 (3) What is the ‘‘unrealized potential’’ 46, p. 447 and ‘‘utility’’ 74, p. 5 of these data when implausible overreporting and 

implausible underreporting are demonstrated in all of the subgroups? (4) Can statistical alchemy transform these implausible data into valid estimates of dietary consumption, or will it continue to spawn searches for machinations that generate numbers with improved correlations (i.e., post hoc data manipulation) while ignoring the 

lack of validity? 

The Pervasiveness of Implausible Results 

The conclusions drawn by our study 33 and the recent British Medical Journal editorial 11 are, in fact, supported by many decades of evidence demonstrating that M– 

BMs have severe, intractable systematic biases that render the data implausible 

and, therefore, invalid.11, 13, 37, 44, 75, 76 Research with ‘‘. . . motivated . . . well-educated, non-smoking-Caucasians’’ 35, p. 957 (i.e., respondents less likely to misreport) 

demonstrated that compared with doubly labeled water, a biomarker for TEE, selfreported dietary intake was significantly misestimated.35, 38 Men underreported EI 

12% to 14% using the average of two 24HRs and 31% to 36% using FFQs. Women 

underreported by 16% to 20% using the average of two 24HRs and by 34%to 38% 

using FFQs. Contrary to the oft-repeated statement that additional self-reports improve precision and accuracy, the second administration of the 24HR ‘‘showed greater underreporting.’’ 38, p. 12 These results are in agreement with our analyses of the 

NHANES in which the mean estimates for the second 24HR in every NHANES 

wave from 2001 to 2010 exhibited significantly greater levels of underreporting than 

the first. We agree with the authors of the Observing Protein and Energy Nutrition 

study when they wrote, ‘‘[w]e measure energy so poorly . . .’’ 38, p. 12 and ‘‘[t]he 

24HR . . . may be particularly problematic in the obese.’’ 35,p956 These words echo 

statements on underreporting from 60 years ago.77

Recently, some of the strongest proponents of M–BMs have provided additional 

data that clearly demonstrate the futility of the continued use of these methods.36

In the paper by Freedman, et al.,36 the pooled, squared average correlation between 

true EI and self-reported EI were similar to our results using NHANES data, ranging from 0.04 to 0.10. This suggests that the measurement noise (i.e., error) is more 

than nine times greater than the signal (i.e., valid information) derived from M– 

BMs. Nevertheless, an important finding from the Observing Protein and Energy 


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80 

Nutrition study that Freedman, et al.36 overlook in their analyses is that despite 

the fact that the second administration of the 24HR ‘‘showed greater underreporting,’’ 38, p. 12 the correlations between true and reported EI increased. This 

demonstrates an increase in precision with a concomitant reduction in the accuracy 

of the estimate. These results clearly support our position that M–BM data ‘‘offer 

an inadequate basis for scientific conclusions’’ 13, p. 1413 and, more importantly, that 

statistical machinations, however sophisticated, cannot overcome the systematic recall bias that renders all inferences suspect.41, 78

The phenomenon of misreporting is not limited to U.S. epidemiologic studies or 

specific populations.45 The European Prospective Investigation Into Cancer and Nutrition study is one of the largest epidemiologic studies in the world and found 

strong evidence of systemic underreporting across all study sites, with approximately 10% to 14% of survey respondents being ‘‘extreme underreporters,’’ 79, p. 1329

and ‘‘. . . most centres were below the expected reference value.’’ 79, p. 1330 These results are consistent with research from the early 1990s that found that more than 

65% of the mean rEI values were physiologically implausible in 37 studies across 

ten countries.45 The misreporting value of more than 65% is strikingly similar to 

our NHANES results using similar methods.33 In 2015, a multinational report demonstrated that misreporting ‘‘in five populations of the African Diaspora’’ 80, p. 464

was substantial, with the South African cohort exhibiting an astounding 52.1% 

underreporting of dietary EI.80 With respect to age, Forrestal 81 found in children 

and adolescents that misreporting ‘‘. . . appeared to be more common than it is 

among adults.’’ p. 112 The ubiquitous nature of misreporting and the consistency of 

research results over many decades and across multiple populations, cohorts, and 

countries provide strong support that M–BM measures of EI are fatally flawed, and, 

therefore, diet-health inferences from studies that use M–BMs are essentially meaningless. 

Examinations of Dietary Patterns via M–BMs 

It is well-established that specific macronutrients, foods, beverages, and food 

groups (e.g., protein, fat, carbohydrate, alcohol, sugar, and vegetables) are subject 

to differential misreporting that significantly affects subsequent estimates of EI.38,

78, 82–88 Because EI is the foundation of dietary consumption and all nutrients must 

be consumed within the quantity of food and beverages needed to meet minimum 

energy requirements,89 it is a logical and analytic truth that dietary patterns (i.e., 

macronutrient and micronutrient consumption; e.g., protein, carbohydrate, fat, vitamins, and minerals) are differentially and unpredictably misreported when total rEI 

is physiologically implausible. For example, both macronutrient and micronutrient 

composition are significantly altered in underreporters, with reported fat and carbohydrate consumption often lower and reported protein, fruit, and vegetable intakes 

higher.42, 82, 86 In other words, participants qualitatively and quantitatively 

misreport owing to both unintentional (e.g., forgetting and false memories) and intentional (e.g., health-related perceptions) factors. This nonuniformity of 

misreporting leads to macronutrient- and micronutrient-specific errors,86 –87 which 

alter nutrient to EI ratios in an unpredictable and nonquantifiable manner. This 

simple fact renders energy adjustments fallacious 41, 78 and demonstrates that the 

assumption that M–BM data can be used to examine patterns of diet or dietary composition is not logically valid. 

The Validity of Human Memory and Recall as Instruments for the Generation of Scientific Data 

Overview 

The use of M–BMs requires faith in the belief that human perception, memory, 

and recall are accurate and reliable instruments for the generation of scientific data. 

Nevertheless, more than 80 years of research demonstrates that this belief is patently false.50, 58, 70, 90 The discrepancy between objective reality and human memory 

is well established,48, 91 and the limitations of recall are widely acknowledged in disciplines outside of nutrition and obesity.47–49, 69, 70, 92 In fact, the scientific study and 

analysis of memory would be impossible if it were not for the inherent fallibility of 

memory.49 Bartlett 93 presented the first empirical evidence that the human memory 

is not a literal, accurate, or precise reproduction of past events. During the ensuing 

80 years, research has clearly demonstrated that the encoding of memories 69, 91 and 

subsequent recall depend on constructive and reconstructive processes (e.g., imagination) 48, 69, 53 that are susceptible to errors, distortions, omissions, complete fabrications, false reports, and illusions.50, 58, 69, 70, 90

Given the breadth of this research, reported memories, such as those presented 

in 24HRs and FFQs, can be most accurately defined as mere attributions based on 

mental experiences that are strongly influenced by the respondents’ idiosyncratic 

81 

qualities (i.e., education), previous memories and information, knowledge and beliefs, motives, goals, habitual behavior, and the social context in which the memories are encoded or reported.47, 49, 58 Perhaps the most salient example of the fallibility of memory and recall (and misplaced confidence) is that false reporting (i.e., 

inaccurate eyewitness testimony) was a key factor in approximately 75% of the first 

100 cases of individuals exonerated by DNA evidence after conviction for crimes that 

they did not commit.57 The following subsections provide a survey of the evidence 

to support the contention that data can be only as valid as the accuracy of the instrument used in its collection and that human memory and recall are not valid instruments for the generation of data to be used in the scientific formulation of nutrition guidelines. 

The Social Sciences 

Numerous studies, dating back more than 50 years, have reported that there is 

little or no correlation between self-reported behavior and actual behavior.94–95 Bernard, et al.58 reviewed the validity of self-reported data in ‘‘The Problem of Informant Accuracy.’’ Surveying multiple research domains, including health care, child 

care, communications, nutrition, criminal justice, economics, anthropology, and psychology, Bernard, et al.58 concluded that ‘‘[t]he results of all of these studies leads 

to one overwhelming conclusion: on average, about 1⁄2 of what informants report is 

probably incorrect in some way.’’ p. 503 Bernard, et al.58 also provide a prescient commentary: ‘‘In sum, despite the evidence, the basic fact of informant inaccuracy seems 

not to have penetrated either graduate training or professional social science research. Informant inaccuracy remains both a fugitive problem and a well-kept open 

secret.’’ p. 504 Given the substantial funding of M–BMs each year,9 –10 it seems that 

this 30 year old commentary also applies to nutrition and obesity research. 

Furthermore, when events or behaviors are commonplace (e.g., food and beverage 

consumption), previous experiences (e.g., previous memories and mental schema 69,

96 of past meals) will determine what is encoded in memory and not the actual perception of behavior. For example, Freeman, et al.97 demonstrated a 52% error rate 

in recalling social interactions, with reports of social interactions shaped by typical 

past experiences. They explain their results by suggesting that when events are repeatedly experienced, each specific event will be minimally processed and the ‘‘actual memory of such elements will be poor,’’ and ‘‘attempts at recall result in a constructive process that taps into the general structure rather than the specific memory.’’ 97, p. 315

Importantly, Bernard, et al.58 lamented two common problems with social scientific data: (1) the lack of an explicit formal theory of human behavior and (2) objective evidence from which to test the plausibility of self-reported data. Nevertheless, nutrition epidemiologists have both a formal theory (i.e., human metabolism 

and the basic energy requirements of human life) and voluminous objective 

data 44–45 by which to test the validity of M–BMs.33 Despite the availability of formal theory and overwhelming evidence that self-reported EI data are not accurate, 

‘‘plausible,’’ 33 or even ‘‘compatible with life,’’ 11, p.7 self-reported EI continues to be 

assumed a valid-measure of actual energy and nutrient consumption that can be 

used to inform public nutrition and dietary policy.30

A detailed review of the social research literature is beyond the scope of this 

paper, and we direct our readers to Bernard, et al.’s review.58 Nevertheless, one 

more notable example is warranted. Immediately on leaving a restaurant, 

Kronenfeld, et al.98 had participants report on the attire of the waitstaff and the 

restaurants’ choice of music.58 Participants demonstrated much greater agreement 

on what the waiters were wearing compared with the waitresses’ attire. The interesting finding was that these restaurants had an all-female waitstaff (i.e., there 

were no waiters in the restaurants). Participants also provided much greater detail 

on the music from restaurants that were not playing music than from restaurants 

that were.58, 98 These results raise the question: What is the possibility that selfreported food and beverage consumption in a restaurant setting will be a literal, accurate, or reliable representation of actual ingestive behavior? 

Cognitive Neuroscience 

The domain of cognitive neuroscience supports the hypothesis that human memory is an amalgam of dynamic constructive and reconstructive processes.47–53, 55–57,

69, 70 For example, encoding is not a process that begins de novo with each perception. Encoding is the result of the limited amount of information available to perception at any given moment being ‘‘patched together to form memories with varying 

degrees of accuracy’’ 49, p. 149 (e.g., the process of associative grouping via semantic 

relatedness 50, 92, 99) and subject to ‘‘the distorting influences of present knowledge, 

beliefs, and . . . previous experience.’’ 49, p. 149 As such, the general knowledge and 

82 

availability of mental schemas from previous eating occasions intrude on the encoding of current consumption to produce false and fuzzy (i.e., gist) memories.51, 100

Memory and recall are subject to a myriad of unintentional ‘‘sins,’’ 70 including but 

not limited to distortions, misattribution, suggestibility, simple forgetting, falsehoods, and omissions.49, 90–91 Because selective and elaborative processes operate on 

the perceptions that are encoded and recalled, ‘‘memory does not [and cannot] operate like a video recording.’’ 57, p. 119

Recently, the process of reconsolidation (i.e., the reconstruction and re-encoding of 

memories after recall) has been demonstrated in rodents, and the evidence in humans is supportive.101–102 Reconsolidation involves the same neural processes as the 

encoding of the original memory.91 Therefore, each time a memory is recalled, it is 

irretrievably changed such that the original memory no longer exists and a new 

memory of unquantifiable error replaces it.101–102 This fact has implications for the 

current state-of-the-art 24HR instrument the U.S. Department of Agriculture 

(USDA) Automated Multiple-Pass Method.31 With each pass of the multipass procedure, the process of reconsolidation alters the original memory so that by the end 

of the data collection period, the result will be an amalgam of multiple new memories and reports with unquantifiable error. As such, neither the researchers nor the 

participants know the validity or reliability of the reported food and beverage consumption. 

False Reporting: An Inherent Design Feature of M–BMs 

False Reporting and FFQs 

False reports are the recollection of an event, or details of an event, that did not 

actually occur.69 False memories and recalls may be produced in multiple contexts 

(e.g., during research,55, 103 psychotherapy, and criminal investigatory interviews 60). 

Although research has demonstrated that false memories of ingestive behavior and 

subsequent false reporting of foods occur in laboratory settings,55, 61, 103 there is a 

larger literature base outside of nutrition. The Deese-Roediger and McDermott 

(DRM) paradigm is commonly used in research settings to elicit false reports.104–105

In this protocol, a list of semantically related words (e.g., breakfast, bacon, sausage, 

orange juice, and cereal) are presented or read to participants. After a delay (minutes to days), participants are asked to report the words they remember. The mere 

presentation of lists of semantically related words induces extremely high levels 

(i.e., >75%) of the false reporting of related but nonpresented words (i.e., critical 

lures; 49, 99, 105 e.g., the word egg in the previous example). The DRM paradigm is 

so effective at inducing false reports that memory distortions occur even in the 

small percentage of individuals with highly superior memories.50 With the DRM 

paradigm, respondents are often more confident in their false reports than in the 

presented words.92

Researchers familiar with FFQs will recognize that, by design, FFQs mimic the 

DRM protocol in that lists of semantically related words (i.e., foods and beverages) 

are presented and respondents are expected to provide a response. Given that FFQs 

mimic the procedures designed to produce false recall, it is not surprising that FFQs 

with longer lists of semantically related words elicit more responses.106 Given the 

vast literature demonstrating misreporting with FFQs 35, 38, 42, 107 and the parallel 

literature on the extremely high level of false reports using the DRM paradigm,92,

100, 104–105 it is not a question of whether FFQs induce false reporting but to what 

extent. As stated previously, neither the researchers nor the participants know the 

validity or reliability of the reported food and beverage consumption, and neither 

can they quantify the error induced via false reporting. As we discuss in a later section, the inability of current nutrition epidemiologic research designs to independently falsify or confirm M–BM data renders the error due to false reports 

unquantifiable and, therefore, inadmissible as scientific data. 

False Reporting and the WWEIA–NHANES 24HR 

Recent research has examined the effects of creating ‘‘false memories for food preferences and choices.’’ 55, 61, p. 134 We refer our readers to a review by Bernstein and 

Loftus.55 Their work has established that it is relatively simple to ‘‘implant false 

beliefs and memories regarding a variety of early childhood food-related experiences.’’ 55, p. 138 We assert that false memories and reports are induced via the 

NHANES interview protocol itself, as has been demonstrated in other interviewing 

contexts.60 The factors that potentially induce false memories and reporting are well 

established. For example, the development of a rapport between an authority figure 

and respondents followed by the use of guided imagery, silence in responding, repetition, props, suggestive or repeated questioning, and encouragement to reminisce, 

imagine, or elaborate on past behaviors have all been shown to increase false recall.55, 69, 91, 92, 100, 105 All of these factors are explicitly described in the training 

83 

manual for the research personnel who conduct the NHANES 24HR.59 The use of 

rapport, silence, imagery, props, repeated questioning, eye contact, and ‘‘expectant 

looks,’’ p. 4–12 to ‘‘motivate the respondent to answer more fully’’,p. 4–4 are explicit and 

noteworthy in the training manual.59 For example, the following directive is an exemplar of the potentially false memorye inducing protocol: ‘‘If you sit quietly—but 

expectantly—your respondent will usually think of something. Silence and waiting 

are frequently your best probes for a ‘don’t know’ reply. Always try at least once 

to obtain a reply to a ‘don’t know’ response, before accepting it as the final answer.’’ 59, p. 4–13 The use of rapport combined with repeated questioning, silence, eye 

contact, and expectant looks is especially coercive when applied by an authority figure in a research context. In addition, NHANES personnel are directed to ask respondents to ‘‘imagine,’’ and ‘‘think’’ about their food intake and to ‘‘encourage’’ and 

ensure that the respondents are ‘‘convinced of the importance of the survey.’’ 59, p.

4–3 Throughout the manual there are examples of guided imagery and suggestive 

questioning, such as directing participants to begin ‘‘thinking about where you were, 

who you were with, or what you were doing, like working, eating out, or watching 

television,’’ 59, p. 6–2 and directives such as, ‘‘Your own state of mind your conviction 

that the interview is important will strongly influence the respondent’s cooperation. 

Your belief that the information you obtain will be significant and useful will help 

motivate the respondent to answer fully . . .’’ p. 4–4 Although the NHANES training 

manual states that ‘‘[t]his methodology is designed to maximize respondents’ opportunities for remembering and reporting foods they have eaten,’’ p. 6–2 the scientific 

literature on false memories and recall strongly supports the contention that the 

NHANESM–BM generates significant false reporting. Given that imagination and 

coercive techniques (e.g., the use of silence 59) are known to increase the probability 

of illusory (i.e., false) recollections,53, 60 it may be that most 24HR data are false 

reports. If true, the NHANES 24HR is a mere exercise in number generation, and, 

therefore, by design, it does not provide proxy estimates of energy or nutrient consumption. This premise provides an empirically supported explanation why most M– 

BM data are implausible and have trivial relationships with reality (i.e., actual EI 

and nutrient intake.) Nevertheless, without objective corroboration it is impossible 

to quantify what percentage of the recalled foods and beverages are completely false, 

grossly inaccurate, or somewhat congruent with actual consumption. Regardless, it 

is clear that people consistently ‘‘remember [and report] events that never happened.’’ 105 ,p. 803

The Inadmissibility of M–BM Data 

Criteria for Scientific Research: Observable, Measurable, and Falsifiable 

Although the terms science and research are used interchangeably, they are not 

synonymous. Science is more than mere data collection; it is an attempt to discover 

order, a potentially self-correcting, explanatory, and predictive process that demonstrates lawful relations (e.g., diets high in vitamin C prevent scurvy). In contrast, 

research is simply the process of collecting information, and many forms of research 

do not meet the rigor necessary for the results to be scientific. There is a long history of efforts to formally demarcate scientific from nonscientific and pseudoscientific data, the most famous of which may be Popper’s falsifiability criterion.64–66

For example, in U.S. jurisprudence, the Daubert standard 108–109 provides the rules 

of evidence for the admissibility of expert testimony. The criterion of falsifiability 

is central to expert scientific testimony and was used by Judge William Overton in 

ruling in McLean v. Arkansas Board of Education. This case determined that creation science was not a science because it was not falsifiable and, therefore, could 

not be taught as science in Arkansas public schools.110 As we detail in later sections, we assert that M–BM data are akin to creation science in that they fail to 

meet the basic requirements of scientific research. 

Although philosophers continue to debate demarcation criteria, practicing scientists must set forth principles from which to judge the admissibility of data in 

scientific research. We extend Popper’s criterion and proffer the following widely accepted principles of scientific inquiry. First, for results to be scientific, the study’s 

protocols must produce outcomes that are subject to replication. To accomplish this 

goal, the data must be (1) independently observable (i.e., accessible by others), (2) 

measureable, (3) falsifiable, (4) valid, and (5) reliable. These nonmetaphysical criteria were first suggested by Roger Bacon in the 13th century and later were elaborated on by the ‘‘father of empiricism,’’ Sir Francis Bacon, in the late 16th century.111 They were again reiterated by Sir Isaac Newton in the 17th century 112 and 

have been subsequently clarified and defined.62–66, 68 The skepticism and empirical 

rigor inherent in these criteria are of such importance to science that The Royal Society of London, the oldest scientific society in the modern world, succinctly summarized them in its motto, Nullius in Verba. This phrase, derived from Horace’s EpisVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00087 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
84 

tles,113 is translated as ‘‘on the word of no one’’ or ‘‘take no one’s word for it’’ and 

suggests that scientific knowledge should be based not on authority, rhetoric, or 

mere words but on objective evidence. 

The first three criteria (i.e., independently observable, measureable, and 

falsifiable) define the phenomena that are in the domain of science (i.e., able to be 

examined via the scientific method), and the final two criteria (i.e., validity and reliability) refer to the concordance between a measurement and its referent as well 

as the error associated with the measurement protocols used to collect the data. Together, the five basic tenets distinguish scientific research from mere data collection 

and pseudoscience. For example, if someone is eating an apple, his or her behavior 

can be independently observed, measured, and verified or refuted. Yet, if he or she 

reports eating an apple at some point in the past (e.g., as with an FFQ or 24HR), 

neither the past behavior nor the neural correlates of the memory of that behavior 

are independently observable or quantifiable, and without additional information, 

his or her statement cannot be falsified or confirmed. It is a rather obvious fact that 

the respondent is the only person who has access to the raw data of M–BMs (i.e., 

his or her memories of consumption). As such, researchers cannot examine the validity of the memory and base M–BM research results on their faith in the verbal 

report (i.e., the belief that the participant is telling the truth). Nevertheless, faith 

and belief are basic tenets of religion, not science. The unwavering credulity of nutrition epidemiologists with respect to verbal reports is literally in direct opposition 

to Nullius in Verba (i.e., take no one’s word for it) and skeptical, rigorous science. 

The confluence of these simple facts and the well-documented failure of self-reported 

EI to accurately correspond to reality,33, 35 demonstrate that the memory and subsequent recall of ingestive behavior are not within the realm of the scientific investigation of nutrition and obesity. As the philosopher Karl Popper stated, ‘‘all the 

statements of empirical science must be capable of being finally decided, with respect to their truth and falsity,’’ 65, p. 17 and it is wholly impossible to verify or refute 

something that cannot be directly or indirectly independently observed and measured (e.g., memories). 

The Pseudoscience of Nutrition Epidemiology 

The term pseudoscience describes data or results that are presented as scientific 

but lack plausibility because they cannot be reliably, accurately, and independently 

observed, quantified, and confirmed or refuted.62–66 When M–BMs are examined 

from the perspective of the basic tenets of science, the reason for the explanatory 

and predictive failure of epidemiologic nutrition research becomes obvious. First and 

foremost, scientific conclusions cannot result from nonempirical (i.e., unobserved) or 

subjective (i.e., private, not publically accessible) data that are not subject to independent observation, quantification, and falsification. When a person provides a dietary report, the data collected are not actual food or beverage consumption but rather an error-prone and highly edited anecdote regarding memories of food and beverage consumption. As such, M–BMs do not meet the basic requirements of the scientific method and, by definition, are pseudoscientific when presented as actual estimates of energy or nutrient consumption. Two famous physicists of the 20th century, Wolfgang Pauli and Arthur Schuster, summed up the problem with pseudoscientific data eloquently when they stated, respectively, that a pseudoscientific conclusion ‘‘is not only not right, it is not even wrong . . .’’ 114,p. 186 and ‘‘[w]e all prefer 

being right to being wrong, but it is better to be wrong than to be neither right nor 

wrong .’’ 115, p. 117

It is difficult to determine the empirical consequences of M–BMs because the primary data (i.e., memories: private information to which the respondents have privileged access) do not meet the basic tenets of scientific methods (e.g., independent 

observation of data, falsifiability, and accuracy). If neither the researchers nor the 

participants are able to quantify what percentage of the recalled foods and beverages are completely false reports, grossly inaccurate, or reports that are somewhat 

congruent with actual consumption, it is impossible to know the validity and the 

error associated with each report. As Dhurandhar, et al.75 recently suggested, the 

use of M–BM-based data is a context in which ‘‘. . . something is not better than 

nothing.’’ p. 1 Given the forgoing, M–BM-derived data are inadmissible and constitute 

a substantial ongoing threat to nutrition and obesity research and national Dietary 

Guidelines because the greatest obstacle to scientific progress is not ignorance but 

the illusion of knowledge created by pseudoscientific data that are neither right nor 

wrong. 

Nevertheless, performing rigorous science is a skill that can be learned, but only 

if mentors understand and practice rigorous science. Given the ubiquitous use of M– 

BMs over many decades, it seems that nutritional epidemiologists have eschewed 

the inherent rigor and skepticism of Nullius in Verba (i.e., take no one’s word for 

85 

it) and literally replaced it with Totius in Verba (i.e., take everyone’s word for it). 

As a result, skeptical rigorous science is not practiced or taught in nutrition and 

obesity epidemiologic research.24

National Nutrition Surveillance: M–BM Data and USDA Food Availability 

Economic Data 

If the two major components of U.S. national nutritional surveillance are valid 

(i.e., NHANES M–BM data and USDA Food Availability economic data), estimates 

from these surveillance tools should track together and independently provide population-level approximations of trends in food consumption or use. Nevertheless, history demonstrates that this is not the case. Trends in estimates of macronutrient 

consumption from population-level epidemiologic surveys (i.e., M–BMs) exhibited 

statistically significant trends that were in opposition to those of USDA economic 

data for fat, carbohydrates, protein, and energy (i.e., kilocalories per day) from the 

1960s to the late 1980s.116 It should be apparent that U.S. residents could not be 

simultaneously consuming more and less fat, protein, carbohydrates, and energy 

over time. The contradictory patterns and striking lack of correspondence between 

the two primary U.S. nutrition surveillance tools suggest that one or more likely 

both protocols are invalid. As with the severe misreporting demonstrated across the 

globe,45, 80 these contradictory patterns are not limited to the United States; many 

countries exhibit considerable disparity between national surveillance via M–BMs 

and economic/food supply data.117–120 This fact is further evidence that M–BMs are 

fatally flawed and diet-health inferences from M–BM-derived data are meaningless. 

PA and CRF: Essential Elements in Nutrition, Obesity, and Health Research 

The lack of explanatory and predictive power of epidemiologic nutrition research 

may also be explained by the limited acknowledgement of nonnutritional determinants of health and disease, such as nongenetic evolution,6–8 PA,121–122 CRF,123

and other components of nutrient partitioning and energy balance.124–130 For example, more than 50 years ago the Food and Agriculture Organization of the United 

Nations and the World Health Organization determined that human food energy requirements should be estimated using TEE and that PA and basal energy expenditure were the primary determinants.131–132 Yet, most nutrition research does not 

measure any form of energy expenditure or objectively quantify PA. Currently, there 

is only one manuscript of which we are aware that uses the NHANES objectively 

measured PA data to directly assess nutrition-related outcomes 133 and no nutritionrelated publications that include the NHANES treadmill CRF data in analyses. The 

lack of publications may be due to the fact that only two waves in the more than 

40 year history of the NHANES include objective measures of PA, and despite the 

widespread acknowledgment of the necessity of daily PA for health and well-being, 

it is routinely discounted by governmental public health funding agencies. For example, PA, CRF, and exercise are not even listed on the National Institutes of 

Health’s spreadsheet of categorical spending of nearly 250 classifications through 

2016.9 This is unfortunate given that 80% of Americans are not at risk for most nutritional deficiencies,2 but 95% of Americans are at risk for PA deficiency (i.e., inactivity or high sedentary behavior) and do not meet the Federal recommendations of 

30 minutes per day of moderate to vigorous PA.134

Given that PA and CRF are major determinants of health 122–123, 133, 135–137 and 

that PA is the only major modifiable determinant of TEE and nutrient-energy partitioning (i.e., the metabolic fate of the foods we consume),6, 124–130, 133 it is clear that 

PA and CRF must be objectively measured and controlled for in analyses if the 

health effects of any dietary intervention are to be examined accurately. Yet, because PA questionnaires are susceptible to many of the same systematic biases 75,

138–139 and inadmissibility issues as M–BMs, the failure to objectively-measure PA 

and control for it in analyses renders health inferences from previous nutrition epidemiologic studies moot. Fortunately, for the science of health and disease, there are 

objective tools for the measurement of PA (e.g., pedometers and accelerometry-based 

PA monitors),140 and despite limitations,141 these should be used in place of surveys 

and questionnaires to quantify PA in future examinations of health and disease. 

Summary and Future Directions 

A wise man proportions his belief to the evidence. 

DAVID HUME 142, p. 87

This critical review provides empirical and analytic evidence to support the position that (1) M–BM estimates of EI and nutrient intake have trivial relationships 

with actual EI and nutrient intake; (2) the assumption that human memory and recall provide literal, accurate, or precise reproductions of past ingestive behavior is 

86 

indisputably false; (3) M–BMs require participants to submit to protocols that mimic 

procedures known to induce false recall; (4) the subjective (i.e., private, not publically accessible) mental phenomena (i.e., memories) from which M–BM data are 

derived are not subject to independent observation, quantification, or falsification; 

therefore, these data are pseudoscientific and inadmissible in scientific research; 

and (5) the failure to objectively measure and control for PA and CRF in analyses 

renders inferences regarding most diet-health relationships moot. 

Given the overwhelming evidence in support of our hypotheses, we conclude that 

M–BM data cannot be used to informational Dietary Guidelines and that continued 

funding of M–BMs constitutes an unscientific and major misuse of research resources. In addition, given that there are objective data on the nutrition-related 

health status of Americans,2 we find the DGAC’s reliance on M–BMs to be without 

scientific support or merit. We think that skepticism and rigor are essential requirements in scientific investigations, and we fault the overly credulous nature of nutrition epidemiology for the obvious and well-demonstrated failures of the scientific 

community to properly inform previous Federal Dietary Guidelines (e.g., cholesterol 

consumption).30, 143 We think that our nation’s Dietary Guidelines should not be 

based on the pseudoscientific and highly edited anecdotes of M–BMs, and although 

others may disagree, we ask that they do as we have done and provide empirical 

evidence rather than rhetoric to support their positions. Without valid evidence, the 

dogmatic defense of illusory knowledge and the status quo in nutrition and obesity 

research (e.g., see previous commentaries and guidelines 30, 46, 74) is an impediment 

to scientific progress and empirically supported public nutrition and obesity policy. 

We began this critical review with evidence that our nation’s food supply and the 

nutritional status of Americans have improved to a level unparalleled in human history.2–3, 5 Given this reality and recent work on the intergenerational transmission 

of obesity and type 2 diabetes mellitus,6–8 we posit that the American diet is no 

longer a significant risk factor for disease for most individuals. This hypothesis is 

supported by multiple lines of evidence, such as a 40% decline in the age-adjusted 

mortality rate from 1969 to 2010,144 a progressive decades long reduction in ageadjusted cardiovascular disease incidence and mortality,145–146 and a 1.5% per 

annum reduction in age-adjusted mortality rates from all major cancers as well as 

significant reductions in lung cancer incidence in men and women between 2001 and 

2010.147 Given the forgoing and the evidence presented herein demonstrating the 

pseudoscientific nature of M–BMs, we assert that research efforts and funding of 

M–BMs and diet-health research are misdirected and argue that those resources 

would be better targeted to the most prevalent disease of deficiency of the 21st century: inactivity (i.e., a lack of PA and exercise and high levels of sedentary behavior).121, 134

Conclusion 

In this critical review, we argued that the essence of science is the ability to discern fact from fiction, and we presented evidence from multiple fields to support the 

position that the data generated by nutrition epidemiologic surveys and questionnaires are not falsifiable. As such, these data are pseudoscientific and inadmissible 

in scientific research. Therefore, these protocols and the resultant data should not 

be used to inform national Dietary Guidelines or public health policy, and the continued funding of these methods constitutes an unscientific and major misuse of research resources. 

Acknowledgments 

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 

Abbreviations and Acronyms: BMR = basal metabolic rate; CRF = cardiorespiratory fitness; DRM = Deese-Roediger and 

McDermott; DGAC = Dietary Guidelines Advisory Committee; EI = energy intake; FFQ = food frequency questionnaire; M–BM = 

memory-based dietary assessment method; NHANES = National Health and Nutrition Examination Survey; PA = physical activity; rEI = reported energy intake; TEE = total energy expenditure; USDA = U.S. Department of Agriculture; WWEIA = What We 

Eat in America; 24HR = 24 hour dietary recall 

Grant Support: This work was supported by grant T32DK062710 (E.A., G.P.) from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. 

Potential Competing Interests: Dr. Archer has received honoraria from the International Life Sciences Institute and The Coca 

Cola Company. Dr. Lavie reports receiving consulting fees and speaking fees from The Coca-Cola Company and writing a book on 

the obesity paradox with potential royalties. 

Correspondence: Address to Edward Archer, Ph.D., Office of Energetics, Nutrition Obesity Research Center, University of Alabama at Birmingham, Birmingham, AL 35222 (archer1@UAB.edu). 

References 

1. Samuelson P. The Keynes centenary. THE ECONOMIST. 1983;287: 19–21. 

2. Pfeiffer C.M., Sternberg M.R., Schleicher R.L., Haynes B.M., Rybak M.E., Pirkle J.L. The CDC’s Second National Report on 

Biochemical Indicators of Diet and Nutrition in the U.S. Population is a valuable tool for researchers and policy makers. J. NUTR. 

2013; 143(6):938S–947S. 

3. Gerrior S., Bente L., Hiza H.. Nutrient Content of the U.S. Food Supply, 1909–2000. Washington, D.C.: Center for Nutrition 

Policy and Promotion, U.S. Department of Agriculture; 2004: Home Economics Research Report No. 56. 

4. Rajakumar K. Pellagra in the United States: a historical perspective. SOUTH MED. J. 2000; 93(3):272–277. 

87 

5. CDC. National Report on Biochemical Indicators of Diet and Nutrition in the U.S. Population 1999–2002. Atlanta, GA: National Center for Environmental Health; 2008. 

6. Archer E. The childhood obesity epidemic as a result of nongenetic evolution: the maternal resources hypothesis. MAYO CLIN. 

PROC. 2015; 90(1):77–92. 

7. Archer E. The mother of all problems. NEW SCI. 2015; 225:32–33. 

8. Archer E. In reply—Maternal, paternal, and societal efforts are needed to ‘‘cure’’ childhood obesity. MAYO CLIN. PROC. 2015; 

90(4):555–557. 

9. Estimates of Funding for Various Research, Condition, and Disease Categories. Washington, D.C.: U.S. Department of Health 

and Human Services; 2013. 

10. American Association for the Advancement of Science. Historical trends in Federal R&D. http://www.aaas.org/page/historical-trends-federal-rd. Accessed February 21, 2015. 

11. Ioannidis J.P.A. Implausible results in human nutrition research [editorial]. BMJ. 2013; 347:f6698. 

12. Taubes G. Epidemiology faces its limits. SCIENCE. 1995; 269(5221):164–169. 

13. Schoeller D.A., Thomas D., Archer E., et al. Self-report-based estimates of energy intake offer an inadequate basis for scientific 

conclusions. AM. J. CLIN. NUTR. 2013;97(6):1413–1415. 

14. Stampfer M.J., Hennekens C.H., Manson J.E., Colditz G.A., Rosner B., Willett W.C. Vitamin E consumption and the risk of 

coronary disease in women. N. ENGL. J. MED. 1993; 328(20):1444–1449. 

15. Rimm E.B., Stampfer M.J., Ascherio A., Giovannucci E., Colditz G.A., Willett W.C. Vitamin E consumption and the risk of 

coronary heart disease in men. N. ENGL. J. MED. 1993; 328(20):1450–1456. 

16. Tatsioni A., Bonitsis N.G., Ioannidis J.P. Persistence of contradicted claims in the literature. JAMA. 2007; 298(21):2517–2526. 

17. Young S.S., Karr A. Deming, data and observational studies. SIGNIFICANCE. 2011; 8(3):116–120. 

18. Moorthy D., Chung M., Lee J., Yu W.W., Lau J., Trikalinos T.A. Concordance Between the Findings of Epidemiological Studies and Randomized Trials in Nutrition: An Empirical Evaluation and Citation Analysis. Rockville, MD: Agency for Healthcare Research and Quality; 2013: Nutritional Research Series; vol. 6. 

19. Prentice R.L. Clinical trials and observational studies to assess the chronic disease benefits and risks of multivitamin-multimineral supplements. AM. J. CLIN. NUTR. 2007; 85(1):308S–313S. 

20. Druesne-Pecollo N., Latino-Martel P., Norat T., et al. Betacarotene supplementation and cancer risk: a systematic review and 

metaanalysis of randomized controlled trials. INT. J. CANCER. 2010; 127(1):172–184. 

21. Schatzkin A., Mouw T., Park Y., et al. Dietary fiber and wholegrain consumption in relation to colorectal cancer in the NIH– 

AARP Diet and Health Study. AM. J. CLIN. NUTR. 2007; 85(5):1353–1360. 

22. Schoenfeld J.D., Ioannidis J.P. Is everything we eat associated with cancer? a systematic cookbook review. AM. J. CLIN. NUTR. 

2013; 97(1):127–134. 

23. Rowe S., Alexander N. Are nutrition scientists communicating worse or has the situation just gotten more complicated? NUTR. 

TODAY. 2013; 48(6):251–254. 

24. Archer E. A wolf in sheep’s clothing. TheScientist website. http://www.the-scientist.com/?articles.view/articleNo/37918/title/ 

OpinioneA-Wolf-in-Sheep-s-Clothing. Published October 22, 2013. Accessed February 21, 2015. 

25. Oparil S. Low sodium intake: cardiovascular health benefit or risk? N. ENGL. J. MED. 2014;371(7):677–679. 

26. Keys A., Aravanis C., Blackburn H.W., et al. Epidemiological studies related to coronary heart disease: characteristics of men 

aged 40–59 in seven countries. ACTA. MED. SCAND. SUPPL. 1966; 460:1–392. 

27. Ravnskov U. The questionable role of saturated and polyunsaturated fatty acids in cardiovascular disease. J. CLIN. EPIDEMIOL. 

1998; 51(6):443–460. 

28. Sievenpiper J.L., de Souza R.J., Kendall C.W., Jenkins D.J. Is fructose a story of mice but not men? J. AM. DIET. ASSOC. 2011; 

111(2):219–220: author reply 220–212. 

29. David Wang D., Sievenpiper J.L., de Souza R.J., et al. Effect of fructose on postprandial triglycerides: a systematic review and 

meta-analysis of controlled feeding trials. ATHEROSCLEROSIS. 2014; 232(1):125–133. 

30. Dietary Guidelines Advisory Committee. Scientific Report of the 2015 Dietary Guidelines Advisory Committee. Washington, 

D.C.: U.S. Dept. of Health and Human Services and U.S. Dept. of Agriculture; 2015. 

31. Thompson F.E., Subar A.F. Dietary assessment methodology. In: Coulston A.M., Boushey C.J., eds. NUTRITION IN THE PREVENTION AND TREATMENT OF DISEASE. 2nd ed. San Diego, CA: Academic Press; 2008: 3–30. 

32. Willett W. Nutritional Epidemiology. 2nd ed. New York, NY: Oxford University Press; 1990. 

33. Archer E., Hand G.A., Blair S.N. Validity of U.S. nutritional surveillance: National Health and Nutrition Examination Survey 

caloric energy intake data, 1971–2010. PLOS ONE. 2013; 8(10):e76632. 

34. Dwyer J., Picciano M.F., Raiten D.J. Estimation of usual intakes: What We Eat in America—NHANES. J. NUTR. 2003; 133(2): 

609S–623S. 

35. Lissner L., Troiano R.P., Midthune D., et al. OPEN about obesity: recovery biomarkers, dietary reporting errors and BMI. INT. 

J. OBES. (Lond). 2007; 31(6):956–961. 

36. Freedman L.S., Commins J.M., Moler J.E., et al. Pooled results from 5 validation studies of dietary self-report instruments 

using recovery biomarkers for energy and protein intake. AM. J. EPIDEMIOL. 2014; 180(2):172–188. 

37. Schoeller D.A. Limitations in the assessment of dietary energy intake by self-report. METABOLISM. 1995; 44 (2 suppl. 2):18–22. 

38. Subar A.F., Kipnis V., Troiano R.P., et al. Using intake biomarkers to evaluate the extent of dietary misreporting in a large 

sample of adults: the OPEN study. AM. J. EPIDEMIOL. 2003; 158(1):1–13. 

39. Goris A.H., Westerterp-Plantenga M.S., Westerterp K.R. Undereating and underrecording of habitual food intake in obese 

men: selective underreporting of fat intake. AM. J. CLIN. NUTR. 2000; 71(1):130–134. 

40. Scagliusi F.B., Polacow V.O., Artioli G.G., Benatti F.B., Lancha A.H., Jr. Selective underreporting of energy intake in women: 

magnitude, determinants, and effect of training. J. AM. DIET. ASSOC. 2003; 103(10):1306–1313. 

41. Heitmann B.L., Lissner L. Can adverse effects of dietary fat intake be overestimated as a consequence of dietary fat underreporting? PUBLIC HEALTH NUTR. 2005; 8(8):1322–1327. 

42. Heitmann B.L., Lissner L., Osler M. Do we eat less fat, or just report so? INT. J. OBES. RELAT. METAB. DISORD. 2000; 

24(4):435–442. 

43. Heitmann B.L., Milman N., Hansen G.L. Relationship between dietary iron intake, corrected for diet reporting error, and 

serum ferritin in Danish women aged 35–65 years. BR. J. NUTR. 1996; 75(6):905–913. 

44. Black A.E., Goldberg G.R., Jebb S.A., Livingstone M.B., Cole T.J., Prentice A.M. Critical evaluation of energy intake data 

using fundamental principles of energy physiology, 2: evaluating the results of published surveys. EUR. J. CLIN. NUTR. 1991; 45(12): 

583–599. 

45. Goldberg G.R., Black A.E., Jebb S.A., et al. Critical evaluation of energy intake data using fundamental principles of energy 

physiology, 1: derivation of cut-off limits to identify underrecording. EUR. J. CLIN. NUTR. 1991; 45(12):569–581. 

46. He ́bert J., Hurley T.G., Steck S.E., et al. Considering the value of dietary assessment data in informing nutrition-related 

health policy. ADV. NUTR. 2014; 5(4):447–455. 

47. Johnson M.K., Raye C.L., Mitchell K.J., Ankudowich E. The cognitive neuroscience of true and false memories. NEBR. SYMP. 

MOTIV. 2012; 58:15–52. 

48. Schacter D.L. Constructive memory: past and future. DIALOGUES CLIN. NEUROSCI. 2012; 14(1):7–18. 

49. Schacter D.L., Slotnick S.D. The cognitive neuroscience of memory distortion. NEURON. 2004; 44(1):149–160. 

50. Patihis L., Frenda S.J., LePort A.K.R., et al. False memories in highly superior autobiographical memory individuals. PROC. 

NATL. ACAD. SCI. USA. 2013; 110(52):20947–20952. 

51. Schooler J.W. The distinctions of false and fuzzy memories. J. EXP. CHILD PSYCHOL. 1998; 71(2):130–143. 

52. Loftus E. Our changeable memories: legal and practical implications. NAT. REV. NEUROSCI. 2003; 4(3):231–234. 

53. Goff L., Roediger H. Imagination inflation for action events: repeated imaginings lead to illusory recollections. MEM. COGNIT. 

1998; 26(1):20–33. 

54. Brockmeier J. After the archive: remapping memory. CULTURE PSYCHOL. 2010; 16(1):5–35. 

55. Bernstein D.M., Loftus E.F. The consequences of false memories for food preferences and choices. PERSPECT. PSYCHOL. SCI. 

2009; 4(2):135–139. 

88 

56. Loftus E.F. The malleability of human memory. AM. SCI. 1979; 67(3):312–320. 

57. Schacter D.L., Loftus E.F. Memory and law: what can cognitive neuroscience contribute? NAT. NEUROSCI. 2013; 16(2):119–123. 

58. Bernard H.R., Killworth P., Kronenfeld D., Sailer L. The problem of informant accuracy: the validity of retrospective data. 

ANNU. REV. ANTHROPOL. 1984; 13(1):495–517. 

59. Centers for Disease Control and Prevention. NHANES MEC in-person dietary interviewers procedures manual. http:// 

www.cdc.gov/nchs/data/nhanes/nhanes_09_10/DietaryInterviewers_Inperson.pdf. Published January 2009. Accessed August 9, 

2014. 

60. Shaw J., Porter S. Constructing rich false memories of committing crime. PSYCHOL. SCI. 2015;26(3):291–301. 

61. Bernstein D.M., Laney C., Morris E.K., Loftus E.F. False beliefs about fattening foods can have healthy consequences. PROC. 

NATL. ACAD. SCI. USA. 2005; 102(39):13724–13731. 

62. Platt J.R. Strong inference: certain systematic methods of scientific thinking may produce much more rapid progress than others. SCIENCE. 1964; 146(3642):347–353. 

63. Sober E. Philosophy of Biology. Boulder, CO: Westview Press; 1993. 

64. Popper K. Conjectures and Refutations: The Growth of Scientific Knowledge. London, England: Routledge; 2004/1965. 

65. Popper K.R. The Logic of Scientific Discovery. London, England: Hutchinson; 1959. 

66. Popper K.R. Objective Knowledge: An Evolutionary Approach. New York, NY: Oxford University Press; 1972. 

67. Heitmann B.L. Social desirability bias in dietary self-report may compromise the validity of dietary intake measures. Implications for diet disease relationships. INT. J. EPIDEMIOL. 1996; 25(1):222–225. 

68. Michell J. Measurement: a beginner’s guide. J. APPL. MEAS. 2003; 4(4):298–308. 

69. Straube B. An overview of the neuro-cognitive processes involved in the encoding, consolidation, and retrieval of true and false 

memories. BEHAV. BRAIN FUNCT. 2012; 8:35. 

70. Schacter D. The Seven Sins of Memory. Boston, MA: Houghton Mifflin Harcourt; 2001. 

71. Mencken H.L. Counter-Offensive. THE AMERICAN MERCURY MAGAZINE. Vol. May. Whitefish, MT: Kessinger Publishing, LLC; 

1926:123–124. 

72. Black A.E. Critical evaluation of energy intake using the Goldberg cut-off for energy intake: basal metabolic rate: a practical 

guide to its calculation, use and limitations. INT. J. OBES. RELAT. METAB. DISORD. 2000; 24(9):1119–1130. 

73. Institute of Medicine. Report of the Panel on Macronutrients: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, 

Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Washington D.C.: The National Academies Press; 2005. 

74. Satija A., Yu E., Willett W.C., Hu F.B. Understanding nutritional epidemiology and its role in policy. ADV. NUTR. 2015; 

6(1):5–18. 

75. Dhurandhar N.V., Schoeller D., Brown A.W., et al. Energy balance measurement: when something is not better than nothing 

[published online November 13, 2014]. INT. J. OBES. (Lond). 

76. Archer E., Blair S.N. Implausible data, false memories, and the status quo in dietary assessment. ADV. NUTR. 2015; 6(2):229– 

230. 

77. Beaudoin R., Mayer J. Food intakes of obese and non-obese women. J. AM. DIET. ASSOC. 1953; 29(1):29–33. 

78. Bellach B., Kohlmeier L. Energy adjustment does not control for differential recall bias in nutritional epidemiology. J. CLIN. 

EPIDEMIOL. 1998; 51(5):393–398. 

79. Ferrari P., Slimani N., Ciampi A., et al. Evaluation of under and overreporting of energy intake in the 24-hour diet recalls in 

the European Prospective Investigation into Cancer and Nutrition (EPIC). PUBLIC HEALTH NUTR. 2002; 5(6B):1329–1345. 

80. Orcholski L., Luke A., Plange-Rhule J., et al. Under-reporting of dietary energy intake in five populations of the African Diaspora. BR. J. NUTR. 2015; 113(3):464–472. 

81. Forrestal S.G. Energy intake-misreporting among children and adolescents: a literature review. MATERN. CHILD. NUTR. 2011; 

7(2):112–127. 

82. Pomerleau J., Ostbye T., Bright-See E. Potential underreporting of energy intake in the Ontario Health Survey and its relationship with nutrient and food intakes. EUR. J. EPIDEMIOL. 1999; 15(6):553–557. 

83. Poslusna K., Ruprich J., de Vries J.H., Jakubikova M., van’t Veer P. Misreporting of energy and micronutrient intake estimated by food records and 24 hour recalls, control and adjustment methods in practice. BR. J. NUTR. 2009; 101 (suppl. 2):S73–S85. 

84. Banna J.C., Fialkowski M.K., Townsend M.S. Misreporting of dietary intake affects estimated nutrient intakes in low-income 

Spanish-speaking women [published online August 12, 2014]. J. ACAD. NUTR. DIET. 

85. Hill R.J., Davies P.S. The validity of self-reported energy intake as determined using the doubly labelled water technique. BR. 

J. NUTR. 2001; 85(4):415–430. 

86. Lafay L., Mennen L., Basdevant A., et al. Does energy intake underreporting involve all kinds of food or only specific food 

items? results from the Fleurbaix Laventie Ville Sante (FLVS) study. INT. J. OBES. RELAT. METAB. DISORD. 2000; 24(11): 1500–1506. 

87. Westerterp K.R., Goris A.H. Validity of the assessment of dietary intake: problems of misreporting. CURR. OPIN. CLIN. NUTR. 

METAB. CARE. 2002; 5(5):489–493. 

88. Krebs-Smith S.M., Graubard B.I., Kahle L.L., Subar A.F., Cleveland L.E., Ballard-Barbash R. Low energy reporters vs. others: 

a comparison of reported food intakes. EUR. J. CLIN. NUTR. 2000; 54(4):281–287. 

89. Livingstone M.B., Black A.E. Markers of the validity of reported energy intake. J. NUTR. 2003; 133 (suppl. 3):895S–920S. 

90. Schacter D.L., Norman K.A., Koutstaal W. The cognitive neuroscience of constructive memory. ANNU. REV. PSYCHOL. 1998; 

49:289–318. 

91. Johnson M.K. Memory and reality. AM. PSYCHOL. 2006; 61(8):760–771. 

92. Gallo D.A. False memories and fantastic beliefs: 15 years of the DRM illusion. MEM. COGNIT. 2010; 38(7):833–848. 

93. Bartlett F.C. Remembering: A Study in Experimental and Social Psychology. Cambridge, England: Cambridge University 

Press; 1932. 

94. Storms M.D., Nisbett R.E. Insomnia and the attribution process. J. PERS. SOC. PSYCHOL. 1970; 16(2):319–328. 

95. Zimbardo P.G., Cohen A., Weisenberg M., Dworkin L., Firestone I. The control of experimental pain. In: Zimbardo P.G., ed. 

THE COGNITIVE CONTROL OF MOTIVATION. Glenview, IL: Foresman; 1969. 

96. Mandler J.M. Categorical and schematic organization in memory. In: Puff C.R., ed. MEMORY ORGANIZATION AND STRUCTURE. 

New York, NY: Academic Press; 1979. 

97. Freeman L.C., Romney A.K., Freeman S.C. Cognitive structure and informant accuracy. AM. ANTHROPOLOGIST. 1987; 

89(2):310–325. 

98. Kronenfeld D.B., Kronenfeld J., Kronenfeld J.E. Toward a science of design for successful food service. INST. VOL. FEED. MANAGE. 1972; 70(11):38–44. 

99. Gallo D.A., Roberts M.J., Seamon J.G. Remembering words not presented in lists: can we avoid creating false memories? 

PSYCHON. BULL. REV. 1997; 4(2):271–276. 

100. Cann D.R., McRae K., Katz A.N. False recall in the Deese-Roediger-McDermott paradigm: the roles of gist and associative 

strength. Q.J. EXP. PSYCHOL. 2011; 64(8):1515–1542. 

101. Besnard A., Caboche J., Laroche S. Reconsolidation of memory: a decade of debate. PROG. NEUROBIOL. 2012; 99(1):61–80. 

102. Schwabe L., Nader K., Pruessner J.C. Reconsolidation of human memory: brain mechanisms and clinical relevance. BIOL. 

PSYCHIATRY. 2014; 76(4):274–280. 

103. Mojet J, Ko ̈ster E.P. Sensory memory and food texture. FOOD QUAL. PREFERENCE. 2005; 16(3):251–266. 

104. Deese J. On the prediction of occurrence of particular verbal intrusions in immediate recall. J. EXP. PSYCHOL. 1959; 58(1):17– 

22. 

105. Roediger H.L., McDermott K.B. Creating false memories: remembering words not presented in lists. J. EXP. PSYCHOL. LEARN. 

MEM. COGN. 1995; 21(4):803–814. 

106. Molag M.L., de Vries J.H.M., Ocke ́ M.C., et al. Design characteristics of food frequency questionnaires in relation to their validity. AM. J. EPIDEMIOL. 2007; 166(12):1468–1478. 

107. Neuhouser M.L., Tinker L., Shaw P.A., et al. Use of recovery biomarkers to calibrate nutrient consumption self-reports in the 

Women’s Health Initiative. AM. J. EPIDEMIOL. 2008; 167(10): 1247–1259. 

108. Berger M.A. What has a decade of Daubert wrought? AM. J. PUBLIC HEALTH. 2005; 95 (suppl. 1):S59–S65. 

109. Krimsky S. The weight of scientific evidence in policy and law. AM. J. PUBLIC HEALTH. 2005; 95 (suppl. 1):S129–S136. 

89 

110. McLean v. Arkansas Board of Education, 529 F. Sup. 1255, 1258–1264; E.D. Ark. 1982. 

111. Bacon F. Of the Proficience and Advancement of Learning, Divine and Human. London, England: J.W. Parker and Son; 1605/ 

1852. 

112. Newton I. The Principia: Mathematical Principles of Natural Philosophy. Berkeley, CA: University of California Press; 1687/ 

1999. 

113. Horace. (Quintus Horatius Flaccus), Epistulae, Book I. http://www.thelatinlibrary.com/horace/epist1.shtml. Accessed April 

2015. 

114. Peierls R.E. Wolfgang Ernst Pauli: 1900–1958. BIOGRAPHICAL MEMOIRS FELLOWS ROY. SOC. 1960; 5:174–192. 

115. Schuster A. The Progress of Physics. Cambridge, England: Cambridge University Press; 1911. 

116. Crane N.T., Lewis C.J., Yetley E.A. Do time trends in food supply levels of macronutrients reflect survey estimates of 

macronutrient intake? AM. J. PUBLIC HEALTH. 1992; 82(6):862–866. 

117. Serra-Majem L., MacLean D., Ribas L., et al. Comparative analysis of nutrition data from national, household, and individual levels: results from a WHO–CINDI collaborative project in Canada, Finland, Poland, and Spain. J. EPIDEMIOL. COMMUNITY

HEALTH. 2003; 57(1):74–80. 

118. Serra-Majem L. Food availability and consumption at national, household and individual levels: implications for food-based 

dietary guidelines development. PUBLIC HEALTH NUTR. 2001; 4(2B):673–676. 

119. Rodriguez-Artalejo F., Banegas J.R., Graciani A., Hernandez-Vecino R., del Rey-Calero J. Food supply versus household survey data: nutrient consumption trends for Spain, 1958–1988. EUR. J. EPIDEMIOL. 1996;12(4):367–371. 

120. Matsumura Y. Nutrition trends in Japan. ASIA PAC. J. CLIN. NUTR. 2001; 10 (suppl.):S40–S47. 

121. Blair S.N. Physical inactivity: the biggest public health problem of the 21st century. BR. J. SPORTS MED. 2009; 43(1):1–2. 

122. Archer E., Blair S.N. Physical activity and the prevention of cardiovascular disease: from evolution to epidemiology. PROG. 

CARDIOVASC. DIS. 2011; 53(6):387–396. 

123. Blair S.N., Kohl H.W., III, Paffenbarger R.S., Jr., Clark D.G., Cooper K.H., Gibbons L.W. Physical fitness and all-cause mortality: a prospective study of healthy men and women. JAMA. 1989; 262(17):2395–2401. 

124. Krogh-Madsen R., Thyfault J.P., Broholm C., et al. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J. APPL. PHYSIOL. 2010; 108(5):1034–1040. 

125. Thyfault J.P., Krogh-Madsen R. Metabolic disruptions induced by reduced ambulatory activity in free-living humans. J. 

APPL. PHYSIOL. (1985). 2011; 111(4):1218–1224. 

126. Bergouignan A., Kealey E.H., Schmidt S.L., Jackman M.R., Bessesen D.H. Twenty-four hour total and dietary fat oxidation 

in lean, obese and reduced-obese adults with and without a bout of exercise. PLOS ONE. 2014; 9(4):e94181. 

127. Bergouignan A., Momken I., Schoeller D.A., et al. Regulation of energy balance during long-term physical inactivity induced 

by bed rest with and without exercise training. J. CLIN. ENDOCRINOL. METAB. 2010; 95(3):1045–1053. 

128. Bergouignan A., Rudwill F., Simon C., Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bedrest studies. J. APPL. PHYSIOL. (1985). 2011; 111(4): 1201–1210. 

129. Bergouignan A., Schoeller D.A., Normand S., et al. Effect of physical inactivity on the oxidation of saturated and 

monounsaturated dietary fatty acids: results of a randomized trial. PLOS CLIN. TRIALS. 2006; 1(5):e27. 

130. Bergouignan A., Trudel G., Simon C., et al. Physical inactivity differentially alters dietary oleate and palmitate trafficking. 

DIABETES. 2009; 58(2):367–376. 

131. Food and Agriculture Organization. Calorie Requirements: Report on the Second Committee on Calorie Requirements. Rome, 

Italy: Food and Agriculture Organization; 1957: Nutrition Studies No. 15. 

132. FAO/WHO/UNU. Energy and Protein Requirements. Geneva, Switzerland: World Health Organization; 1985: WHO Technical 

Report Series 724. 

133. Archer E., Hand G.A., He ́bert J.R., et al. Validation of a novel protocol for calculating estimated energy requirements and average daily physical activity ratio for the U.S. population: 2005–2006. MAYO CLIN. PROC. 2013; 88(12):1398–1407. 

134. Troiano R.P., Berrigan D., Dodd K.W., Masse L.C., Tilert T., McDowell M. Physical activity in the United States measured by 

accelerometer. MED. SCI. SPORTS EXERC. 2008; 40(1):181–188. 

135. Lee I.M., Shiroma E.J., Lobelo F., Puska P., Blair S.N., Katzmarzyk P.T. Effect of physical inactivity on major noncommunicable diseases worldwide: an analysis of burden of disease and life expectancy. LANCET. 2012; 380(9838):219–229. 

136. LaMonte M.J., Blair S.N., Church T.S. Physical activity and diabetes prevention. J. APPL. PHYSIOL. 2005; 99(3):1205–1213. 

137. Sui X., Lee D.C., Matthews C.E., et al. Influence of cardiorespiratory fitness on lung cancer mortality. MED. SCI. SPORTS

EXERC. 2010; 42(5):872–878. 

138. Prince S.A., Adamo K.B., Hamel M.E., Hardt J., Connor Gorber S., Tremblay M. A comparison of direct versus self-report 

measures for assessing physical activity in adults: a systematic review. INT. J. BEHAV. NUTR. PHYS. ACT. 2008; 5:56. 

139. Shephard R.J. Limits to the measurement of habitual physical activity by questionnaires. BR. J. SPORTS MED. 2003; 

37(3):197–206:discussion 206. 

140. Trost S.G., McIver K.L., Pate R.R. Conducting accelerometer-based activity assessments in field-based research. MED. SCI. 

SPORTS EXERC. 2005; 37(11 suppl):S531–S543. 

141. Pedisic Z., Bauman A. Accelerometer-based measures in physical activity surveillance: current practices and issues. BR. J. 

SPORTS MED. 2015; 49(4):219–223. 

142. Hume D. An enquiry concerning human understanding, and concerning the principles of morals. In: Ingram J., ed. THE

PROJECT GUTENBERG. http://www.gutenberg.org/files/9662/9662-h/9662-h.htm. Accessed February 22, 2015. 

143. Dietary Guidelines Advisory Committee. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines 

for Americans, 2010. Springfield, VA: U.S. Dept. of Agriculture, U.S. Dept. of Health and Human Services; 2010. 

144. Hoyert D.L. 75 Years of Mortality in the United States, 1935–2010. Hyattsville, MD: National Center for Health Statistics; 

2012: NCHS Data Brief No. 88. 

145. Members W.G., Roger V.L., Go A.S., et al. Heart disease and stroke statistics—2012 update: a report from the American 

Heart Association. CIRCULATION. 2012; 125(1):e2–e220. 

146. Cooper R., Cutler J., Desvigne-Nickens P., et al. Trends and disparities in coronary heart disease, stroke, and other cardiovascular diseases in the United States: findings of the National Conference on Cardiovascular Disease Prevention. CIRCULATION. 

2000; 102(25):3137–3147. 

147. Edwards B.K., Noone A.-M., Mariotto A.B., et al. Annual report to the nation on the status of cancer, 1975–2010, featuring 

prevalence of comorbidity and impact on survival among persons with lung, colorectal, breast, or prostate cancer. CANCER. 2014; 

120(9):1290–1314. 

EXHIBIT C

Validity of U.S. Nutritional Surveillance: National Health and Nutrition Examination Survey Caloric Energy Intake Data, 1971–2010 

PLOS ONE 

PLoS ONE≥www.plosone.org≥October 2013≥Volume 8≥Issue 10≥e76632 

90 

1Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, United States of America. 2Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, 

South Carolina, United States of America. 

* E-mail: archerec@email.sc.edu. 

Edward Archer 1 *, Gregory A. Hand,1 Steven N. Blair 1, 2

Abstract 

Importance: Methodological limitations compromise the validity of U.S. nutritional surveillance data and the empirical foundation for formulating dietary guidelines and public health policies. 

Objectives: Evaluate the validity of the National Health and Nutrition Examination Survey (NHANES) caloric intake data throughout its history, and examine 

trends in the validity of caloric intake estimates as the NHANES dietary measurement protocols evolved. 

Design: Validity of data from 28,993 men and 34,369 women, aged 20 to 74 years 

from NHANES I (1971–1974) through NHANES 2009–2010 was assessed by: calculating physiologically credible energy intake values as the ratio of reported energy 

intake (rEI) to estimated basal metabolic rate (BMR), and subtracting estimated 

total energy expenditure (TEE) from NHANES rEI to create ‘disparity values’. 

Main Outcome Measures: (1) Physiologically credible values expressed as the 

ratio rEI/BMR and (2) disparity values (rEI–TEE). 

Results: The historical rEI/BMR values for men and women were 1.31 and 1.19, 

(95% CI: 1.30–1.32 and 1.18–1.20), respectively. The historical disparity values for 

men and women were ¥281 and ¥365 kilocalorie-per-day, (95% CI: ¥299, ¥264 

and ¥378, ¥351), respectively. These results are indicative of significant under-reporting. The greatest mean disparity values were ¥716 kcal/day and ¥856 kcal/day 

for obese (i.e., ≥30 kg/m2) men and women, respectively. 

Conclusions: Across the 39 year history of the NHANES, EI data on the majority 

of respondents (67.3% of women and 58.7% of men) were not physiologically plausible. Improvements in measurement protocols after NHANES II led to small decreases in underreporting, artifactual increases in rEI, but only trivial increases in 

validity in subsequent surveys. The confluence of these results and other methodological limitations suggest that the ability to estimate population trends in caloric 

intake and generate empirically supported public policy relevant to diet-health relationships from U.S. nutritional surveillance is extremely limited. 

Citation: Archer E., Hand G.A., Blair S.N. (2013) Validity of U.S. Nutritional Surveillance: National Health and Nutrition Examination Survey Caloric Energy Intake Data, 1971–2010. PLOS ONE 8(10): e76632. doi:10.1371/journal.pone.0076632. 

Editor: Darcy Johannsen, Pennington Biomed Research Center, United States of America Received May 9, 2013; Accepted August 25, 2013; Published October 9, 2013. 

Copyright: ©2013 Archer, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 

License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are 

credited. 

Funding: This study was funded via an unrestricted research grant from The Coca-Cola Company. The sponsor of the study had 

no role in the study design, data collection, data analysis, data interpretation, or writing of the report. 

Competing Interests: Dr. Gregory Hand has received consultancy fees from the National Institutes of Health (NIH) and grants 

from the NIH, and The Coca-Cola Company. Dr. James He ́bert is supported by an Established Investigator Award in Cancer Prevention and Control from the Cancer Training Branch of the National Cancer Institute (K05 CA136975). Dr. Steven Blair receives 

book royalties (<$5,000/year) from Human Kinetics; honoraria for service on the Scientific/Medical Advisory Boards for Clarity, 

Technogym, Santech, and Jenny Craig; and honoraria for lectures and consultations from scientific, educational, and lay groups 

which are donated to the University of South Carolina or not-for-profit organizations. Dr. Blair is a consultant on research projects 

with the University of Texas-Southwestern Medical School and the University of Miami. During the past 5 year period Dr. Blair 

has received research grants from The Coca-Cola Company, the National Institutes of Health, and Department of Defense. Funding 

for the study was provided by an unrestricted research grant from The Coca-Cola Company. The sponsor of the study had no role in 

the study design, data collection, data analysis, data interpretation, or writing of the report, and does not alter the authors’ adherence to all the PLoS ONE policies on sharing data and materials. 

Introduction 

The rise in the population prevalence of obesity has focused attention on U.S. nutritional surveillance research and the analysis of trends in caloric energy intake 

(EI). Because these efforts provide the scientific foundation for many public health 

policies and food-based guidelines, poor validity in dietary measurement protocols 

can have significant long-term implications for our nation’s health. 

In the U.S., population-level estimates of EI are derived from data collected as 

part of the National Health and Nutrition Examination Survey (NHANES), a complex, cross-sectional sample of the U.S. population. The primary method used in 

NHANES to approximate EI is the 24 hour dietary recall interview (24HR) [1]. The 

data collected are based on the subject’s self-reported, retrospective perceptions of 

food and beverage consumption in the recent past. To calculate EI estimates, these 

subjective data are translated into nutrient food codes and then assigned numeric 

energy (i.e., caloric) values from food and nutrient databases. Prior to 2001–2002, 

the NHANES relied upon databases of varying quality and composition for the postVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00094 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
91 

hoc conversion of food and beverage consumption (24HR) data into energy values 

[2–5]. After 2001–2002, the NHANES and the U.S. Department of Agriculture’s 

(USDA) Continuing Survey of Food Intakes by Individuals were integrated into the 

‘‘What We Eat in America’’ program [6], and the translation process was standardized via use of successive versions of the USDA’s National Nutrient Database for 

Standard Reference (NNBS) [7]. 

Misreporting 

Given the indirect, pseudo-quantitative nature of the method (i.e., assigning numeric values to subjective data without objective corroboration), nutrition surveys 

frequently report a range of energy intakes that are not representative of the respondents’ habitual intakes [8], and estimates of EI that are physiologically implausible (i.e., incompatible with survival) have been demonstrated to be widespread [9– 

11]. For example, in a group of ‘‘highly educated’’ participants, Subar, et al. (2003) 

demonstrated that when total energy expenditure (TEE) via doubly labeled water 

(DLW) was compared to reported energy intake (rEI), the raw correlations between 

TEE and rEI were 0.39 for men and 0.24 for women. Men and women underreported 

energy intake by 12–14% and 16–20%, respectively. The level of underreporting increased significantly after correcting for the weight gain of the sample over the 

study period [9], and underreporting was greater for fat than for protein, thereby 

providing additional support for the well-documented occurrence of the selective 

misreporting of specific macronutrients (e.g., fat and sugars) [12–15]. These results 

are consistent with earlier work, in which the correlations between DLW-derived 

TEE and seven 24HR and the average of two 7 day dietary recalls were 0.33 and 

0.30, respectively [16]. 

Because the NHANES collected dietary data over the period in which the population prevalence of obesity was increasing, these data have been used (despite the 

widely acknowledged issues [17]) to examine the association of trends in EI with increments in mean population body mass index (BMI) and rates of obesity (e.g., [18– 

20]). Given that implausible rEI values and the misreporting of total dietary intake 

render the relationships between dietary factors, BMI and other indices of health 

ambiguous [21], and diminish the usefulness of nutrition data as a tool to inform 

public health policy, this report examines the validity of U.S. nutrition surveillance 

EI data from NHANES I (1971–1974) through NHANES 2010 (nine survey periods) 

using two protocols: the ratio of reported energy intake (rEI) to basal metabolic rate 

(rEI/BMR) [22,23] and the disparity between rEI and estimated total energy expenditure (TEE) from the Institute of Medicine’s (IOM) predictive equations [24]. 

Table 1. rEI/BMR values for all men and women from NHANES I through 

NHANES 2009–2010. 

Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Men & Women (20– 

74 years); NHANES I–NHANES 2009–2010 

NHANES Survey 

Year Sex 

Estimate 

rEI/RMR 

(mean) * 

Standard 

Error 

95% Confidence 

Interval 

rEI 

Value 

Plausible 

Y = Yes 

N = No Lower Upper 

NHANES I Men (n = 4,652) 1.30 0.012 1.28 1.32 N 

Women (n = 7,709) 1.10 0.010 1.08 1.12 N 

NHANES II Men (n = 5,236) 1.28 0.010 1.26 1.30 N 

Women (n = 6,006) 1.08 0.008 1.06 1.09 N 

NHANES III Men (n = 6,122) b 1.36 0.011 1.34 1.39 Y 

Women (n = 7,127) a 1.22 0.009 1.20 1.24 N 

NHANES I999–00 Men (n = 1,600) 1.31 0.018 1.27 1.34 N 

Women (n = 1,886) a 1.23 0.016 1.19 1.26 N 

NHANES 2001–2002 Men (n = 1,782) 1.31 0.015 1.28 1.34 N 

Women (n = 2,029) a 1.24 0.011 1.22 1.26 N 

NHANES 2003–2004 Men (n = 1,671) 1.32 0.013 1.30 1.35 Y 

Women (n = 1,838) a 1.23 0.018 1.20 1.27 N 

NHANES 2005–2006 Men (n = 1,749) c 1.34 0.013 1.31 1.36 Y 

Women (n = 1,998) a 1.21 0.014 1.18 1.24 N 

NHANES 2007–08 Men (n = 2,154) 1.27 0.017 1.24 1.30 N 

Women (n = 2,306) a 1.19 0.020 1.15 1.23 N 

NHANES 2009–2010 Men (n = 2,319) 1.29 0.013 1.26 1.31 N 

Women (n = 2,532) a 1.20 0.007 1.18 1.21 N 

All Surveys Men (n = 27,285) 1.31 0.005 1.30 1.32 N 

Women (n = 33,431) 1.19 0.005 1.18 1.20 N 

* All estimates are weighted means. 

92 

aSignificantly different from NHANES I at p≤0.001 (Women). bSignificantly different from NHANES I at p≤0.001 (Men). cSignificantly different from NHANES I at p≤0.05 (Men). 

Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values <1.35 are considered implausible and indicative of underreporting. 

TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation. 

Values <1.35 are not physiologically credible. 

doi:10.1371/journal.pone.0076632.t001. 

Methods 

Population 

Data were obtained from the National Health and Nutrition Examination Surveys 

for the years 1971–2010 [1]. The NHANES is a complex multi-stage, cluster sample 

of the civilian, non-institutionalized U.S. population conducted by the Centers for 

Disease Control and Prevention (CDC). The National Center for Health Statistics 

ethics review board approved protocols and written informed consent was obtained 

from all NHANES participants. 

Inclusion Criteria 

The study sample was limited to adults aged ≥20 and ≤74 years at the time of 

the NHANES in which they participated, and had a body mass index (BMI) ≥18 kg/ 

m2, and with complete data on age, sex, height, weight, and dietary energy intake. 

Dietary Data 

Estimates of EI were obtained from a single 24HR from each of the nine 

NHANES study periods [1]. Energy content of the self-reported food consumption 

was determined by NHANES using nutrient databases based on previous versions 

of the USDA National Nutrient Database for Standard Reference (NNDS) [7]. 

Table 2. rEI/BMR index for all women by BMI categories from NHANES I 

through NHANES 2009–2010. 

Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Women (20–74 

years); NHANES I–NHANES 2009–2010 

NHANES Survey 

Year BMI Category 

Estimate 

rEI/BMR 

(mean) * 

Standard 

Error 

95% Confidence 

Interval 

rEI 

Value 

Plausible 

Y = Yes 

N = No Lower Upper 

NHANES I Normal (n = 4,222) 1.20 0.013 1.18 1.23 N 

Overweight (n = 2,028) 1.00 0.012 0.98 1.02 N 

Obese (n = 1,459) 0.88 0.014 0.86 0.91 N 

NHANES II Normal (n = 3,171) 1.18 0.010 1.16 1.20 N 

Overweight (n = 1,671) 0.98 0.012 0.96 1.01 N 

Obese (n = 1,164) 0.89 0.012 0.87 0.91 N 

NHANES III Normal (n = 2,661) 1.32 0.014 1.30 1.35 Y 

Overweight (n = 2,150) 1.18 0.019 1.14 1.22 N 

Obese (n = 2,316) 1.07 0.015 1.04 1.10 N 

NHANES 1999–2000 Normal (n = 555) 1.36 0.020 1.32 1.40 Y 

Overweight (n = 572) 1.19 0.033 1.12 1.25 N 

Obese (n = 759) 1.12 0.030 1.06 1.18 N 

NHANES 2001–2002 Normal (n = 630) 1.38 0.018 1.35 1.42 Y 

Overweight (n = 639) 1.26 0.028 1.21 1.32 N 

Obese (n = 760) 1.08 0.012 1.05 1.10 N 

NHANES 2003–2004 Normal (n = 550) 1.35 0.031 1.29 1.41 Y 

Overweight (n = 546) 1.19 0.027 1.14 1.25 N 

Obese (n = 742) 1.15 0.026 1.10 1.20 N 

NHANES 2005–2006 Normal (n = 615) 1.34 0.026 1.29 1.39 Y 

Overweight (n = 558) 1.19 0.028 1.13 1.24 N 

Obese (n = 825) 1.10 0.024 1.05 1.15 N 

NHANES 2007–2008 Normal (n = 634) 1.30 0.038 1.23 1.38 Y 

Overweight (n = 694) 1.17 0.026 1.12 1.22 N 

Obese (n = 978) 1.10 0.020 1.06 1.14 N 

NHANES 2009–2010 Normal (n = 690) 1.31 0.022 1.26 1.35 Y 

Overweight (n = 745) 1.23 0.024 1.18 1.28 N 

Obese (n = 1,097) 1.08 0.006 1.06 1.09 N 

* All estimates are weighted means. 

Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values <1.35 are considered implausible and indicative of underreporting. 

TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation. 

93 

doi:10.1371/journal.pone.0076632.t002. 

Table 3. rEI/BMR index for all men by BMI categories from NHANES I 

through NHANES 2009–2010. 

Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Men (20–74 years); 

NHANES I–NHANES 2009–2010 

NHANES Survey 

Year BMI Category 

Estimate 

rEI/BMR 

(mean) * 

Standard 

Error 

95% Confidence 

Interval 

rEI 

Value 

Plausible 

Y = Yes 

N = No Lower Upper 

NHANES I Normal (n = 2,115) 1.41 0.016 1.38 1.44 Y 

Overweight (n = 1,945) 1.24 0.017 1.21 1.28 N 

Obese (n = 592) 1.08 0.025 1.04 1.13 N 

NHANES II Normal (n = 2,431) 1.37 0.009 1.35 1.39 Y 

Overweight (n = 2,111) 1.25 0.015 1.22 1.28 N 

Obese (n = 694) 1.08 0.018 1.05 1.12 N 

NHANES III Normal (n = 2,275) 1.47 0.018 1.43 1.50 Y 

Overweight (n = 2,482) 1.35 0.015 1.32 1.38 Y 

Obese (n = 1,365) 1.20 0.018 1.17 1.24 N 

NHANES 1999–2000 Normal (n = 476 ) 1.42 0.020 1.38 1.46 Y 

Overweight (n = 655) 1.33 0.022 1.28 1.37 Y 

Obese (n = 469) 1.16 0.036 1.09 1.23 N 

NHANES 2001–2002 Normal (n = 493) 1.43 0.038 1.35 1.50 Y 

Overweight (n = 774) 1.32 0.017 1.29 1.36 Y 

Obese (n = 515) 1.18 0.027 1.13 1.24 N 

NHANES 2003–2004 Normal (n = 465) 1.46 0.029 1.41 1.52 Y 

Overweight (n = 659) 1.35 0.025 1.30 1.40 Y 

Obese (n = 547) 1.18 0.035 1.11 1.24 N 

NHANES 2005–2006 Normal (n = 413) 1.51 0.030 1.45 1.57 Y 

Overweight (n = 735) 1.33 0.023 1.29 1.38 Y 

Obese (n = 601) 1.22 0.014 1.19 1.25 N 

NHANES 2007–2008 Normal (n = 539) 1.40 0.038 1.32 1.47 Y 

Overweight (n = 835) 1.29 0.017 1.26 1.32 N 

Obese (n = 790) 1.15 0.019 1.12 1.19 N 

NHANES 2009–2010 Normal (n = 563) 1.38 0.027 1.33 1.44 Y 

Overweight (n = 872) 1.35 0.021 1.31 1.39 Y 

Obese (n = 884) 1.16 0.016 1.13 1.19 N 

* All estimates are weighted means. 

Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values <1.35 are considered implausible and indicative ofunderreporting. 

TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofieldpredictive equation. 

doi:10.1371/journal.pone.0076632.t003. 

Determination of Physiologically Credible rEI Values 

The ratio of rEI to BMR (rEI/BMR) <1.35 [22,23,25] was used to determine EI values that were implausible. BMR was estimated via the Schofield predictive equations [26]. The <1.35 cut-off for implausible EI values was used because ‘‘it is highly 

unlikely that any normal, healthy free-living person could habitually exist at a PAL 

[i.e., TEE/BMR] of less than 1.35’’ [22]. 

It is important to note that the <1.35 cut-off does not assess all forms of 

misreporting (e.g., over-reporting). To avoid the confounding effects of potential overreporting, all rEI/BMR values >2.40 [27] were excluded from analyses of underreporting. One form of misreporting that neither cut-off addresses is the underreporting of EI from a high caloric intake associated with elevated levels of physical 

activity. 

Disparity of the rEI and Estimated Total Energy Expenditure (TEE) 

In 2002, the IOM used datasets derived from studies using DLW to create factorial equations to estimate energy requirements for the U.S. population. IOM TEE 

values were subtracted from the NHANES rEI to calculate disparity values. Negative values indicate underreporting. 

IOM Equations for Predicting TEE Normal Weight (NW) Adults only (≥19 Years) 

Equation 1 Men: TEE= 864¥(9.72×age [y])+PA*×(14.2×weight 

[kg]+503×height[m]) (Ò202). 

Equation 2 Women: TEE = 387¥(7.31×age [y]+PA*×(10.8×weight 

[kg]+660.7×height[m]) (Ò156). 

94 

* Physical activity (PA) values were 1.12 and 1.14 for NW men and 

women, respectively. The use of these values assumes physical activity level 

(PAL) of ≥1.4 and <1.6, which is indicative of a ‘‘low active’’ population [24]. 

Figure 1 

Percent of Plausible Reporters 

(rEI/BMR >1.35) 

U.S. Men & Women (20–74 yrs) 

Percent of plausible reporters (i.e., rEI/BMR >1.35) by sex from NHANES 

I to NHANES 2009–2010; U.S. Men and women (20–74 years). 

IOM Equations for Predicting TEE Overweight (OW)/Obese (OB) Adults Only (≥19 

Years) 

Equation 3 Men: TEE= 1,086¥(10.1×age [y])+PA*×(13.76weight 

[kg]+416×height [m]). 

Equation 4 Women: TEE= 448¥(7.95×age [y])+PA*×(11.46weight 

[kg]+619×height [m]). 

* PA values were 1.12 and 1.16 for OW/OB men and women, respectively. 

The use of these values assumes a physical activity level (PAL) of ≥1.4 and <1.6, which is indicative of a ‘‘low active’’ population [24]. 

Note: age (years); weight (kg); height (m; meters); BMI= body mass index, 

(kg/m2), IOM= Institute of Medicine; TEE = total energy expenditure. 

Anthropometry [1] 

Body mass was measured to Ò0.1 kg. Height was measured to Ò0.1 cm. BMI was 

calculated as weight (kg)/height (m)2. The sample was divided into three standard 

BMI categories: BMI ≥18 kg/m2 and <25 kg/m2 were normal weight (NW), BMI between 25 kg/m2 and 29.9 kg/m2 were overweight (OW), and ≥30 kg/m2 were obese 

(OB). 

Statistical Analyses 

Data processing and statistical analyses were performed using SAS®, V 9.2 and 

SPSS® V.19 in 2012–2013. Analyses accounted for the NHANES’ complex survey design via the incorporation of stratification, clustering and post-stratification 

weighting to maintain a nationally representative sample for each survey period. All 

analyses included adjusted means, and α <0.05 (2-tailed) was used to identify statistical significance. 


11429014.eps
95 

Results 

Examination of Underreporting via rEI/BMR 

Table 1 depicts the rEI/BMR values for men and women from NHANES I through 

NHANES 2009–2010. rEI was from NHANES 24HR data and BMR was calculated 

using the Schofield predictive equations [26]. Values <1.35 are considered implausible and indicative of underreporting. 

Table 4. Disparity of rEI and TEE for men and women (20–74 years). 

Disparity between rEI and IOM TEE U.S. Men & Women (20–74 years) NHANES I–NHANES 2009–2010 

NHANES Survey 

Year Sex 

Estimate 

rEI 

minus 

TEE 

(mean) * 

Standard 

Error 

95% Confidence 

Interval (CI) 

Validity: 

95% CI 

includes 

zero (Y = 

Yes, N= 

No) 

Lower Upper 

NHANES I Men (n = 4,652) ¥290.8 20.3 ¥330.7 ¥250.9 N 

Women (n = 7,709) ¥479.7 14.5 ¥508.1 ¥451.3 N 

NHANES II Men (n = 5,236) ¥323.2 17.8 ¥358.1 ¥288.3 N 

Women (n = 6,006) ¥505.8 11.6 ¥528.4 ¥483.1 N 

NHANES III Men (n = 6,122) b¥183.3 19.1 ¥220.8 ¥145.7 N 

Women (n = 7,127) a¥325.3 13.5 ¥351.7 ¥298.8 N 

NHANES 1999–2000 Men (n = 1,600) ¥285.3 37.7 ¥359.3 ¥211.4 N 

Women (n = 1,886) a¥328.7 27.3 ¥382.3 ¥275.1 N 

NHANES 2001–2002 Men (n = 1,782) ¥270.3 26.8 ¥322.9 ¥217.7 N 

Women (n = 2,029) a¥306.0 15.5 ¥336.3 ¥275.6 N 

NHANES 2003–2004 Men (n = 1,671) ¥255.6 24.7 ¥304.0 ¥207.3 N 

Women (n = 1,838) a¥308.2 27.2 ¥361.5 ¥254.8 N 

NHANES 2005–2006 Men (n = 1,749) ¥232.2 25.3 ¥281.8 ¥182.6 N 

Women (n = 1,998) a¥347.5 20.8 ¥388.4 ¥306.6 N 

NHANES 2007–08 Men (n = 2,154) ¥355.0 32.1 ¥417.9 ¥292.0 N 

Women (n = 2,306) d¥379.4 28.5 ¥435.3 ¥323.5 N 

NHANES 2009–2010 Men (n = 2,319) ¥330.9 22.7 ¥375.4 ¥286.4 N 

Women (n = 2,532) a¥366.9 9.8 ¥386.1 ¥347.7 N 

All Surveys Men (n = 27,285) ¥281.4 9.1 ¥299.3 ¥263.5 N 

Women (n = 33,431) ¥364.6 7.0 ¥378.3 ¥351.0 N 

* All estimates are weighted means. 

aSignificantly different from NHANES I at p≤0.001 (Women). bSignificantly different from NHANES I at p≤0.001 (Men). cSignificantly different from NHANES I at p≤0.05 (Men). dSignificantly different from NHANES I at p≤0.05 (Women). 

Note: TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI = reported 

energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictiveequation. 

These values were calculated by subtracting the IOM TEE from the NHANES rEI. Negative 

values indicate the kilocalorie-per-day (kcal/day) value of underreporting. 

doi:10.1371/journal.pone.0076632.t004 

As Table 1 depicts, the 95% confidence intervals (CI) suggest that all mean rEI 

values for women and six of nine mean rEI values for men were apparently implausible. 

Table 2 depicts the rEI/BMR index for all women by BMI categories from 

NHANES I through NHANES 2009–2010. 

As Table 2 depicts, the 95% CI suggest that in 20 of the 27 measurement categories (i.e., three BMI categories and nine surveys) the rEI values were not in the 

physiologically plausible range. The overall mean for rEI/BMR values for the total 

sample of women (n= 33,431) across all NHANES was 1.19 (95% CI: 1.18, 1.20) and 

therefore not physiologically plausible. 

Table 3 depicts the rEI/BMR index for all men by BMI categories from NHANES 

I through NHANES 2009–2010. 

As shown in Table 3, the 95% CI suggest that in 12 of 27 measurement categories 

(i.e., three BMI categories and nine surveys), the rEI values were not in the physiologically plausible range. The overall mean value for rEI/BMR for the total sample 

of men (n = 27,285) across all NHANES was 1.31 (95% CI: 1.30, 1.32), and therefore 

not in the physiologically plausiblerange. 

Percent of Plausible Reporters 

Figure 1 depicts the percent of plausible reporters (i.e., rEI/BMR >1.35) by sex 

from NHANES I to NHANES 2009–2010. 

As Figure 1 depicts, across the entire study period (i.e., 1971–2010) the majority 

of respondents did not report plausible rEI values in any survey. When stratified 

96 

by sex and BMI categories, plausible reporting in OB women ranged from a low of 

∼12% in NHANES I and II to a high of 31% in NHANES 2003–2004. At no point 

in the history of the NHANES did more than 43% of OW and OB women report 

plausible values. Plausible reporting in NW women ranged from a low of 32% in 

NHANES II to 52% in NHANES 2001–2002. Plausible rEI values in OB men ranged 

from a low of 23% in NHANES II to a high of 35% in NHANES 2005–2006. At no 

point in the history of NHANES did more than 49% of OW and OB men report plausible rEI values. 

Disparity between NHANES rEI and IOM TEE 

Table 4 depicts the disparity of rEI and TEE for men and women (20–74 years). 

These values were calculated by subtracting the IOM TEE from the NHANES rEI. 

Negative values indicate the kilocalorie-per-day (kcal/day) value of underreporting. 

Table 5. Disparity between rEI and the TEE for women (20–74 years) by 

BMI categories. 

Disparity between rEI and IOM TEE; U.S. Women by BMI categories (20–74 years) NHANES I–NHANES 2009–2010 

NHANES Survey 

Year BMI Category 

Estimate 

rEI 

minus 

TEE 

(mean) * 

Standard 

Error 

95% Confidence 

Interval (CI) 

Validity: 

95% CI 

includes 

zero (Y = 

Yes, N= 

No) 

Lower Upper 

NHANES I Normal (n = 4,222) ¥316.0 17.7 ¥350.8 ¥281.2 N 

Overweight (n = 2,028) ¥595.3 17.7 ¥629.9 ¥560.6 N 

Obese (n = 1,459) ¥856.0 23.5 ¥902.0 ¥809.9 N 

NHANES II Normal (n = 3,171) ¥351.6 13.7 ¥378.5 ¥324.8 N 

Overweight (n = 1,671) ¥617.6 17.1 ¥651.1 ¥584.1 N 

Obese (n = 1,164) ¥850.6 19.5 ¥888.9 ¥812.3 N 

NHANES III Normal (n = 2,661) ¥158.6 17.7 ¥193.3 ¥123.9 N 

Overweight (n = 2,150) ¥357.1 26.5 ¥409.1 ¥305.2 N 

Obese (n = 2,316) ¥594.2 22.6 ¥638.5 ¥549.9 N 

NHANES 1999–2000 Normal (n = 555) ¥106.0 27.2 ¥159.3 ¥52.6 N 

Overweight (n = 572) ¥359.6 48.8 ¥455.3 ¥264.0 N 

Obese (n = 759) ¥530.1 50.2 ¥628.5 ¥431.6 N 

NHANES 2001–2002 Normal (n = 630) ¥74.0 21.7 ¥116.6 ¥31.4 N 

Overweight (n = 639) ¥239.6 38.7 ¥315.5 ¥163.7 N 

Obese (n = 760) ¥591.1 20.5 ¥631.4 ¥550.9 N 

NHANES 2003–2004 Normal (n = 550) ¥116.3 39.2 ¥193.2 ¥39.4 N 

Overweight (n = 546) ¥339.0 37.7 ¥413.0 ¥265.0 N 

Obese (n = 742) ¥477.1 42.2 ¥560.0 ¥394.2 N 

NHANES 2005–2006 Normal (n = 615) ¥131.1 34.1 ¥198.0 ¥64.3 N 

Overweight (n = 558) ¥342.8 38.0 ¥417.4 ¥268.3 N 

Obese (n = 825) ¥567.3 38.7 ¥643.2 ¥491.3 N 

NHANES 2007–2008 Normal (n = 634) ¥173.2 52.1 ¥275.4 ¥71.0 N 

Overweight (n = 694) ¥374.1 35.8 ¥444.4 ¥303.7 N 

Obese (n = 978) ¥567.3 33.2 ¥632.5 ¥502.1 N 

NHANES 2009–2010 Normal (n = 690) ¥173.0 27.8 ¥227.5 ¥118.4 N 

Overweight (n = 745) ¥288.9 34.0 ¥355.7 ¥222.2 N 

Obese (n = 1,097) ¥590.5 14.0 ¥617.8 ¥563.1 N 

Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of 

Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation. 

These values were calculated by subtracting the IOM TEE from the NHANES rEI for each respondent. Negative values indicate the kcal/day value of underreporting. 

doi:10.1371/journal.pone.0076632.t005 

As Table 4 depicts, in no survey group (i.e., men & women in nine surveys) does 

the 95% CI for the disparity between rEI and TEE include zero. This suggests that 

that underreporting of EI occurred in both men and women, and across all surveys. 

The overall mean value for the disparity of rEI and IOM TEE for the total sample 

of women (n= 33,431) across all NHANES was ¥365 kcal/day (95% CI: ¥378, 

¥351), or ∼18% of TEE, and for the total sample of men (n= 27,285) was ¥281 kcal/ 

day (95% CI: ¥299, ¥264), or ∼10% of TEE. 

When stratified by sex and BMI categories (see Tables 5 & 6), the disparities between rEI and TEE in OB women ranged from 2,856 kcal/day (95% CI: ¥902, 

¥810), an underreporting of ∼41% of TEE, to 2477 kcal/day (95% CI: ¥560, ¥394), 

an underreporting of 20% of TEE. The disparities between rEI and TEE in OB men 

ranged from ¥717 kcal/day (95% CI: ¥790, ¥643) in NHANES II to ¥464 kcal/ 

day (95% CI: ¥527, ¥401) underreporting of 25% and 15%, respectively. 

97 

Trends in Underreporting 

After the removal of over-reporters, both protocols, that is rEI/BMR (Figure 1) and 

the disparity between rEI and IOM TEE (Table 4) exhibited significant decreases 

in underreporting from NHANES II and NHANES III (p<0.001). There were significant negative linear trends for both men and women in changes in underreporting 

total caloric intake from NHANES I to NHANES 2009–2010 (rEI/BMR: p<0.001, 

and disparity: p =0.028). 

Trends in Over-Reporting 

Across the study period, approximately 4.9% of men and 2.9% of women reported 

rEI/BMR values suggestive of over-reporting (i.e., rEI/BMR >2.4) with no significant 

trends. The greatest increase in the percentage of over-reporters between survey periods occurred from NHANES II to NHANES III, with men increasing from 4.1% 

to 6.4%, and women from 1.7% to 3.4% (both p<0.001). The greatest absolute percentage of over-reporters was in NHANES III, with 6.4% of men over-reporting and 

NHANES 2003–2004, with 3.9% of women over-reporting. 

Table 6. Disparity between rEI and the TEE for all men (20–74 years) by 

BMI categories. 

Disparity between rEI and IOM TEE; U.S. Men by BMI categories (20–74 years) NHANES I–NHANES 2009– 

2010 

NHANES Survey 

Year BMI Category 

Estimate 

rEI 

minus 

TEE 

(mean) * 

Standard 

Error 

95% Confidence 

Interval (CI) 

Validity: 

95% CI 

includes 

zero (Y = 

Yes, N= 

No) 

Lower Upper 

NHANES I Normal (n = 2,115) ¥96.3 26.8 ¥149.0 ¥43.6 N 

Overweight (n = 1,945) ¥374.7 30.8 ¥435.1 ¥314.2 N 

Obese (n = 592) ¥702.1 49.7 ¥799.7 ¥604.5 N 

NHANES II Normal (n = 2,431) ¥178.7 15.9 ¥209.9 ¥147.6 N 

Overweight (n = 2,111) ¥367.6 27.0 ¥420.5 ¥314.6 N 

Obese (n = 694) ¥716.5 37.3 ¥789.8 ¥643.3 N 

NHANES III Normal (n = 2,275) ¥8.8 31.1 ¥69.8 52.2 Y 

Overweight (n = 2,482) ¥191.5 27.9 ¥246.3 ¥136.7 N 

Obese (n = 1365) ¥494.4 38.0 ¥569.0 ¥419.9 N 

NHANES 1999–2000 Normal (n = 476) ¥87.2 34.8 ¥155.6 ¥18.8 N 

Overweight (n = 655) ¥221.8 41.5 ¥303.3 ¥140.2 N 

Obese (n 469) ¥590.9 76.8 ¥741.6 ¥440.2 N 

NHANES 2001–2002 Normal (n = 493) ¥64.1 63.1 ¥188.0 59.9 Y 

Overweight (n = 774) ¥229.2 29.5 ¥287.1 ¥171.3 N 

Obese (n = 515) ¥527.5 55.3 ¥636.1 ¥418.9 N 

NHANES 2003–2004 Normal (n = 465) ¥6.8 47.3 ¥99.6 86.0 Y 

Overweight (n = 659) ¥175.4 46.9 ¥267.4 ¥83.4 N 

Obese (n = 547) ¥549.8 72.0 ¥691.1 ¥408.5 N 

NHANES 2005–2006 Normal (n = 413) 70.4 53.0 ¥33.7 174.5 Y 

Overweight (n = 735) ¥222.4 39.7 ¥300.3 ¥144.4 N 

Obese (n = 601) ¥464.2 32.1 ¥527.2 ¥401.2 N 

NHANES 2007–2008 Normal (n = 539) ¥117.9 64.8 ¥245.2 9.3 Y 

Overweight (n = 835) ¥286.7 31.3 ¥348.1 ¥225.2 N 

Obese (n = 790) ¥608.0 42.2 ¥690.8 ¥525.2 N 

NHANES 2009–2010 Normal (n = 563) ¥154.4 43.5 ¥239.8 ¥69.1 N 

Overweight (n = 872) ¥178.9 42.1 ¥261.5 ¥96.4 N 

Obese (n = 884) ¥590.9 32.9 ¥655.4 ¥526.4 N 

Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of 

Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation. 

These values were calculated by subtracting the estimated IOM TEE from the NHANES rEI for 

each respondent. Negative numbers indicate the kcal/day value of underreporting. 

doi:10.1371/journal.pone.0076632.t006. 

Discussion 

Validity of NHANES EI Data 

Our results suggest that across the 39 year history of U.S. nutrition surveillance 

research, rEI data on the majority of respondents (67.3% of women and 58.7% of 

men) were not physiologically plausible. The historical average rEI/BMR values for 

all men and women were 1.31 and 1.19 respectively (Table 1). These values are indicative of substantial underreporting. The expected average values for healthy, free 

living men and women are ∼1.55, with a range of >1.35 to <2.40 [23, 27]. In no survey did at least 50% of the respondents report plausible EI values (Figure 1). These 

98 

data are consistent with previous research demonstrating that the misreporting of 

EI in nutrition surveys is widespread [9, 11, 28–34]. Goldberg, et al. (1991) demonstrated that in 37 studies across ten countries, >65% of the mean rEI/BMR values 

were below the study-specific plausibility cut-off [23]. In addition to the extensive 

underreporting in our sample, 4.9% of men and 2.9% of women reported rEI/BMR 

values suggestive of over-reporting (i.e., rEI/BMR >2.40). 

Disparity between NHANES rEI and IOM Derived TEE 

Throughout the study period (i.e., 1971–2010) the disparity between rEI and TEE 

values were large and variable across BMI and sex categories suggesting substantial 

systematic biases in underreporting (Tables 4, 5, 6). The overall mean disparity values for men and women were ¥281 kcal/day and 2365 kcal/day, respectively. The 

greatest mean disparity values were ¥717 kcal/day (25% of TDEE) and ¥856 kcal/ 

day (41% of TEE) in OB men and women, respectively. 

Trends in the Validity and Inferences from NHANES rEI Data 

As depicted in Tables 1 and 2, and Figure 1, there were large decreases in underreporting between NHANES II and NHANES III. This is clearly evidenced by the 

increase in rEI/BMR index (Table 1), the large and significant increase in the percent of plausible reporters (Figure 1), and the reduction in the disparity between 

NHANES rEI and NAS/IOM EER (Table 4). This decrement in underreporting between NHANES II and subsequent surveys across all sex and BMI categories is 

likely the result of improvements in survey protocols for NHANES III, such as the 

inclusion of more days of dietary recall (i.e., weekends), automated multi-pass methodology, and increased staff training and quality control (see [35]), The extent of 

these improvements is notable; for example, the percentage of OB women reporting 

implausible values decreased from ∼88% in NHANES II to 74% in NHANES III. 

These changes in measurement protocols led to an apparent increase in mean rEI 

values that has been reported as an actual increase in population-level EI despite 

caveats that the ‘‘Interpretation of trends in energy and nutrient intakes is difficult 

when methodologic changes occur between surveys’’ [36]. Nevertheless, Briefel and 

Johnson state (without caveat) in their abstract, ‘‘During the 30 year period, mean 

energy intake increased among adults . . .’’ [37]. The data presented in the present 

report refute this inference. When the NHANES dietary measurement protocols 

were altered after NHANES II, the improved method captured a higher percentage 

of actual intakes. The apparent increase in mean rEI was merely an artifact of improved measurement protocols and not indicative of a true increase in caloric consumption. Despite this fact, the apparent increase has been regularly published and 

uncritically accepted as a true upward trend in caloric consumption (e.g., [37, 38]) 

and the cause of the obesity epidemic (e.g., [39, 40]). 

Changes in Underreporting and Public PolicyRecommendations 

In addition to the ubiquity of misreporting, there is strong evidence that the reporting of ‘socially undesirable’ (e.g., high fat and/or high sugar) foods has changed 

as the prevalence of obesity has increased [12–15]. Additionally, research has demonstrated that interventions emphasizing the importance of ‘healthy’ behaviors may 

lead to increased misreporting as participants alter their reports to reflect the adoption of the ‘healthier’ behaviors independent of actual behavior change [17, 41]. It 

appears that lifestyle interventions ‘‘teach’’ participants the socially desirable or acceptable responses [17, 42]. As such, the ubiquity of public health messages to ‘eat 

less and exercise more’ may induce greater levels of misreporting and may explain 

the recent downward bias in both self-reported EI [20] and body weight [17, 43], 

especially given that social desirability bias is often expressed in the underreporting 

of calorically dense foods [44]. 

Selective misreporting of specific macronutrients has important ramifications for 

epidemiological research and nutrition surveillance. Heitmann and Lissner (2005) 

demonstrated that the selective misreporting of dietary fat by groups at an increased risk of chronic non-communicable diseases may result in an overestimated 

association between fat consumption and disease [45]. If the potentially negative effects of high-fat diets are overestimated due to selective misreporting, current recommendations for fat intake may be overly conservative [45]. 

Additional Systematic Biases of Nutrition Surveillance Data 

In addition to known sources of systematic reporting error, there are numerous 

sources of systematic bias in nutrition surveillance research protocols that are not 

addressed via our data. Another potentially large source of error is the translation 

of food and beverage consumption data (e.g., 24HR) into nutrient energy values via 

nutrient composition databases. The accuracy of this translation relies on a number 

of assumptions that are rarely justified. As cited earlier, research on misreporting 

99 

shows that reports do not accurately reflect the quantity or number of foods consumed, and are not representative of usual intakes [12–15, 46–50]. Given that the 

basic methodological assumptions are violated, it is not surprising that research has 

demonstrated that food data to nutrient energy conversions are ‘‘riddled with potential pitfalls at all stages’’ that ‘‘hamper the interpretability of the results’’ [51–53], 

and represent a major source of systematic error in national nutrition surveillance 

efforts [2]. 

Throughout its history, the NHANES has relied upon databases of varying quality 

and composition for the post-hoc conversion of food and beverage consumption (i.e., 

24HR) data into energy values [2–5, 53]. This makes the analysis of trends extremely complex because the nutrient energy (i.e., caloric) values in the databases 

varied considerably over time [54, 55]. Additionally, research has demonstrated that 

the energy content of restaurant food (and especially fast-food outlets) vary significantly when compared to the industry values used in the NNDS [56], and an internal quality review of NHANES 2003–2004 data led to ∼400 substantive changes in 

nutrient and energy values. [57]. The result of these limitations are discussed in detail elsewhere, see [4, 5, 58]. 

As with the improvements in the NHANES survey protocols, the progressive alterations to the nutrient database combined with changes in the types of foods that 

are available for consumption led to artifactual differences in nutrient and energy 

consumption estimates that frustrate efforts to examine trends in caloric consumption [58]. To account for these changes, researchers must maintain the real differences in the composition of foods while correcting for artifactual differences attributable to improvements in the quality of nutrient data [58]. Given the lack of 

comprehensive crossover studies and metrics for adjustment as the food and nutrient databases evolved, papers examining trends in caloric consumption must be 

treated with skepticism [51,58]. 

Commercially Prepared Foods and Meals Away From Home 

One of the most prominent systematic errors from 24HR data-to-nutrient energy 

conversions is due to the increased reliance on the food service industry and the 

substantial rise in meals eaten ‘away from home’ [59–61]. As stated previously, the 

vast majority of foods and beverages in the NNDS have not been evaluated empirically and research has demonstrated that the energy and macro/micro nutrient content of commercially prepared foods varies significantly compared to the industry 

values used in the NNDS [56]. When foods or commodities are not in the database, 

substitutions are necessitated. For these interpolations to be accurate, the analogues 

must be similar in composition to the consumed food or beverage. This is extremely 

difficult to perform in practice because no two foods or commodities are identical, 

and local vs. imported foods/commodities differ significantly. For example, in survey 

data collection, knowledge of the specific preparation and cut of beef are essential 

since the energy content of generic beef substitutions may differ dramatically (e.g., 

166 kcals per 100 grams in round steak to 257 kcals in top sirloin [62]) [63,64]. 

Given these realities, USDA estimates of caloric consumption may be increasingly 

inaccurate as the number of food and beverages supplied by the commercial sector 

expands rapidly. 

Recent research has attempted to quantify the changes in consumer packaged 

foods and beverages, and their impact on the American diet [65]. Nevertheless, 

these efforts suffer from the same limitations as all food data-to-nutrient energy 

value conversions via nutrient composition databases. Additionally, the translation 

of ‘‘as-purchased’’ foods and beverages (using information from the commercial sector) to ‘‘as-consumed’’ energy and macro/micronutrient content for national surveillance relies on the accurate quantification of food preparation and waste [65]. Unfortunately, these data are limited and highly variable [52, 66]. In a report from the 

USDA’s Economic Research Service, Muth, et al. (2011) state that the current data 

are incomplete and overstate actual consumption because the level of ‘‘documentation of food losses . . . ranged from little to none for estimates at the retail and customer levels.’’ [67]. These results clearly demonstrate the conceptual and methodological complexity of translating food and beverage purchases into nutrient energy 

and macro/micronutrient intake in the context of a rapidly evolving food supply. 

Methods of Adjustment for Systematic Biases 

There are various methods that attempt to improve estimates of caloric consumption derived from self-reported dietary intake [32, 68–72]. While these methods may 

improve the shape of the distribution of the estimates, none can address the significant systematic biases described in this report. For example, the National Research 

Council and the Iowa State University methods provide significantly improved estimates of the shape of the distribution, but do not substantially improve estimates 

100 

of mean energy intake (10–15% underestimation) or protein consumption (6–7% 

underestimation) [70]. 291. 

Strengths and Limitations 

A strength of the present study was the use of the established rEI/BMR method 

for the determination of physiologically implausible EI values. We used a liberal cutoff (i.e., <1.35) that is below the study-specific theoretical cutoff for our smallest subgroup (i.e., n >400). The use of the more conservative cutoff of rEI/BMR <1.50 recommended by Goldberg, et al., (1991) [22] increased underreporting by 10% in 

women and 7% in men across all surveys. A second strength was the use of a rEI/ 

BMR >2.4 for the elimination of potential over-reporters to correct the limitations 

of previous research [29]. 

Finally, the use of the IOM factorial equations for estimating TEE for specific subgroups (i.e., OW & OB respondents) in the calculation of disparity values is a significant strength. The results of this additional protocol demonstrated significant 

underreporting in all surveys, and that the disparity values closely paralleled the 

implausible values in 15 of the 18 sub-groups (i.e., men & women in nine surveys). 

The close agreement between these two dissimilar protocols increases confidence in 

our results and conclusions. 

A potential limitation to our analysis was the use of the Schofield predictive equation for estimating BMR. The Schofield predictive equations may overestimate BMR 

in some populations [73, 74]. If the Schofield equation overestimated BMR, a greater 

percentage of survey respondents would be classified as underreporters. To address 

this potential limitation, we performed the analyses using the Mifflin equation [75], 

which has been validated in OW and OB populations such as the U.S. [74]. The results of those analyses were similar to those obtained using the Schofield equation, 

with substantial underreporting (>50%) in all surveys, significant trends in changes 

in underreporting, and a small increase in over-reporting. To remain consistent with 

past research on implausible rEI and underreporting [29, 33], we chose to present 

the results from the Schofield predictive equations. 

Conclusions 

Throughout its history, NHANES dietary measurement protocols have failed to 

provide accurate estimates of the habitual caloric consumption of the U.S. population. Furthermore, successive changes to the nutrient databases used for the 

24HR data-to-energy conversations and improvements in measurement protocols 

make it exceedingly difficult to discern temporal patterns in caloric intake that can 

be related to changes in population rates of obesity. As such, there are no valid population-level data to support speculations regarding trends in caloric consumption 

and the etiology of the obesity epidemic. Because under-reporting and physiologically implausible rEI values are a predominant feature of U.S. nutritional surveillance, the ability to generate empirically supported public policy and Dietary Guidelines relevant to the obesity epidemic based on these data is extremely limited. 

Acknowledgments 

The data used in this study are available at: http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm. 

Author Contributions 

Conceived and designed the experiments: E.A., S.N.B. Performed the experiments: E.A. Analyzed the data: E.A., G.A.H., S.N.B. 

Wrote the paper: E.A. 

References 

1. CDC (2012) National Health and Examination Survey. Atlanta, GA: Centers for Disease Control and Prevention. 

2. Blair D. (1992) Dietary methodology issues related to energy balance measurement for NHANES III. VITAL & HEALTH STATISTICS 4: 43–50. 

3. Phillips K.M., Patterson K.Y., Rasor A.S., Exler J., Haytowitz D.B, et al. (2006) Quality-control materials in the USDA National Food and Nutrient Analysis Program (NFNAP). ANAL. BIOANAL. CHEM. 384: 1341–1355. 

4. Weihrauch J.L. (1992) Problems in Energy Calculations. In: USDA, editor; Baltimore, Maryland. Human Nutrition Information 

Service, HNIS. 

5. Perloff B., Ahuja J.K. (1998) Development and maintenance of nutrient databases for national dietary surveys. PUBLIC HEALTH. 

REV. 26: 43–47. 

6. Dwyer J., Picciano M.F., Raiten D.J. (2003) Collection of food and dietary supplement intake data: What We Eat in America— 

NHANES. J. NUTR. 133: 590S–600S. 

7. USDA (2012) National Agricultural Library National Nutrient Database for Standard Reference. 

8. Black A.E., Cole T.J. (2001) Biased over- or under-reporting is characteristic of individuals whether over time or by different assessment methods. J. AM. DIET. ASSOC. 101: 70–80. 

9. Subar A.F., Kipnis V., Troiano R.P., Midthune D., Schoeller D.A., et al. (2003) Using intake biomarkers to evaluate the extent of 

dietary misreporting in a large sample of adults: the OPEN study. AM. J. EPIDEMIOL. 158: 1–13. 

10. Schoeller D.A. (1995) Limitations in the assessment of dietary energy intake by self-report. METABOLISM 44: 18–22. 

11. Huang T.T.K., Roberts S.B., Howarth N.C., McCrory M.A. (2005) Effect of Screening Out Implausible Energy Intake Reports 

on Relationships between Diet and BMI. OBESITY RESEARCH 13: 1205–1217. 

12. Goris A.H., Westerterp-Plantenga M.S., Westerterp K.R. (2000) Undereating and underrecording of habitual food intake in 

obese men: selective underreporting of fat intake. AM. J. CLIN. NUTR. 71: 130–134. 

13. Scagliusi F.B., Polacow V.O., Artioli G.G., Benatti F.B., Lancha A.H., Jr. (2003) Selective underreporting of energy intake in 

women: magnitude, determinants, and effect of training. J. AM. DIET. ASSOC. 103: 1306–1313. 

14. Lissner L., Heitmann B.L., Bengtsson C. (2000) Population studies of diet and obesity. BR. J. NUTR. 83 Suppl. 1: S21–24. 

101 

15. Heitmann B.L., Lissner L., Osler M. (2000) Do we eat less fat, or just report so? INT. J. OBES. RELAT. METAB. DISORD. 24: 435– 

442. 

16. Hebert J.R., Ebbeling C.B., Matthews C.E., Hurley T.G., Ma Y., et al. (2002) Systematic errors in middle-aged women’s estimates of energy intake: comparing three self-report measures to total energy expenditure from doubly labeled water. ANN. EPIDEMIOL. 

12: 577–586. 

17. Schoeller D.A., Thomas D., Archer E., Heymsfield S.B., Blair S.N., et al. (2013) Self-report-based estimates of energy intake 

offer an inadequate basis for scientific conclusions. AM. J. CLIN. NUTR. 97: 1413–1415. 

18. Austin G.L., Ogden L.G., Hill J.O. (2011) Trends in carbohydrate, fat, and protein intakes and association with energy intake 

in normal-weight, overweight, and obese individuals: 1971–2006. THE AMERICAN JOURNAL OF CLINICAL NUTRITION 93: 836–843. 

19. Skinner A.C., Steiner M.J., Perrin E.M. (2012) Self-reported energy intake by age in overweight and healthy-weight children in 

NHANES, 2001–2008. PEDIATRICS 130: e936–942. 

20. Ford E.S., Dietz W.H. (2013) Trends in energy intake among adults in the United States: findings from NHANES. AM. J. 

CLIN. NUTR. 

21. McCrory M.A., Hajduk C.L., Roberts S.B. (2002) Procedures for screening out inaccurate reports of dietary energy intake. PUBLIC HEALTH NUTR. 5: 873–882. 

22. Goldberg G.R., Black A.E., Jebb S.A., Cole T.J., Murgatroyd P.R., et al. (1991) Critical evaluation of energy intake data using 

fundamental principles of energy physiology: 1. Derivation of cut-off limits to identify under-recording. EUR. J. CLIN. NUTR. 45: 569– 

581. 

23. Black A.E., Goldberg G.R., Jebb S.A., Livingstone M.B., Cole T.J., et al. (1991) Critical evaluation of energy intake data using 

fundamental principles of energy physiology: 2. Evaluating the results of published surveys. EUR. J. CLIN. NUTR. 45: 583–599. 

24. IOM (2005) Report of the Panel on Macronutrients: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty 

Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Washington D.C.: The National Academies Press. 

25. Livingstone M.B.E., Black A.E. (2003) Markers of the Validity of Reported Energy Intake. 895S–920S. 

26. Schofield W.N., Schofield C., James W.P.T. (1985) Basal metabolic rate-review and prediction, with an annotated bibliography 

of source material. HUMAN NUTRITION CLINICAL NUTRITION 39C: 1–96. 

27. FAO/WHO/UNU (2004) Human energy requirements: Report of a Joint FAO/WHO/UNU Expert Consultation. Rome World 

Health Organization, Food and Agriculture Organization of the United Nations, United Nations University. 

28. Heerstrass D.W., Ocke M.C., Bueno-de-Mesquita H.B., Peeters P.H., Seidell J.C. (1998) Underreporting of energy, protein and 

potassium intake in relation to body mass index. INT. J. EPIDEMIOL. 27: 186–193. 

29. Briefel R.R., Sempos C.T., McDowell M.A., Chien S., Alaimo K. (1997) Dietary methods research in the third National Health 

and Nutrition Examination Survey: underreporting of energy intake. AM. J. CLIN. NUTR. 65: 1203S–1209S. 

30. Johansson L., Solvoll K., Bjorneboe G.E., Drevon C.A. (1998) Under- and overreporting of energy intake related to weight status and lifestyle in a nationwide sample. AM. J. CLIN. NUTR. 68: 266–274. 

31. Okubo H., Sasaki S. (2004) Underreporting of energy intake among Japanese women aged 18–20 years and its association with 

reported nutrient and food group intakes. PUBLIC HEALTH NUTR. 7: 911–917. 

32. Yanetz R., Kipnis V., Carroll R.J., Dodd K.W., Subar A.F., et al. (2008) Using biomarker data to adjust estimates of the distribution of usual intakes for misreporting: application to energy intake in the U.S. population. J. AM. DIET. ASSOC. 108: 455–464; 

discussion 464. 

33. Ferrari P., Slimani N., Ciampi A., Trichopoulou A., Naska A., et al. (2002) Evaluation of under- and overreporting of energy 

intake in the 24-hour diet recalls in the European Prospective Investigation into Cancer and Nutrition (EPIC). PUBLIC HEALTH

NUTR. 5: 1329–1345. 

34. Becker W., Foley S., Shelley E., Gibney M. (1999) Energy under-reporting in Swedish and Irish dietary surveys: implications 

for food-based dietary guidelines. BR. J. NUTR. 81 Suppl. 2: S127–131. 

35. McDowell M., Briefel R.R., Buzzard I.M., Gardner S.N., Warren R.A., et al. (1994) The Dietary Collection System—An Automated Interview and Coding System for NHANES III; accessed 11/12/2012; available at CDC website: www.cdc.gov/nchs/tutorials/ 

dietary/additionalresources/NNDB94.pdf. Centers for Disease Control and Prevention, National Center for Health Statistics. 

36. McDowell M.A. (1994) Update on the Third National Health and Nutrition Examination Survey. Centers for Disease Control 

and Prevention, National Center for Health Statistics. Available: www.nutrientdataconf.org/pastconf/ndbc19/6-5_mcdowell.pdf. 

Accessed 2012 Jun. 11. 

37. Briefel R.R., Johnson C.L. (2004) Secular trends in dietary intake in the United States. ANNU. REV. NUTR. 24: 401–431. 

38. CDC (2004) Trends in intake of energy and macronutrients—United States, 1971–2000. MMWR MORB. MORTAL. WKLY. REP. 

53: 80–82. 

39. Finkelstein E.A., Ruhm C.J., Kosa K.M. (2005) Economic causes and consequences of obesity. ANNU. REV. PUBLIC HEALTH 26: 

239–257. 

40. Cutler D.M., Glaeser E.L., Shapiro J.M. (2003) Why Have Americans Become More Obese? JOURNAL OF ECONOMIC PERSPECTIVES v17: 93–118. 

41. Taber D.R., Stevens J., Murray D.M., Elder J.P., Webber L.S., et al. (2009) The effect of a physical activity intervention on bias 

in self-reported activity. ANN. EPIDEMIOL. 19: 316–322. 

42. Racette S.B., Schoeller D.A., Kushner R.F., Neil K.M. (1995) Exercise enhances dietary compliance during moderate energy restriction in obese women. AM. J. CLIN. NUTR. 62: 345–349. 

43. Shiely F., Hayes K., Perry I.J., Kelleher C.C. (2013) Height and weight bias: the influence of time. PLOS ONE 8: e54386. 

44. Hebert J.R., Clemow L., Pbert L., Ockene I.S., Ockene J.K. (1995) Social desirability bias in dietary self-report may compromise the validity of dietary intake measures. INT. J. EPIDEMIOL. 24: 389–398. 

45. Heitmann B.L., Lissner L. (2005) Can adverse effects of dietary fat intake be overestimated as a consequence of dietary fat 

underreporting? PUBLIC HEALTH NUTR. 8: 1322–1327. 

46. Goris A.H., Westerterp K.R. (1999) Underreporting of habitual food intake is explained by undereating in highly motivated 

lean women. J. NUTR. 129: 878–882. 

47. Johansson G., Wikman A., Ahren A.M., Hallmans G., Johansson I. (2001) Underreporting of energy intake in repeated 24-hour 

recalls related to gender, age, weight status, day of interview, educational level, reported food intake, smoking habits and area of living. PUBLIC HEALTH NUTR. 4: 919–927. 

48. Lichtman S.W., Pisarska K., Berman E.R., Pestone M., Dowling H., et al. (1992) Discrepancy between self-reported and actual 

caloric intake and exercise in obese subjects. N. ENGL. J. MED. 327: 1893–1898. 

49. McGowan M.J., Harrington K.E., Kiely M., Robson P.J., Livingstone M.B., et al. (2001) An evaluation of energy intakes and 

the ratio of energy intake to estimated basal metabolic rate (EI/BMRest) in the North/South Ireland Food Consumption Survey. 

PUBLIC HEALTH NUTR. 4: 1043–1050. 

50. Trabulsi J., Schoeller D.A. (2001) Evaluation of dietary assessment instruments against doubly labeled water, a biomarker of 

habitual energy intake. AM. J. PHYSIOL. ENDOCRINOL. METAB. 281: E891–899. 

51. Kelly A., Becker W., Helsing E. (1991) Food Balance Sheets. In: Becker W., Helsing E., editors. Food and health data: Their 

use in nutrition policy-making: WHO Regional Publications, European Series, No. 34. 39–48. 

52. Kohlmeier L. (1991) Problems and pitfalls of food-to-nutrient conversion. In: Becker W., Helsing E., editors. Food and health 

data: Their use in nutrition policy-making: WHO Regional Publications, European Series, No. 34. 73–84. 

53. Kelly A., Becker W. (1991) Nutrition information systems and data quality requirements. In: Becker W., Helsing E., editors. 

Food and health data: their use in nutrition policy-making: WHO Regional Publications, European Series, No. 34. 15–24. 

54. Ahuja J.K.C., Goldman J.D., Perloff B.P. (2006) The effect of improved food composition data on intake estimates in the United 

States of America. JOURNAL OF FOOD COMPOSITION AND ANALYSIS 19, Supplement: S7–S13. 

55. Ahuja J.K.C., Lemar L., Goldman J.D., Moshfegh A.J. (2009) The impact of revising fats and oils data in the U.S. Food and 

Nutrient Database for Dietary Studies. JOURNAL OF FOOD COMPOSITION AND ANALYSIS 22, Supplement: S63–S67. 

56. Urban L.E., McCrory M.A., Dallal G.E., Das S.K., Saltzman E., et al. (2012) Accuracy of stated energy contents of restaurant 

foods. JAMA 306: 287–293. 

57. Ahuja J.K.C., Perloff B.P. (2008) Quality control procedures for the USDA Food and Nutrient Database for Dietary Studies nutrient values. JOURNAL OF FOOD COMPOSITION AND ANALYSIS 21, Supplement: S119–S124. 

102 

58. Guenther P.M., Perloff B.P., Vizioli T.L., Jr. (1994) Separating fact from artifact in changes in nutrient intake over time. J. 

AM. DIET. ASSOC. 94: 270–275. 

59. Guthrie J.F., Lin B.H., Frazao E. (2002) Role of food prepared away from home in the American diet, 1977–78 versus 1994– 

96: changes and consequences. J. NUTR. EDUC. BEHAV. 34: 140–150. 

60. Stewart H., Yen S.T. (2004) Changing household characteristics and the away-from-home food market: a censored equation 

system approach. FOOD POLICY 29: 643–658. 

61. Stewart H., Blisard N., Bhuyan., Nayga R.M.J. (2012) The Demand for Food Away From Home. Full-Service or Fast Food? In: 

USDA, editor. Electronic Report from the Economic Research Service: Economic Research Service. 

62. USDA (2011) Nutrient Data Set for Retail Beef Cuts. Beltsvile, MD: Nutrient Data Laboratory (NDL), Agricultural Research 

Service, U.S. Department of Agriculture. 

63. Smith A.M., Harris K.B., Haneklaus A.N., Savell J.W. (2011) Proximate composition and energy content of beef steaks as influenced by USDA quality grade and degree of doneness. MEAT SCI. 89: 228–232. 

64. O’Neil C.E., Zanovec M., Keast D.R., Fulgoni V.L., 3rd, Nicklas T.A. (2011) Nutrientcontribution of total and lean beef in diets 

of U.S. children and adolescents: National Health and Nutrition Examination Survey 1999–2004. MEAT SCI. 87: 250–256. 

65. Slining M.M., Ng S.W., Popkin B.M. (2013) Food companies’ calorie-reduction pledges to improve U.S. diet. AM. J. PREV. MED. 

44: 174–184. 

66. FAO (2001) Food Balance Sheets: A handbook. Rome, Italy: Food and Agriculture Organization of the United Nations. 

67. Muth M.K., Karns S.A., Nielsen S.J., Buzby J.C., Wells H.F. (2011) Consumer-Level Food Loss Estimates and Their Use in the 

ERS Loss-Adjusted Food Availability Data. USDA Economic Research Service, Technical Bulletin (TB–1927). 123 p. 

68. Nusser S.M., Carriquiry A.L., Dodd K.W., Fuller W.A. (1996) A Semiparametric Transformation Approach to Estimating 

Usual Daily Intake Distributions. JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION 91: 1440–1449. 

69. Dodd K.W., Guenther P.M., Freedman L.S., Subar A.F., Kipnis V., et al. (2006) Statistical methods for estimating usual intake 

of nutrients and foods: a review of the theory. J. AM. DIET. ASSOC. 106: 1640–1650. 

70. Freedman L.S., Midthune D., Carroll R.J., Krebs-Smith S., Subar A.F., et al. (2004) Adjustments to improve the estimation of 

usual dietary intake distributions in the population. J. NUTR. 134: 1836–1843. 

71. Tooze J.A., Kipnis V., Buckman D.W., Carroll R.J., Freedman L.S., et al. (2010) A mixed-effects model approach for estimating 

the distribution of usual intake of nutrients: the NCI method. STAT. MED. 29: 2857–2868. 

72. IOM (2003) Dietary Reference Intakes: Applications in Dietary Planning: The National Academies Press. 

73. Frankenfield D., Roth-Yousey L., Compher C. (2005) Comparison of predictive equations for resting metabolic rate in healthy 

nonobese and obese adults: a systematic review. J. AM. DIET. ASSOC. 105: 775–789. 

74. Frankenfield D.C., Rowe W.A., Smith J.S., Cooney R.N. (2003) Validation of several established equations for resting metabolic rate in obese and nonobese people. J. AM. DIET. ASSOC. 103: 1152–1159. 

75. Mifflin M.D., St. Jeor S.T., Hill L.A., Scott B.J., Daugherty S.A., et al. (1990) A new predictive equation for resting energy expenditure in healthy individuals. AM. J. CLIN. NUTR. 51: 241–247. 

SUBMITTED LETTER BY SHANNON CAMPAGNA, DIRECTOR, FEDERAL GOVERNMENT

AFFAIRS, MARS, INCORPORATED

October 6, 2015 

Hon. K. MICHAEL CONAWAY, 

Chairman, 

House Agriculture Committee, 

Washington, D.C.; 

Hon. COLLIN C. PETERSON, 

Ranking Minority Member, 

House Agriculture Committee, 

Washington, D.C. 

Dear Chairman Conaway and Ranking Member Peterson: 

Mars, Incorporated (Mars) is pleased to submit these comments to the House Agriculture Committee in advance of its hearing titled, ‘‘Public Hearing: 2015 Dietary 

Guidelines for Americans’’ scheduled for Wednesday, October 7. Mars shares its recommendations to improve the scientific review process of the Dietary Guidelines for 

Americans (DGAs or policy document). 

Mars, Incorporated is a private, family-owned business with more than a century 

of history and some of the best-loved brands in the world including M&M’S®, PEDIGREE®, DOUBLEMINT® and UNCLE BEN’S®. Headquartered in McLean, VA, 

Mars has more than $33 billion in sales from six diverse business segments: 

Petcare, Chocolate, Wrigley, Food, Drinks, and Symbioscience. More than 75,000 Associates across 73 countries are united by the company’s Five Principles: Quality, 

Efficiency, Responsibility, Mutuality, and Freedom and strive every day to create relationships with stakeholders that deliver growth we are proud of as a company. 

Recommendations to Improve the Scientific Review Process 

Mars believes that the scientific review process of the DGAs can be improved to 

ensure its integrity. For example, Mars understands that the U.S. Department of 

Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) 

can only address issues in the DGAs if scientific studies have been properly submitted to the National Evidence Library (NEL) and have been reviewed and rated 

by the Dietary Guidelines Advisory Committee (DGAC). Mars’ concern, however, is 

that if the DGAC elects not to conduct a systematic review of the scientific studies 

for a variety of reasons that do not pertain to the quality of the studies, HHS and 

USDA cannot use their discretion to address the issue in the policy document. 

For example, during the most recent DGAC scientific review process, over 50 scientific studies and literature on the oral health benefits of chewing sugar-free gum 

103 

1 2005 Dietary Guidelines Advisory Committee, ‘‘The Report of the Dietary Guidelines Advisory Committee on Dietary Guidelines for Americans, 2005,’’ at Part A: Executive Summary, 

page 6, (2005), available at http://www.health.gov/dietaryguidelines/dga2005/report/ (last 

accessed September 29, 2015). 2 2010 Dietary Guidelines Advisory Committee, ‘‘Report of the Dietary Guidelines Advisory 

Committee on the Dietary Guidelines for Americans, 2010,’’ at Part D: Carbohydrates, page 286, 

(2010), available at http://www.cnpp.usda.gov/sites/default/files/dietary_guidelines_for_americans/2010DGACReport-camera-ready-Jan11-11.pdf (last accessed September 29, 2015). 3 National School Lunch Program and School Breakfast Program: Nutrition Standards for All 

Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010, 78 FED. REG. 

125 (June 28, 2013) (to be codified at 21 CFR pts. 210 and 220). 

were submitted properly and in a timely manner to the NEL. The scientific studies 

covered over 40 years of research showing that chewing sugar-free gum stimulates 

salivary flow, which neutralizes plaque acids and enhances remineralization of the 

tooth enamel, as well as reduces dental caries. 

The 2015 DGAC, however, decided for reasons unclear to us not to conduct a scientific review of this evidence, which means that these studies were never rated as 

strong, moderate, or weak. Because these studies were never rated, HHS confirmed 

that neither Department has the discretion to include guidelines on the oral health 

benefits of chewing sugar-free gum, even if the preponderance of evidence exists. As 

such, stakeholders must wait until the 2020 DGAs to address the issue. Therefore, 

we recommend that if the DGAC decides not to conduct a scientific review 

of studies on a specific topic, then it must provide a justification for its decision. This would be especially helpful when past DGACs have provided 

recommendations on that topic and there are properly submitted studies 

and literature looking to update those recommendations. By taking this approach, USDA and HHS would then have greater discretion to decide whether the 

agencies should address the topic in the policy document along with stakeholder 

input and other considerations. 

For example, in the 2005 scientific report, the DGAC concluded that there is a 

relationship between the intake of sugars and starches and the formation of dental 

caries. The report also focused on how to best optimize oral hygiene practices and 

recommended drinking fluoridated water and/or using other fluoride containing dental hygiene products to help reduce the risk of dental caries.1 The 2010 DGAC affirmed these recommendations in its scientific report, but the 2015 DGAC did not 

reaffirm these conclusions or make additional recommendations on oral health 

measures despite receiving over 50 studies on the oral health benefits of chewing 

sugar-free gum.2

Mars also recommends that if a DGAC fails to conduct a scientific review, HHS 

and USDA should have the discretion to address the issue in the policy document 

if either Department has previously made a decision on that issue in a formal rulemaking or through another significant proceeding. As it relates to the oral health 

benefits of chewing sugar-free gum, USDA previously recognized that chewing 

sugar-free gum after meals reduces dental caries through the Smart Snacks rulemaking, which was based on the exact same studies submitted to the NEL for the 

2015 DGAC scientific review process. In the final rule allowing sugar-free gum products to be sold in schools, USDA stated that ‘‘[c]linical studies have shown that 

chewing sugarless gum for 20 minutes following meals can help prevent tooth 

decay.’’ 3 Therefore, if an issue has already been reviewed through a formal 

rulemaking or another significant proceeding within HHS or USDA, this 

could be considered to be evidence, similar to a DGAC’s scientific recommendation. Otherwise, it would appear that the DGAC has absolute authority 

to foreclose opportunities for USDA and HHS to address topics in the DGAs, even 

when there is a preponderance of scientific evidence that the agency has already examined. This raises concerns as USDA and HHS are authoritative bodies, as opposed to the DGAC. 

Last, Mars notes that during the 2015 scientific review process the DGAC considered studies that were not submitted properly to the NEL. By doing so, the DGAC 

has set a disruptive precedent that must be addressed. Currently, studies properly submitted to the NEL do not have to be reviewed, which means that they can 

be automatically disqualified from consideration by HHS and USDA. Studies not 

submitted to the NEL, however, can be used to support the DGAC’s recommendations and thus give authority for HHS and USDA to address the issue in the policy 

document. We are not necessarily arguing that studies cannot supplement the 

DGAC’s findings, but we do have concerns that such studies may take priority over 

those properly submitted to the NEL. 

104 

Conclusion 

Once again, Mars recognizes the significant effort undertaken by the DGAC, as 

well as USDA and HHS, to update the DGAs to reflect the latest nutritional science. 

Specifically, Mars supports the DGAC’s recommendations on limiting intake of 

added sugars and sodium. 

We also thank the Committee for considering our concerns with the current scientific review process. For the Committee’s review, we have attached a letter signed 

by 13 Members of Congress expressing similar concerns about the DGAC’s failure 

to conduct a scientific review of the studies on the oral health benefits of chewing 

sugar-free gum. 

If you would like to discuss our positions, please do not hesitate to contact Shannon Campagna at [Redacted] or [Redacted]. 

Sincerely, 

SHANNON CAMPAGNA, Mars, Incorporated. 

ATTACHMENT

May 13, 2015 

Hon. THOMAS ‘‘TOM’’ J. VILSACK, Secretary, 

U.S. Department of Agriculture, 

Washington, D.C.; 

Hon. SYLVIA MATHEWS BURWELL

Secretary, 

U.S. Department of Health and Human Services, 

Washington, D.C. 

Dear Secretaries Vilsack and Burwell: 

We are concerned that the 2015 Scientific Report of the Dietary Guidelines Advisory Committee (DGAC) did not meaningfully address oral health despite the fact 

that both the 2005 and 2010 editions of the Dietary Guidelines for Americans 

(DGAs) recognized oral health as a public health priority. 

The absence of oral health as a public health priority in the Scientific Report of 

the 2015 Dietary Guidelines Advisory Committee is a step backward in the Federal 

Government’s long-standing effort to address the chronic, yet preventable disease of 

tooth decay. Fifteen years ago, in the first Surgeon General’s report on oral health, 

the Surgeon General called for a ‘‘national effort to improve oral health among all 

Americans.’’ The report found that ‘‘oral health is integral to general health,’’ and 

stated that ‘‘you cannot be healthy without oral health.’’ 

In recognizing oral health as a public health priority, both the 2005 and 2010 

DGAs concluded that there is a relationship between the intake of sugars and 

starches and the formation of dental cavities. Both DGAs also focused on how to 

best optimize oral hygiene practices and recommended drinking fluoridated water 

and/or using other fluoride-containing dental hygiene products to help reduce the 

risk of dental cavities. The 2015 Scientific Report, however, did not make such recommendations. Therefore, we request that the 2015 Policy Document reaffirm the 

oral health conclusions from the 2005 and 2010 DGAs. 

We also strongly encourage the U.S. Department of Health and Human Services 

(HHS) and the U.S. Department of Agriculture (USDA) to identify additional scientifically-proven ways to optimize hygiene practices, including the chewing of 

sugar-free gum after eating meals. Over 40 years of research has shown that chewing sugar-free gum stimulates salivary flow, which neutralizes plaque acids and enhances remineralization of the tooth enamel, as well as reduces dental cavities. 

This research, which includes over 50 scientific studies and literature, was submitted properly and in a timely manner to USDA’s National Evidence Library; however, the 2015 DGAC decided for reasons unclear to us not to conduct a systematic 

review of this evidence. Therefore, we request HHS and USDA conduct a systematic 

review of the submitted evidence or affirm USDA’s science-based regulatory finding 

in the Smart Snacks rule that chewing sugar-free gum after meals reduces dental 

cavities. In that rule, and based on USDA’s review of the same studies submitted 

to the 2015 DGAC, USDA recognized that ‘‘[c]linical studies have shown that chewing sugarless gum for 20 minutes following meals can help prevent tooth decay’’ in 

allowing sugar-free gum products to be sold in schools. 

As a global leader, the United States should continue to make great strides in addressing tooth decay, which remains the most prevalent chronic disease in both children and adults, yet it is largely preventable. We ask that HHS and USDA continue 

105 

to make oral health a public priority in the 2015 Dietary Guidelines for Americans 

because oral health is essential to improving general health. 

Sincerely, 

Hon. DOUG COLLINS, Hon. SANFORD D. BISHOP, JR., 

Member of Congress; Member of Congress; 

Hon. BRENDA L. LAWRENCE, Hon. STEVE CHABOT, 

Member of Congress; Member of Congress; 

Hon. JOSEPH J. HECK, Hon. DONALD M. PAYNE, JR., 

Member of Congress; Member of Congress; 

Hon. JOYCE BEATTY, Hon. BRIAN BABIN, 

Member of Congress; Member of Congress; 

Hon. RYAN A. COSTELLO, Hon. DINA TITUS, 

Member of Congress; Member of Congress; 

Hon. LYNN JENKINS, Hon. PAUL COOK, 

Member of Congress; Member of Congress; 

Hon. DIANE BLACK, 

Member of Congress. 


11429005.eps 11429006.eps 11429007.eps 11429008.eps 11429009.eps 11429010.eps 11429011.eps
106 

1Quote found at 00:12:18 of October, 7, 2015 Full Committee on Agriculture hearing (http:// 

www.c-span.org/video/?328598-1/secretaries-tom-vilsack-sylvia-burwell-testimony-nutritionalguidelines); this is the source for all quotation time marks used herein. 2 01:25:00. 

SUBMITTED LETTER BY PAMELA SCHOENFELD, M.S., R.D., EXECUTIVE DIRECTOR; 

ADELE HITE, M.P.H., R.D., PUBLIC POLICY ADVISOR, HEALTHY NATION COALITION

House Committee on Agriculture U.S. Senate Committee on Agriculture, 

Nutrition, and Forestry, 

Washington, D.C.; Washington, D.C. 

Why the USDA/HHS Dietary Guidelines for Americans (DGA) development process must be overhauled: 

The DGA: 

1. Exceed the language of their authorizing statute. 

2. Do not achieve the stated goals of prevention of chronic disease and promotion 

of healthyweight. 

3. Are inappropriate for large sectors of the American population—especially children. 

4. Do not ensure that Americans meet essential nutrition needs. 

5. Are out-of-step with our multicultural nation and diverse dietary practices. 

6. Do not reflect the most up-to-date and comprehensive research findings. 

7. Act to limit or restrict the availability of certain categories of foods. 

8. Are not held to rigorous scientific standards. 

9. May be contributing in part to our nation’s health problems. 

10. Should be replaced by guidance, for use by the general public, focused on essential nutrition. 

1. The DGA exceed the language of their authorizing statute. 

According to Secretary Vilsack: ‘‘I struggle with the Dietary Guidelines because 

I think it is important to understand precisely what they are and are not. These 

guidelines are a set of recommendations based on a series of well-informed opinions 

that create a framework that is designed to encourage and educate Americans about 

what they can do to increase their chance of prevention of chronic disease. This is 

not about treating disease, this is about trying to prevent chronic disease.’’ 1

Vilsack continues ‘‘We’re looking at what the law requires us to do, and that is 

focus on dietary and nutritional guidelines relative to prevention.’’ 2

As posted on the Department of Health and Human Services website (http:// 

health.gov/dietaryguidelines/purpose.as): 

These recommendations aim to: 

• Promote health. 

• Prevent chronic disease. 

• Help people reach and maintain a healthy weight. 

Yet, there exists no language in the legislation that specifies that the DGA should 

be designed for the prevention of chronic disease. The key part of the legislative 

mandate is below: 

7 U.S. Code § 5341—Establishment of dietary guidelines 

(1) IN GENERAL

At least every 5 years the Secretaries shall publish a report entitled 

‘‘Dietary Guidelines for Americans.’’ Each such report shall contain nutritional and dietary information and guidelines for the general public, 

and shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program. 

(2) BASIS OF GUIDELINES

The information and guidelines contained in each report required 

under paragraph (1) shall be based on the preponderance of the scientific and medical knowledge which is current at the time the report 

is prepared. 

Note that the report is to contain guidelines for the ‘‘general public.’’ 

107 

3For examples of historical USDA dietary guidance please see: http://www.nal.usda.gov/ 

fnic/history/8549v.gif (WWII era); http://www.nal.usda.gov/fnic/history/0007v.gif (post-war 

era); and others at: https://nutritionhistory.nal.usda.gov/. 4 2010 Dietary Guidelines for Americans, p. 50 5 01:44:30. 

6 01:47:10. 

The ‘‘general public’’ is a demographically diverse population with an equally diverse set of nutritional needs. Attempting to design guidelines for the prevention of 

chronic disease has led to a narrow and limited focus and has shifted our priority 

away from ensuring the intake of adequate levels of essential nutrients demonstrated to be required for human health, reproduction, and growth. In the past, 

USDA dietary guidance emphasized the inclusion of a wide variety of animal and 

plant foods with the goal of meeting essential nutritional requirements.3

2. The DGA do not achieve the above stated goals of prevention of chronic 

disease and promotion of healthy weight. 

While there are no goals specifically mandated in the legislation, the increases in 

the prevalence of obesity, diabetes, and related diseases such as non-alcoholic fatty 

liver, demonstrate that the DGA have not had the desired impact on the health of 

Americans. 

These increases should not come as a surprise: the food patterns in the DGA have 

‘‘not been specifically tested for health benefits.’’ 4 Although we might surmise that 

the ‘‘goal’’ of the DGA from their inception was to reduce incidence of chronic disease, this has never been shown to be the case. 

3. The DGA are inappropriate for large sectors of the American population—especially children. 

The following exchange from the hearing illustrates this critical point: 

Rep. Rodney Davis raised his ‘‘most serious concern today is what I see as a lack 

of evidence to show that the recommended dietary patterns proposed by the DGA 

have been based on any evidence on children. According to citations in some previous advisory reports for recommendations, the recommended diet has been tested 

almost exclusively on middle age men and women whose nutritional needs obviously 

are very different from young people and growing children. In particular, I am concerned because young children need certain vitamins and minerals obviously in 

order to grow and develop.’’ Of note is the fact that the recommended diet has not 

been tested at all; the studies used to support the guidelines have been conducted 

in adults, generally males.5

Secretary Burwell addressed [her] concern: ‘‘My team brought up the issue of children yesterday as we look to making sure we have appropriate evidence for a number of the things that you are talking about for the next set [of guidelines in 2010]. 

Because I think what you are appropriately reflecting is the research doesn’t exist 

because it is on older [adults]. So we need to get started on that now. So with regard 

to the issue of do we need to understand this better. We don’t have the facts yet. 

We don’t have a science base. If we start now we will for the next’’ [emphasis 

added].6

It is clear that applying guidelines to children where ‘‘research doesn’t exist’’ is 

irresponsible at best. We should be very careful not to draw conclusions or make 

recommendations when we cannot even meet the required preponderance of evidence standard. The DGA as they stand now must not be applied to children (inclusive of birth to 18 years of age). In the interim, guidelines to ensure essential nutritional needs for children are met, including vitamins and minerals, should be developed in their place. We already have a strong evidence base to use in their development, which are the Dietary Reference Intakes published by the Institute of Medicine 

(http://iom.nationalacademies.org/Activities/Nutrition/SummaryDRIs/DRI-Tables.aspx). 

4. The DGA do not ensure that Americans meet essential nutrition needs. 

This is an extension of the previous concern. 

In the 2015 DGAC report, the Committee characterized the following as shortfall 

nutrients: ‘‘vitamin A, vitamin D, vitamin E, vitamin C, folate, calcium, magnesium, 

fiber, and potassium. For adolescent and premenopausal females iron also is a 

shortfall nutrient. Of the shortfall nutrients, calcium, vitamin D, fiber, and potassium also are classified as nutrients of public health concern because their underconsumption has been linked in the scientific literature to adverse health outcomes. 

Iron is included as a shortfall nutrient of public health concern for adolescent feVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00111 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
108 

7Scientific Report of the 2015 DGAC: Executive Summary. Part A. p 2., herein cited as ‘‘Report.’’ 8See point number 3 on page 9 of the attached commentary,* where we address nutrient 

shortfalls. Your attention to the entire attached letter (written by the undersigned on behalf of 

the Weston A. Price Foundation) would be very much appreciated as we have outlined several 

others scientifically supported concerns we have with the 2015 DGAC Report as well as the 

process utilized for the development of the DGA. * Editor’s note: The document referred to is retained in Committee file. 9https://nutritionhistory.nal.usda.gov/download/CAT40000623/PDF 

10https://nutritionhistory.nal.usda.gov/download/1759104/PDF; https://nutritionhistory. 

nal.usda.gov/download/1759103/PDF. 11 Report: Part D. Ch. 1, Line 2838. 12 01:37:40. 13 01:38:10. 14 Report: Part D. Ch. 1, Line 642. 

males and adult females who are premenopausal due to the increased risk of irondeficiency in these groups.’’ 7

Zinc, while not cited by the Committee as a shortfall nutrient, is an important 

mineral that may be underconsumed when animal proteins, especially red meat, are 

limited. This is of particular concern for young children, who have high physiologic 

requirements for iron and zinc to support rapid growth and brain development. The 

recommended ‘‘healthy vegetarian pattern’’ is devoid of red meat and is thus inappropriate to indiscriminately recommend for children. 

The recommendations of previous and the current DGA have actually served to 

increase the risk for below-adequate intake of several of the above-listed nutrients. 

We provide scientific support on the reasons for this in the attached commentary 

previously submitted to the USDA/HHS through their website during the allotted 

period.8

Of significance, as recent as 2000, the DGA continued to include beef, turkey dark 

meat, and liver and other organ meats and dark meat as good sources of iron.9 Previous DGA editions also included pork and lamb. No mention of organ or dark meat 

is made in either the current 2010 DGA or the 2015 DGAC Report. In addition, 

USDA-sponsored family and consumer literature published by the University of Arkansas Division of Agriculture in 2010 do recommend liver a source of iron for infants and toddlers: and for young children.10 We highly recommend that liver and 

other organ meats be re-evaluated as a nutrient dense food for inclusion in the DGA 

recommendations. 

5. The DGA are out-of-step with our multicultural nation and diverse dietary practices. 

Unfortunately, the DGAC Report does not consider this diversity when deciding 

on the three recommended dietary patterns: the Healthy U.S.-style Pattern, the 

Healthy Mediterranean-style Pattern, and the Healthy Vegetarian Pattern (Report: 

Part D. Ch 1. Line 2827). We ask that the USDA and HHS be required to consider 

the foodways of our immigrant and native populations when making populationwide recommendations. This is especially necessary given the DGAC’s recognition 

of a need for future research to ‘‘[e]xpand WWEIA (What We Eat in America) participation to include more respondents from race/ethnic minorities and non-U.S. born 

residents; while acknowledging that ‘[v]ery little is known about the dietary habits 

of many of the cultural subgroups in the United States. This knowledge is essential 

to moving forward any nutrition programs for first and second generation immigrants.’ ’’ 11

Secretary Burwell discussed keeping the DGA information ‘‘simple enough’’ that 

it can be used ‘‘in your own cultural context’’; 12 Secretary Vilsack highlighted the 

USDA programs that are ‘‘working with Native Americans to reflect [their] traditions and culture.’’ 13 We commend these ideas and efforts and urge they be emphasized in the upcoming edition. 

6. The DGA do not reflect the most up-to-date and comprehensive research 

findings. 

To illustrate the lack of sound scientific methodology that has permeated the DGA 

processes from its inception please consider the following: 

The 2015 DGAC reversed the long-standing opinions of previous DGACs and recommendation of previous DGA that dietary cholesterol should be limited to less 

than 300 mg per day, stating: ‘‘The 2015 DGAC will not bring forward this recommendation because available evidence shows no appreciable relationship between 

consumption of dietary cholesterol and serum cholesterol, consistent with the conclusions of the AHA/ACC report (2, 35). Cholesterol is not a nutrient of concern for 

over-consumption.’’ 14 The same evidence was available to the 2010 DGAC which 

109 

15Other examples of weak scientific methodology are detailed in the attached commentary * 

to the USDA/HHS; point number 1, page 2, provides a key example. 

* Editor’s note: The document referred to is retained in Committee file. 16 Berkey et al., 2005 ARCH. PEDIATR. ADOLESC. MED. 159(6); Scharf et al., 2013 ARCH. DIS. 

CHILD. doi :10.1136/archdischild-2012–302941. 17 00:13:40. 18 01:41:04. 19 01:42:09. 

continued to recommend cholesterol limits; these limits were carried forward into 

the 2010 DGA. 

Graded evidence is not provided by the 2015 DGAC to support this revision. This 

is unfortunate considering the language of H.R. 3049: ‘‘Each revision to any nutritional or dietary information or guideline contained in the 2010 edition of the Dietary Guidelines for Americans and any new nutritional or dietary information or 

guideline to be included in the eighth edition of the Dietary Guidelines for Ameri- cans—(A) shall be based on scientific evidence that has been rated ‘‘Grade I: Strong’’ 

by the grading rubric developed by the Nutrition Evidence Library of the Department of Agriculture.’’ 

We strongly encourage your committees to reconsider the language of the proposed bill. We respectfully offer that any standing guideline be carried forward only 

if it can be supported by Grade I: Strong evidence per the NEL process, subject to 

an independent scientific review.15

7. The DGA act to limit or restrict the availability of certain categories of 

foods. 

A key example here is the removal of whole (3.5% fat) milk from the National 

School Lunch Program (NSLP). Preventive public health measures must provide an 

expected benefit to the individual upon whom the intervention is imposed, with 

minimal risk of harm, as ascertained by strict standards of evidence. For example, 

whole milk has been removed from the NSLP. However, there is limited evidence 

of benefit from restricting whole milk, and there has been no recognition of potential 

harm from alternative choices, such as inadequate nutrition (if students refuse to 

drink milk at all rather than drink reduced-fat milk) or excess intake of sugar (if 

students choose sweetened milk when full-fat milk is unavailable). Parents may feel 

it is better for their children to have whole milk rather than no milk or sweetened 

milk. That choice should not be made by government officials without strong evidence of the singular benefits of reduced-fat milk and the specific harms of whole 

milk. 

A recent Washington Post article (http://www.washingtonpost.com/news/ 

wonkblog/wp/2015/10/06/for-decades-the-government-steered-millions-away-fromwhole-milk-was-that-wrong/) presented more up-to-date scientific findings that 

whole milk has a place in a nutritionally balanced diet. Not mentioned in the article 

is additional research showing that whole milk consumption is associated with a 

lower risk for overweight/obesity in children.16

8. The DGA are not held to rigorous scientific standards. 

Notwithstanding Secretary Vilsack’s current view that a ‘‘gold standard process’’ 17

is being adhered to, the current process lacks rigor. For future DGA, scientific 

standards should be raised to ‘‘beyond a reasonable doubt’’ that a recommendation 

will provide benefit and will not cause harm. 

For the development of 2020 DGA, we concur with Rep. Trent Kelly who suggested that the preponderance of evidence standard is not the right standard to use: 

‘‘Maybe it is clear and convincing evidence or maybe it’s beyond a reasonable doubt 

that when we have science that we hold them to a standard that makes sure that 

the end result is something that we have a good belief that it will be viable and 

it will be the right answer’’ [emphasis added].18 The right answer may not be a single answer for all individuals; it should however ensure that we provide the best 

fundamental information so that the majority of Americans can meet their basic nutritional needs. Secretary Vilsack is in agreement with Rep. Trent and provides an 

opportune solution: ‘‘We have to follow the Congressional mandate. So if you all believe that it should be a higher standard, that is your call and whatever your call 

is, we will follow it.’’ 19

9. The DGA may be contributing in part to our nation’s health problems. 

During the hearing, statistics were cited on the rising prevalence of obesity and 

diabetes. We cannot afford to wait another 5 years; our survival as a great nation 

depends on getting this right. According to Rep. David Scott, ‘‘Agriculture is indeed 

our most important industry. It’s the food we eat. It’s the water we drink. It’s our 

110 

20 02:22:30. 21 01:24:20. 

survival. And I think that you got the feeling from this Committee how important 

this is.’’ 20 We wholeheartedly concur with the Rep. Scott and other Members of the 

Committee and ask that the entire DGA process and resulting guidelines be given 

an immediate and thorough review by Congress and by an independent scientific 

panel selected by Congress and under their direction. 

10. The DGA should be replaced by guidance, for use by the general public, 

focused on essential nutrition. 

The DGA should, first and foremost, provide general dietary guidance on selecting 

from a variety of foods that supply adequate essential nutrients. This could look like 

previous editions produced by the USDA (examples cited above in point 1), perhaps 

with multicultural versions to meet our diverse population’s dietary preferences. To 

ensure scientific rigor, the DRIs should be utilized. Any and all guidance for the prevention of chronic disease must be limited to that designated as Grade 1: Strong 

evidence by the USDA Nutrition Evidence Library and directed only at relevant demographic group(s). 

In conclusion, any measurement of the success of the DGA must not be in regard 

to how well the American public applies and adheres to them as Secretary Vilsack 

states.21 Success must be measured by nutrition and health outcomes including the 

following: 

• Are Americans, especially children, meeting all of their nutrient needs? 

• Are we seeing meaningful declines in the prevalence of obesity, diabetes, fatty 

liver, and other diseases that are afflicting our children? 

From the questions asked of Secretaries Burwell and Vilsack, we know that a 

number of policymakers share our concerns. We commend the language in the 

House’s Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies (section 734) and Departments of Labor, Health and 

Human Services and Education and Related Agencies, (section 230) Fiscal Year 

2016 Appropriations Bills that indicates a call for the highest standards of evidence, 

and we suggest that these standards be applied to all national nutrition guidance. 

Respectfully submitted by, 

PAMELA SCHOENFELD, M.S., R.D., 

Executive Director, 

ADELE HITE, M.P.H., R.D., 

Public Policy Advisor, 

The Healthy Nation Coalition. 

www.forahealthynation.org 

SUBMITTED STATEMENT BY NINA TEICHOLZ, AUTHOR, THE BIG FAT SURPRISE: WHY

BUTTER, MEAT AND CHEESE BELONG IN A HEALTHY DIET

I want to thank Chairman Michael Conaway (R–TX) and Ranking Member Collin 

Peterson (D–MN) for holding this important hearing on the U.S. Dietary Guidelines 

for Americans. My name is Nina Teicholz and I am an investigative journalist who 

spent 10 years researching the science, politics and history of U.S. nutrition policy 

and particularly how we came to believe that dietary fat is bad for health. This 

work culminated in my best-selling book, The Big Fat Surprise: Why Butter, Meat 

and Cheese Belong in an Healthy Diet, which was named a ‘‘Best Book’’ of 2014 by 

the Economist, Wall Street Journal, Forbes, Mother Jones, Library Journal, and 

Kirkus Reviews, and received strong review in both the BMJ and American Journal 

of Clinical Nutrition. In the spring of 2015, I received a grant from the Laura and 

John Arnold Foundation to undertake a comprehensive scientific analysis of the Dietary Guidelines, resulting in a report (‘‘Critical Review’’) that is available to the public at www.forbetterdietaryguidelines.com. Based on that work, I wrote a comprehensive peer-reviewed, fact-checked investigation of the guidelines that was published 

by the British Medical Journal (BMJ), available to read here: http://www.bmj.com/ 

content/351/bmj.h4962. My testimony today is based on this body of work. 

In general, I found that expert report underpinning the next set of U.S. Dietary 

Guidelines for Americans fails to reflect much relevant scientific literature in its reviews of crucial topics and therefore risks giving a misleading picture. The omissions seem to suggest a reluctance by the committee behind the report to consider 

any evidence that contradicts the last 35 years of nutritional advice. 

111 

My analysis for the BMJ found that the committee’s report used weak scientific 

standards, reversing recent efforts by the government to strengthen the scientific review process. This backsliding seems to have made the report vulnerable to internal 

bias as well as outside agendas. 

The 2015 report states that the committee abandoned established methods for 

most of its analyses. Since its inception, the guideline process has suffered from a 

lack of rigorous methods for reviewing the science on nutrition and disease, but a 

major effort was undertaken in 2010 to implement systematic reviews of studies to 

bring scientific rigor and transparency to the review process. The U.S. Department 

of Agriculture set up the Nutrition Evidence Library (NEL) to help conduct systematic reviews using a standardized process for identifying, selecting, and evaluating 

relevant studies.3

However, my BMJ analysis found that on questions requiring reviews of the scientific literature, the committee did not use the NEL for 63% of them. The questions 

include some of the most controversial issues in nutrition today.4 Instead, the committee relied on systematic reviews by external professional associations, almost exclusively the American Heart Association (AHA) and the American College of Cardiology (ACC), or conducted ad hoc examinations of the scientific literature without 

well defined systematic criteria for how studies or outside review papers were identified, selected, or evaluated. 

Use of external reviews by professional associations is problematic because these 

groups conduct literature reviews according to different standards and are supported by food and drug companies. The ACC reports receiving 38 percent of its revenue from industry in 2012, and the AHA reported 20 percent of revenue from industry in 2014. Potential conflicts of interest include, for instance, decades of support from vegetable oil manufacturers, whose products the AHA has long promoted 

for cardiovascular health. This reliance on industry backed groups clearly undermines the credibility of the government report. 

Saturated Fats 

On saturated fats, for example, the committee did not ask the NEL to conduct 

a formal review of the literature from the past 5 years, even though this topic clearly merited re-examination. When the committee started its work in 2012, there had 

been several prominent papers, including a meta-analysis 5 that failed to confirm an 

association between saturated fats and heart disease, and two major reviews (one 

systematic) 6–7 that did not consistently show an causal effect of saturated-fat reduction on cardiovascular mortality. 

Restrictions on saturated fats have been a foundation of nutrition policy since the 

first guidelines in 1980 and have had a dominant role in determining which foods, 

such as low fat dairy and lean meats, are considered ‘‘healthy.’’ Instead of requesting a new NEL review for the recent literature on this crucial topic, however, the 

2015 committee recommended extending the current cap on saturated fats, at 10% 

of calories, based on a review by the AHA and ACC,8 a 2010 NEL review, and the 

2015 committee’s ad hoc selection of seven review papers (see table A on 

thebmj.com).9

The NEL systematic review on saturated fats from 2010 10 covers only the literature published from 2004 to 2009, the period which the 2010 committee had been 

asked to review. Fewer than 12 small trials are cited, and none supports the hypothesis that saturated fats cause heart disease (see table B on thebmj.com). 

More significantly, the 2010 review omits a large controlled clinical trial, the 

Women’s Health Initiative, which included nearly 49,000 people and achieved a significantly lower intake of saturated fat in the intervention group yet, compared with 

controls, observed no benefits for this group in incidence of fatal and non-fatal coronary heart disease events and total cardiovascular disease, including stroke.11

Papers on saturated fats published since 2010 were covered by the committee’s 

ad hoc review, which did not use a systematic method to select or evaluate studies. 

One of the meta-analyses it cited was arguably inappropriately included because it 

considered polyunsaturated vegetable oils rather than saturated fats.12 Another 

analysis cited in great detail had already been covered by the 2010 NEL review, so 

including it again amounted to double counting.13 Three meta-analyses concluded 

that saturated fats did not increase cardiovascular mortality,14–16 but the committee 

downplays these findings. And two other included meta-analyses had mixed results: 

saturated fats generally looked more atherogenic than polyunsaturated fats but less 

atherogenic than carbohydrates or monounsaturated fat.17–18 Despite this conflicting 

evidence, however, the committee’s report concludes that the evidence linking consumption of saturated fats to cardiovascular disease is ‘‘strong.’’ 

Perhaps more important are the studies that have never been systematically reviewed by any of the Dietary Guideline committees.19 These include the large, govVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00115 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
112 

ernment funded randomized controlled trials on saturated fats and heart disease 

from the 1960s and 1970s. Taken together, these trials followed more than 25,000 

people, some for up to 12 years. They are some of the most ambitious, well controlled nutrition studies ever undertaken.20–25 These studies showed mixed health 

outcomes for saturated fats, but early critical reviews, including one by the National 

Academy of Sciences, which cautioned against the inconclusive state of the evidence 

on saturated fats and heart disease, were dismissed by the USDA when it launched 

the first Dietary Guidelines in 1980.26 Subsequent guideline committees have never 

gone back to systematically review these early trials but instead relied on other government reports. 

Low Carbohydrate Diets 

Another important topic that was insufficiently reviewed is the efficacy of low carbohydrate diets. Again, the 2015 committee did not request a NEL systematic review of the literature from the past 5 years. The report says that this was because, 

after conducting ‘‘exploratory searches’’ of the literature since 2000, the committee 

could find ‘‘only limited evidence [on] low-carbohydrate diets and health, particularly evidence derived from U.S. based populations.’’ 27

The report provides no documentation of these ‘‘exploratory searches,’’ yet many 

studies of carbohydrate restriction have been published in peer review journals since 

2000, nearly all of which were in U.S. populations. These include nine pilot studies, 

11 case studies, 19 observational studies, and at least 74 randomised controlled 

trials, 32 of which lasted 6 months or longer (see table C on thebmj.com). A metaanalysis and a critical review have concluded that low carbohydrate diets are better 

than other nutritional approaches for controlling type 2 diabetes,28–29 and two metaanalyses have concluded that a moderate to strict low carbohydrate diet is highly 

effective for achieving weight loss and improving most heart disease risk factors in 

the short term (6 months).30–31 Weight loss benefits on different diets tended to converge over the long term (12 months), according to various reviews, but a recent 

meta-analysis found that if carbohydrates are kept ‘‘very low,’’ weight loss is greater 

than with a low fat diet maintained for a year.32 Given the growing toll taken by 

these conditions and the failure of existing strategies to make meaningful progress 

in fighting obesity and diabetes to date, one might expect the guideline committee 

to welcome any new, promising dietary strategies. It is thus surprising that the 

studies listed above were considered insufficient to warrant a review. 

New Strategies 

The committee’s approach to the evidence on saturated fats and low carbohydrate 

diets reflects an apparent failure to address any evidence that contradicts what has 

been official nutritional advice for the past 35 years. The foundation of that advice 

has been to recommend eating less fat and fewer animal products (meat, dairy, 

eggs) while shifting calorie intake towards more plant foods (fruits, vegetables, 

grains, and vegetable oils) for good health. And in the past decades, this advice has 

remained virtually unchanged.33

Because the guidelines have obviously not led to better health, however, there has 

been a need to find new strategies to tackle nutrition related diseases. The committee’s most significant shift, which began in 2010, however, has been to redouble its 

efforts towards emphasizing a plant based diet. This can be seen in a number of 

ways in the 2015 report, none of which is supported by strong evidence. 

New proposals by the 2015 report include not only deleting meat from the list of 

foods recommended as part of its healthy diets, but also actively counseling reductions in ‘‘red and processed meats.’’ 34 This advice has been the subject of much debate, which guideline supporters have successfully characterized as a conflict between the self interested meat industry versus virtuous efforts to safeguard health 

(and the environment).35–36 Yet framed this way, the debate fails to address the 

question fundamental to nutrition: would reducing meat lead to better health? Consulting the NEL for a review on this topic turns up a surprising fact: a systematic 

review on health and red meat has not been done. Although several analyses look 

at ‘‘animal protein products,’’ these reviews include eggs, fish, and dairy and therefore do not isolate the health effects of red meat, or meat of any kind.37

Importantly, some of the report’s findings also contradict the dietary committee’s 

advice on red meat. For example, to support the idea that red meat harms health, 

the committee repeatedly cites one large randomized trial conducted in Spain. However, this trial did not intend to lower consumption of red and processed meats in 

the experimental group, compared with the control group, so cannot be said to support the committee’s advice.38 Also, the sole diagram on red meat in the committee’s 

report, which plots the data from observational studies, shows a roughly equal numVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00116 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
113 

ber of health benefits associated with the diets higher in red meat as with diets 

lower in red meat.39

Recommended Diets 

Another clear move towards a plant based approach in the report is the introduction of the ‘‘healthy vegetarian diet’’ as one of three recommended diets (the others 

are: ‘‘healthy Mediterranean-style’’ and ‘‘healthy U.S.-style’’).2 A NEL review of a 

healthy vegetarian diet does exist, but it concludes that the evidence for this diet’s 

disease fighting powers is only ‘‘limited,’’ which is the lowest rank for available 

data.40 Moreover, although the NEL conducted eight reviews on fruits and vegetables, none found strong (grade 1) evidence to support the assertion that these foods 

can provide health benefits.41

In general, the quality of the evidence supporting the report’s three recommended 

diets is limited (table D on the bmj.com). The committee could find only ‘‘limited’’ 

to ‘‘not assignable’’ evidence to show that its diets protect against osteoporosis, congenital abnormalities, or neurological or psychological illnesses.27 The NEL review 

found only ‘‘limited’’ or ‘‘insufficient’’ evidence that the diets could combat diabetes.42 In a highly unorthodox move, the guideline committee overruled the NEL’s 

systematic reviews on this topic and decided to upgrade the rank to ‘‘moderate,’’ 

based on its opinion that one review paper on observational data, which showed 

positive results, was particularly strong. 

And are the recommended diets better than other diets in helping people lose 

weight? On this question, the report ranked the evidence as moderate, yet to support this claim, it presents only a single clinical trial in 180 people with metabolic 

syndrome, which found the Mediterranean diet produced more weight loss than a 

low fat diet.43 One randomized controlled trial listed by the review did not actually 

test weight loss, only the ability to adhere to the diet,44 which, although important, 

is relevant only if the diet works. Three trials 45–47 and an AHA/ACC review 48 concluded that compared with other diets, those recommended by the Dietary Guidelines offered at best a marginal advantage in fighting obesity (less than a pound 

over trial periods lasting up to 7 years). 

The report also gave a strong rating to the evidence that its recommended diets 

can fight heart disease.27 Again, several studies are presented, but none unambiguously supports this claim. Eight trials reviewed by the NEL to support its strong 

grade include one trial that should not have been included because it lacked a comparable control group; 49 three that showed no beneficial effects on cardiovascular 

health other than improved blood pressure (and studied hypertensive populations) 50–52; another, also in hypertensive people, showing that the recommended 

diet had poorer cardiovascular outcomes than other options that were higher in 

monounsaturated fat or protein; 53 one showing mixed results on cardiovascular risk 

factors (although low density lipoprotein cholesterol fell, so did ‘‘good’’ high density 

lipoprotein cholesterol); 54 and the largest one, which concluded that the diet was 

ineffective for reducing cardiovascular risk.11 The committee also cites an AHA/ACC 

review, but this paper examines trials already covered by the NEL review, so including them again amounts to double counting.8 The committee reviewed other, 

more recent studies but not using any systematic or predefined methods. 

In conclusion, the recommended diets are supported by a minuscule quantity of 

rigorous evidence that only marginally supports claims that these diets can promote 

better health than alternatives. Furthermore, the NEL reviews of the recommended 

diets discount or omit important data. There have been at a minimum, three National Institutes of Health funded trials on some 50,000 people showing that a diet 

low in fat and saturated fat is ineffective for fighting heart disease, obesity, diabetes, or cancer.46, 11, 55–59 Two of these trials are omitted from the NEL review. The 

third trial is included, but its results are ignored. This oversight is particularly 

striking because this trial, the Women’s Health Initiative (WHI), was the largest nutrition trial in history.55–56 Nearly 49,000 women followed a diet low in fat and high 

in fruits, vegetables, and grains for an average of 7 years, at the end of which investigators found no significant advantage of this diet for weight loss, diabetes, heart 

disease, or cancer of any kind.11, 56–59 Critics dismiss this trial for various reasons, 

including the fact that fat consumption did not differ enough significantly between 

the intervention and control groups, but the percentage of calories from both fat and 

saturated fat were more than 25% lower in the intervention group than in the control group (26.7% v. 36.2% for total fat and 8.8% v. 12.1% for saturated fats).57 The 

WHI findings have been confirmed by other sizeable studies and are therefore hard 

to dismiss. When the omitted findings from these three clinical trials are factored 

into the review, the overwhelming preponderance of rigorous evidence does not support any of the dietary committee’s health claims for its recommended diets. 

114 

[1]DGAC report, (Part D, Ch. 1, p. 22, lines 827–828 (http://www.health.gov/ 

dietaryguidelines/2015-scientific-report/06-chapter-1/d1-2.asp)) (Appendix E–3.1, Text and Figure 4 (http://www.health.gov/dietaryguidelines/2015-scientific-report/15-appendix-E3/e3- 

1.asp)). [2] 2015 DGAC report, Part D, Ch. 1, Figure D1.1, p. 131. [3] Appendix E–3.2, Table 3, (http://health.gov/dietaryguidelines/2015-scientific-report/15-appendix-e3/e3-2.asp) see ‘‘grains’’ for the contributions of these foods to nutritional sufficiency. 

My Critical Review makes additional points about the recommended diets. One 

is that although the committee states that these diets offer ‘‘multiple ways’’ for people to eat a healthy diet, they are, in fact, all still virtually the same. In other 

words, the committee is still recommending a ‘‘one-size-fits-all’’ diet. This is problematic, given that there is clearly great variation in the nutrition needs of various 

populations, depending on age, gender, genetic background and state of metabolic 

disease state. (see Critical Review, pages 31–32). Moreover, the recommended diets 

are nearly identical to previous DGA dietary advice (pages 29–30), so in effect, ‘‘Dietary Patterns’’ are simply a new name on the same diet that has been recommended 

for more than a decade. 

Moreover, this diet is modeled, in the tables of the report, to be low in fat (32– 

34% of calories as fat), even though the report concludes that a diet low in fat worsens important heart disease risk factors. In effect, this low-fat advice may potentially worsen heart-attack risk. 

Another serious problem with the recommended diets is that, according to the 

committee, they are not nutritionally sufficient. The committee states that the nutrients ‘‘for which adequacy goals are not met’’ in most of the recommended diets 

are ‘‘potassium, vitamin D, vitamin E, and choline.’’ [1] Vitamin A sufficiency is reported as borderline,[2] and without consumption of fortified grains, primarily refined-grain breakfast cereals, the diets are also deficient in iron and folate.[3] Thus, 

although the committee recommends consuming primarily whole grains, the reality 

is that the recommended diets remain just as high in refined grains as in the past, 

due to the need for nutrients from fortification. Indeed, the recommended diets contain an equal amount of refined grains as whole grains. 

The committee does not address the issue of how its recommended diets might 

become nutritionally sufficient. However, it does note that for a number of nutrients 

for which the American population is currently ‘‘under-consumed,’’ including calcium, iron, and Vitamin D, the best and most bioavailable sources of these nutrients 

are animal foods. For example, red meat is ‘‘an excellent source’’ of heme iron, and 

the greatest amount of calcium, in its most bioavailable form, is in hard cheeses, 

yet these foods are limited in the recommended diets due to the overall cap on saturated fat. The evidence suggests that easing or eliminating the limit on saturated 

fat would eliminate these nutritional deficiencies. A more complete discussion of 

these issues can be found in my Critical Review. 

A final area examined by The BMJ where the report offers advice that contradicts 

its data is on sodium. The committee says that it ‘‘concurs’’ with a recent report by 

the Institute of Medicine, which states that the evidence is ‘‘inconsistent and insufficient to conclude that lowering sodium intakes below 2,300 mg/day will have any 

effect on cardiovascular risk or overall mortality.’’ 9 Yet the report recommends that 

sodium intake ‘‘should be less than 2,300 mg/day’’ and encourages the choice of low 

salt options without reservation. 

Questions About Bias 

The overall lack of sound science and proper methods in the 2015 report could 

be seen as a reluctance to depart from existing dietary recommendations. Many experts, institutions, and industries have an interest in keeping the status quo advice, 

and these interests create a bias in its favor. Abandoning the NEL review methods, 

as the 2015 committee has done, opens the door not only for bias but also for influence from outside agendas and commercial interests, and all of these can be observed in the report. 

For example, a bias towards the longstanding view that saturated fats are harmful can be seen in the report’s designation of them, together with sugar, as a new 

category it calls ‘‘empty calories.’’ 2 The report repeatedly mentions the need to reduce ‘‘sugar and solid fats,’’ because, ‘‘both provide calories, but few or no nutrients.’’ 2 Yet this pairing is unsupported by nutrition science. Unlike sugar, saturated 

fats are mostly consumed as an inherent part of foods such as eggs, meat, and dairy, 

which together contain nearly all of the vitamins and minerals needed for good 

health. 

Not following the NEL methods has also allowed outside agendas to enter into 

the report, most clearly in the form of the new consideration for environmental sustainability. Although, as the report states, the environmental effects of food and 

115 

drink production are considerable, they are outside the committee’s formal mandate 

to provide the Federal Government with the ‘‘current scientific evidence on topics 

related to diet, nutrition, and health.’’ 2 In a new development for 2015, the USDA 

hired a food policy analyst focused on environmental issues to oversee the guideline 

committee’s work, reflecting a new agenda in the process.60

Much has been written about how industries try to influence nutrition policy, so 

it is surprising that unlike authors in most major medical journals, guideline committee members are not required to list their potential conflicts of interest. A cursory investigation shows several such possible conflicts: one member has received 

research funding from the California Walnut Commission 61 and the Tree Nut Council,62 as well as vegetable oil giants Bunge and Unilever.63–64 Another has received 

more than $10,000 from Lluminari, which produces health related multimedia content for General Mills, PepsiCo, Stonyfield Farm, Newman’s Own, and ‘‘other companies.’’ 65 And for the first time, the committee chair comes not from a university 

but from industry: Barbara Millen is President of Millennium Prevention, a company based in Westwood, MA, that sells web-based platforms and mobile applications for self health monitoring. While there is no evidence that these potential conflicts of interest influenced the committee members, the report recommends a high 

consumption of vegetable oils and nuts as well as use of self monitoring technologies 

in programs for weight management. 

Still, it’s important to note that in a field where public research dollars are scarce, 

nearly all nutrition scientists accept funding from industry. Of far greater influence 

is likely to be bias in favor of an institutionalized hypothesis as well as a ‘‘white 

hat’’ bias to distort information for what is perceived as righteous ends.66

The report is highly confident that its findings are supported by good science, 

stating that ‘‘The evidence base has never been stronger to guide solutions.’’ 2 Millen 

told The BMJ, ‘‘You don’t simply answer these questions on the basis of the NEL. 

Where we didn’t feel we needed to, we didn’t do them. On topics where there were 

existing comprehensive guidelines, we didn’t do them. We used those resources and 

that time to cover other questions. The notion that every question that we posed 

should have a NEL is flawed.’’ She said she would ‘‘go to the mat’’ to defend the 

committee’s approach. ‘‘That’s why you have an expert committee . . . to bring expertise,’’ including ‘‘our own original analyses.’’ 

‘‘These folks know how to do this work. People who criticize this are coming from 

the point of view that they don’t like the answer. They don’t like the fact that 

randomised controlled trials testing these dietary patterns are successful. I think 

you have to read the report. NEL helped us to do the searches to update the literature. That is stated. If it doesn’t satisfy you, that is all I can say. It’s well stated 

and been reviewed by dozens of people.’’ 

On saturated fats, especially, she said, ‘‘We thought we nailed it.’’ Millen said that 

her committee’s work had not been entirely without methodology but had ‘‘worked 

with the NEL and USDA assistance to identify the research literature.’’ She said 

that ’’it was clear that polyunsaturated fats reduced heart disease risk and mortality,’’ yet that the ‘‘evidence is not as clear on whether replacement of saturated 

fat with monounsaturated fats or carbohydrates reduces cardiovascular disease risk, 

and likely depends on the type and source.’’ 

On diets low in carbohydrates, she said that there was ‘‘not substantial evidence’’ 

to consider. ‘‘Many popular diets don’t have evidence. But can you achieve healthiness, the answer is yes.’’ 

Regarding the committee’s conflicts of interest, she said that members were vetted 

by counsel to the Federal Government. She would not reveal details of her company’s activities. Critics of the report, she said, ‘‘are coming from the point of view 

that they don’t like the answer.’’ 

The argument by the USDA has been that the Guidelines have not been successful because people do not adequately follow them. However, government data contradicts this explanation: from 1970 to 2005, Americans increased consumption of 

vegetables by 23% (with one of the biggest percentile increases being in leafy 

greens), fruit by 13%, grains by 41% and vegetable oils by 91%. At that same time, 

Americans have decreased consumption of animal fats by 16%, red meat by 17%, 

(beef by 22%), whole milk by 73%, butter by 14%, and eggs by 17%. (67) These numbers suggest that Americans have successfully followed the Guidelines, yet clearly 

better health has not been the result. 

After 35 years of pursuing the same flawed nutrition policy, the time has come 

for an objective scientific review of the proposed Dietary Guidelines. Congress initiated the guidelines 35 years ago and Congress should require an objective scientific 

review of the guidelines by the National Academy of Sciences, and the Administration should embrace this transparent, objective analysis of one of the fundamental 

tenets of national nutrition policy. 

116 

Notes 

• Competing interests: I have received modest honorariums for presenting my research findings presented in the book to a 

variety of groups related to the medical, restaurant, financial, meat, and dairy industries. I am also a board member of a 

nonprofit organization, the Nutrition Coalition, dedicated to ensuring that nutrition policy is based on rigorous science. 

• This article was fully funded with a grant from the Laura and John Arnold Foundation. The analysis was conducted independently, and the report reflects the views of the author and not necessarily those of the foundation. The article was submitted in June and provisionally accepted for publication in July of 2015. 

• Provenance and peer review: Commissioned; externally peer reviewed and fact checked. 

References 

1. U.S. Department of Agriculture. The food assistance landscape. 2015. www.ers.usda.gov/media/1806461/eib137.pdf. 

2. Dietary Guidelines Advisory Committee. Scientific report. 2015. http://health.gov/dietaryguidelines/2015-scientific-report/. 

3. Nutrition Evidence Library. Frequently asked questions. www.nel.gov/faq. #Involvement 

4. Dietary Guidelines Advisory Committee. Scientific report part C: methodology. Approaches to reviewing the evidence. http:// 

health.gov/dietaryguidelines/2015-scientific-report/05-methodology.asp. 

5. Siri-Tarino P.W., Sun Q., Hu F.B., Krauss R.M.. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. AM. J. CLIN. NUTR. 2010; 91:535–46. 

6. Siri-Tarino P.W., Sun Q., Hu F.B., Krauss R.M. Saturated fat, carbohydrate, and cardiovascular disease. AM. J. CLIN. NUTR. 

2010; 91:502–9. 

7. Hooper L., Summerbell C.D., Thompson R., et al. Reduced or modified dietary fat for preventing cardiovascular disease. 

COCHRANE DATABASE SYST. REV. 2012; 5:CD002137. 

8. Eckel R.H., Jakicic J.M., Ard J.D., et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. J. AM. COLL. CARDIOL. 

2014; 63:2960–84. 

9. Dietary Guidelines Advisory Committee. Scientific report part D: chapter 6. Cross-cutting topics of public health importance— 

continued. http://health.gov/dietaryguidelines/2015-scientific-report/11-chapter-6/d6-2.asp. 

10. National Evidence Library. What is the effect of saturated fat intake on increased risk of cardiovascular disease or type 2 diabetes? www.nel.gov/evidence.cfm?evidence_summary_id=250189. 

11. Howard B.V., Horn L.V., Hsia J., et al. Low-fat dietary pattern and risk of cardiovascular disease: the Women’s Health Initiative randomized controlled dietary modification trial. JAMA 2006; 295:655–66. 

12. Farvid M.S., Ding M., Pan A., et al. Dietary linoleic acid and risk of coronary heart disease: a systematic review and metaanalysis of prospective cohort studies. CIRCULATION 2014; 130:1568–78. 

13. Jakobsen M.U., O’Reilly E.J., Heitmann B.L., et al. Major types of dietary fat and risk of coronary heart disease: a pooled 

analysis of 11 cohort studies. AM. J. CLIN. NUTR. 2009; 89:1425–32. 

14. Chowdhury R., Warnakula S., Kunutsor S., et al. Association of dietary, circulating, and supplement fatty acids with coronary 

risk: a systematic review and meta-analysis. ANN. INTERN. MED. 2014; 160:398–406. 

15. Hooper L., Summerbell C.D., Thompson R., et al. Reduced or modified dietary fat for preventing cardiovascular disease. 

COCHRANE DATABASE SYST. REV. 2012; 5:CD002137. 

16. Siri-Tarino P.W., Sun Q., Hu F.B., Krauss R.M. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. AM. J. CLIN. NUTR. 2010; 91:535–46. 

17. Mozaffarian D., Micha R., Wallace S. Effects on coronary heart disease of increasing polyunsaturated fat in place of saturated 

fat: a systematic review and meta-analysis of randomized controlled trials. PLOS MED. 2010; 7:e1000252. 

18. Skeaff C.M., Miller J. Dietary fat and coronary heart disease: summary of evidence from prospective cohort and randomised 

controlled trials. ANN. NUTR. METAB. 2009; 55:173–201. 

19. Siri-Tarino P.W., Sun Q., Hu F.B., Krauss R.M. Saturated fat, carbohydrate, and cardiovascular disease. AM. J. CLIN. NUTR. 

2010; 91:502–9. 

20. Leren P. The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction: a controlled clinical trial. 

ACTA. MED. SCAND. SUPPL. 1966; 466: 1–92. 

21. Seymour D., Pearce M.L., Hashimoto S., Dixon W.J., Tomiyasu U. A controlled clinical trial of a diet high in unsaturated fat 

in preventing complications of atherosclerosis. CIRCULATION 1969; 40 (suppl. 2):1–63. 

22. Frantz I.D., Dawson E., Ashman P.L., et al. Test of effect of lipid lowering by diet on cardiovascular risk: the Minnesota coronary survey. ARTERIOSCLER. THROMB. VASC. BIOL. 1989; 1:129–35; 

23. Turpeinen O., Karvonen M., Pekkarinen M., Miettinen M., Elosuo R., Paavilainen E. Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study. INT. J. EPIDEMIOL. 1979; 2: 99–118. 

24. Research Committee to the Medical Research Council. Controlled trial of soya-bean oil to the Medical Research Council. LANCET 1968; 2:693–9. 

25. Multiple Risk Factor Intervention Trial Research Group. Multiple risk factor intervention trial: risk factor changes and mortality results. JAMA 1982; 12:1465–77. 

26. National Research Council, Food and Nutrition Board, National Academy of Sciences. Toward healthful diets. National Academy Press, 1980. 

27. Dietary Guidelines Advisory Committee. Scientific report part D: chapter 2. Dietary patterns, foods and nutrients, and health 

outcomes—continued. http://health.gov/dietaryguidelines/2015-scientific-report/07-chapter-2/d2-2.asp. 

28. Feinman R.D., Pogozelski W.K., Astrup A., et al. Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. NUTRITION 2015; 31:1–13. 

29. Ajala O., English P., Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of 

type 2 diabetes. AM. J. CLIN. NUTR. 2013; 97:505–16. 

30. Santos F.L., Esteves S.S., da Costa Pereira A., Yancy W.S., Jr., Nunes J.P. Systematic review and meta-analysis of clinical 

trials of the effects of low carbohydrate diets on cardiovascular risk factors. OBES. REV. 2012; 13:1048–66. 

31. Johnston B.C., Kanters S., Bandayrel K., et al. Comparison of weight loss among named diet programs in overweight and 

obese adults: a meta-analysis. JAMA 2014; 312:923–33. 

32. Bueno N.B., de Melo I.S., de Oliveira S.L., da Rocha Ataide T. Very-low-carbohydrate ketogenic diet v. low-fat diet for longterm weight loss: a meta-analysis of randomised controlled trials. BR. J. NUTR. 2013; 110:1178–87. 

33. Center for Nutrition Policy and Promotion. Dietary guidelines for Americans, 1980 TO 2000. www.health.gov/ 

dietaryguidelines/1980_2000_chart.pdf. 

34. Dietary Guidelines Advisory Committee. Scientific report: part B. Chapter 2: 2015 DGAC themes and recommendations: integrating the evidence. http://health.gov/dietaryguidelines/2015-scientific-report/04-integration.asp. 

35. Hering G. Meat industry has a cow over U.S. Dietary Guidelines. GUARDIAN 2015 May 19. www.washingtonpost.com/blogs/ 

wonkblog/wp/2015/01/07/why-the-governments-new-dietary-guidelines-could-be-a-nightmare-for-the-meat-industry. 

36. Jalonick M.C., Neergaard L. Let them eat meat. ASSOCIATED PRESS 2015 Jun. 24. www.usnews.com/news/politics/articles/ 

2015/06/24/republicans-push-back-against-proposed-dietary-guidelines. 

37. Nutrition Evidence Library. Meat: systematic review questions. www.nel.gov/topic.cfm?cat=3289. 

38. Estruch R., Ros E., Salas-Salvado ́ J., et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N. ENGL. 

J. MED. 2013; 368:1279–90. 

39. Dietary Guidelines Advisory Committee. Scientific report: part D. Chapter 1. http://health.gov/dietaryguidelines/2015-scientific-report/06-chapter-1/. 

40. Nutrition Evidence Library. How do the health outcomes of a vegetarian diet compare to that of a diet which customarily includes animal products? www.nel.gov/evidence.cfm?evidence_summary_id=250379. 

41. Nutrition Evidence Library. Vegetables/fruit: systematic review questions. www.nel.gov/topic.cfm?cat=3290. 

117 

42. Nutrition Evidence Library. What is the relationship between adherence to dietary guidelines/recommendations or specific dietary patterns, assessed using an index or score, and risk of type 2 diabetes? www.nel.gov/conclusion.cfm?conclusion_statement_id=250400&full_review=true. 

43. Esposito K., Marfella R., Ciotola M., et al. Effect of a Mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA 2004;2 92:1440–6. 

44. Jacobs D.R., Jr., Sluik D., Rokling-Andersen M.H., Anderssen S.A., Drevon C.A. Association of 1-y changes in diet pattern 

with cardiovascular disease risk factors and adipokines: results from the 1-y randomized Oslo Diet and Exercise Study. AM. J. CLIN. 

NUTR. 2009; 89:509–17. 

45. Estruch R., Martı ́nez-Gonza ́lez M.A., Corella D., et al. Effects of a Mediterranean-style diet on cardiovascular risk factors: a 

randomized trial. ANN. INTERN. MED. 2006; 145:1–11. 

46. Howard B.V., Manson J.E., Stefanick M.L., et al. Low-fat dietary pattern and weight change over 7 years: the Women’s Health 

Initiative Dietary Modification Trial. JAMA 2006; 295:39–49. 

47. Blumenthal J.A., Babyak M.A., Sherwood A., Craighead L., et al. Effects of the dietary approaches to stop hypertension diet 

alone and in combination with exercise and caloric restriction on insulin sensitivity and lipids. HYPERTENSION 2010; 55:1199–205. 

48. Jensen M.D., Ryan D.H., Apovian C.M., et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity 

in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The 

Obesity Society. J. AM. COLL. CARDIOL. 2014; 63:2985–3023. 

49. Adamsson V., Reumark A., Fredriksson I.B., et al. Effects of a healthy Nordic diet on cardiovascular risk factors in 

hypercholesterolaemic subjects: a randomized controlled trial (NORDIET). J. INTERN. MED. 2011; 269:150–9. 

50. Appel L.J., Moore T.J., Obarzanek E., et al. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N. ENGL. J. MED. 1997; 336:1117–24. 

51. Sacks F.M., Svetkey L.P., Vollmer W.M., et al. Effects on blood pressure of reduced dietary sodium and the dietary approaches 

to stop hypertension (DASH) diet. DASH—Sodium Collaborative Research Group. N. ENGL. J. MED. 2001; 344:3–10. 

52. Margetts B.M., Beilin L.J., Armstrong B.K., Vandongen R. A randomized control trial of a vegetarian diet in the treatment of 

mild hypertension. CLIN. EXP. PHARMACOL. PHYSIOL. 1985; 12:263–6. 

53. Appel L.J., Sacks F.M., Carey V.J., et al. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure 

and serum lipids: results of the OmniHeart randomized trial. JAMA 2005; 294:2455–64. 

54. Obarzanek E., Sacks F.M., Vollmer W.M., et al. Effects on blood lipids of a blood pressure-lowering diet: the Dietary Approaches to Stop Hypertension (DASH) Trial. AM. J. CLIN. NUTR. 2001; 74:80–9. 

55. Walden C.E., Retzlaff B.M., Buck B.L., et al. Differential effect of national cholesterol education program (NCEP) step II diet 

on HDL cholesterol, its subfractions, and apoprotein AI levels in hypercholesterolemic women and men after 1 year: The beFIT 

Study. ARTERIOSCLER. THROMB. VASC. BIOL. 2000; 20:1580–7. 

56. Beresford S.A.A., Johnson K.C., Ritenbaugh C., et al. Low-fat dietary pattern and risk of colorectal cancer: the Women’s Health 

Initiative Randomized Controlled Dietary Modification Trial. JAMA 2006; 295:643–54 

57. Knopp R.H., Walden C.E., Retzlaff B.M., et al. Long-term cholesterol-lowering effects of 4 fat-restricted diets in 

hypercholesterolemic and combined hyperlipidemic men. the dietary alternatives study. JAMA 1997; 278:1509–15. 

58. Prentice R.L., Caan B., Chlebowski R.T., et al. Low-fat dietary pattern and risk of invasive breast cancer: the Women’s Health 

Initiative randomized controlled dietary modification trial. JAMA 2006; 295:629–42 

59. Prentice R.L., Thomson C.A., Caan B., et al. Low-fat dietary pattern and cancer incidence in the Women’s Health Initiative dietary modification randomized controlled trial. J. NATL. CANCER. INST. 2007; 99:1534–43. 

60. Harrington E. USDA hires environmentalist food activist to oversee dietary guidelines. WASHINGTON FREE BEACON 2015 Jun 

10. http://freebeacon.com/issues/usda-hires-environmentalist-food-activist-to-oversee-dietary-guidelines/. 

61. Kris-Etherton P.M., Hu F.B., Ros E., Sabate ́ J. The role of tree nuts and peanuts in the prevention of coronary heart disease: 

multiple potential mechanisms. J. NUTR. 2008; 138:1746–51S. 

62. Bao Y., Han J., Hu F.B., et al. Association of nut consumption with total and cause-specific mortality. N. ENGL. J. MED. 2013; 

369:2001–11. 

63. Shi Y., Hu F.B. The global implications of diabetes and cancer. LANCET 2014; 383:1947–8. 

64. Mozaffarian D., Hao T., Rimm E.B., Willett W.C., Hu F.B. Changes in diet and lifestyle and long-term weight gain in women 

and men. N. ENGL. J. MED. 2011; 364:2392–404. 

65. Herman J. Saving U.S. dietary advice from conflicts of interest. FOOD DRUG LAW J. 2010; 65:285–316. 

66. Cope M.B., Allison D.B. White hat bias: examples of its presence in obesity research and a call for renewed commitment to 

faithfulness in research reporting. INT. J. OBES. 2010; 34:84–8. 

67. Wells, Hordan F. and Buzby, Jean C., ‘‘Dietary Assessment of Major Trends in U.S. Food Consumption, 1970–2005,’’ Economic Information Bulletin, Number 33, USDA Economic Research Service, March 2008. 

SUBMITTED LETTER BY KRISTIN PEARSON WILCOX, VICE PRESIDENT OF GOVERNMENT

RELATIONS, INTERNATIONAL BOTTLED WATER ASSOCIATION

October 7, 2015 

Hon. K. MICHAEL CONAWAY, Hon. COLLIN C. PETERSON, 

Chairman, Ranking Minority Member, 

House Committee on Agriculture, House Committee on Agriculture, 

Washington D.C.; Washington D.C. 

Dear Chairman Conaway and Ranking Member Peterson: 

On behalf of the members of the International Bottled Water Association (IBWA), 

thank you for holding the hearing today on the importance of basing the 2015 Dietary Guidelines for Americans (DGA) on sound science. 

IBWA is the primary, authoritative source of information on bottled water. This 

includes all types of water, such as spring, mineral, sparkling, artesian and purified 

bottled water. Our membership includes over 700 United States and international 

bottlers, suppliers and distributors that are small, medium and large-sized companies. IBWA and the bottled water industry are committed to making safe and 

healthy products. In addition to U.S. Food and Drug Administration (FDA) and 

state regulations, IBWA member bottlers must adhere to the IBWA Bottled Water 

Code of Practice. In some cases, the FDA and IBWA standards for bottled water are 

more stringent than the U.S. Environmental Protection Agency (EPA) regulations 

for tap water. 

118 

We appreciate your attention today to the nutritional health of our citizens. Every 

American is affected by the nutritional recommendations made in the Dietary 

Guidelines. It is essential for them to be based on consistent, and sound nutritional 

science. We want to provide you with our insights on the nutritional importance of 

water, and its role in health, as you examine the Administration’s efforts to finalize 

the 2015 Dietary Guidelines. We believe the science supports having the final guidelines stress the importance of water consumption, including bottled water consumption. 

Making healthy hydration an equally important part of the wellness equation, 

along with a well-balanced diet and daily physical activity for all Americans, should 

be a clear focus of the 2015 DGAs. Bottled water presents a healthy option for consumers when making a beverage choice. Having no calories and no sugar, it is often 

the best choice as a beverage on the go. This simplicity gives bottled water an advantage over other packaged beverages when consumers are trying to make a 

healthy beverage selection. 

Scientific studies clearly demonstrate the importance of water consumption, and 

science and health professionals are speaking up on behalf of water. For example, 

on September 10, 2014, fourteen researchers, scientists, nutritionists, clinicians, and 

public health professionals wrote a letter to the Dietary Guidelines Advisory Committee (DGAC) asking them to strengthen the language for drinking water in the 

2015 Dietary Guidelines and adding a water graphic to the MyPlate nutrition guide. 

We think the science is clear, and researchers and clinicians are saying Americans 

should drink more water. And, consumers are listening. 

Americans’ consumption of bottled water increased by 7.3 percent to 11 billion gal- lons in 2014 and bottled water sales were up 6.4 percent to $13 billion (wholesale) 

over the previous year. Americans upped their annual bottled water consumption 

by almost 11 gallons per person during the period 2004 to 2015. It went from 23.2 

gallons per person in 2004 to 34 gallons in 2014, according to Beverage Marketing 

Corporation (BMC). BMC reported that over the past 5 years alone, bottled water 

has increased its ‘‘share of stomach’’ of the overall beverage market from 14.4 percent in 2009, to 17.8 percent in 2014. 

We hope that the revised DGA’s will take this growth, and the advice of nutrition 

experts, into account in the final 2015 DGA document. Numerous peer-reviewed scientific studies indicate that water consumption can aid in weight management and 

that there is a need to promote the consumption of water. IBWA submitted a full 

list of the scientific research supporting the importance of water consumption to the 

DGAC. 

This impressive list of academic endorsements of the importance of water consumption is supported by the government’s own data. The U.S. Department of Agriculture’s (USDA) National Health and Nutrition Examination Survey (NHANES) IV 

data show that older adults are not consuming enough water. Neither are children. 

Water accounted for only 29% of children’s total fluid intake; the majority coming 

from soda, sports drinks and teas. Of children 4–8 years, 75% failed to satisfy the 

Daily Recommended Intake (DRI) for water. Dr. Adam Drewnoski, of the Center for 

Public Health Nutrition at the University of Washington, who conducted this study 

of NHANES data, concluded, ‘‘Increasing total water consumption can be achieved 

through various means, though promotion and encouragement of non-caloric beverages is likely to be the most successful avenue for increasing water consumption.’’ 

IBWA and its members believe the Dietary Guidelines should encourage the consumption of water of all kinds: bottled, filtered, and tap. It is our hope that the 2015 

Dietary Guidelines will reinforce those healthy behaviors that are already changing 

for the better. As noted, people are forming new habits like drinking more water— 

both bottled and tap. Besides growing in consumption nationally, bottled water is 

already outselling carbonated soft drinks in supermarkets here in Washington, D.C. 

and in 17 other major markets, including New York, Los Angeles, Miami, and Philadelphia. And according to BMC, bottled water will become the number one beverage 

product in the United States by 2020. 

The message to drink more water is resonating around the world. For example, 

the Mediterranean Diet Pyramid includes drinking water as an essential component 

of a healthy diet. The DGAC has discussed the merits of the Mediterranean Diet 

during its deliberation of the 2015 Guidelines. The Japanese Food Guide also includes water at the top of its pyramid. Again, they all recognize water as an important element of a well-balanced lifestyle. Other countries, such as France, Spain, 

Germany, and Austria, include water in their dietary guideline visual depictions. 

We believe the U.S. should join these countries and include water in its Dietary 

Guidelines and on the MyPlate visual. 

The DGAs do not need to pit healthy foods and beverages against each other. No 

one supports healthy beverage choices, such as milk, more than our industry and 

119 

* American Bakers Association; American Institute of Baking International Grain Foods Foundation; Independent Bakers Association; National Association of Wheat Growers; National Pasta 

Association; North American Millers’ Association; Retail Bakers of America; USA Rice Federation; Wheat Foods Council. 

we recognize the nutrient value of milk and 100% fruit juice. We are, however, suggesting that science supports having water, along with milk and dairy, on the 

MyPlate nutrition guide. According to a recent W.K. Kellogg Foundation poll, 90 

percent of the people polled say they support making water a preferred beverage 

in the new 2015 Dietary Guidelines for Americans. IBWA commissioned a study by 

the Artemis Strategy Group on the different MyPlate visuals. One of the visuals included the original USDA/HHS MyPlate, which has a dairy cup next to a plate. Another visual had a cup of dairy and cup of water next to one another alongside the 

plate. Among the 76% of those surveyed who reported that they are very or somewhat likely to consume dairy when viewing the original MyPlate, 49% of them said 

they that they would drink both water and dairy when they saw a MyPlate visual 

including water and dairy. 

The 2015 Dietary Guidelines and MyPlate will serve as a platform for Americans 

to begin or continue living a healthy lifestyle. We hope that both will include messaging and visuals to encourage the adoption of healthy hydration habits. Americans 

should be healthier and drink more water. If we want Americans to drink more 

water, there should be a consistent ‘‘think water’’ encouragement in the Dietary 

Guidelines’ final recommendations. Delivery of this message to American families is 

critical. 

We are concerned about two messages in the DGAC recommendations. In particular, its steps into providing economic rather than nutritional advice when the 

DGAC stresses that consumers should drink ‘‘free’’ water. We think the final Guidelines should encourage consumers to drink ‘‘accessible’’ water. 

We are also concerned about the DGAC’s straying into a discussion of environmental sustainability. We want to make sure that you are aware of bottled water’s 

small impact on the environment, and on our small water use, as you deliberate on 

what beverages to promote. Bottled water has the smallest environmental footprint 

among all packaged beverages. 

Statistics show that the bottled water industry is a sustainability leader. From 

an environmental standpoint, when people choose bottled water instead of any other 

canned or bottled beverage, they are choosing less packaging, less energy consumption, and less use of natural resources. According to a 2014 Antea Group Study, bottled water facilities have the lowest water use ratio and energy use ratio when compared to other beverage products, including sugar-sweetened beverages. These ratios 

represent the average amount of water and energy used within the facility to 

produce 1 liter of bottled water. The Antea study found that it only takes 1.32 liters 

of water to produce 1 liter of bottled water and that includes the liter that is consumed. 

PET plastic bottled water containers are the single most recycled item in nationwide curbside collection programs. And large 3 and 5 gallon bottled water containers 

are washed, sanitized and reused between 30–50 times before being recycled. Data 

derived from EPA figures demonstrate that plastic water bottles make up less than 

1⁄3 of 1 percent of the entire U.S. waste stream. 

Bottled water producers, like the American farmers this Committee works to uplift and protect, care about the quality of the water and land that produce the food 

and beverage products that Americans and people around the world consume. 

We pledge to remain good stewards of water resources. And we stand ready to 

partner with you and the Administration to help ensure good nutritional health for 

all Americans. 

Thank you for this opportunity to comment on this important issue. 

Sincerely, 

KRISTIN PEARSON WILCOX

Vice President of Government Relations. 

SUBMITTED LETTER BY GRAIN CHAIN * 

October 19, 2015 


11429001.eps
120 

Hon. K. MICHAEL CONAWAY, 

Chairman, 

House Agriculture Committee 

Washington, D.C. 

RE: Grain Chain Comments for Hearing Record: House Agriculture Committee Hearing on 2015 Dietary Guidelines for Americans (October 7, 

2015) 

Dear Chairman Conaway: 

As the organizations comprising the Grain Chain, a grains industry coalition from 

farm to table, we are pleased to provide written comments for the public hearing 

record on the House Agriculture Committee’s recent hearing to review the 2015 Dietary Guidelines for Americans. 

We commend the Chairman and the Committee on analysis of the dietary guideline review process and for emphasizing that as the 2015 recommendations are finalized by HHS and USDA, there needs to be a base of strong scientific evidence 

and within scope. 

The Grain Chain comments provide detailed justification for the following specific 

recommendations: 

1. Retain the DGAC 2010 recommendation for six servings of grains with balance between whole and enriched (refined); 

2. Use the term ‘‘enriched grains’’ when referring to refined grains, since more 

than 95% of the refined grains in the U.S. are enriched and fortified; 

3. Reject the DGAC 2015 recommendation to limit added sugar to no more than 

10% of total calories; 

4. Reject the DGAC 2015 recommendation to restrict dietary sodium to less than 

2300 mg per day; 

5. Acknowledge the emerging evidence of the beneficial effects of whole grains 

on maintaining a healthy microbiome; 

6. Note the negative health implications of fad diets. 

In the following sections we provide the scientific rationale for each of our recommendations. 

1. Retain the DGAC 2010 Recommendation for Six Servings of Grains with 

Balance Between Whole and Enriched (Refined) 

The Crucial Role of Enriched Grains in the Diet 

The Grain Chain fully endorses the 2015 Dietary Guidelines Advisory Committee’s decision to ‘‘bring forward’’ the recommendation of the 2010 Dietary Guidelines 

for Americans which called for 1⁄2 of all grain intake to come from whole grains. This 

would allow Americans to reap the multiple, established health benefits of whole 

grains, leaving the other 1⁄2 of daily grain intake for enriched grain products, which 

have their own unique benefits. Furthermore, because at least 95% of the refined 

grains in the U.S. are enriched and fortified and labeled as such, it is more appropriate to use the term ‘‘enriched grains’’ as opposed to ‘‘refined grains,’’ especially 

when speaking to staple grain products [see below, section on ‘‘Clarification of Terminology’’]. Since Americans have yet to achieve the current Dietary Guidelines rec- ommendation for whole grain intake, the recommendation’s goal is still valid and 

vital in the setting of a calorically appropriate diet. As well, the science does not 

show that there are benefits to higher daily intake of whole grains beyond ‘‘making 

1⁄2 your grains whole grains,’’ reinforcing that all grains have a place in a balanced 

eating pattern. 

As a category, grain foods contribute vital, and often underconsumed, nutrients 

to the American diet, including 43.7% of all fiber.1 Approximately 2⁄3 of the grain 

contribution to total fiber intake comes from enriched grains.2 The contributions of 

both whole and enriched grains to total fiber intake are important because more 

than 90% of adults and children fall short of dietary fiber recommendations.2 Enriched grains also are the largest contributor of folate in the American diet.3 Although the current dietary fiber shortfall could theoretically be made up by consuming more fruits and vegetables, which together contribute 43.8% of total dietary 

fiber intake,1 a reduction in enriched grain intake could have unintended health 

consequences (e.g., nutrient shortfalls from reduced intake of enriched grain products—see section 2, below). Furthermore, a number of scientific reports have demonstrated the distinctive benefits of cereal fiber compared to fiber from fruits and 

vegetables. For example: 

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• A 2007 meta-analysis including nine cohort studies demonstrated a 33% reduction in type 2 diabetes incidence associated with cereal fiber intake, but no association with either fruit or vegetable fiber intake.4

• A 2014 analysis of data from 17 prospective studies found an inverse linear relationship between cereal fiber intake and reduction in type 2 diabetes risk but 

no such associations with fruit or vegetable fiber intake.5

• A 2014 publication using data on survivors of myocardial infarction among participants in the Nurses’ Health Study and Health Professionals Follow-up Study 

showed a 27% reduced risk in all-cause and CVD mortality associated with cereal fiber intake, but no association with fiber from either fruit or legumes.6

These articles are not presented to diminish the established benefits of fruits and 

vegetables, but rather to highlight the findings that when compared head-to-head, 

a considerable body of evidence (i.e., 28 separate cohorts examined in these three 

studies) indicates that cereal fiber may be more important for reducing all-cause 

and some cause-specific mortality. Fiber from enriched grains makes up approximately 2⁄3 of total cereal fiber in the American diet. 

While whole grains have a well-established link to reduced obesity risk, the 2015 

DGAC has overstated the evidence against refined (enriched) grains. For example: 

• A systematic review of the literature showed little relationship between refined 

(enriched) grain intake and body mass index.7

• A 2012 special review for Nutrition Reviews concluded that the published data 

on the relationship between refined (enriched) grain intake and body weight are 

mixed, with no clear and consistent trends.8

• Refined (enriched) grain intake was not associated with any measure of body 

fat distribution in older adults.9

• Among adolescent girls and boys in the NHANES III study, both refined (enriched) grain intake and whole grain intake were inversely associated with central adiposity, measured by waist circumference.10

With respect to facilitating weight loss, both refined (enriched) grains and whole 

grains may be equally effective: 

• A 2014 report showed that when consuming a hypocaloric diet, enriched-grain 

foods and whole-grain foods were equally effective in facilitating weight loss and 

reducing abdominal adipose tissue in men and women with increased waist circumference.11

• A 2008 publication demonstrated that whole- and enriched-grain diets produced 

equal weight loss and improvements in several CVD risk markers in men and 

women with the Metabolic Syndrome.12

Refined (Enriched) Grain Intake and Chronic Disease: Weak Scientific Evidence 

The 2015 DGAC concluded that higher consumption of refined (enriched) grains 

is linked to higher risk of several chronic diseases. This conclusion is not consistent 

with a large body of scientific evidence and again, reflects the disconnect in how staple grain products are classified. We have shared some examples of these inconsistencies but ultimately request a continued recommendation for balanced intake between enriched and whole grains. 

Some examples: 

• The 2015 DGAC report cited a 2014 meta-analysis in the Journal of Human 

Nutrition and Dietetics that indicated a positive relationship between refined 

(enriched) grain intake and risk of type 2 diabetes.13 However, refined grains 

were not analyzed separately, but only as part of a dietary pattern. Surprisingly, the 2015 DGAC report did not cite a 2013 meta-analysis published in the 

European Journal of Epidemiology that showed no relationship between refined 

(enriched) grain intake and diabetes risk.14 The impact factor for the Journal 

of Human Nutrition and Dietetics is 2.07, while the impact factor for the European Journal of Epidemiology is 5.15. It is important to note that the article 

not cited by the committee found no association between diabetes risk and refined grain intake, even up to seven servings per day. This information is extremely relevant because Figure D1.28 in the DGAC report (p. 144) shows that 

refined (enriched) grain intake ranged between three and 6.5 servings per day, 

depending on sex and age group, between 2001 and 2010 (based on NHANES 

data). Furthermore, the reduced diabetes risk associated with whole grain intake was maximized at three servings per day, which is completely consistent 

with the current recommendations of ∼3 servings per day of whole grains. If 

122 

total grain intake is to stay at six servings per day, there is no reason to advocate that all servings should come from whole grains. 

• A report from the Framingham Heart Study showed that the lowest level of visceral abdominal fat was observed in persons who consumed approximately two 

servings per day of refined (enriched) grains and approximately three servings 

per day of whole grains. There was no benefit of reducing refined (enriched) 

grain intake to less than one serving per day.15

• A 2012 review concluded, ‘‘The totality of evidence shows that consumption of 

up to 50% of all grain foods as refined-grain foods (without high levels of added 

fat, sugar, or sodium) is not associated with any increased disease risk.’’ 16

• Among 28,926 participants in the Women’s Health Study, refined (enriched) 

grain intake was not associated with hypertension, but whole grain intake was 

inversely associated with hypertension risk. The lack of an association with refined (enriched) grain intake was observed even at intakes of six or more 

servings per day.17

All Grain-Based Foods Can Be Part of a Healthy Diet 

Recent data analyses presented at the 2015 Experimental Biology meeting in Boston that was supported by the Grain Foods Foundation revealed how many grainbased foods can cost-effectively fit into a healthy diet.18–20 The results of these three 

separate analyses are described below: 

• The 2015 DGAC relied on food pattern modeling analyses performed by the 

2005 and 2010 DGACs to answer questions related to the impact of reducing 

refined/enriched grain consumption, and overall grain consumption, on nutrient 

intake. We would like to bring to your attention recent modeling research, supported by the Grain Foods Foundation, and presented at the 2015 Experimental 

Biology meeting.18 The modeling analysis was conducted within a 2,000 kcal/ 

d USDA ideal food pattern where the ideal USDA grain food composite was replaced with ten different grain food patterns based on data from What We Eat 

In America 2005–2010. All patterns were compared to the USDA ideal and 

USDA typical food patterns. All ten models examined provided less energy in 

comparison to the USDA typical food pattern. Several grain patterns, including 

refined grains, contributed nutrient and energy intakes similar to USDA recommendations. In fact, a pattern that included three servings of refined grains, 

two high-fiber grain servings and one serving of whole grains resulted in less 

sodium intake and greater intake of folate and fiber than a dietary pattern that 

included six servings of whole grains. 

• A cluster analysis using data from What We Eat in America 2005–2010 found 

that there were no significant differences observed comparing those in the ‘‘no 

grains’’ cluster to those in several different grain patterns, including many nonwhole grain-based foods, for body mass index or fasting blood concentrations of 

glucose, insulin, total cholesterol, LDL-cholesterol and triglycerides.19 Thus, inclusion of several grain foods patterns in the diet is associated with several 

health- and nutrition-related outcomes in adults. 

• A cost-of-nutrients analysis used NHANES 2003–2004 data and the USDA Center for Nutrition Policy and Promotion prices database to show that certain 

grain-based foods are a ‘‘nutrition bargain’’ for American consumers.20 The 

rolls/buns category and the rice category were particularly cost effective, each 

ranking in the top five most cost effective food categories for 13–14 of the nutrients/substances evaluated, including dietary fiber, protein, folate, iron, magnesium, calcium, niacin and thiamin. 

2. Clarification of Terminology: Use the Term ‘‘Enriched Grains’’ When Referring to Refined Grains 

We would like to clarify some important points on grains terminology. 

Although the 2015 DGAC acknowledged the enrichment and fortification of 

grains, its repeated recommendations to reduce consumption of ‘‘refined’’ grains to 

improve health undermines the established benefits of enriched grain products. 

Furthermore, rather than ‘‘refined,’’ ‘‘enriched’’ is a more appropriate term to describe the grain products that the average American sees in the grocery aisle. These 

staple foods contain some fiber and are enriched with important nutrients, like 

thiamin, niacin, riboflavin and iron. They are fortified with folic acid, which is essential for women of childbearing age to help prevent neural tube birth defects. The 

rate of neural tube defects in the United States has decreased by 35 percent since 

the fortification of enriched grains began in 1998.21

Enriched grains, as mandated by the U.S. Government since 1941, have the three 

major B vitamins and iron replaced in equal or larger amounts to those in whole 

123 

grain products as defined by the standards of identity. These essential B vitamins 

help maintain a healthy nervous system, increase energy production, and may play 

a role in lowering cholesterol. Due to this enrichment policy, serious diseases, including pellagra and beriberi, have been eradicated from the U.S. population. The 

reduction in neural tube defects has reduced health care costs associated with spina 

bifida and anencephaly, resulting in annual savings in total direct costs of approximately $508 million for the NTD-affected births that were prevented with folic acid 

fortification.21

Enriched, fortified grain foods are the primary source of folic acid in Americans’ 

diets. This is particularly important for women of child-bearing age, the majority of 

which do not take folic acid supplements. Furthermore, folic acid is better absorbed 

by the body than natural folate, almost twice as efficiently.22 The U.S. also has a 

growing Hispanic population, and adequate consumption of folate-rich foods is critical for this group since statistically, Hispanic women are 1.5 to 3 times more likely 

to have a baby with an NTD.23

A Centers for Disease Control and Prevention (CDC) proclamation in 2011 named 

the fortification of folic acid to enriched grains as one of the top ten health achievements in the first decade of this century.24 This fortification policy has also almost 

totally eradicated folate-deficiency anemia in older adults in the U.S.25

3. Reject the DGAC 2015 Recommendation To Limit Added Sugar To No 

More Than 10% of Total Calories 

The 2015 DGAC recommends limiting added sugars to a maximum of 10% of total 

daily caloric intake. This recommendation was based on the food pattern modeling 

analysis conducted by the 2015 DGAC and on the scientific evidence review on 

added sugars and chronic disease risk conducted by the Committee. The DGAC 

rated the evidence as ‘‘strong.’’ But the two major meta-analyses that the 2015 

DGAC relied heavily upon reported rather small associations between sugar intake 

and body weight.26–27 Moreover, the committee did not include several published reports that showed no significant relationships between sugar intake and a number 

of health outcomes.28–34

The association with obesity, for example, has been shown to be primarily due to 

caloric excess rather than sugar itself.31–32 Furthermore, data on adults from the 

1999–2006 National Health and Nutrition Examination Surveys (NHANES) demonstrated that sugar consumption was not positively associated with body weight or 

indicators of the metabolic syndrome.33 Similarly, among children ages 6–18 participating in the 2003–2006 National Health and Nutrition Examination Survey, intake 

of added sugars was not associated with body weight, BMI z-score or any measure 

of adiposity.30 In fact, added sugar consumption explained less than 0.25% of the 

variance in BMI z-scores of the children in this study, indicating that more than 

99.75% of the variation in BMI z-scores of these children was due to factors other 

than sugar. It is difficult to justify specific recommendations for sugar consumption 

when this macronutrient’s contribution to body weight and blood biomarkers for cardiovascular health is so small. Sugars have no specific role as a determinant of body 

weight other than being one of many sources of energy.34

We would also like to point out that the benefits of whole-grain consumption are 

independent of sugar consumption, and can be documented even with relatively high 

sugar intakes: 

• In children ages 2–5, 6–12, and 13–18, whole-grain intake was found to be associated with higher diet quality (assessed by the Healthy Eating Index that reflects recommendations of the Dietary Guidelines for Americans), despite the 

fact that total sugar intake did not differ across quartiles of whole-grain intake. 

Highest diet quality was observed in children consuming more than three 

servings of whole grains per day. Sugar intake in these groups accounted for 

19–23% of total calories.28

• In adults ages 51 and older participating in the National Health and Nutrition 

Examination Survey, 1999–2004, whole-grain intake was associated with a significantly higher Healthy Eating Index score, despite no differences in total 

sugar intake across quartiles of whole-grain intake.29

4. Reject the DGAC 2015 Recommendation To Restrict Dietary Sodium to 

Less Than 2,300 mg Per Day 

The recommendation of the 2015 DGAC for dietary sodium intake to below 2,300 

mg may not be compatible with minimizing risk for mortality or cardiovascular disease as stated in the 2013 Institute of Medicine (IOM) report on ‘‘Sodium Intake 

in Populations: Assessment of Evidence’’ and in other peer reviewed journals.35–41

Evidence linking sodium intake to mortality outcomes is scant and inconsistent.36–41

Several publications in 2014 and 2015 have demonstrated an increased mortality 

124 

risk associated with low sodium intake.38–41 Because sodium reduction has physiological effects that may adversely affect health outcome, it is premature to recommend sodium levels lower than 2300 mg until more definitive data can justify 

such broad population-wide advice. 

5. Acknowledge the Emerging Evidence of the Beneficial Effects of Whole 

Grains on Maintaining a Healthy Microbiome 

In recent years there has been heightened interest in the role of the gastrointestinal system in overall health, but after conducting an exploratory search the 

2015 DGAC concluded that there was insufficient evidence to address the role of 

diet in the microbiome. 

While we agree that this is an emerging area of study, we would also like to emphasize that published research indicates that grains, especially those with high 

amounts of resistant starches, are important for maintaining a healthy composition 

of gut bacteria. Whole grain cereals, among other plant foods, are associated with 

the up-regulation of various bacteria that are beneficial to gut health.42 Resistant 

starches found in whole grains have a prebiotic action that helps create a healthy 

composition of gut bacteria which may reduce risk of some cancers, inflammatory 

conditions and cardiovascular disease.43–50 Despite the relatively small number of 

studies, the data that have been published call attention to a very prominent role 

for grain-based foods in creating a healthy microbiome. We think that this should 

be at least acknowledged in the 2015 Dietary Guidelines, especially as an area for 

future study. 

6. Note the Negative Health Implications of Fad Diets 

Fad diets are temporary interventions that may carry long-term health consequences for the American public. 

Contrary to the nature of fad diets, the Dietary Guidelines for Americans are focused on setting the stage for a long-term, healthful eating pattern for all Americans, one that is based on a common sense approach built on balance, variety and 

moderation. As a Grain Chain, we believe that healthy weight maintenance/loss relies on the simple equation of balancing calories in (consumed) with calories out (expended), not eliminating specific foods or relying primarily on one food group. 

While there are countless fad diet plans available to the average American, we 

would like to briefly address the evidence countering three plans which often receive 

attention in the popular press: low-carbohydrate/Atkins, grain- and wheat-free (such 

as the plans detailed in the books Wheat Belly and Grain Brain) and gluten-free. 

Low-carbohydrate/Atkins: Two meta-analyses published in 2014 showed no difference between low-fat and low-carbohydrate diets for weight loss or cardiovascular 

risk factors; researchers concluded that weight loss is determined by calorie deficit 

regardless of calorie type and asserted most cardiovascular improvements can be attributed to the weight loss.51–52 More importantly, in a sample of nearly 44,000 

Swedish women followed for an average of 15.7 years, study organizers found ‘‘low 

carbohydrate, high-protein diets used on a regular basis and without consideration 

of the nature of carbohydrates or the source of proteins are associated with increased risk of cardiovascular disease.’’ 53 Carbohydrate consumption is also associated with better body weights. According to a study published in the Journal of the 

Academy of Nutrition and Dietetics, those who consume a medium-to-high percentage of carbohydrates in their diets have a reduced risk of obesity. The study also 

showed that people following a low-carbohydrate diet actually had a higher risk of 

being overweight or obese.54

Grain- and wheat-free: Carbohydrates are the preferred fuel source for the 

human brain; beyond this necessary role, grain consumption has been shown to 

have positive effects on brain function, specifically: 

• As part of an overall healthful eating pattern, specifically one that follows the 

principles of the Mediterranean diet, consuming whole grain foods has been 

shown to positively impact cognitive function.55–60

• Consumption of dietary fiber and B vitamins found in grain foods is associated 

with better cognitive health.61–63

• Folic acid fortification of enriched grain foods has been shown to be a cost effective method of improving cognitive health and brain development in utero.64–68

Gluten-free: Gluten-free dieting has gained popularity in the general population 

out of proportion to the prevalence of gluten-related disorders such celiac disease 

(CD), non-celiac gluten sensitivity (NCGS), and wheat allergy; supporting this are 

findings from a 2013 survey by Mintel indicating that 65% of American adults say 

they eat gluten-free products because they think they are more healthful, and 27% 

eat gluten-free products to lose weight. 

125 

Despite these claims for gluten-free eating, no published experimental evidence 

supports a weight loss claim for a gluten-free diet or suggests that the general population would be better off by avoiding gluten.69 Furthermore, no published studies 

have found that a gluten-free diet produces weight loss in patients without CD or 

NCGS. This may be because gluten-free foods are not necessarily low-calorie and 

often times contain more calories than their gluten-containing counterparts. Moreover, a gluten-free diet may also result in lower intake of whole grains and dietary 

fiber and some evidence suggests that following a gluten-free diet reduces concentrations of beneficial gut bacteria; on the other hand, a gluten-rich diet may boost the 

numbers of beneficial gut bacteria. 

We appreciate the opportunity to provide comments to the public hearing record. 

Should the Committee have questions or seek additional information, please contact 

Lee Sanders, American Bakers Association Senior Vice President for Government 

Relations and Public Affairs at [Redacted] or at [Redacted]. 

Sincerely, 

American Bakers Association (ABA); 

American Institute of Baking International; 

Grain Foods Foundation (GFF); 

Independent Bakers Association; 

National Association of Wheat Growers (NAWG); 

National Pasta Association (NPA); 

North American Millers’ Association; 

Retail Bakers of America; 

USA Rice Federation; 

Wheat Foods Council (WFC). 

References 

1. King D.E., Mainous III, A.G., Lambourne C.A. Trends in dietary fiber intake in the United States, 1999–2008. J. ACAD. NUTR. 

DIET. 2012; 112:642–648. 

2. Clemens R., Kranz S., Mobley A.R., et al. Filling America’s fiber intake gap: summary of a roundtable to probe realistic solutions with a focus on grain-based foods. J. NUTR. 2012; 142(7):1390S–1401S. 

3. Dietrich M., Brown C.J.P., Block G. The effect of folate fortification of cereal-grain products on blood folate status, dietary folate 

intake, and dietary folate sources among adult non-supplement users in the United States. J. AM. COLL. NUTR. 2005; 24:266–274. 

4. Schulze M.B., Schulz M., Heidemann C., et al. Fiber and magnesium intake and incidence of type 2 diabetes. ARCH. INT. MED. 

2007; 167:956–965. 

5. Yao B., Fang H., Xu W., et al. Dietary fiber intake and risk of type 2 diabetes: a dose-response analysis of prospective studies. 

EUR. J. EPIDEMIOL. 2014; 29:79–88. 

6. Li S., Flint A., Pai J.K., et al. Dietary fiber intake and mortality among survivors of myocardial infarction: prospective cohort 

study. BMJ. 2014; 348:g2659. 

7. Gaesser G.A. Carbohydrate quantity and quality in relation to body mass index. J. ACAD. NUTR. DIET. (Formerly J. AM. DIET. 

ASSOC.). 2007; 107:1768–1780. 

8. Bautista-Castano I., Serra-Majem L. Relationship between bread consumption, body weight, and abdominal fat distribution: 

evidence from epidemiological studies. NUTR. REV. 2012; 70:218–233. 

9. McKeown N.M., Yoshida M., Shea M.K., et al. Whole-grain intake and cereal fiber are associated with lower abdominal adiposity in older adults. J. NUTR. 2009; 139:1950–1955. 

10. Bradlee M.L., Singer M.R., Qureshi M.M., Moore L.L. Food group intake and central obesity among children and adolescents 

in the Third National Health and Nutrition Examination Survey (NHANES III). PUB. HEALTH. NUTR. 2010; 13:797–805. 

11. Jackson K.H., West S.G., VandenHeuval J.P., et al. Effects of whole and refined grains in a weight-loss diet on markers of 

metabolic syndrome in individuals with increased waist circumference: a randomized controlled-feeding trial. AM. J. CLIN. NUTR. 

2014; 100:577–586. 

12. Katcher H.I., Legro R.S., Kunselman A.R., et al. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. AM. J. CLIN. NUTR. 2008; 87:79–90. 

13. Alhazmi A., Stojanovski E., McEvoy M., Garg M.L. The association between dietary patterns and type 2 diabetes: a systematic 

review and meta-analysis of cohort studies. J. HUM. NUTR. DIET. 2014; 27:251–260. 

14. Aune D., Norat T., Romundstad P., Vatten L.J. Whole grain and refined grain consumption and the risk of type 2 diabetes: a 

systematic review and dose-response meta-analysis of cohort studies. EUR. J. EPIDEMIOL. 2013; 28:845–858. 

15. McKeown N.M., Troy M., Jacques P.F., et al. Whole and refined-grain intakes are differentially associated with abdominal visceral and subcutaneous adiposity in healthy adults. AM. J. CLIN. NUTR. 2010; 92:1165–1171. 

16. Williams P.G. Evaluation of the evidence between consumption of refined grains and health outcomes. NUTR. REV. 2012; 70:80– 

99. 

17. Wang L., Gaziano J.M., Liu S., et al. Whole- and refined-grain intakes and the risk of hypertension in women. AM. J. CLIN. 

NUTR. 2007; 86:472–479. 

18. Papanikolaou Y., Fulgoni V. Modeling changes in daily grain foods intake: An analysis to determine the impact on nutrient intakes in comparison to the USDA ideal food pattern. Abstract. FASEB J. 2015; 29 (suppl.):741.8. 

19. Papanikolaou Y., Fulgoni V. Consumption of certain grain food patterns is associated with improved diet quality and nutrient 

intakes in U.S. adults: A NHANES 2005–2010 analysis. FASEB J. 2015; 29 (suppl.):736.7. 

20. Fulgoni V., Papanikolaou Y.. Cost of nutrients analyses using the National Health and Nutrition Examination Survey: A focus 

on grain foods. FASEB J. 2015; 29 (suppl.):903.5. 

21. Williams J., Mai C.T., Mulinare J., et al. Updated estimates of neural tube defects prevented by mandatory folic acid fortification—United States, 1995–2011. MMWR. 2015; 64:1–5. 

22. Pitkin R.M. Folate and Neural Tube Defects. AM. J. CLIN. NUTR. 2007; 85 (suppl.): 285S–8S 

23. Folic Acid Knowledge and Use Among Hispanic Women. http://www.cdc.gov/omhd/populations/HL/HHP/Folic.htm. 

24. CDC. Ten Great Public Health Achievements—U.S. 2001–2010. MMWR. (19) 619–613, May 2011. 

25. Odewole O.A., Williamson R.S., Zakai N.A., et al. Near-elimination of folate-deficiency anemia by mandatory folic acid fortification in older U.S. adults: Reasons for Geographic and Racial Differences in Stroke study 2003–2007. AM. J. CLIN. NUTR. 2013; 

98:1042–1047. 

26. TeMorenga L., Mallard S., Mann J. Dietary sugars and body weight: systematic review and meta-analyses of randomised controlled trials and cohort studies. BMJ. 2012; 345;e7492. 

27. Malik V.S., Pan A., Willett W.C., Hu F.B. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. AM. J. CLIN. NUTR. 2013; 98:1084–1102. 

126 

28. O’Neil C.E., Nicklas T.A., Zanovec M., et al. Consumption of whole grains is associated with improved diet quality and nutrient intake in children and adolescents: the National Health and Nutrition Examination Survey 1999–2004. PUB. HEALTH NUTR. 

2011; 14:347–355. 

29. O’Neil C.E., Nicklas T.A., Zanovec M., Cho S. Whole-grain consumption is associated with diet quality and nutrient intake in 

adults: The National Health and Nutrition Examination Survey, 1999–2004. J. ACAD. NUTR. DIET. (Formerly J. AM. DIET. ASSOC.). 

2010; 110:1461–1468. 

30. Nicklas T.A., O’Neil C.E., Liu Y. Intake of added sugars is not associated with weight measures in children 6 to 18 years: National Health and Nutrition Examination Surveys 2003–2006. NUTR. RES. 2011; 31:338–346. 

31. Sievenpiper J.L., de Souza R.J., Mirrahimi A., et al. Effect of fructose on body weight in controlled feeding trials. A systematic 

review and meta-analysis. ANN. INT. MED. 2012; 156:291–304. 

32. Mattes R.D., Shikany J.M., Kaiser K.A., Allison D.B. Nutritively sweetened beverage consumption and body weight: a systematic review and meta-analysis of randomized experiments. OBES. REV. 2011; 12:346–365. 

33. Sun S.Z., Anderson G.H., Flickinger B.D., et al. Fructose and non-fructose sugar intakes in the U.S. population and their associations with indicators of metabolic syndrome. FOOD CHEM. TOXICOL. 2011; 49:2875–2882. 

34. Food and Nutrition Board, Institute of Medicine of the National Academies. Dietary reference intakes for energy, carbohydrate, 

fiber, fat, fatty acids, cholesterol, protein, amino acids (macronutrients). National Academies Press, 2005. 

35. Institute of medicine. Sodium Intake in Populations: Assessment of evidence. 2013. Accessed at https://www.iom.edu/Reports/2013/Sodium-Intake-in-Populations-Assessment-of-Evidence.aspx. 

36. Cohen H.W., Hailpern S.M., Fang J., Alederman M.H. Sodium intake and mortality in the NHANES II follow-up study. AM. 

J. MED. 2006; 119:275.e7–14. 

37. Stolarz-Skrzypek K., Kuznetsova T., Thijs L., et al. Fatal and nonfatal outcomes, incidence of hypertension, and blood pressure 

changes in relation to urinary sodium excretion. JAMA. 2011; 305:1777–1785. 

38. Graudal N., Jurgens G., Baslund B., Alderman M.H. Compared with usual sodium intake, low- and excessive-sodium diets are 

associated with increased mortality: a meta-analysis. AM. J. HYPERTENS. 2014 (doi:10.1093/ajh/hpu028). 

39. O’Donnell M., Mente A., Yusuf S. Sodium intake and cardiovascular health. CIRC. RES. 2015; 116:1046–1057. 

40. O’Donnell M., Mente A., Rangarajan S., et al. Urinary sodium and potassium excretion, mortality, and cardiovascular events. 

NEW ENGL. J. MED. 2014; 371:612–623. 

41. Pfister R., Michels G., Sharp S.J., et al. Estimated urinary sodium excretion and risk of heart failure in men and women in the 

EPIC-Norfolk study. EUR. J. HEART. FAILURE. 2014; 16:394–402. 

42. Tuohy K.M., Conterno L., Gasperotti M., Viola R. Up-regulating the human intestinal microbiome using whole plant foods, 

polyphenols, and/or fiber. J. AGRIC. FOOD CHEM. 2012; 60:8776–8782. 

43. Neyrinck A.M., Delzene N.M. Potential interest of gut microbial changes induced by nondigestible carbohydrates of wheat in 

the management of obesity and related disorders. CURR. OPIN. CLIN. NUTR. METAB. CARE. 2010; 13:722–728. 

44. Gibson G.R. Prebiotics as gut microflora management tools. J. CLIN. GASTROENTEROL. 2008; 42 (suppl. 2):S75–S79. 

45. Delzenne N.M., Cani P.D. Gut microbiota and the pathogenesis of insulin resistance. CURR. DIAB. REP. 2011; 11:154–159. 

46. Jonnalagadda S.S., Harnack L., Liu R.H., McKeown N., Seal C., Liu S., Fahey G.C. Putting the whole grain puzzle together: 

health benefits associated with whole grains—summary of American Society for Nutrition 2010 Satellite Symposium. J. NUTR. 2011; 

141:1011S–1022S. 

47. Harris K.A., Kris-Etherton P.M. Effects of whole grains on coronary heart disease risk. CURR. ATHEROSCLER. REP. 2010; 

12:368–376. 

48. Slavin J. Why whole grains are protective: biological mechanisms. PROC. NUTR. SOC. 2003; 62:129–134. 

49. Fava F., Gitau R., Lovegrove J., Tuohy K.M. The gut microflora and lipid metabolism: implications for human health. CURR. 

MED. CHEM. 2006; 13:3005–3021. 

50. Rastall R.A., Gibson G.R., Gill H.S., Guarner F., Klaenhammer T.R., Pot B., Reid G., Rowland I.R., Sanders M.E. Modulation 

of the microbial ecology of the human colon by probiotics, prebiotics and synbiotics to enhance human health: an overview of enabling science and potential applications. FEMS. 2005; 52:145–152. 

51. Naude C.E., Schoonees A., Senekal M., Young T., Garner P. and Volmink J. Low Carbohydrate versus Isoenergetic Balanced 

Diets for Reducing Weight and Cardiovascular Risk: A Systematic Review and Meta-Analysis. PLOS ONE 9(7) July 2014. 

52. Johnston B.C., Kanters S., Bandayrel K., Wu P., Naji F., Siemieniuk R.A., Ball G.D.C., Busse J.W., Thorlund K., Guyatt G., 

Jansen J.P., and Mills E.J. Comparison of Weight Loss Among Named Diet Programs in Overweight and Obese Adults. A Meta-analysis. JAMA. 312(9) 2014. 

53. Lagiou P., Sandin S., Lof M., Trichopoulos D., Adami H.O., Weiderpass E. Low carbohydrate-high protein diet and incidence 

of cardiovascular diseases in Swedish women: prospective cohort study. BMJ. 2012 Jun 26; 344: e4026. 

54. Merchant A., et al. Carbohydrate intake and overweight and obesity among healthy adults. J. AMER. DIET. ASSOC. 2009; 109: 

1165–1172. 

55. Xingwang, et al., J. ACAD. NUTR. DIETETICS, 2013. Mediterranean Diet, Healthy Eating Index 2005, and Cognitive Function in 

middle-aged and older Puerto Rican adults. 

56. Samieri, et al., J. NUTR., 2013. Long-Term Adherence to the Mediterranean Diet Is Associated with Overall Cognitive Status, 

but not Cognitive Decline, in Women. 

57. Fe ́art, et al., CURR. OPIN. CLIN. NUTR. METAB. CARE, 2010. Mediterranean Diet and Cognitive Function in Older Adults. 

58. Gardener, et al., ARCH. NEUROL., 2012. Mediterranean Diet and White Matter Hyperintensity Volume in the Northern Manhattan Study. 

59. Gardener, et al., TRANSL. PSYCH., 2012. Adherence to a Mediterranean Diet and Alzheimer’s Disease Risk in an Australian 

Population. 

60. Cholerton, et al., DIABETIC. MED., 2011. Insulin Resistance and Pathological Brain Ageing. 

61. Nurk, et al., BRITISH J. NUTR., 2010. Cognitive Performance among the Elderly in Relation to the Intake of Plant Foods. The 

Hordaland Health Study. 

62. Parletta, et al., J. NUTR. BIOCHEM., 2013. Nutritional Modulation of Cognitive Function and Mental Health. 

63. Kim, et al., J. ALZHEIMER’S DIS., 2012. Relationship of Cognitive Function with B Vitamin Status, Homocysteine, and Tissue 

Factor Pathway Inhibitor in Cognitively Impaired Elderly: A Cross-Sectional Survey. 

64. Fajardo and Varela-Moreiras, INT. J. VITAM. NUTR. RES., 2012. Efficacy of Adding Folic Acid to Foods. 

65. Bhate, et al., J. DEV. ORIGINS HEALTH DIS., 2012. Vitamin B12 and Folate during Pregnancy and Offspring Motor, Mental 

and Social Development at 2 Years of Age. 

66. Veena, et al., J. NUTR., 2013. Higher Maternal Plasma Folate but not Vitamin B–12 Concentrations during Pregnancy Are Associated with Better Cognitive Function Scores in 9- to 10-Year-Old Children in South India. 

67. Rajasekaran and Kalaivani, J. FOOD SCI. TECHNOL., 2013. Designer Foods and Their Benefits: A Review. 

68. Ramakrishnan, et al., PEDIATRIC PERINATAL EPIDEMIOL., 2012. Effect of Women’s Nutrition before and during Early Pregnancy 

on Maternal and Infant Outcomes: A Systematic Review. 

69. Gaesser G, Angadi S. JOURNAL OF THE AMERICAN ACADEMY OF PHYSICIAN ASSISTANTS, 2015. Navigating the gluten-free boom. 

Descriptions of Grain Industry Organizations 

American Bakers Association (ABA) is the Washington, D.C.-based voice of the wholesale baking industry. Since 1897, ABA 

has represented the interests of bakers before the U.S. Congress, Federal agencies, and international regulatory authorities. ABA 

advocates on behalf of more than 700 baking facilities and baking company suppliers. ABA members produce bread, rolls, crackers, 

bagels, sweet goods, tortillas and many other wholesome, nutritious baked products for America’s families. The baking industry 

generates more than $103 billion in economic activity annually and employs 633,000 highly skilled people. [Redacted] 

American Institute of Baking International (AIB) is a corporation founded by the North American wholesale and retail baking industries in 1919 as a technology transfer center for bakers and food processors. The original mission of the organization was 

to ‘‘put science to work for the baker,’’ which is still central to all of the programs, products, and services provided by AIB to baking 

and general food production industries worldwide. [Redacted] 

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Grain Foods Foundation (GFF), a joint venture of members of the milling, baking and allied industries formed in 2004, is 

dedicated to advancing the public’s understanding of the beneficial role grain-based foods play in the human diet. Directed by a 

board of trustees, funding for the Foundation is provided through voluntary donations from private grain-based food companies and 

is supplemented by industry associations. [Redacted] 

Independent Bakers Association (IBA) The Independent Bakers Association is a Washington, D.C. based national trade association of over 400 mostly family owned wholesale bakeries and allied industry trades. The Association was founded in 1968 to protect the interests of independent wholesale bakers. [Redacted] 

National Association of Wheat Growers (NAWG) is a federation of 21 state wheat grower associations that works to represent the needs and interests of wheat producers before Congress and Federal agencies. Based in Washington, D.C., NAWG is 

grower-governed and grower-funded, and works in areas as diverse as Federal farm policy, trade, environmental regulation, research and climate change. [Redacted] 

National Pasta Association (NPA) Founded in 1904, NPA is an organization of pasta and pasta-related product manufacturers, millers and suppliers to the U.S. pasta industry serving as a cohesive industry advocate, a promoter of pasta and a center of 

knowledge for its members, the government and the public. [Redacted] and [Redacted] 

North American Millers’ Association (NAMA) is the trade association of the wheat, corn, oat, and rye milling industries. 

Member companies operate mills in 38 states and Canada, representing more than 90 percent of total industry production capacity. 

[Redacted] 

Retail Bakers of America (RBA) was founded in 1918. Its purpose is to assist retail bakers in furthering the health of the nation by making available delicious bakery foods; to foster a better relationship between the public and the baking industry; to promote and encourage the production of high quality, wholesome, healthful bakery foods; and to represent the baking industry, especially its retail branch, to the government. [Redacted] 

USA Rice Federation is the global advocate for all segments of the U.S. rice industry with a mission to promote and protect the 

interests of producers, millers, merchants and allied businesses. Over 20 billion pounds of long, medium, and short grain, and organic and specialty rice is grown and harvested each year by farmers in Arkansas, California, Louisiana, Texas, Mississippi and

Missouri. [Redacted] 

Wheat Foods Council (WFC) is a nonprofit organization formed in 1972 to help increase public awareness of grains, complex 

carbohydrates, and fiber as essential components of a healthful diet. The Council is supported voluntarily by wheat producers, millers, bakers and related industries. [Redacted] 

SUBMITTED QUESTIONS

Joint Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department of 

Health and Human Services; Hon. Thomas ‘‘Tom’’ J. Vilsack, Secretary, 

U.S. Department of Agriculture 

Question Submitted by Hon. Randy Neugebauer, a Representative in Congress from 

Texas 

Question. Secretary Burwell, what instructions were given to the Advisory Committee members regarding the FACA and the Advisory Committee’s disbandment? 

Answer. HHS and USDA are strongly committed to an open and transparent process around their Federal Advisory Committees. The two Departments conducted an 

administrative webinar with the 2015 Dietary Guidelines Advisory Committee 

(DGAC) in January 2015 a few weeks before its Advisory Report was submitted to 

HHS and USDA. At this webinar, the Committee was reminded that it would formally disband upon submittal of its Advisory Report to the Secretaries as specified 

in its charter; the transition from being a Special Government Employee (SGE) as 

a Federal advisory committee member to being a former SGE/member after disbandment was described. Included in this discussion was a specific instruction that after 

disbandment each former member cannot speak on behalf of the U.S. Government 

or the DGAC (while in no way limiting their ability to speak as individual citizens 

on their own behalf). This instruction is an important point that each individual 

should convey in any situation that he/she chooses to engage in regarding the Committee’s works, such as media interviews or professional presentations. After disbandment, each former DGAC member only represents themselves. When former 

Committee members held a public event regarding the Advisory Report, they were 

no longer SGEs and were not speaking on behalf of the Committee or the Federal 

government. They were private citizens voicing their opinions. As such, the Federal 

government has not assisted or provided support for former members for public 

speaking events. 

Questions Submitted by Hon. Eric A. ‘‘Rick’’ Crawford, a Representative in Congress 

from Arkansas 

Question 1. In light of the controversial nature of many of the comments and recommendations of the 2015 Dietary Guidelines Advisory Committee (DGAC), and in 

light of the fact that the final Guidelines are prepared with very limited transparency, will the Departments of Health and Human Services, and Agriculture consider publishing the draft Guidelines in the Federal Register, and allowing for a 60– 

90 day public comment period before producing your final Guidelines? 

Answer. We understand that an open and transparent Dietary Guidelines process 

is a priority and share your interest. We place a high value upon public input and 

have prioritized it throughout the development of the Dietary Guidelines. The Dietary Guidelines Advisory Committee (DGAC) deliberated on the scientific evidence 

through seven public meetings, spanning June 2013 to December 2014. The public 

attended the meetings, provided oral comments during one of the meetings, and was 

invited to submit written comments to the DGAC throughout the 19 months of its 

128 

deliberations. All of the scientific studies they reviewed were posted on 

DietaryGuidelines.gov after each public meeting, during which the studies’ topics 

were discussed and deliberated, providing transparency of the evidence being examined and allowing the public to provide sufficient comment on that and anything 

else the DGAC covered. A new public comment period opened when the 2015 Advisory Report was published in February 2015. During this period, HHS and USDA 

also held a public meeting for oral testimony from the public. The public comment 

period also was extended from the scheduled 45 days to 75 days. For context, the 

public comment period for the 2010 Advisory Report was 30 days. In addition, HHS 

and USDA provided several briefings on the Dietary Guidelines to House Agriculture Committee and Appropriations Subcommittee staff in 2015. We have and 

will continue to conduct our business with the utmost integrity and transparency, 

in accordance with all legal requirements. 

Question 2. I recognize this would be a slightly extraordinary step in the process, 

but don’t you agree that the American public’s acceptance of the scientific validity 

of the data supporting the final Guidelines outweighs an arbitrary deadline for their 

publication? 

Answer. The National Nutrition Monitoring and Related Research Act of 1990 

(NNMRRA) requires HHS and USDA to publish the Dietary Guidelines for Americans at least every 5 years. The public was invited to participate in the process 

through meeting participation and public comment throughout the 19 months of the 

DGAC’s scientific review, and during the 75 day period for public comment on the 

published Advisory Report. Throughout this time and up to the present, all science 

informing the Advisory Report has been listed for the public on 

DietaryGuidelines.gov. Every comment received from Federal agencies and the public is reviewed by HHS and USDA. Although all public comments are valued, to ensure the scientific foundation of the 2015 Dietary Guidelines for Americans, emphasis is placed on those comments with scientific justification. As required by the 

NNMRRA, the 2015 Dietary Guidelines will be based on the preponderance of the 

scientific and medical knowledge which is current at the time the report is prepared. 

Question 3. On several occasions during the House Agriculture Committee hearing 

you noted that the final Dietary Guidelines will be based on ‘the preponderance of 

scientific evidence’. In light of the fact that the Dietary Guidelines Advisory Committee acknowledged it employed the USDA’s Nutrition Evidence Library (NEL) for 

less than 25% of its final recommendations—and based many of its findings on limited-grade evidence (nearly the lowest of the NEL’s grading scale)—how are the 

Agencies interpreting the term ‘‘preponderance’’? 

Answer. The 2010 and 2015 Dietary Guidelines Advisory Committees (DGAC) 

both utilized four science-based sources of evidence to answer their research questions: (1) Original systematic reviews conducted by USDA’s Nutrition Evidence Library (NEL); (2) High-quality existing reports, comprised primarily of systematic reviews; (3) Data analyses of the typical American diet; and (4) Food pattern modeling 

to ensure Americans meet their food and nutrient needs. For each research question, the DGAC determined which method was appropriate, given the nature of the 

question. For example, questions regarding current intakes of different foods and 

nutrients in the United States were answered using data analyses, as this information is not available through a systematic review of scientific studies. Food pattern 

modeling was used to answer questions about how Americans can meet the Daily 

Reference Intakes (DRIs). 

The NEL is a systematic review methodology designed specifically to analyze food, 

nutrition and public health science. For context, the medical field has used systematic reviews as the gold standard and standard practice for more than 25 years to 

inform the development of national guidelines for health professionals. Use of systematic reviews in nutrition, became common practice more recently. At the time 

that the NEL was created by USDA for use in informing the 2010 Dietary Guidelines for Americans, it was among the first to apply the systematic review methodology in the field of nutrition—thus, there were very few existing nutrition-focused 

systematic reviews that the 2010 DGAC could draw from. Since that time, systematic reviews in the nutrition field have become common practice. Therefore, as stated in their Advisory Report on DietaryGuidelines.gov, ‘‘unlike the 2010 DGAC, the 

2015 Committee was able to use existing sources of evidence to answer an additional 45 percent of the questions . . .’’ and that ‘‘[t]his was done to prevent duplication of effort and promote time and resource management.’’ The 2015 DGAC answered 70 percent of its research questions using NEL systematic reviews or existing reviews and reports. The Committee used existing systematic reviews when 

available and complemented them with original reviews of evidence newly published 

since the existing review was conducted. Existing systematic reviews underwent 

129 

quality assessment to ensure they were just as rigorous and were held to the same 

high standards as the NEL systematic reviews. The remaining questions were answered using data analyses and food pattern modeling, consistent with the 2010 

DGAC’s scientific review. 

The Committee considers all evidence at the time of the systematic review that 

(1) addresses the question they seek to answer and (2) meets the pre-determined 

inclusion criteria. The quality of each included study is evaluated using the NEL 

Bias Assessment Tool. The DGAC then looks at the entire body of evidence as a 

whole to draw a conclusion statement and uses predefined criteria to evaluate and 

grade the strength of the evidence. The grade communicates to decision makers and 

stakeholders the strength of the evidence supporting a specific conclusion statement. 

The grade for the body of evidence and conclusion statement is based on five elements outlined in the NEL grading rubric: quality, quantity, consistency, impact 

and generalizability. 

Questions Submitted by Hon. Jackie Walorski, a Representative in Congress from Indiana 

Question 1. In testimony before the House Agriculture Appropriations Subcommittee last month, Angie Tagtow of USDA’s Center for Nutrition Policy and Promotion described the Nutrition Evidence Library as ‘‘the gold standard for informing 

recommendations’’ and stated in her written testimony: 

The NEL provides a rigorous and transparent system to review the scientific 

literature and uses the preponderance of science to inform nutrition policy and 

programs. The NEL also ensures compliance with the Consolidated Appropriations Act of 2001, or Data Quality Act, which mandates that Federal agencies 

ensure the quality, objectivity, utility, and integrity of the information used to 

form Federal guidance. 

I applaud the NEL’s development, which was first developed by 2005 Advisory 

Committee out of need to ensure a transparent process for reviewing and ranking 

the overwhelming amount of science that needs to be considered. Then the 2010 Advisory Committee was able to use it and relied heavily on it for the majority of their 

recommendations. 

Now the 2015 Dietary Guidelines Advisory Committee’s report states that it did 

not use the Nutrition Evidence Library for more than 70 percent of its analyses. Instead, the report states that it used the following approaches: 

• Outside systematic reviews used for 45 percent of research questions; and 

• Original data analyses and food pattern modeling analyses used for 30 percent 

of research questions. 

One example of the concern with systemic reviews is caffeine. Secretary Vilsack, 

you mentioned in your written testimony the ‘‘Cochrane Collaboration’’ approach as 

being a well-respected and it is. But in the example of caffeine, as stated on page 

381 of the report, it was a ‘‘modification’’ of that method that was used. So while 

DGAC correctly acknowledge that new scientific evidence existed since the last report, making it the first Advisory Committee on caffeine’s positive health benefits, 

it did not use the gold-standard NEL. Instead they used a systematic review of the 

data that allowed them to make claims that straight black coffee was the only acceptable approach to consuming caffeine, as opposed to energy drinks or other alternatives. 

For comparison, the 2010 Advisory Committee used the NEL for nearly three out 

of every four of their recommendations. Why did the 2015 DGAC circumvent the 

NEL process for more than 70% of their recommendations? Do the existing reports 

that were used follow the same scientific rigor and approach as the NEL? 

Under FACA, this is your Advisory Committee so I ask, how was the decision 

made that the NEL should not be used for a particular research question? Was it 

ad hoc, or were there established criteria? 

Answer. Thank you for raising this issue. The 2010 and 2015 Dietary Guidelines 

Advisory Committees (DGAC) both utilized four science-based sources of evidence to 

answer their research questions: (1) Original systematic reviews conducted by 

USDA’s Nutrition Evidence Library (NEL); (2) High-quality existing reports, comprised primarily of systematic reviews; (3) Data analyses of the typical American 

diet; and (4) Food pattern modeling to ensure Americans meet their food and nutrient needs. For each research question, the DGAC determined which method was appropriate, given the nature of the question. For example, questions regarding current intakes of different foods and nutrients in the United States were answered 

using data analyses, as this information is not available through a systematic reVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00133 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
130 

view of scientific studies. Food pattern modeling was used to answer questions 

about how Americans can meet the Dietary Reference Intakes (DRIs). 

The NEL is a systematic review methodology designed specifically to analyze food, 

nutrition and public health science. For context, the medical field has used systematic reviews as the gold standard and standard practice for more than 25 years to 

inform the development of national guidelines for health professionals. Use of systematic reviews in nutrition became common practice more recently. At the time 

that the NEL was created by USDA for use in informing the 2010 Dietary Guidelines for Americans, it was among the first to apply the systematic review methodology in the field of nutrition—thus, there were very few existing nutrition-focused 

systematic reviews that the 2010 DGAC could draw from. Since that time, systematic reviews in the nutrition field have become common practice. Therefore, as stated in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report) on DietaryGuidelines.gov, ‘‘unlike the 2010 DGAC, the 2015 Committee 

was able to use existing sources of evidence to answer an additional 45 percent of 

the questions . . .’’ and that ‘‘[t]his was done to prevent duplication of effort and 

promote time and resource management.’’ The 2015 DGAC answered 70 percent of 

its research questions using NEL systematic reviews or existing reviews and reports. The Committee used existing systematic reviews when available and complemented them with original reviews of evidence newly published since the existing 

review was conducted. Existing systematic reviews underwent quality assessment to 

ensure they were just as rigorous and were held to the same high standards as the 

NEL systematic reviews. The remaining 30 percent of the questions that could not 

be answered using the systematic review methodology were answered using data 

analyses and food pattern modeling, consistent with the 2010 Advisory Committee’s 

scientific review. 

Question 2. In a letter dated October 2, 2015 from Secretaries Vilsack and Burwell 

to U.S. Senator Johnny Isakson you stated that ‘‘in regard to caffeine and energy 

drinks, the (Advisory) Committee noted that these drinks are highly variable in caffeine content’’ and that ‘‘until safety has been demonstrated, limited or no consumption of high-caffeine drinks or other caffeine-containing products is advised for children and adolescents.’’ This statement also holds true for coffee (i.e., home brewed 

vs. coffee house, where the range could be 50–400mg of caffeine). 

According to the American Beverage Association, mainstream energy drinks— 

which represent more than 95% of the entire American energy drink market—contain the same, or less, caffeine than coffee. Further, there is no chemical difference 

between the caffeine in coffee and the caffeine in energy drinks, tea, or soda and 

all leading and credible health authorities from around the world have acknowledged that caffeine metabolism is a function of body weight and composition (body 

fat, etc.) rather than age. 

Last, it is worth noting the conclusion reached by the European Food Safety Authority, which was published in its extensive report, Scientific Opinion on the Safety 

of Caffeine: ‘‘The single doses of caffeine considered to be of no concern for adults 

(3mg/kg bw per day) may also be applied to children, because the rate at which children and adolescents process caffeine is at least that of adults, and the studies 

available on the acute effects of caffeine on anxiety and behavior in children and 

adolescents support this level.’’ 

Given this body of evidence, how do you rationalize the recommendations made 

by the Advisory Committee to focus on only one class of products when it comes to 

limiting caffeine intake? If there is to be any recommendations consistent with the 

evidence, shouldn’t it be about caffeine intake generally, regardless of the class of 

products? 

Answer. The 2015 Dietary Guidelines Advisory Committee (DGAC) developed its 

report to provide advice and recommendations to the government on the current 

state of scientific evidence on nutrition and health for the general public. The DGAC 

identified the area of caffeine consumption as a public health concern. It included 

the safety of caffeinated drinks for children and adolescents in its review of the evidence because of case reports of adverse events associated with consumption of highcaffeine drinks and in light of recommendations of caution from the American Academy of Pediatrics and the American Medical Association. The Committee also noted 

that the limited evidence in regard to high-caffeine energy drinks and health outcomes shows mixed results. Much of the available evidence on caffeine focuses on 

coffee intake. The Committee stated that moderate coffee consumption (three to five 

8 oz. cups/day, or providing up to 400 mg/day of caffeine) can be incorporated into 

healthy eating patterns. 

HHS and USDA are considering the information in the Committee’s report as well 

as public and Federal agency comments in the development of the 2015 Dietary 

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Guidelines for Americans. We look forward to working on this issue with you moving 

forward. 

Question Submitted by Hon. David Rouzer, a Representative in Congress from North 

Carolina 

Question. Can the House Committee on Agriculture be assured that you will both 

work to ensure that the final Dietary Guidelines state that protein is critical to a 

balanced diet and that the inclusion of lean meats are essential to a ‘‘balanced diet?’’ 

Answer. We understand this is a priority for you and share your interest. The Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report) 

states that ‘‘lean meats can be a part of a healthy dietary pattern.’’ While we cannot 

comment on the content of the 2015 Dietary Guidelines for Americans, which is still 

under development, we can highlight that the amount of ‘‘meat, poultry, and eggs’’ 

recommended in the Advisory Report is the same as the amount recommended in 

the 2010 Dietary Guidelines for Americans—26 oz. per week for a 2,000 calorie diet. 

The Advisory Report recommends reducing the amount of red and processed meat 

consumed compared to current consumption, not compared to the 2010 Guidelines. 

Questions Submitted by Hon. John R. Moolenaar, a Representative in Congress from 

Michigan 

Question 1. I have personally met with a wide variety of constituents on the topic 

of school nutrition in my District in Michigan, including a local school food service 

director. On multiple occasions, my constituents expressed concerns regarding sodium limits in the National School Lunch and School Breakfast Programs, and the 

dramatic effect the implementation of the target levels has had on consumption and 

food waste. 

As you are aware, the sodium limits were placed on a time line, with key targets 

to reach by designated years. A primary concern I have is the implementation of 

any further reductions to sodium to reach the target two and final target levels. In 

your findings, is there sound scientific evidence that the target two levels of sodium 

limits were necessary? 

If target two levels are implemented, what effect do you believe this will have on 

other foods, such as cheeses and others that are served in school meal programs? 

Answer. USDA remains committed to applying the most up-to-date, evidencebased guidelines to all nutritional parameters set forth in Child Nutrition Programs 

regulations. As required by both the FY 2012 Agriculture Appropriations Act and 

the Consolidated and Further Continuing Appropriations Act, 2015, USDA continues 

to evaluate the science as it relates to sodium intake and human health. The 2015 

Dietary Guidelines Advisory Committee (DGAC) reviewed and analyzed the most recent scientific literature evaluating the relationship between sodium intake and 

blood pressure among children and their findings can be found in their Advisory Report, which was submitted to HHS and USDA in February 2015. The DGAC used 

an extensive systematic review process to critique relevant literature on this topic, 

and the Advisory Report affirmed that sodium reduction to the levels reflected in 

the targets is beneficial to children. 

USDA is providing significant technical assistance to help school food operators 

lower the sodium content of school meals. Consistent with the Congressional directive, prior to requiring school compliance with the second (school year 2017–18) and 

final (school year 2022–23) sodium targets, USDA’s Food and Nutrition Service 

(FNS) will review the 2015 Dietary Guidelines for Americans, once released. Because 

the sodium goals apply to the average meal offered over the course of the school 

week, menu planners have and will retain under target 2 the flexibility to incorporate some higher sodium items, such as cheese, into some of the meals. To help 

menu planners offer a variety of nutritious and flavorful foods, while lowering the 

sodium content of meals, USDA recently unveiled What’s Shaking? Creative Ways 

to Boost Flavor with Less Sodium. This is a national collaborative sodium reduction 

initiative to foster creative ways to boost flavor and maximize taste in an effort to 

lower the sodium content of school meals. The website, http:// 

healthymeals.nal.usda.gov/menu-planning/sodium-reduction is dedicated to helping 

schools find the resources they need to increase awareness of the need for dietary 

sodium reduction, and move in the right direction. 

Question 2. I am concerned about the selective nature taken by the Dietary Guidelines Advisory Committee (DGAC) with respect to existing data. For example, when 

it comes to energy drinks, the Committee noted that the evidence was of a limited 

grade. At the same time, the DGAC chose to completely disregard an extensive and 

authoritative body of evidence developed by the European Food Safety Authority 

(EFSA), and in particular its most recent Scientific Opinion on the Safety of Caffeine. Is there any reason why the DGAC appeared to disregard the EFSA’s work? 

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What are your thoughts on the information from EFSA that was disregarded by the 

DGAC? 

Also, as you develop the final guidelines, what threshold of evidence will be used 

to determine whether to issue a recommendation, and will limited grade evidence 

be permitted in the classification of preponderance of scientific evidence‘? 

Answer. The European Food Safety Authority (EFSA) published its Scientific 

Opinion on the Safety of Caffeine in May of 2015. The 2015 Dietary Guidelines Advisory Committee (DGAC) released its Scientific Report in February of 2015. As such, 

the DGAC had disbanded prior to the release of the EFSA report. It should be noted 

that the 2015 DGAC did use the EFSA Scientific Opinion on the Re-evaluation of 

Aspartame as a Food Additive for their question on aspartame and health. This report was published within the timeframe of the DGAC’s work. As mandated in the 

National Nutrition Monitoring and Related Research Act of 1990, the 2015 Dietary 

Guidelines for Americans will be based on the preponderance of the scientific and 

medical knowledge which is current at the time it is prepared. While we cannot 

comment on the content of the 2015 Dietary Guidelines for Americans, which are 

still under development, the recommendations will be made based on the strongest 

available evidence. The 2010 Dietary Guidelines included statements supported by 

different grades of evidence. As described in the 2010 Dietary Guidelines, ‘‘[w]hen 

appropriate, specific statements in Dietary Guidelines for Americans, 2010 indicate 

the strength of the evidence (e.g., strong, moderate, or limited) related to the topic 

as summarized by the 2010 DGAC. The strength of evidence is provided so that 

users are informed about how much evidence is available and how consistent the 

evidence is for a particular statement or recommendation. This information is useful 

for educators when developing programs and tools. Statements supported by strong 

or moderate evidence can and should be emphasized in educational materials over 

those with limited evidence.’’ When only limited evidence is available on a topic, it 

may still be appropriate for discussion in the Dietary Guidelines, such as when the 

evidence for that topic reinforces recommendations on related topics that have a 

stronger evidence base, to clarify that it is not possible to make a recommendation, 

or to identify an area of emerging research. 

Question 3. According to the Charter for the 2015 Dietary Guidelines Advisory 

Committee (DGAC), Committee members were selected based upon their knowledge 

in the fields of human nutrition and chronic disease. However, it appears the DGAC 

made many recommendations far outside of the scope of its Charter and far beyond 

issues of human nutrition and chronic disease. 

For example, matters involving ingredient safety (i.e., caffeine and aspartame) 

and risk assessment rest squarely within the scope of the Food and Drug Administration (FDA), not the Dietary Guidelines. Despite this, the DGAC chose to offer recommendations on what is and is not safe. 

During your testimony you noted that the FDA, along with the National Institutes 

of Health and the Centers for Disease Control and Prevention, are providing technical expertise as you finalize the Guidelines. 

Is it the intention of both Departments to make new assertions about ingredient 

safety in the Dietary Guidelines that have not been previously made by the FDA? 

If yes, will matters of such importance be subject to the appropriate rulemaking by 

the relevant agency in charge? 

Answer. No, the Departments will not make new assertions about ingredient safety in the Dietary Guidelines. The purpose of the Dietary Guidelines does not include 

rulemaking. The charge of the 2015 DGAC included identifying areas it felt were 

of public health concern. The DGAC chose to address the relationship of caffeine 

consumption and of aspartame consumption to health because they are of high public health concern, are commonly consumed in food and beverages, and evidence had 

been recently updated in the scientific literature. Dealing with these issues was 

within the scope of the DGAC’s charge to provide the Government with advice and 

recommendations on the current state of scientific evidence on nutrition and health. 

We appreciate your feedback on this topic. 

Questions Submitted by Hon. Dan Newhouse, a Representative in Congress from 

Washington 

Question 1. I understand the HHS and USDA are planning to note that moderate 

alcohol consumption is an important part in a healthy diet pattern, which I appreciate. What are your Departments doing to provide recommendations on how best to 

inform consumers about what that looks like? 

Answer. Thank you for raising this important issue. HHS and USDA are working 

together to finalize the 2015 Dietary Guidelines, which are expected to be completed 

in December of this year. We are unable to comment on the final content of the 

forthcoming edition of the Dietary Guidelines at this time, as they are still under 

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development. However, to clarify, the Dietary Guidelines Advisory Committee 

(DGAC) found that moderate alcohol consumption can be a component of a healthy 

eating pattern but did not include alcohol in its three examples of healthy, nutrient 

dense food patterns (Healthy U.S.-style, Healthy Vegetarian, and Healthy Mediterranean-style). The DGAC stated, ‘‘it is not recommended that anyone begin 

drinking or drink more frequently on the basis of potential health benefits.’’ 

Question 2. The 2010 Dietary Guideline’s section on sodium seems to suggest that 

all alcoholic beverages are the same, and there is such a thing as a standard drink. 

It does nothing to differentiate different benefits or risks derived from wine, beer, 

distilled spirits, hard ciders, and so on, or that alcohol levels can vary significantly 

even internally in each of these categories. Many scientific studies claim different 

health effects depending on the type of alcohol consumed, and the Tax and Trade 

Bureau guidance from May 2013 refutes the idea of a ‘‘standard drink’’ as a tool 

to inform consumers. Can you tell me if there are any plans in the 2015 Dietary 

Guidelines to clarify or establish different nutritional benefits or drawbacks related 

to different alcohol types? 

Answer. As noted above, HHS and USDA are working together to finalize the 

2015 Dietary Guidelines for Americans, which is expected to be completed in December of this year. We are unable to comment on the final content of the forthcoming 

edition of the Dietary Guidelines at this time, as they are still under development. 

HHS and USDA are cognizant of the variability of alcohol content in different alcoholic beverages and the value in better articulating this variability in dietary guidance. Several industry associations and individuals have provided both oral and 

written comments on this issue, which we will take into consideration as we develop 

the Dietary Guidelines. 

Question 3. The Dietary Guidelines Advisory Committee claimed that Americans 

are eating more meat than recommended; however, the DGAC also holds up the socalled Mediterranean Diet as a healthy dietary pattern. When compared to the Mediterranean Diet, Americans are consuming less than recommended. How do you account for this discrepancy? 

Answer. There are numerous studies based on different variations of a Mediterranean Diet, and, as such, there is not ‘‘one’’ Mediterranean Diet. Therefore, there is 

not a single, consistent recommendation on meat for comparison. The DGAC used 

current research to inform the development of its Healthy Mediterranean-Style Eating Pattern. As shown in the Advisory Report, the quantitative amount of meat, 

poultry, and eggs the DGAC recommended in the Healthy U.S.-Style Eating Pattern 

and the Healthy Mediterranean-Style Eating Pattern are identical—26 oz. per week 

for a 2,000 calorie diet. 

Question 4. The Dietary Guidelines Advisory Committee recommends that Americans continue to eat the same quantity of lean meat as the 2010 Dietary Guidelines 

recommend, but the current DGAC report also recommends that Americans consume less processed meat. What is the recommendation for lean, processed meat? 

Answer. The Scientific Report of the 2015 Dietary Guidelines Advisory Committee 

(Advisory Report) states that ‘‘lean meats can be a part of a healthy dietary pattern.’’ While we cannot comment on the content of the 2015 Dietary Guidelines for 

Americans, which are still under development, we can highlight that the amount of 

‘‘meat, poultry, and eggs’’ recommended in the Advisory Report is the same as the 

amount recommended in the 2010 Dietary Guidelines—26 oz. per week for a 2,000 

calorie diet. The 2010 Dietary Guidelines for Americans and the 2015 Advisory Report do not make a quantitative recommendation specifically for lean processed 

meat. 

Question 5. In testimony before the House Appropriations Agriculture Subcommittee, Angie Tagtow of USDA’s Center for Nutrition Policy and Promotion stated, ‘‘the Nutrition Evidence Library (NEL) provides a rigorous and transparent system to review the scientific literature and uses the preponderance of science to inform nutrition policy and programs.’’ That being said, the 2015 Dietary Guidelines 

Advisory Committee only used the NEL in 27 percent of their nutritional recommendations, while the 2010 one used NEL for more than 70 percent. What justification can you provide for the departure from such an important resource? Did 

USDA or HHS provide any guidance to the Dietary Guidelines Advisory Committee 

on what resources were available or which should be used? 

Answer. The 2010 and 2015 DGACs both utilized four science-based sources of evidence to answer their research questions: (1) Original systematic reviews conducted 

by USDA’s Nutrition Evidence Library (NEL); (2) High-quality existing reports, 

comprised primarily of systematic reviews; (3) Data analyses of the typical American diet; and (4) Food pattern modeling to ensure Americans meet their food and 

nutrient needs. For each research question, the DGAC determined which method 

134 

was appropriate, given the nature of the question. For example, questions regarding 

current intakes of different foods and nutrients in the United States were answered 

using data analyses, as this information is not available through a systematic review of scientific studies. Food pattern modeling was used to answer questions 

about how Americans can meet the Dietary Reference Intakes (DRIs). 

The NEL is a systematic review methodology designed specifically to analyze food, 

nutrition and public health science. For context, the medical field has used systematic reviews as the gold standard and standard practice for more than 25 years to 

inform the development of national guidelines for health professionals. Use of systematic reviews in nutrition became common practice more recently. At the time 

that the NEL was created by USDA for use in informing the 2010 Dietary Guidelines for Americans, it was among the first to apply the systematic review methodology in the field of nutrition—thus, there were very few existing nutrition-focused 

systematic reviews that the 2010 DGAC could draw from. Since that time, systematic reviews in the nutrition field have become common practice. Therefore, as stated in their Advisory Report on DietaryGuidelines.gov, ‘‘unlike the 2010 DGAC, the 

2015 Committee was able to use existing sources of evidence to answer an additional 45 percent of the questions . . .’’ and that ‘‘[t]his was done to prevent duplication of effort and promote time and resource management.’’ The 2015 DGAC answered 70 percent of its research questions using NEL systematic reviews or existing reviews and reports. The Committee used existing systematic reviews when 

available and complemented them with original reviews of evidence newly published 

since the existing review was conducted. Existing systematic reviews underwent 

quality assessment to ensure they were just as rigorous and were held to the same 

high standards as the NEL systematic reviews. The remaining 30 percent of the 

questions that could not be answered using the systematic review methodology were 

answered using data analyses and food pattern modeling, consistent with the 2010 

DGAC’s scientific review. 

Question 6. FDA recently announced that it is proposing additional revisions to 

the Nutrition Facts Panel. The supplemental proposal would require the declaration 

of daily reference value and percent daily value for added sugars. The additional 

declarations for added sugars are based on new information and findings from the 

2015 Dietary Guidelines Advisory Committee’s (DGAC) technical report. This is a 

great departure from the past because FDA has a long history of relying on the Institute of Medicine (IOM) to develop Dietary Reference Intakes. The 2015 DGAC 

recommendation of less than 10% of total calories from added sugar as noted in the 

supplemental proposal is based on, ‘‘modeling of dietary patterns, current added 

sugars consumption data, and a published meta-analysis on sugars intake and body 

weight.’’ I am concerned that a balanced, scientifically rigorous process such as that 

used by the IOM was not used to develop the recommendation. Why is FDA applying the DGAC recommendations to develop nutrition labeling regulations instead of 

the most recent IOM recommendations? Do you believe this is appropriate, given your 

testimony on the scope and nature of the DGAC recommendations, and how they differ from the actual guidelines? 

Answer. The Food and Drug Administration (FDA or the Agency) considered the 

scientific evidence underpinning the recommendations provided in the 2015 Dietary 

Guidelines Advisory Committee (DGAC) technical report in setting a proposed Dietary Reference Value (DRV) for added sugars. The 2015 DGAC report evaluated 

more recent scientific evidence than the evidence that had been evaluated by the 

Institute of Medicine (IOM) when it issued its 2002 report. FDA will consider all 

of the public comments received by the Agency as it proceeds with this rulemaking 

process and will keep your office updated as we progress. 

Question 7. I am interested in the recommendations related to coffee. According 

to the Dietary Guidelines Advisory Committee, three to five cups of coffee per day 

are not associated with long-term health risks. It was also noted that this amount 

of coffee correlated with reduced risk for heart disease and type 2 diabetes. Can you 

share what scientific evidence or process the DGAC used to suggest this change? 

Answer. The 2015 DGAC examined the relationship between usual caffeine consumption and health. Specifically, they asked the question, What is the relationship 

between usual coffee/caffeine consumption and health? Furthermore, they examined 

the relationship between coffee/caffeine consumption and its impact on total mortality, cardiovascular disease, type 2 diabetes, cancers, Parkinson’s disease, cognitive function, and pregnancy. Below is the list of scientific evidence examined by 

the Advisory Committee to answer the questions related to coffee/caffeine consumption. 

It is important to note that while the DGAC was interested in usual caffeine intake, most of the available research was conducted with coffee as the source of cafVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00138 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
135 

feine. After reviewing the evidence, the Committee stated that moderate coffee consumption can be incorporated into a healthy lifestyle. However, the DGAC noted 

that caloric additions from cream, milk, and added sugars should be minimized. 

Furthermore, the Advisory Committee stated that individuals who do not consume 

caffeinated coffee should not start to consume it for potential health benefits alone. 

The Advisory Committee recommendations are not binding on the Departments, but 

are intended to inform the Departments’ work. 

For additional details on this body of evidence, visit: Appendix E–2.39a Evidence Portfolio available at http://health.gov/dietaryguidelines/2015-scientific-report/14-appendix-E2/e2-39a.asp. (Attachment 1) 

Question 8. I think it would be helpful for you to provide the Committee evidence 

in writing to confirm that your agencies did, in fact, make attempts to oversee the 

Advisory Committee once it became clear they were delving to areas of public policy. 

In response I would like to see evidence that your agencies provided instructions 

to the committee during their assembly to ensure they were staying focused on the 

right guidance, and not straying into policy matters outside their scope or mandate. 

And, likewise, I would like to receive documented evidence of the instructions agencies provided to the committee on the public law to help them understand their report must be based on the preponderance of scientific and medical knowledge that 

is current at the time of publication. 

Answer. Thank you for raising this issue. Shortly after the 2015 DGAC was appointed by the Secretaries of HHS and USDA in May 2013 and before its first meeting held on June 13–14, 2013, HHS and USDA conducted two administrative 

webinars with the Committee members to provide orientation and training. (Note 

that meetings of the full Committee that are solely administrative in nature are not 

required by the Federal Advisory Committee Act (FACA) to be open to the public.) 

Topics included the charge to the Advisory Committee, the National Nutrition Monitoring and Related Research Act, the charter and bylaws of the Advisory Committee, 

and FACA, which included a presentation by an HHS attorney in the Office of the 

General Counsel. 

Below are some of the materials you requested. 

1. FACA Pamphlet—http://www.gsa.gov/portal/content/101010 (Attachment 2) 

2. Ethics Rules for SGEs—https://ethics.od.nih.gov/topics/SGE-Training-Oct04.pdf (Attachment 3) 

3. Charge—http://health.gov/dietaryguidelines/2015-BINDER/meeting1/ 

chargeCommittee.aspx (Attachment 4) 

4. Charter—http://health.gov/dietaryguidelines/2015/committee-resources.asp 

(http://health.gov/dietaryguidelines/dgac2015-charter-final.pdf) (Attachment 

5) 

At the first public meeting (June 13–14, 2013), the charge was reviewed by USDA 

Under Secretary Concannon and subsequently the objectives and purpose of the Advisory Committee were presented by the Designated Federal Officer (DFO). The 

agenda, meeting summary, and videocast of this first meeting are available at 

http://health.gov/dietaryguidelines/2015-BINDER/meeting1/index.aspx. In addition, at that public meeting, the DGAC members were divided into three work 

groups, which met separately in the afternoon of the first day of this meeting; at 

those work group meetings, the first item on the agenda was a discussion led by 

federal staff on the charge and guiding principles for their work. 

Throughout the DGAC’s work, the DFO or his representative was present on all 

work-group/subcommittee calls or meetings, and at all public Committee meetings 

to ensure FACA was being followed; this includes following the charge as approved 

by the charter. The DGAC’s charge was read at each public Committee meeting and 

during Subcommittee meetings. 

Question 9. And, finally, I would like to welcome your comments on any advice 

you could give future secretaries as to future Advisory Committees, and how they 

could stay focused on their charter, and produce a recommendation that really stays 

coloring with in the lines. So I would appreciate a response. Thank you. 

Answer. We would advise future secretaries to continue the process of distinguishing what the Dietary Guidelines for Americans are and what they are not. 

There is a misunderstanding that the DGAC’s report is the Dietary Guidelines for 

Americans or a draft of the Guidelines—it is not. The Guidelines are recommendations for the general public, intended to prevent diet-related conditions, not to treat 

disease. 

Diabetes and other chronic, diet-related diseases cost Americans billions of dollars 

annually and contribute to rising health care costs across the health system. HowVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00139 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
136 

ever, we know that diet plays a critical role in disease prevention and in both individual and public health—a good diet can help prevent diabetes, high blood pressure, and cardiovascular disease. The Dietary Guidelines are a critical tool to help 

Americans make healthy choices in their daily lives to prevent these diseases and 

enjoy a healthy diet. They are used to inform the development of federal food, nutrition, and health policies and programs. 

Questions Submitted by Hon. Suzan K. DelBene, a Representative in Congress from 

Washington 

Question 1. Ensuring that the Federal Government is providing women with latest, science-based nutrition advice based on the latest science to benefit both their 

body and their children is of utmost importance. One area where there is substantial confusion today is regarding seafood consumption during pregnancy. It was encouraging when FDA issued updated draft seafood advice in June 2014 that attempted to clarify that confusion. According to the Federal Register notice (http:// 

www.gpo.gov/fdsys/pkg/FR-2014-06-11/pdf/2014-13584.pdf), this draft advice was 

based on data from the Food and Agriculture Organization of the United Nations 

(FAO), the World Health Organization (WHO) and the FDA’s net effects report entitled: ‘‘A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment 

from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal 

Development in Children).’’ Will FDA be issuing final seafood advice that follows the 

draft advice with changes to make it consistent with the FAO, WHO and FDA’s latest science? 

Answer. Thank you for raising this issue. The final seafood consumption advice 

is undergoing review. In developing it, HHS has taken and will continue to take 

steps to ensure that it is reflective of the latest nutrition science. 

By way of background, in June 2014, FDA and the Environmental Protection 

Agency (EPA) jointly issued a draft update to the seafood advice they last issued 

in 2004. The joint advice in the draft update is consistent with the current recommendation in the Dietary Guidelines for Americans 2010, in that it advises pregnant women, women who may become pregnant, and nursing women to eat at least 

8, and up to 12, ounces per week of a variety of fish lower in mercury in order to 

optimize the developmental benefits that fish could provide. 

The FDA Risk Communication Advisory Committee held a public meeting on the 

advice provided in the draft update in November 2014, and the comment period for 

the draft updated advice closed in March 2015. 

FDA and EPA have studied the public comments, are making the appropriate 

modifications to the advice, and then will publish the final advice. As with the 2014 

draft version of the advice, the purpose is to provide useful and science-based information to pregnant and breastfeeding women and to caregivers of young children. 

We will keep your office updated as we progress on this issue. 

Question 2. I was interested to learn about the information related to coffee consumption. The report indicated that consumption of coffee within the moderate 

range (three to five cups per day) is not associated with increased long-term health 

risks and is associated with reduced risk of type 2 diabetes and cardiovascular disease in adults. Can you share some of the other diseases prevention or risks also 

associated with moderate coffee intake? 

Answer. The 2015 Dietary Guidelines Advisory Committtee (DGAC) addressed 

this issue in the question, ‘‘What is the relationship between usual coffee/caffeine 

consumption and health?’’ In reviewing chronic disease health outcomes, evidence 

was available primarily on coffee consumption and total mortality, cardiovascular 

disease (CVD), type 2 diabetes, and cancer. The Committee identified research on 

coffee consumption and CVD, stroke, heart failure, hypertension, and several intermediate outcomes including blood pressure, blood lipids, and blood glucose; the specific findings are detailed in its Advisory Report. The DGAC examined several types 

of cancer in regard to coffee consumption, including lung, liver, breast, prostate, 

ovarian, endometrium, bladder, pancreas, upper digestive and respiratory tract, 

esophagus, stomach, colon, and rectum. Regular coffee consumption is associated 

with reduced risk of cancer of the liver and endometrium. 

Questions Submitted by Hon. James P. McGovern, a Representative in Congress from 

Massachusetts 

Question 1. According to the National Consumers League, a typical serving of coffee, soda or an energy drink all contain about the same amount of caffeine. The Dietary Guidelines Advisory Committee report recommends the establishment of a 

guideline for caffeine but also recommends that coffee be classified as a ‘normal’ caffeine drink and energy drinks as ‘high’ caffeine drinks. If each of these products are 

137 

essentially the same, how can you support such a distinction? Can you elaborate on 

the scientific rational for this distinction? 

Answer. The Dietary Guidelines Advisory Committee (DGAC) did not recommend 

that HHS and USDA classify coffee as a ‘‘normal’’ caffeine drink or energy drinks 

as ‘‘high’’ caffeine drinks. Instead, the references the Committee made to ‘‘coffee’’ 

and ‘‘high-caffeine energy drinks’’ were to the evidence it reviewed related to intake 

of these products and health outcomes. For example, the literature that the Committee reviewed demonstrated the highly variable amount of caffeine in energy 

drinks and shots; a table in the article by Reissig, et al. (reference 122 in Part D, 

Chapter 5: Food Sustainability and Safety) shows that many energy drinks are in 

the same caffeine concentration range as coffee although many have serving sizes 

twice that of an 8 oz. coffee serving. The table also lists ‘‘higher caffeine energy 

drinks’’ as well as ‘‘high concentration energy drinks’’ also known as energy shots. 

Much of the available evidence on caffeine focuses on coffee intake. The Committee 

stated that moderate coffee consumption (three to five 8 oz. cups/day, or providing 

up to 400 mg/day of caffeine) can be incorporated into healthy eating patterns. The 

Committee also noted there is not currently enough available evidence to support 

a recommendation for the general population regarding energy drinks. 

Question 2. As you may know, cranberries are the state fruit of Massachusetts, 

one of three fruits native to North America, and a perennial crop grown commercially in five states. They are power packed with unique compounds that have documented health benefits, but not blessed by Mother Nature with natural sweetness 

like other juices and dried fruit products. 

Cranberry growers are concerned that if required to include a % Daily Value 

(%DV) in a modified Nutrition Facts Panel for added sugar in addition to total sugars as currently proposed, consumers will be misled to believe that cranberry products, for which sugar is added for palatability, are less nutritious than other fruit 

products containing the same or higher levels of intrinsic or natural sugar. They are 

also concerned that these consumers will be misled about how much total sugar is 

contained in cranberry products. 

While the Dietary Guidelines for Americans are updated every 5 years, modifications to the Nutrition Facts Panel happen less frequently. Therefore, it is critical 

that we get the labels right. How can FDA ensure that consumers will not be misled 

about the healthfulness of cranberry products under the proposed FDA Nutrition 

Facts Panel labeling regulation? Specifically, has FDA considered how consumers 

will react when comparing products with natural sugars that contain equal or more 

total sugars and calories than cranberry products with a declared %DV? If not, is 

additional information needed? 

Answer. FDA is reviewing its own consumer research and other research that has 

been submitted to the Agency, along with the science regarding an added sugars 

declaration and Percent Daily Value (%DV). FDA will also consider all of the comments submitted regarding the healthfulness of foods containing added sugars, including cranberry products, as it proceeds with this rulemaking process. 

Question 2a. Has FDA considered the potential economic impact to agriculture 

producers of perennial crops like cranberries in which producers cannot rotate into 

other fruit, vegetable or row crops to offset potential losses and broader agribusinesses? If not, why was this not considered? 

Answer. FDA’s estimate of the total cost of the proposed Nutrition Facts Label 

and Serving Size rules is an aggregate measure of costs, and captures relabeling 

costs associated with adding the added sugars declaration and percent daily value 

to the Nutrition Facts Panel, and reformulation costs associated with product reformulation aimed at reducing added sugars content in products (e.g., substituting a 

high-intensity, low-calorie sweetener for sugar). FDA did not explicitly consider the 

potential economic impact to agriculture producers of perennial crops like cranberries because the industry may reformulate products to include less added sugars 

(by using other sweeteners, for example, or using other juice blends). 

Question 2b. It is my understanding that FDA has based the proposed added 

sugar labeling requirements on the findings of the 2015 Dietary Guidelines Committee Report which is currently still under review by HHS and USDA. Is it correct 

that the Committee’s findings do not agree with the Institute of Medicine’s (IOM) 

current recommendations for upper limits on added sugar and that added sugar consumption is declining to levels nearly 50% below the upper limit as recommend by 

the IOM? 

Answer. FDA considered the scientific evidence underpinning the recommendations provided in the 2015 DGAC technical report in setting a proposed Dietary Reference Value (DRV) for added sugars. The 2015 DGAC report evaluated more recent 

scientific evidence than the evidence that had been evaluated by the Institute of 

138 

Medicine (IOM) when it issued its 2002 report. In 2002, the IOM provided a suggested maximum intake level of 25 percent or less of calories for added sugars based 

on data that demonstrated decreased intakes of some micronutrients among American subpopulations whose intake of added sugars exceeded this level. This suggested maximum intake level, however, is not considered an upper level of intake, 

which are set by the IOM for many other nutrients. The 2015 DGAC recommended 

that ten percent or less of calories should come from added sugars. The current average U.S. intake of added sugars is approximately 13.4 percent of total calories, 

with some subpopulations such as adolescents and young adults consuming greater 

amounts. Added sugars intake has decreased for both males and females across all 

age groups between 2001–2004 and 2007–2010, but intakes still exceed the amount 

that can be consumed while meeting food group and nutrient needs within the calorie levels. FDA will consider the scientific evidence and all of the public comments 

received by the Agency as it proceeds with this rulemaking process. 

Questions Submitted by Hon. Ann Kirkpatrick, a Representative in Congress from 

Arizona 

Question 1. The Dietary Guidelines are aimed at general populations based on age 

and gender. But, obesity on tribal land is especially severe. How do the Dietary 

Guidelines help my tribal constituents eat healthier? And will these guidelines be 

achievable for people of all cultures and socioeconomic levels? 

Answer. HHS and USDA are working together to finalize the 2015 Dietary Guidelines for Americans, which are expected to be completed in December of this year. 

We are unable to comment on the final content of the forthcoming edition of the 

Dietary Guidelines at this time, as they are still under development. However, the 

review of the evidence conducted by the Dietary Guidelines Advisory Committee 

(DGAC) included obesity as an outcome on several research questions when applicable, and thus there is evidence on obesity available in the Advisory Report that the 

Departments are taking under consideration when updating the Dietary Guidelines. 

HHS and USDA recognize that many factors influence the diet and physical activity choices individuals make. The United States is a diverse nation, with people 

from many backgrounds, cultures, and traditions with varied personal preferences. 

In addition, significant health and food access disparities exist, with many U.S. 

households having insufficient resources to acquire adequate food to meet their 

needs. All of these factors can have a profound impact on choices. The Dietary 

Guidelines are meant to provide a sound, healthy diet for the general population, 

including those at increased risk for obesity and obesity-related chronic diseases. It 

is not a rigid prescription, but rather, an adaptable framework in which individuals 

can meet their personal, cultural, and traditional food preferences and stay within 

their budget, including those within tribes in the State of Washington. 

Question 2. A typical serving of coffee, soda or an energy drink all contain about 

the same amount of caffeine. The Dietary Guidelines Advisory Committee recommends that you establish a guideline for caffeine, for the first time, but then recommends that you classify coffee as a ‘normal’ caffeine drink and energy drinks— 

and only energy drinks—as a ‘high’ caffeine drink. What is the scientific justification 

for this distinction? 

Answer. The DGAC did not recommend that HHS and USDA classify coffee as a 

‘‘normal’’ caffeine drink or energy drinks as ‘‘high’’ caffeine drinks. Instead, the references the Committee made to ‘‘coffee’’ and ‘‘high-caffeine energy drinks’’ were to 

the evidence it reviewed related to intake of these products and health outcomes. 

For example, the literature that the Committee reviewed demonstrated the highly 

variable amount of caffeine in energy drinks and shots; a table in the article by 

Reissig, et al. (reference 122 in Part D, Chapter 5: Food Sustainability and Safety) 

shows that many energy drinks are in the same caffeine concentration range as coffee, although many have serving sizes twice that of an 8 oz. coffee serving. The table 

also lists ‘‘higher caffeine energy drinks’’ as well as ‘‘high concentration energy 

drinks,’’ also known as energy shots. Much of the available evidence on caffeine focuses on coffee intake. The Committee stated that moderate coffee consumption 

(three to five 8 oz. cups/day, or providing up to 400 mg/day of caffeine) can be incorporated into healthy eating patterns. The Committee also noted that the limited evidence in regard to high-caffeine energy drinks and health outcomes shows mixed results. 

139 

Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department of 

Health and Human Services 

Question Submitted by Hon. John R. Moolenaar, a Representative in Congress from 

Michigan 

Question. In an 18 month process, spanning June 2013–December 2014, the 

DGAC waited until September 2014 to form its Added Sugars Working Group. This 

gave the Committee a mere 90 days to collect, review, synthesize and formulate conclusions on the extensive body of literature on sugars. 

Considering the complexity and recent controversy around sugars intake, why 

wasn’t the review of the scientific evidence on sugars initiated at the very beginning 

of the process? 

Do you believe 90 days was a sufficient amount of time allocated for stakeholders 

to review and provide comment on the scientific evidence used, and conclusions 

made, by this DGAC regarding sugars intake? 

Answer. The work of the 2015 Dietary Guidelines Advisory Committee (DGAC) on 

the topic of added sugars spanned its entire 19 months of work, during which time 

the public was invited to submit comments to the Advisory Committee. The process 

chosen by the Advisory Committee to address the topic was comprehensive and consistent with the methodology it applied across its Advisory Report. The Committee 

began its discussion on added sugars at its first public meeting in June 2013 when 

it began developing the questions it wanted to examine. The Science Review Subcommittee, which served as an executive subcommittee to provide guidance to the 

full Committee to support its reviews of the evidence, decided to form the Added 

Sugars Working Group in June 2014 based on extensive discussion that had already 

occurred within various topic-specific subcommittees and at public meetings. These 

discussions made it clear that an Added Sugars Working Group would be the most 

efficient and consistent way to comprehensively address the topic. The Added Sugars Working Group had its first meeting on July 16, 2014, not in September 2014. 

After the Advisory Report was released in February 2015, a public comment period 

ending May 8, 2015 provided additional time for the public to review this issue and 

submit comments to HHS and USDA. 

Response from Hon. Thomas ‘‘Tom’’ J. Vilsack, Secretary, U.S. Department 

of Agriculture 

Questions Submitted by Hon. Collin C. Peterson, a Representative in Congress from 

Minnesota 

Question 1. In an 18 month process, spanning June 2013–December 2014, the 

DGAC waited until September 2014 to form its Added Sugars Working Group. This 

gave the Committee a mere 90 days to collect, review, synthesize and formulate conclusions on the extensive body of literature on sugars. 

Considering all of the complexity and recent controversy around sugars intake, 

why wasn’t this review of the scientific evidence on sugars initiated at the very beginning of this process? 

Were fewer than 90 days a sufficient amount of time for stakeholders to review 

and provide comment on the scientific evidence used, and conclusions made, by this 

DGAC regarding sugars intake? 

Answer. The work of the 2015 Dietary Guidelines Advisory Committee (DGAC) on 

the topic of added sugars spanned its entire 19 months of work, during which time 

the public was invited to submit comments to the Advisory Committee. The process 

chosen by the Advisory Committee to address the topic was comprehensive and consistent with the methodology it applied across its Advisory Report. The Committee 

began its discussion on added sugars at its first public meeting in June 2013 when 

it began developing the questions it wanted to examine. The Science Review Subcommittee, which served as an executive subcommittee to provide guidance to the 

full Committee to support its reviews of the evidence, decided to form the Added 

Sugars Working Group in June 2014 based on extensive discussion that had already 

occurred within various topic-specific subcommittees and at public meetings. These 

discussions made it clear that an Added Sugars Working Group would be the most 

efficient and consistent way to comprehensively address the topic. The Added Sugars Working Group had its first meeting on July 16, 2014 not in September 2014. 

After the Advisory Report was released in February 2015, a public comment period 

ending May 8, 2015 provided additional time for the public to review this issue and 

submit comments to HHS and USDA. 

Question 2. The following chart was published on the National Consumers League 

website during March 2015, National Nutrition Month, along with an article entitled ‘‘What’s the Buzz on Caffeine?’’. 

140 

Caffiene Equivalence 

70–90 mg of Caffeine 

http://www.nclnet.org/whats_the_buzz_on_caffeine. 

If a typical serving of coffee, soda or an energy drink all contain about the same 

amount of caffeine, do you think final dietary guidance to consumers should be 

based upon recommendations that classify coffee as ‘normal’ caffeine, energy 

drinks—and only energy drinks—as ‘high’ caffeine and did not take tea or other 

common caffeine sources into account whatsoever as far as contribution to daily caffeine intake of Americans is concerned? 

Answer. The DGAC did not recommend that HHS and USDA classify coffee as a 

‘‘normal’’ caffeine drink or energy drinks as ‘‘high’’ caffeine drinks. Instead, the references the Committee made to ‘‘coffee’’ and ‘‘high-caffeine energy drinks’’ were to 

the evidence it reviewed related to intake of these products and health outcomes. 

For example, the literature that the Committee reviewed demonstrated the highly 

variable amount of caffeine in energy drinks and shots; a table in the article by 

Reissig, et al. (reference 122 in Part D, Chapter 5: Food Sustainability and Safety) 

shows that many energy drinks are in the same caffeine concentration range as coffee although many have serving sizes twice that of an 8 oz. coffee serving. The table 

also lists ‘‘higher caffeine energy drinks’’ as well as ‘‘high concentration energy 

drinks’’ also known as energy shots. Much of the available evidence on caffeine focuses on coffee intake. The Committee stated that moderate coffee consumption 

(three to five 8 oz. cups/day, or providing up to 400 mg/day of caffeine) can be incorporated into healthy eating patterns. The Committee also noted that the limited evidence in regard to high-caffeine energy drinks and health outcomes shows mixed results. 

Question Submitted by Hon. Vicky Hartzler, a Representative in Congress from Missouri 

Question. Has the USDA considered moving the Nutrition Evidence Library from 

CNPP to ARS to allow for more open access of the nutrition science data for all government agencies? 

Answer. The Nutrition Evidence Library (NEL) is unique in its special focus on 

systematic reviews specifically in nutrition to help inform Federal nutrition policies 

and programs—it requires the expertise of the professionals at CNPP. Since its inception, the NEL has been fully available and accessible to the public on NEL.gov, 

and all government agencies have had access not only to its contents, but also to 

its staff at CNPP. For example, USDA’s Food and Nutrition Service (FNS) utilized 

the NEL for a series of systematic reviews in order to answer targeted nutrition 

education-related questions to inform guidance, policy, and program development related to FNS-administered nutrition education programs. 

ATTACHMENT 1

Appendix E–2.39a: Evidence Portfolio 

Part D. Chapter 5: Food Sustainability and Safety 

Usual Caffeine Consumption and Health 


11429015.eps
141 

Systematic Review Question: Total Mortality 

What is the relationship between usual caffeine consumption and total 

mortality? 

Conclusion Statement: Strong and consistent evidence shows that consumption of coffee within the moderate range (3 to 5 cups/d or up to 400 mg/d 

caffeine) is not associated with increased risk of major chronic diseases, such as 

cardiovascular disease (CVD) and cancer and premature death in healthy 

adults. 

DGAC Grade: Strong 

Key Findings 

• Coffee consumption was associated with reduced risk of total mortality (3–4% 

lower mortality with 1 cup/day), especially cardiovascular mortality. 

• Decaffeinated coffee consumption was associated with a lower risk of death (5 

studies only). 

• The limited number of studies on decaffeinated coffee indicates that protective 

association of coffee consumption may not be due to caffeine alone. 

Description of the Evidence 

Two systematic reviews and/or meta-analyses (SR/MAs) of 20 and 23 prospective 

cohort studies (Je, 2013 and Malerba, 2013, respectively). Je, et al. examined total 

mortality and Malerba, et al., examined total, CVD, and cancer mortality. Evidence 

suggests a significant inverse relationship between coffee consumption of 1–4 cups/ 

day with total mortality, especially cardiovascular disease mortality. This evidence 

is based on three meta-analyses of more than 20 prospective cohort studies (Je, 

2013; Malerba, 2013; Crippa, 2014). In general, results were similar for men and 

women. The risk reduction associated with each cup of coffee per day was between 

3–4 percent. In addition, Je (2013) found a significant inverse association between 

coffee consumption and cardiovascular disease mortality. This association was 

stronger in women (16% lower risk) than in men (8% lower risk). However, no association was found for cancer mortality. Crippa, et al., found that the lowest risk was 

observed for 4 cups/d for all-cause mortality (16%, 95% CI = 13–18) and 3 cups/d 

for CVD mortality (21%, 95% CI = 16–26), 

Systematic Review Question: Cardiovascular Disease 

What is the relationship between usual caffeine consumption and cardiovascular disease? 

Conclusion Statement: Consistent observational evidence indicates that 

moderate coffee consumption is associated with reduced risk of type 2 diabetes 

and cardiovascular disease in healthy adults. In addition, consistent observational evidence indicates that regular consumption of coffee is associated with 

reduced risk of cancer of the liver and endometrium, and slightly inverse or 

null associations are observed for other cancer sites. 

DGAC Grade: Moderate 

Key Findings 

CVD 

• Non-linear association between coffee intake and risk of CVD 

• Moderate coffee consumption was inversely associated with CVD risk 

» Lowest risk at 3–5 cups/d 

• Heavy consumption was not associated with higher CVD risk 

Stroke 

• Non-linear association between coffee intake and risk of stroke 

• Moderate coffee consumption was inversely associated with stroke 

» Lowest risk at 3–4 cups/d 

• Higher intakes were not associated with higher stroke risk 

CHD 

• Moderate coffee consumption was associated with lower CHD risk 

142 

• Higher intakes were not associated with higher CHD risk 

Heart Failure 

• Moderate (1–5 cups/d) coffee consumption was inversely associated with risk of 

heart failure 

• The largest inverse association observed for 4 cups/d 

Blood Pressure & Hypertension 

• No effect of coffee on long-term BP or risk of HTN 

• For habitual coffee consumption, consumption of >3 cups/d was not associated 

with increased risk of HTN compared with <1 cup/d 

» There was a slightly elevated risk of HTN for light to moderate consumption 

(1–3 cups/d) 

• In hypertensive individuals, caffeine intake produces an acute increase in BP 

for ≥3 h, but there is no evidence of an association between long-term coffee consumption and increased BP 

• Regular caffeine intake (median 410 mg/d) increases BP in short-term RCTs, although when ingested through coffee, BP effect of caffeine was smaller but significant 

Atrial Fibrillation 

• Caffeine was not associated with increased risk of atrial fibrillation 

• Low-dose caffeine exposure (<350 mg) may have a protective effect 

Blood Lipids 

• Caffeinated, but not decaffeinated coffee, had significant effect on serum lipids. 

The effects were mostly found in unfiltered coffee. 

» Coffee consumption increased TC, LDL–C, and TG 

» Positive dose-response relation between coffee intake and TC, LDL–C, and 

TG 

Description of the Evidence 

Twelve SR/MAs examined CVD (Ding, 2014; Caldiera, 2013; Cai, 2013; Kim, 2012; 

Mostofsky, 2012; Steffen, 2012; Zhang, 2011; Mesas, 2011; Larrson, 2011; Wu, 2009; 

Soffi, 2007; Noordjiz, 2005). Some SR/MAs covered only RCTs (Cai, 2013). Others 

included only prospective cohort studies (Larsson, 2011; Zhang, 2011; Kim, 2012; 

Mostofsky, 2012; Wu, 2009). Other SR/MAs covered RCTs and cohort studies (Steffen, 2012); controlled trials (randomized and non-randomized) and cohort studies 

(Mesas, 2011); prospective studies and case-control (Soffi, 2007); prospective cohort 

studies, case-cohort, and nested case-control studies (Ding, 2014); and RCT, prospective or retrospective cohorts and case-control studies (Caldiera, 2013). The number 

of studies included in the SR/MAs ranged from 5–36. 

A large and current body of evidence directly addressed the relationship between 

normal coffee consumption and risk of cardiovascular disease (CVD). The evidence 

included 12 systematic reviews with meta-analyses, all of which had high quality 

ratings (AMSTAR scores 8/11–11/11). CVD incidence and mortality, as well as coronary heart disease (CHD), stroke, heart failure, and hypertension were assessed by 

meta-analyses that consisted primarily of prospective cohort studies; intermediate 

outcomes such as blood pressure, blood lipids, and blood glucose were assessed by 

meta-analyses of randomized controlled trials. 

CVD risk was assessed by a current meta-analysis of 36 prospective cohort studies 

on long-term coffee consumption (Ding, 2014). This analysis showed a non-linear association, such that the lowest risk of CVD was seen with moderate coffee consumption (3–5 cups/day), but higher intakes (>5 cups/day) were neither protective nor 

harmful. Overall, moderate consumption of caffeinated, but not decaffeinated, coffee 

was associated with a 12 percent lower risk of CVD. 

Results from the assessment of CHD risk in three meta-analyses (Ding, 2014; Wu, 

2009; Sofi, 2007) were inconsistent. Ding (2014) found 10 percent lower CHD risk 

with moderate coffee consumption (3–5 cups/day) in a meta-analysis of 30 prospective cohort studies, whereas Wu (2009) and Sofi (2007) in meta-analyses of 21 and 

10 prospective cohort studies, respectively, found no association between coffee consumption and CHD risk. However, in sub-group analysis, Wu (2009) found that habitual moderate coffee consumption (1–4 cups/day) was associated with an 18 percent lower risk among women. Overall, the meta-analyses of Sofi (2007) and Wu 

(2009) were conducted with smaller bodies of evidence and Ding (2014) assessed sevVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00146 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
143 

eral more recent studies. One reason for the inconsistent associations may be that 

coffee brewing methods have changed over time and the filter method has become 

more widely used, replacing unfiltered forms of coffee such as boiled coffee that were 

more widely consumed by participants in earlier studies. 

Risk of stroke was assessed in two systematic reviews with meta-analyses of prospective cohort studies (Larsson, 2011; Kim, 2012) with consistent findings. Kim 

(2012) found that coffee intake of 4 or more cups/day had a protective effect on risk 

of stroke. Larsson (2011) documented a non-linear association such that coffee consumption ranging from 1 to 6 cups/day was associated with an 8 percent–13 percent 

lower risk of stroke, and higher intakes were not associated with decreased or increased risk. The inverse associations were limited to ischemic stroke and no association was seen with hemorrhagic stroke. 

Regarding blood pressure, three meta-analyses evaluated the effect of coffee and 

caffeine on systolic and diastolic blood pressure using controlled trials (Steffen, 

2012; Mesas, 2011; Noordzij, 2005). The most recent meta-analysis of 10 randomized 

controlled trials by Steffen, et al. (2012) showed no effect of coffee on either systolic 

or diastolic blood pressure. Similarly, in another meta-analysis of 11 coffee trials 

and 5 caffeine trials, caffeine doses of <410 mg/day had no effect on systolic and diastolic blood pressure while doses of 410 or more mg/day resulted in a net increase 

(Noordzij, 2005). A third meta-analysis showed that among individuals with hypertension, 200–300 mg of caffeine (equivalent to ∼2–3 cups filtered coffee) resulted in 

an acute increase of systolic and diastolic blood pressure (Mesas, 2011). Additionally, two meta-analyses quantified the effect of coffee on incidence of hypertension 

(Steffen, 2012; Zhang, 2011) and found no association between habitual coffee consumption and risk of hypertension. However, Zhang, et al. (2011) documented a 

slightly elevated risk for light to moderate consumption (1–3 cups/day) of coffee compared to less than 1 cup/day. Regarding blood lipids, in a quantitative analysis of 

short-term randomized controlled trials, Cai, et al. (2012) revealed that coffee consumption contributed significantly to an increase in total cholesterol, LDL-cholesterol, and triglycerides, and that unfiltered coffee had a greater effect than filtered 

coffee. Interestingly, caffeinated, but not decaffeinated (more likely to be filtered), 

coffee had this effect on serum lipids. 

In a meta-analysis of observational study data, including prospective, retrospective, and case-control studies, higher amounts of coffee or caffeine had no association with risk of atrial fibrillation, but low doses of caffeine (<350 mg/day) appeared 

to have a protective effect (Caldeira, 2013). In contrast, coffee consumption of 1–5 

cups/day was found to be inversely associated with risk of heart failure in a metaanalysis of 5 prospective studies (Mostofsky, 2012). A non-linear association was 

documented and the lowest risk was observed for 4 cups/day (Mostofsky, 2012). 

Systematic Review Question: Type 2 Diabetes 

What is the relationship between usual caffeine consumption and type 2 diabetes? 

Conclusion Statement: Consistent observational evidence indicates that 

moderate coffee consumption is associated with reduced risk of type 2 diabetes 

and cardiovascular disease in healthy adults. In addition, consistent observational evidence indicates that regular consumption of coffee is associated with 

reduced risk of cancer of the liver and endometrium, and slightly inverse or 

null associations are observed for other cancer sites. 

DGAC Grade: Moderate 

Key Findings 

• Coffee consumption was inversely associated with T2D risk in a dose-response 

manner. 

• Both caffeinated and decaffeinated coffee were associated with lower T2D risk. 

• Increased coffee consumption by 1 cup/d was associated with 7% lower T2D 

risk. 

• Similar associations were seen in men and women. 

• A smaller number of studies on decaffeinated coffee indicate that protective association of coffee consumption is unlikely to be due to caffeine alone. 

• In T2D individuals, ingestion of caffeine (∼200–500 mg) significantly increased 

blood glucose, serum insulin, and lowered insulin sensitivity in those with T2D 

in short-term RCTs. 

144 

Description of the Evidence 

Five SR/MAs examined T2D (Ding, 2014; Jiang, 2014; Whitehead, 2013; Huxley, 

2009; van Dam, 2005). One SR/MA covered controlled trials (Whitehead, 2013) and 

two others covered only prospective cohort studies (Jiang, 2014; Huxley, 2009). 

Other SR/MAs covered both prospective cohort and nested case-control studies 

(Ding, 2014) or prospective cohort and cross-sectional studies (van Dam, 2005). The 

number of studies included in the SR/MAs ranged from 9–31. 

Coffee consumption has consistently been associated with a reduced risk of type 

2 diabetes. In four meta-analyses of prospective cohort studies (Ding, 2014; Jiang, 

2014; Huxley, 2009; van Dam, 2005) and cross-sectional studies (van Dam, 2005), 

coffee consumption was inversely associated with risk of type 2 diabetes in a doseresponse manner. Risk for type 2 diabetes was 33 percent lower for those consuming 

6 cups/day in the analysis by Ding, et al. (2014) while the risk was 37 percent lower 

for those consuming 10 cups/day in the analysis by Jiang, et al. (2014). Using a subset of the prospective cohorts in the Ding, et al. (2014) and Jiang, et al. (2014) metaanalyses, Huxley (2009) documented that each cup of coffee was associated with a 

7 percent lower risk of type 2 diabetes. Similarly, van Dam (2005) noted that consumption of ≥6 or ≥7 cups/day was associated with a 35 percent lower risk of type 

2 diabetes. Three meta-analyses (Ding, 2014; Jiang, 2014; Huxley, 2009) found protective associations for decaffeinated coffee. Moderate decaffeinated coffee consumption (3–4 cups/day) was associated with a 36 percent lower risk of type 2 diabetes 

(Huxley, 2009). Each cup of decaffeinated coffee was associated with a 6 percent 

lower risk (Ding, 2014) while every 2 cups were associated with a 11 percent lower 

risk (Jiang, 2014). Both reports also documented a dose-response association between caffeine and type 2 diabetes risk such that every 140 mg/day was associated 

with an 8 percent lower risk in the Ding, et al. (2014) meta-analysis while every 

200 mg/day was associated with a 14 percent lower risk in the analysis by Jiang, 

et al. (2014). However, it remains unclear if this inverse association is independent 

of coffee consumption as Ding et al (2014) indicated that none of the studies included in the caffeine dose-response analysis adjusted for total coffee. 

Only one systematic review of 9 randomized controlled trials examined the effects 

of caffeine on blood glucose and insulin concentrations among those with type 2 diabetes (Whitehead & White 2013). Ingestion of 200–500 mg of caffeine acutely increased blood glucose concentrations by 16–28 percent of the area under the curve 

and insulin secretions by 19–48 percent of the area under the curve when taken 

prior to a glucose load. At the same time, these trials also noted a decrease in insulin sensitivity by 14–37 percent. Although it is not clear if the acute effects of caffeine on blood glucose and insulin persist in the long term, evidence from prospective cohorts indicate that caffeine may have no adverse effect on the risk of type 

2 diabetes. 

Systematic Review Question: Cancer 

What is the relationship between usual caffeine consumption and cancer? 

Conclusion Statement: Consistent observational evidence indicates that 

moderate coffee consumption is associated with reduced risk of type 2 diabetes 

and cardiovascular disease in healthy adults. In addition, consistent observational evidence indicates that regular consumption of coffee is associated with 

reduced risk of cancer of the liver and endometrium, and slightly inverse or 

null associations are observed for other cancer sites. 

DGAC Grade: Moderate 

Key Findings 

Total Cancer 

• Total Cancer Coffee drinkers had a modestly lower total cancer incidence compared to nondrinkers or those with the lowest intakes. 

Lung Cancer 

• Coffee consumption was associated with higher risk of lung cancer, but the association was mainly explained by smoking. An association was not founder 

among nonsmokers. 

Liver Cancer 

• Significant inverse association between coffee consumption and liver cancer risk 

seen in both case-control and cohort studies (after adjustment for existing liver 

disease). 

145 

• Risk of hepatocelluar carcinoma was reduced by 40% for any coffee consumption 

versus no coffee consumption. 

Breast Cancer 

• No association between caffeine, coffee, or decaffeinated coffee and breast cancer 

risk. 

» An inverse association was seen in postmenopausal women and a strong inverse association seen in BRCA1 mutation carriers. 

• Borderline lower risk for highest versus lowest coffee consumption. 

» For all studies together, an increase of 2 cups of coffee per day was associated with a 2% marginally lower breast cancer risk. 

Prostate Cancer 

• Regular coffee consumption associated with modestly lower risk of prostate cancer. 

• Significant inverse association documented for cohort studies. For case-control 

studies, a 2 cup increment was associated with a higher risk of prostate cancer. 

• Dose-response meta-analysis of coffee consumption showed inverse association 

with prostate cancer mortality, but not incidence. 

Ovarian Cancer 

• No association between coffee consumption and ovarian cancer risk in high 

versus low or dose-response meta-analysis. 

Endometrial Cancer 

• Increased coffee intake was associated with a reduced risk of endometrial cancer in both cohort and case-control studies. 

• A reduction of ∼20% in endometrial cancer risk among coffee drinkers; >20% 

and >30% reduction in risk among low to mod and heavy drinkers, respectively. 

Bladder Cancer 

• Data from case-control studies suggest that consumption of coffee is associated 

with an increased risk for bladder cancer, but no significant association was 

seen in prospective cohort studies. 

Pancreatic Cancer 

• Meta-analysis of prospective cohort studies showed that coffee drinking was inversely associated with pancreatic cancer risk (in sub-group analyses, there was 

a reduced risk in men but not women). 

• A positive association was found between coffee intake and pancreatic cancer 

in case-control studies that did not adjust for smoking. An inverse association 

was found in prospective cohort studies. 

Upper Digestive & Respiratory Cancer 

• Coffee drinking was inversely related to oral/pharyngeal cancer risk while there 

was no relation with laryngeal cancer, ESCC, and EAC. 

Gastro-esophageal Cancer 

• Coffee consumption was inversely, but non-significantly, associated with risk of 

esophageal cancer. 

• No association between coffee consumption and gastric cancer risk in cohort or 

case-control studies. 

Colorectal Cancer 

• Case-control studies suggest coffee consumption decreases risk of colorectal and 

colon cancer, especially in women; the association was inverse, but marginally 

non-significant, for cohort studies for colorectal and colon cancer. 

• Prospective cohort studies showed no association between coffee consumption on 

colorectal cancer risk (a suggestive inverse association was slightly stronger in 

studies that adjusted for smoking and alcohol). 

Description of the Evidence 

A large number of SR/MAs addressed cancer, including total cancer (Yu, 2011), 

lung cancer (Tang, 2010), liver cancer (Sang, 2013; Bravi, 2013), breast cancer 

(Jiang, 2013; Li, 2013; Tang 2009), prostate cancer (Cao, 2014; Zhong, 2013; 

Discacciati, 2013; Park, 2010), ovarian cancer (Braem, 2012), endometrial cancer 

(Je, 2012; Bravi, 2009), bladder cancer (Zhou, 2012), pancreatic cancer (Turati, 2011; 

146 

Dong, 2011), upper digestive and respiratory tract cancer (Turati, 2011), esophageal 

cancer (Zheng, 2013), gastric cancer (Botelho, 2006), and colorectal cancer (Li, 2012; 

Galeone, 2010; Je, 2009). The majority of the studies included cohort and cross-sectional studies, although some covered only prospective cohort studies or case-control 

studies. The number of studies included in the SR/MAs ranged from 3–54. 

Several systematic reviews and meta-analyses examined the association between 

coffee consumption and risk of cancer. Types of cancer examined by the Committee 

included total cancer, cancers of the lung, liver, breast, prostate, ovaries, endometrium, bladder, pancreas, upper digestive and respiratory tract, esophagus, stomach, colon, and rectum. 

In a quantitative summary of 40 prospective cohort studies with an average follow-up of 14.3 years, Yu (2011) found a 13 percent lower risk of total cancer among 

coffee drinkers compared to non-drinkers or those with lowest intakes. Risk estimates were similar for men and women. In sub-group analyses, the authors noted 

that coffee drinking was associated with a reduced risk of bladder, breast, buccal 

and pharyngeal, colorectal, endometrial, esophageal, hepatocellular, leukemic, pancreatic, and prostate cancers. 

Tang, et al. (2010) evaluated 5 prospective cohorts and 8 case-control studies and 

found that overall those with the highest levels of coffee consumption had a 27 percent higher risk for lung cancer compared to never drinkers or those with least consumption. An increase in coffee consumption of 2 cups/day was associated with a 

14 percent higher risk of developing lung cancer. However, because smoking is an 

important confounder, when analyses were stratified by smoking status, coffee consumption was marginally protective in non-smokers and was not associated with 

lung cancer among smokers. When estimates from 2 studies that examined decaffeinated coffee were summarized, there was a protective association with lung cancer. No association was seen with lung cancer when only case-control studies were 

considered. 

Results from two meta-analyses indicate the coffee consumption is associated with 

a 50 percent lower risk of liver cancer (Sang, 2013) and a 40 percent lower risk of 

hepatocellular carcinoma (Bravi, 2013) when considering both cohort and case-control studies. Associations were significant in men but not in women (Sang, 2013). 

Three meta-analyses of observational studies found no association between coffee 

consumption (Jiang, 2013; Li, 2013; Tang, 2013), caffeine consumption (Jiang, 2013), 

or decaffeinated coffee consumption (Jiang, 2013) and risk of breast cancer. In all 

3 reports, each 2 cup/day of coffee was marginally associated with a 2 percent lower 

risk of breast cancer. However, in sub-group analyses, coffee consumption was protective against breast cancer risk in postmenopausal women (Jiang, 2013), BRCA1 

mutation carriers (Jiang, 2013), and women with estrogen receptor negative status 

(Li, 2013). 

The association between coffee consumption and risk of prostate cancer was 

mixed. Cao (2014) and Zhong (2013) found that regular or high coffee consumption, 

compared to non- or lowest levels of consumption, was associated with a 12 percent– 

17 percent lower risk of prostate cancer in prospective cohort studies. Further, each 

2 cups of coffee per day was associated with a 7% lower risk of prostate cancer. 

However, no associations were seen with case-control data alone or when these studies were examined together with prospective cohort studies. Using a combination of 

both prospective cohort and case-control data, Discacciati (2013) found that each 3 

cups/day of coffee was associated with a 3% lower risk of localized prostate cancer 

and an 11% lower risk of mortality from prostate cancer. On the other hand, after 

summarizing data from 12 prospective cohort and case-control studies, Park (2010) 

found a 16% higher risk of prostate cancer. However, in sub-group analyses by 

study design, the higher risk was observed in case-control but not in cohort studies. 

Consumption of coffee was not associated with risk of ovarian cancer in a metaanalysis of 7 prospective cohort studies with over 640,000 participants (Braem, 

2012). 

Two meta-analyses confirmed an inverse association between coffee consumption 

and risk of endometrial cancer (Je, 2012; Bravi, 2009). In the most recent and updated meta-analysis of prospective cohort and case-control studies, compared to 

those in the lowest category of coffee consumption, those with the highest intakes 

of coffee had a 29% lower risk of endometrial cancer (Je, 2012). Each cup of coffee 

per day was associated with an 8% lower risk of endometrial cancer. Similar results 

were found in the meta-analysis by Bravi (2009) that included a sub-set of the studies in Je (2012) and documented a 20% lower risk of endometrial cancer overall, and 

a 7% decrease for each cup of coffee per day. However, the association was significant only in case-control studies but not in cohort studies, most likely due to lower 

statistical power. 

147 

A recent meta-analysis of 23 case-control studies by Zhou (2012) found coffee was 

a risk factor for bladder cancer. There was a smoking-adjusted increased risk of 

bladder cancer for those in the highest (45%), second highest, (21%), and third highest (8%) groups of coffee consumption, compared to those in the lowest group. No 

association was, however, seen in cohort studies. 

Two meta-analyses of coffee consumption and pancreatic cancer risk provided 

mixed results (Turati, 2011; Dong, 2011). Using both prospective cohort and casecontrol studies, Turati (2011) found that coffee consumption was not associated with 

risk of pancreatic cancer. However, an increased risk was seen in case-control studies that did not adjust for smoking. Using a sub-set of prospective cohorts included 

in the Turati (2011) meta-analysis, Dong (2011) found that coffee drinking was inversely associated with pancreatic cancer risk but did not separate studies based on 

their adjustment for smoking status. Sub-group analyses revealed a protective association in men, but not in women. 

Turati (2011) quantified the association between coffee consumption and various 

upper digestive and respiratory tract cancers using data from observational studies. 

Coffee consumption was associated with a 36% lower risk of oral and pharyngeal 

cancer but not with risk of laryngeal cancer, esophageal squamous cell carcinoma, 

or esophageal adenocarcinoma. In a meta-analysis of prospective cohort and casecontrol studies, Zheng (2013) noted that coffee was inversely, but non-significantly, 

associated with risk of esophageal cancer. Regarding gastric cancer, no association 

between coffee consumption and risk was seen in a meta-analysis of observational 

studies by Botelho (2006). 

Three meta-analyses on the association between coffee consumption and colorectal 

cancer risk (Li, 2012; Galeone, 2012; Je, 2009) have yielded mixed findings. Results 

from case-control studies suggested coffee consumption was associated with lower 

risk of colorectal (15% lower) and colon cancer (21% lower), especially in women. 

However, this inverse association was non-significant for cohort studies. Using all 

but one of the case-control studies, Galeone (2012) arrived at similar conclusions as 

the Li (2012) analysis although associations were in general stronger. Galeone 

(2012) also provided suggestive evidence for a dose-response relationship between 

coffee and colorectal cancer such that each cup of coffee was associated with a 6% 

lower risk of colorectal cancer, 5% lower risk of colon cancer, and 3% lower risk of 

rectal cancer. Using several prospective cohort studies as in the Li (2012) meta-analysis, Je (2009) found no significant association of coffee consumption with risk of 

colorectal cancer. Interestingly, no differences were seen by sex but the suggestive 

inverse associations were slightly stronger in studies that adjusted for smoking and 

alcohol. 

Systematic Review Question: Cognitive Function 

What is the relationship between usual caffeine consumption and cognitive 

function? 

Conclusion Statement: Limited evidence indicates that caffeine consumption is associated with a modestly lower risk of cognitive decline or impairment 

and lower risk of Alzheimer’s disease. 

DGAC Grade: Limited 

Key Findings: 

• There was a trend toward a protective effect of caffeine from different 

sourcesand cognitive impairment/dementia. 

Description of the Evidence 

Two systematic reviews (Arab, 2013; Santos, 2010) and one meta-analysis (Santos, 

2010) examined the effects of caffeine from various sources, including coffee, tea, 

chocolate, on cognitive outcomes. Arab (2013) systematically reviewed six longitudinal cohort studies evaluating the effect of caffeine or caffeine-rich beverages on 

cognitive decline. Most studies in this review used the Mini Mental State Examination Score as a global measure of cognitive decline. The review concluded that estimates of cognitive decline were lower among consumers, although there was no 

clear dose-response relationship. Studies also showed stronger effects among women 

than men. In a metaanalysis of nine cohort and two case-control studies, caffeine 

intake from various sources was associated with a 16% lower risk of various measures of cognitive impairment/decline. Specifically, data from four studies indicate 

that caffeine is associated with a 38% lower risk of Alzheimer’s disease. 

148 

Systematic Review Question: Parkinson’s Disease 

What is the relationship between usual caffeine consumption and Parkinson’s disease? 

Conclusion Statement: Consistent evidence indicates an inverse association 

between caffeine intake and risk of Parkinson’s disease. 

DGAC Grade: Moderate 

Key Findings 

• There was a non-linear inverse association between coffee and Parkinson’s disease risk with maximum protection at ∼3 cups/d (adjusted for smoking). 

• For caffeine consumption, a linear inverse association was found (adjusted for 

smoking); every 300 mg/day was associated with a 24% lower risk of Parkinson’s disease. 

Description of the Evidence 

Evidence from two systematic reviews (Ishihara, 2005; Costa, 2010) and one quantitative meta-analysis (Qi, 2013) confirmed an inverse association between coffee, 

caffeine, and risk of Parkinson’s disease. Qi (2013) evaluated six case-control studies 

and seven prospective articles and documented a non-linear relationship between 

coffee and risk of Parkinson’s disease, overall. The lowest risk was observed at ∼3 

cups/day (smoking-adjusted risk reduction was 28%). For caffeine, a linear dose-response was found and every 200 mg/day increment in caffeine intake was associated 

with a 17% lower risk of Parkinson’s disease. Using a combination of cohort, casecontrol, and cross-sectional data, Costa (2010) summarized that the risk of Parkinson’s disease was 25% lower among those consuming the highest versus lowest 

amounts of caffeine. Like Qi (2013), Costa documented a linear dose-response with 

caffeine intake such that every 300 mg/day was associated with a 24% lower risk 

of Parkinson’s disease. In both reports, associations were weaker among women 

than in men. 

Systematic Review Question: Pregnancy outcomes 

What is the relationship between usual caffeine consumption and pregnancy outcomes? 

Conclusion Statement: Consistent evidence from observational studies indicates that caffeine intake in pregnant women is not associated with risk of 

preterm delivery. Higher caffeine intake (especially >=300 mg/day ) is associated with a small increased risk of miscarriage, stillbirth, low birth weight, and 

small for gestational age (SGA) births. However, these data should be interpreted cautiously due to potential recall bias in the case-control studies and 

confounding by smoking and pregnancy signal symptoms. 

DGAC Grade: Moderate 

Key Findings 

• No important association between caffeine intake during pregnancy and risk of 

pre-term birth were observed in either cohort or case-control studies. 

• Consumption of caffeine from various sources was associated with a significantly increased risk of spontaneous abortion and low birth weight. Control for 

confounders such as maternal age, smoking, and ethanol use was not possible. 

Description of the Evidence 

Two SR/MAs assessed observational studies on the association of caffeine intake 

with adverse pregnancy outcomes (Greenwood, 2014; Maslova, 2010). The pregnancy 

outcomes included miscarriage, pre-term birth, stillbirth, small for gestational age 

(SGA), and low birth-weight. The most recent SR/MA by Greenwood, et al., quantified the association between caffeine intake and adverse pregnancy outcomes from 

60 publications from 53 separate cohort (26) and case-control (27) studies. The evidence covered a variety of countries with caffeine intake categories that ranged from 

non-consumers to those consuming >1,000mg/day. They found that an increment of 

100 mg caffeine was associated with a 14% increased risk of miscarriage, 19% increased risk of stillbirth, 10% increased risk of SGA, and 7% increased risk of low 

birth weight. There was no significant increase in risk of preterm delivery. The 

magnitude of these associations was relatively small within the range of caffeine intakes of the majority women in the study populations, and the associations became 

more pronounced at higher range (>=300 mg/day). The authors also note the subVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00152 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
149 

stantial heterogeneity observed in the meta-analyses shows that interpretation of 

the results should be cautious. In addition, the results from prospective cohort studies and case-control studies were mixed together. Since coffee consumption is positively correlated with smoking, residual confounding by smoking may have biased 

the results toward a positive direction. 

The other SR/MAs did not cover all of the above pregnancy outcomes, but for 

those adverse outcomes covered, the results were in agreement with Greenwood, et 

al., Maslova (2010) reviewed 22 studies (15 cohort and 7 case-control studies) and 

found no significant association between caffeine intake and risk of pre-term birth 

in either casecontrol or cohort studies. For all of the observational studies assessed 

across the three SR/MAs, most studies did not adequately adjust for the pregnancy 

signal phenomenon, i.e., that nausea, vomiting, and other adverse symptoms are associated with a healthy pregnancy that results in a live birth, whereas pregnancy 

signal symptoms occur less frequently when the result is miscarriage. Coffee consumption decreases with increasing pregnancy signal symptoms, typically during 

the early weeks of pregnancy, and this confounds the association (Peck, et al. 2010). 

Greenwood, et al., state that this potential bias is the most prominent argument 

against a causal role for caffeine in adverse pregnancy outcomes. Only one randomized controlled trial of caffeine/coffee reduction during pregnancy has been conducted to date (Bech, 2007). The study found that a reduction of 200 mg of caffeine 

intake per day did not significantly influence birth weight or length of gestation. 

The trial did not examine other outcomes. 

Research Recommendations 

1. Evaluate the effects of coffee on health outcomes in vulnerable populations, 

such as women who are pregnant (premature birth, low birth weight, spontaneous abortion). 

2. Examine the effects of coffee on sleep patterns, quality of life, and dependency 

and addiction. 

3. Evaluate the prospective association between coffee/caffeine consumption and 

cancer at different sites. 

4. Examine prospectively the effects of coffee/caffeine on cognitive decline, 

neurodegenerative diseases, and depression. 

5. Understand the mechanisms underlying the protective effects of coffee on diabetes and CVD. 

6. Understand the association between coffee and health outcomes in individuals 

with existing CVD, diabetes, cancer, neurodegenerative diseases, or depressive symptoms. 

References 

1. Crippa A., Discacciati A., Larsson S.C., Wolk A., Orsini N. Coffee consumption and mortality from all causes, cardiovascular 

disease, and cancer: a dose-response meta-analysis. AM. J. EPIDEMIOL. 2014; 180(8):763–75. PMID: 25156996. http:// 

www.ncbi.nlm.nih.gov/pubmed/25156996. 

2. Je Y., Giovannucci E. Coffee consumption and total mortality: a meta-analysis of twenty prospective cohort studies. BR. J. NUTR. 

2014;111(7):1162–73. PMID: 24279995. http://www.ncbi.nlm.nih.gov/pubmed/24279995. 

3. Malerba S., Turati F., Galeone C., Pelucchi C., Verga F., La Vecchia C., et al. A meta-analysis of prospective studies of coffee 

consumption and mortality for all causes, cancers and cardiovascular diseases. EUR. J. EPIDEMIOL. 2013; 28(7):527–39. PMID: 

23934579. http://www.ncbi.nlm.nih.gov/pubmed/23934579. 

4. Ding M., Bhupathiraju S.N., Satija A., van Dam R.M., Hu F.B. Long-term coffee consumptionand risk of cardiovascular disease: 

a systematic review and a dose-response metaanalysisof prospective cohort studies. CIRCULATION. 2014; 129(6):643–59. PMID: 

24201300. http://www.ncbi.nlm.nih.gov/pubmed/24201300. 

5. Sofi F., Conti A.A., Gori A.M., Eliana Luisi M.L., Casini A., Abbate R., et al. Coffee consumption and risk of coronary heart disease: a meta-analysis. NUTR. METAB. CARDIOVASC. DIS. 2007; 17(3):209–23. PMID: 17156982. http://www.ncbi.nlm.nih.gov/ 

pubmed/17156982. 

6. Wu J.N., Ho S.C., Zhou C., Ling W.H., Chen W.Q., Wang C.L., et al. Coffee consumption and risk of coronary heart diseases: a 

meta-analysis of 21 prospective cohort studies. INT. J. CARDIOL. 2009; 137(3):216–25. PMID: 18707777. http:// 

www.ncbi.nlm.nih.gov/pubmed/18707777. 

7. Kim B., Nam Y., Kim J., Choi H., Won C. Coffee Consumption and Stroke Risk: A Meta-analysis of Epidemiologic Studies. KOREAN J. FAM. MED. 2012; 33(6):356–65. PMID: 23267421. http://www.ncbi.nlm.nih.gov/pubmed/23267421. 

8. Larsson S.C., Orsini N. Coffee consumption and risk of stroke: a dose-response meta-analysis of prospective studies. AM. J. 

EPIDEMIOL. 2011; 174(9):993–1001. PMID: 21920945. http://www.ncbi.nlm.nih.gov/pubmed/21920945. 

9. Mesas A.E., Leon-Munoz L.M., Rodriguez-Artalejo F., Lopez-Garcia E. The effect of coffee on blood pressure and cardiovascular 

disease in hypertensive individuals: a systematic review and meta-analysis. AM. J. CLIN. NUTR. 2011; 94(4):1113–26. PMID: 

21880846. http://www.ncbi.nlm.nih.gov/pubmed/21880846. 

10. Noordzij M., Uiterwaal C.S., Arends L.R., Kok F.J., Grobbee D.E., Geleijnse J.M. Blood pressure response to chronic intake of 

coffee and caffeine: a meta-analysis of randomizedcontrolled trials. J. HYPERTENS. 2005; 23(5):921–8. PMID: 15834273. http:// 

www.ncbi.nlm.nih.gov/pubmed/15834273. 

11. Steffen M., Kuhle C., Hensrud D., Erwin P.J., Murad M.H. The effect of coffee consumption on blood pressure and the development of hypertension: a systematic review and metaanalysis. J. HYPERTENS. 2012; 30(12):2245–54. PMID: 23032138. http:// 

www.ncbi.nlm.nih.gov/pubmed/23032138. 

12. Zhang Z., Hu G., Caballero B., Appel L., Chen L. Habitual coffee consumption and risk of hypertension: a systematic review 

and meta-analysis of prospective observational studies. AM. J. CLIN. NUTR. 2011; 93(6):1212–9. PMID: 21450934. http:// 

www.ncbi.nlm.nih.gov/pubmed/21450934. 

13. Cai L., Ma D., Zhang Y., Liu Z., Wang P. The effect of coffee consumption on serum lipids: a meta-analysis of randomized controlled trials. EUR. J. CLIN. NUTR. 2012; 66(8):872–7. PMID: 22713771. http://www.ncbi.nlm.nih.gov/pubmed/22713771. 

150 

14. Jee S.H., He J., Appel L.J., Whelton P.K., Suh I., Klag M.J. Coffee consumption and serum lipids: a meta-analysis of randomized controlled clinical trials. AM. J. EPIDEMIOL. 2001; 153(4):353–62. PMID: 11207153. http://www.ncbi.nlm.nih.gov/pubmed/ 

11207153. 

15. Caldeira D., Martins C., Alves L.B., Pereira H., Ferreira J.J., Costa J. Caffeine does not increase the risk of atrial fibrillation: 

a systematic review and meta-analysis of observational studies. HEART. 2013; 99(19):1383–9. PMID: 24009307. http:// 

www.ncbi.nlm.nih.gov/pubmed/24009307. 

16. Mostofsky E., Rice M.S., Levitan E.B., Mittleman M.A. Habitual coffee consumption and risk of heart failure: a dose-response 

meta-analysis. CIRC HEART FAIL. 2012;5(4):401–5. PMID: 22740040. http://www.ncbi.nlm.nih.gov/pubmed/22740040. 

17. Ding M., Bhupathiraju S.N., Chen M., van Dam R.M., Hu F.B. Caffeinated and decaffeinated coffee consumption and risk of 

type 2 diabetes: a systematic review and a dose-response meta-analysis. DIABETES CARE. 2014; 37(2):569–86. PMID: 24459154. 

http://www.ncbi.nlm.nih.gov/pubmed/24459154. 

18. Huxley R., Lee C.M., Barzi F., Timmermeister L., Czernichow S., Perkovic V., et al. Coffee, decaffeinated coffee, and tea consumption in relation to incident type 2 diabetes mellitus: a systematic review with meta-analysis. ARCH. INTERN. MED. 2009; 

169(22):2053–63. PMID: 20008687. http://www.ncbi.nlm.nih.gov/pubmed/20008687. 

19. Jiang X., Zhang D., Jiang W. Coffee and caffeine intake and incidence of type 2 diabetesmellitus: a meta-analysis of prospective 

studies. EUR. J. NUTR. 2014; 53(1):25–38. PMID: 24150256. http://www.ncbi.nlm.nih.gov/pubmed/24150256. 

20. van Dam R.M., Hu F.B. Coffee consumption and risk of type 2 diabetes: a systematic review. JAMA. 2005; 294(1):97–104. 

PMID: 15998896. http://www.ncbi.nlm.nih.gov/pubmed/15998896. 

21. Whitehead N., White H. Systematic review of randomised controlled trials of the effects of caffeine or caffeinated drinks on 

blood glucose concentrations and insulin sensitivity in people with diabetes mellitus. J. HUM. NUTR. DIET. 2013; 26(2):111–25. 

PMID: 23331476. http://www.ncbi.nlm.nih.gov/pubmed/23331476. 

22. Yu X., Bao Z., Zou J., Dong J. Coffee consumption and risk of cancers: a meta-analysis of cohort studies. BMC CANCER. 2011; 

11:96. PMID: 21406107. http://www.ncbi.nlm.nih.gov/pubmed/21406107. 

23. Tang N., Wu Y., Ma J., Wang B., Yu R. Coffee consumption and risk of lung cancer: a meta-analysis. Lung Cancer. 2010; 

67(1):17–22. PMID: 19362749. http://www.ncbi.nlm.nih.gov/pubmed/19362749. 

24. Sang L.X., Chang B., Li X.H., Jiang M. Consumption of coffee associated with reduced risk of liver cancer: a meta-analysis. 

BMC GASTROENTEROL. 2013; 13:34. PMID: 23433483. http://www.ncbi.nlm.nih.gov/pubmed/23433483. 

25. Bravi F., Bosetti C., Tavani A., Gallus S., La Vecchia C. Coffee reduces risk for hepato-cellular carcinoma: an updated metaanalysis. CLIN. GASTROENTEROL. HEPATOL. 2013; 11(11):1413–21.e1. PMID: 23660416. http://www.ncbi.nlm.nih.gov/pubmed/ 

23660416. 

26. Jiang W., Wu Y., Jiang X. Coffee and caffeine intake and breast cancer risk: an updated dose-response meta-analysis of 37 

published studies. GYNECOL. ONCOL. 2013; 129(3):620–9. PMID: 23535278. http://www.ncbi.nlm.nih.gov/pubmed/23535278. 

27. Li X.J., Ren Z.J., Qin J.W., Zhao J.H., Tang J.H., Ji M.H., et al. Coffee consumption and risk of breast cancer: an up-to-date 

meta-analysis. PLOS ONE. 2013; 8(1):e52681. PMID: 23308117. http://www.ncbi.nlm.nih.gov/pubmed/23308117. 

28. Tang N., Zhou B., Wang B., Yu R. Coffee consumption and risk of breast cancer: a meta-analysis. AM. J. OBSTET. GYNECOL. 

2009; 200(3):290.e1–9. PMID: 19114275. http://www.ncbi.nlm.nih.gov/pubmed/19114275. 

29. Cao S., Liu L., Yin X., Wang Y., Liu J., Lu Z. Coffee consumption and risk of prostate cancer: a meta-analysis of prospective cohort studies. CARCINOGENESIS. 2014; 35(2):256–61. PMID: 24343360. http://www.ncbi.nlm.nih.gov/pubmed/24343360. 

30. Zhong S., Chen W., Yu X., Chen Z., Hu Q., Zhao J. Coffee consumption and risk of prostate cancer: an up-to-date meta-analysis. EUR. J. CLIN. NUTR. 2014; 68(3):330–7. PMID: 24300907. http://www.ncbi.nlm.nih.gov/pubmed/24300907. 

31. Discacciati A., Orsini N., Wolk A. Coffee consumption and risk of nonaggressive, aggressive and fatal prostate cancer—a doseresponse meta-analysis. ANN. ONCOL. 2014; 25(3):584–91. PMID: 24276028. http://www.ncbi.nlm.nih.gov/pubmed/24276028. 

32. Park C.H., Myung S.K., Kim T.Y., Seo H.G., Jeon Y.J., Kim Y. Coffee consumption and risk of prostate cancer: a meta-analysis 

of epidemiological studies. BJU INT. 2010; 106(6):762–9. PMID: 20590551. http://www.ncbi.nlm.nih.gov/pubmed/20590551. 

33. Braem M.G., Onland-Moret N.C., Schouten L.J., Tjonneland A., Hansen L., Dahm C.C., et al. Coffee and tea consumption and 

the risk of ovarian cancer: a prospective cohort study and updated meta-analysis. AM. J. CLIN. NUTR. 2012; 95(5):1172–81. PMID: 

22440851. http://www.ncbi.nlm.nih.gov/pubmed/22440851. 

34. Bravi F., Scotti L., Bosetti C., Gallus S., Negri E., La Vecchia C., et al. Coffee drinking and endometrial cancer risk: a 

metaanalysis of observational studies. AM. J. OBSTET. GYNECOL. 2009; 200(2):130–5. PMID: 19110217. http:// 

www.ncbi.nlm.nih.gov/pubmed/19110217. 

35. Je Y., Giovannucci E. Coffee consumption and risk of endometrial cancer: findings from alarge up-to-date meta-analysis. INT. 

J. CANCER. 2012; 131(7):1700–10. PMID: 22190017. http://www.ncbi.nlm.nih.gov/pubmed/22190017. 

36. Zhou Y., Tian C., Jia C. A dose-response meta-analysis of coffee consumption and bladder cancer. PREV. MED. 2012; 55(1):14– 

22. PMID: 22564775. http://www.ncbi.nlm.nih.gov/pubmed/22564775. 

37. Turati F., Galeone C., Edefonti V., Ferraroni M., Lagiou P., La Vecchia C., et al. A meta-analysis of coffee consumption and 

pancreatic cancer. ANN. ONCOL. 2012; 23(2):311–8. PMID: 21746805. http://www.ncbi.nlm.nih.gov/pubmed/21746805. 

38. Dong J., Zou J., Yu X.F. Coffee drinking and pancreatic cancer risk: a meta-analysis of cohort studies. WORLD J. 

GASTROENTEROL. 2011; 17(9):1204–10. PMID: 21448427. http://www.ncbi.nlm.nih.gov/pubmed/21448427. 

39. Turati F., Galeone C., La Vecchia C., Garavello W., Tavani A. Coffee and cancers of the upper digestive and respiratory tracts: 

meta-analyses of observational studies. ANN. ONCOL. 2011; 22(3):536–44. PMID: 20943597. http://www.ncbi.nlm.nih.gov/pubmed/ 

20943597. 

40. Zheng J.S., Yang J., Fu Y.Q., Huang T., Huang Y.J., Li D. Effects of green tea, black tea, and coffee consumption on the risk of 

esophageal cancer: a systematic review and meta-analysis of observational studies. NUTR. CANCER. 2013; 65(1):1–16. PMID: 

23368908. http://www.ncbi.nlm.nih.gov/pubmed/23368908. 

41. Botelho F., Lunet N., Barros H. Coffee and gastric cancer: systematic review and meta-analysis. CAD. SAUDE. PUBLICA. 2006; 

22(5):889–900. PMID: 16680342. http://www.ncbi.nlm.nih.gov/pubmed/16680342. 

42. Galeone C., Turati F., La Vecchia C., Tavani A. Coffee consumption and risk of colorectal cancer: a meta-analysis of case-control studies. CANCER CAUSES CONTROL. 2010; 21(11):1949–59. PMID: 20680435. http://www.ncbi.nlm.nih.gov/pubmed/20680435. 

43. Je Y., Liu W., Giovannucci E. Coffee consumption and risk of colorectal cancer: a systematic review and meta-analysis of prospective cohort studies. INT. J. CANCER. 2009; 124(7):1662–8. PMID: 19115212. http://www.ncbi.nlm.nih.gov/pubmed/19115212. 

44. Li G., Ma D., Zhang Y., Zheng W., Wang P. Coffee consumption and risk of colorectal cancer: a meta-analysis of observational 

studies. PUBLIC HEALTH NUTR. 2013; 16(2):346–57. PMID: 22694939. http://www.ncbi.nlm.nih.gov/pubmed/22694939. 

45. Costa J., Lunet N., Santos C., Santos J., Vaz-Carneiro A. Caffeine exposure and the risk of Parkinson’s disease: a systematic 

review and meta-analysis of observational studies. J. ALZHEIMERS DIS. 2010;20 Suppl 1:S221–38. PMID: 20182023. http:// 

www.ncbi.nlm.nih.gov/pubmed/20182023. 

46. Ishihara L., Brayne C. A systematic review of nutritional risk factors of Parkinson’s disease. NUTR. RES. REV. 2005; 18(2):259– 

82. PMID: 19079910. http://www.ncbi.nlm.nih.gov/pubmed/19079910. 

47. Qi H., Li S. Dose-response meta-analysis on coffee, tea and caffeine consumption with risk of Parkinson’s disease. GERIATR. 

GERONTOL. INT. 2014; 14(2):430–9. PMID: 23879665. http://www.ncbi.nlm.nih.gov/pubmed/23879665. 

48. Arab L., Khan F., Lam H. Epidemiologic evidence of a relationship between tea, coffee, or caffeine consumption and cognitive 

decline. ADV. NUTR. 2013; 4(1):115–22. PMID: 23319129. http://www.ncbi.nlm.nih.gov/pubmed/23319129. 

49. Santos C., Costa J., Santos J., Vaz-Carneiro A., Lunet N. Caffeine intake and dementia: systematic review and meta-analysis. 

J. ALZHEIMERS DIS. 2010; 20 Suppl. 1:S187–204. PMID: 20182026. http://www.ncbi.nlm.nih.gov/pubmed/20182026. 

50. Greenwood D.C., Thatcher N.J., Ye J., Garrard L., Keogh G., King L.G., et al. Caffeine intake during pregnancy and adverse 

birth outcomes: a systematic review and dose-response meta-analysis. EUR. J. EPIDEMIOL. 2014; 29(10):725–34. PMID: 25179792. 

http://www.ncbi.nlm.nih.gov/pubmed/25179792. 

51. Maslova E., Bhattacharya S., Lin S.W., Michels K.B. Caffeine consumption during pregnancy and risk of preterm birth: a 

meta-analysis. AM. J. CLIN. NUTR. 2010; 92(5):1120–32. PMID: 20844077. http://www.ncbi.nlm.nih.gov/pubmed/20844077. 

151 

Analytical Framework 

Inclusion Criteria 

PubMed was searched for original research articles published in English in peerreviewed journals. Studies published since January 2000 with subjects who were 

healthy or at elevated chronic disease risk from countries with high or very high 

human development were considered. Study design was limited to systematic reviews or systematic reviews with meta-analyses. All other study designs were excluded. Studies were required to specify level of caffeine and included caffeine from 

any source. Both short- and long-term health outcomes were included. Studies that 

examined low-calorie diets and other treatment diets were excluded. Finally, studies 

were required to include a description of the dietary pattern along with sustainability or food security outcomes. 

Search Results 

ATTACHMENT 2

The Federal Advisory Committee Act (FACA) Brochure 

An Overview 

U.S. General Services Administration, 

Office of Governmentwide Policy, 

Committee Management Secretariat, 


11429016.eps 11429017.eps
152 

Washington, D.C. 20417 

Advisory committees have played an important role in shaping programs and policies of the Federal Government from the earliest days of the Republic. Since President George Washington sought the advice of such a committee during the Whiskey 

Rebellion of 1794, the contributions made by these groups have been impressive and 

diverse. 

Today, an average of 1,000 advisory committees with more than 60,000 members 

advise the President and the Executive Branch on such issues as the disposal of 

high-level nuclear waste, the depletion of atmospheric ozone, the national fight 

against Acquired Immune Deficiency Syndrome (AIDS), efforts to rid the nation of 

illegal drugs, to improve schools, highways, and housing, and on other major programs. 

Through enactment of the Federal Advisory Committee Act (FACA) of 1972 (Public Law 92–463), the U.S. Congress formally recognized the merits of seeking the 

advice and assistance of our nation’s citizens. At the same time, the Congress also 

sought to assure that advisory committees: 

• Provide advice that is relevant, objective, and open to the public; 

• Act promptly to complete their work; and 

• Comply with reasonable cost controls and record keeping requirements. 

Role of Federal Advisory Committees 

With the expertise from advisory committee members, federal officials and the nation have access to information and advice on a broad range of issues affecting federal policies and programs. The public, in return, is afforded an opportunity to provide input into a process that may form the basis for government decisions. 

Federal Agency Responsibility 

Each Federal agency that sponsors advisory committees must adhere to the requirements established by the FACA, as well as regulations promulgated by the 

U.S. General Services Administration’s (GSA) Committee Management Secretariat. 

GSA has had the responsibility for overseeing the FACA since 1977. 

GSA’s Role Under the FACA 

With approximately 1,000 advisory committees in existence at any given time, 

special attention is required to assure compliance with the FACA, the Freedom of 

Information Act, and related regulations, as well as to encourage effective and efficient use of committee resources. 

While Executive Branch departments and agencies are responsible for continually 

reviewing committee performance and compliance in these areas, the General Services Administration was designated by the President in 1977 to monitor committee 

activities government-wide. As part of this responsibility, GSA: 

• Conducts annual reviews of advisory committee activities and accomplishments; 

• Responds to requests from agencies on establishing new committees or the renewal of existing groups; and 

• Maintains a FACA database on the internet from which advisory committee information may be obtained. 

Together, GSA and the Federal community work to eliminate the overlap or duplication of advisory bodies, terminate unnecessary or inactive committees, and develop committee management regulations, guidelines, and training in response to 

requirements of the Executive Branch and Congress. 

Complying with FACA 

Any advisory group, with limited exceptions, that is established or utilized by a 

federal agency and that has at least one member who is not a Federal employee, 

must comply with the FACA. To find out if a group comes under the FACA, contact 

the sponsoring agency’s Committee Management Officer. The GSA Committee Management Secretariat is an additional resource (see the last section ‘‘For More Information . . .’’). 

Requirements for Establishing and Managing Advisory Committees 

Under the Federal Advisory Committee Act, advisory committees can be created 

only when they are essential to the performance of a duty or responsibility conveyed 

upon the Executive Branch by law or Presidential Directive. Before committees can 

be set up, high-level officials within the sponsoring agency must review and approve 

the request. Once a committee is approved, a charter is prepared outlining the committee’s mission and specific duties and forwarded to GSA’s Committee ManageVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00156 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
153 

ment Secretariat for final review. Following a required public notification period, 

and the filing of the charter with Congress, the committee may begin operation. 

Committee Management Officer and Designated Federal Officer 

The Federal Advisory Committee Act also provides that each agency sponsoring 

a federal advisory committee must appoint a Committee Management Officer to 

oversee the administration of the Act’s requirements. 

In addition, a Designated Federal Officer must be assigned to each committee to: 

• Ensure compliance with FACA, and any other applicable laws and regulations; 

• Call, attend, and adjourn committee meetings; 

• Approve agendas; 

• Maintain required records on costs and membership; 

• Ensure efficient operations; 

• Maintain records for availability to the public; and 

• Provide copies of committee reports to the Committee Management Officer for 

forwarding to the Library of Congress. 

Expiration of a Committee’s Charter 

Unless the renewal of a committee charter is justified under the FACA, the charter automatically expires after a 2 year period (or as otherwise provided by law). 

Advisory Committee Members 

Federal advisory committee members are drawn from nearly every occupational 

and industry group and geographical section of the United States and its territories. 

The FACA requires that committee memberships be ‘‘fairly balanced in terms of the 

points of view represented and the functions to be performed.’’ 

As a result, members of specific committees often have both the expertise and professional skills that parallel the program responsibilities of their sponsoring agencies. In balancing committee memberships, agencies are expected to consider a 

cross-section of those directly affected, interested, and qualified, as appropriate to 

the nature and function of the advisory committee. 

Appointing Committee Members 

Agency officials, Members of Congress, the general public, or professional societies 

or current and former committee members may nominate potential candidates for 

membership on a committee. 

Selection of committee members is made based on the FACA’s requirements and 

the potential member’s background and qualifications. Final selection is made by 

the president or heads of departments or agencies. 

Prior to accepting an appointment with a Federal advisory committee, each prospective member should clarify his/her role, obligations, duties, allowable expenses, 

compensation limitations, and any ethics requirements with their committee’s Designated Federal Officer and/or Committee Management Officer, as appropriate. 

Federal Ethics and Conflict of Interest Laws 

Agency officials must provide prospective advisory committee members with information regarding any applicable standards of conduct—including those imposed by 

federal conflict of interest statutes. In some instances, members may be subject to 

special limitations during the course of their service on an advisory committee. For 

some members, these restrictions also may apply (for limited periods) after their 

committee assignments have ended. 

Some agencies may impose additional administrative requirements as well. To 

avoid potential conflicts, each advisory committee member should assure that he or 

she receives adequate information from the sponsoring agency and completes any 

required appointment papers and disclosure forms prior to service on a committee. 

Oral briefings and other explanatory material may be obtained through the sponsoring agency’s Committee Management Officer, Designated Agency Ethics Official, 

or from the Office of Government Ethics, which has government-wide jurisdiction on 

federal ethics issues. 

Limits on Membership Terms 

Each agency may set limits (unless provided by law or Presidential Directive) on 

the lengths of terms for serving on advisory committees to allow for new membership. 

Open Access to Committee Meetings and Operations 

Under the provisions of the Federal Advisory Committee Act, Federal agencies 

sponsoring advisory committees must: 

154 

• Arrange meetings that are reasonably accessible and at convenient locations 

and times; 

• Publish adequate advance notice of meetings in the Federal Register; 

• Open advisory committee meetings to the public (with some exceptions—see the 

section on ‘‘Government in the Sunshine Act’’ below); 

• Make available for public inspection, subject to the Freedom of Information Act, 

papers and records, including detailed minutes of each meeting; and 

• Maintain records of expenditures. 

Government in the Sunshine Act 

Advisory committee meetings may be closed or partially closed to the public based 

upon provisions of the Government in the Sunshine Act of 1976 (Public Law 94– 

409). Examples of meetings that may be closed under the FACA are: 

• Those including discussions of classified information; 

• Reviews of proprietary data submitted in support of Federal grant applications; 

and 

• Deliberations involving considerations of personnel privacy. 

For More Information . . . 

For more information on the requirements of the Federal Advisory Committee 

Act, contact the General Services Administration’s Committee Management Secretariat at cms@gsa.gov or via the internet at: 

http://www.gsa.gov/faca; or 

http://www.gsa.gov/committeemanagement 

Examples of materials available on the Committee Management Secretariat 

website are: 

• Federal Advisory Committee Act (http://www.gsa.gov/portal/content/100916) 

• GSA Final Rule on Federal Advisory Committee Management (http:// 

www.gsa.gov/portal/content/104034) 

• Guidance documents 

• Access to the Federal Advisory Committee Act database (http:// 

www.facadatabase.gov/) 

• Information on the Federal Advisory Committee Act Training course (http:// 

www.gsa.gov/portal/content/162635). 

Other materials, such as samples of nominating letters and committee reports, 

are available from each sponsoring agency. 

(Accessed December 10, 2015.) 

ATTACHMENT 3

Office of the General Counsel Ethics Division 

Revised October 2004 (Previous Editions Obsolete) 

Ethics Rules for Advisory Committee Members and Other Individuals Appointed as Special Government Employees (SGEs) 

Introduction 

This summary has been prepared primarily for individuals appointed to serve as 

‘‘special Government employees’’ (SGEs) on Department of Health and Human Services (HHS) advisory committees or Presidential boards, councils, or commissions 

that are attached to HHS for purposes of administration. The information also will 

be useful to other SGEs without advisory committee responsibilities, such as ‘‘experts or consultants’’ or ‘‘personal services contractors.’’ 

New appointees, especially those that provide temporary, intermittent services 

only a few days a year, often are surprised by, or even resentful of, the complexity 

of the rules governing Federal employees. The ethics rules do not appear to many 

people to be logical, intuitive, or even, fair. Ignoring these rules, however, can result 

in serious consequences or embarrassment, both personally and for the Department. 

Criminal conflict of interest violations are ‘‘strict liability’’ offenses, and even an inadvertent, ‘‘technical’’ violation will require the initiation of an Inspector General investigation and possible referral to the Department of Justice. Moreover, the entire 

matter in which a violator participates may be considered so compromised that the 

Department may have to nullify, cancel, or retract any agency action that is perceived as tainted by the conflict. Therefore, if you have questions on any of the topVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00158 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
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ics covered in this guidance, you should consult with the Designated Federal Official 

responsible for your committee or the Deputy Ethics Counselor assigned to your operating or staff division. 

Definition of a Special Government Employee (SGE) 

A ‘‘special Government employee’’ is an officer or employee in the Executive 

Branch of the Federal Government who is appointed to perform temporary duties, 

with or without compensation, for a period not to exceed 130 days during any period 

of 365 consecutive days. 18 U.S.C. § 202(a). This status is important because the 

ethics rules for SGEs are somewhat less restrictive than the rules for other Federal 

employees and officials. Some members of advisory committees are appointed for a 

multi-year term. During each year of their term of appointment, committee members generally will not be expected to perform work for HHS in excess of 130 days 

during any period of 365 consecutive days. Thus, most committee members will be 

considered ‘‘SGEs.’’ 

In addition, individuals who provide advice as an ‘‘expert or consultant’’ or render 

assistance under a ‘‘personal services contract’’ for a period that is not expected to 

exceed 130 days do so as the functional equivalent of an employee and thus are 

treated as SGEs for ethics purposes. Only ‘‘true’’ independent contractors are excluded from the definition. Although several factors are evaluated to determine 

independent contractor status, this category, for the most part, comprises individuals who produce a defined ‘‘end product’’ or ‘‘deliverable’’ without detailed supervision by a Federal employee. 

Financial Disclosure Reporting Requirements 

HHS advisory committee members appointed as SGEs are required under the 

Ethics in Government Act, as amended by the Ethics Reform Act of 1989, and 5 

CFR Part 2634, to file a financial disclosure report when first appointed and annually thereafter on the anniversary date of their appointment. Committee members 

also may be required to update the information on the report before each meeting 

throughout their term of appointment. (Certain committee members are permitted 

to utilize an alternative reporting system, e.g., FDA Form 3410, that focuses solely 

on each filer’s assets and associational interests that are directly implicated by the 

subjects on the meeting agenda.) The information reported is used to determine the 

matters for which a committee member must be disqualified under the criminal financial conflict of interest statute, 18 U.S.C. § 208(a), and the matters for which a 

committee member may be granted a waiver under 18 U.S.C. § 208(b). 

Complete reporting is essential to protect the committee member from inadvertently violating any of the criminal conflict of interest statutes, and to assure the 

public that the advice provided by an HHS advisory committee is free from any real, 

or perceived, conflicts of interest. The information reported by committee members 

is confidential and may not be released except under the limited circumstances described in the Privacy Act notice provided with the report or by order of a Federal 

court. (SGEs who serve more than 60 days in any period of 365 consecutive days 

and who are compensated at certain pay levels may be required to file a publicly 

available financial disclosure report.) 

Criminal Conflict of Interest Statutes 

The following criminal conflict of interest statutes apply to SGEs: 

18 U.S.C § 201. Section 201, commonly known as the ‘‘bribery and illegal gratuities’’ statute, prohibits Federal employees, including SGEs, from seeking, accepting, 

or agreeing to receive anything of value in return for being influenced in the performance of an official act. 

18 U.S.C. § 203. Section 203 prohibits an SGE from receiving compensation for 

representational services rendered by the employee or another person before HHS 

or another Federal agency or other specified entity (such as a court or commission) 

in any particular matter involving a specific party (i) in which the SGE has participated personally and substantially as a government employee, or (ii) which is pending in the government agency in which the SGE is serving if the SGE has served 

for more than 60 days during the immediately preceding 365 days. 

Exempted from this rule are representations required in the proper discharge of 

official duties. Also exempted are representations determined by the head of the 

agency to be required in the performance of work under a grant, contract or other 

agreement with or for the benefit of the government. 

A particular matter involving specific parties is a matter that is focused upon the 

interests of identified persons in a specific proceeding or an isolatable transaction 

or related set of transactions. Examples include, but are not limited to, reviews of 

grant proposals or contract applications, or similar funding decisions; recommendations or approvals of scientific studies, projects, clinical trials, new drug applicaVerDate Mar 15 2010 16:18 Dec 10, 2015 Jkt 041481 PO 00000 Frm 00159 Fmt 6621 Sfmt 6621 P:\DOCS\114-29\97182.TXT BRIAN
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tions; and other actions that involve deliberation, decision, or action affecting the 

legal rights of identified parties. 

In contrast, a particular matter of general applicability is a matter that is focused 

on the interests of a discrete and identifiable class of persons or entities, but does 

not involve specific parties. Examples include recommendations or consideration of 

legislative proposals, regulatory initiatives, or policy development that affect an industry, group of manufacturers, or health care providers. 

Pay close attention to which type of particular matter is involved in your assignment because the ethics rules may differ depending upon whether a ‘‘specific party 

matter’’ or a ‘‘general policy matter’’ is involved. The terms ‘‘matter’’ or ‘‘particular 

matter,’’ without more description, are deemed to encompass both types. 

Representational services include communications (written or oral) and appearances made on behalf of someone else, generally with the intent to influence or persuade the government. An inquiry as to the status of a pending matter is not necessarily a representation, although depending upon the context of the inquiry, it 

could give rise to the appearance of a prohibited representation. 

To avoid appearance problems, during the period in which a committee is in session, committee members are advised not to contact Department staff concerning 

any matters pending before the agency, or as to which the agency has an interest. 

Such matters would include, for example, applications for Federal funding, progress 

reports regarding Cooperative Research and Development Agreements (CRADAS) or 

clinical trials, and pending drug investigations or applications. 

18 U.S.C. § 205. Section 205 prohibits an SGE from representing a party, with or 

without compensation, before HHS or another Federal agency or other specified entity (such as a court or commission) in any particular matter involving a specific 

party in which the United States is a party or has a direct and substantial interest: 

(i) that the SGE participated in personally and substantially as a government employee; or (ii) which is pending in the agency in which the SGE is serving, if the 

SGE has served for more than 60 days during the immediately preceding 365 days. 

18 U.S.C. § 207. Section 207, the ‘‘post-employment’’ statute, imposes a lifetime 

ban on a former SGE from representing another person or entity to HHS or another 

Federal agency or other specified entity (such as a court or commission) in any particular matter involving a specific party in which the former SGE participated personally and substantially while serving in the government. In addition, for two 

years after terminating Federal employment, an SGE may not make such representational communications to the government regarding specific party matters that 

were pending under his or her official responsibility during the last year of government service. Moreover, ‘‘senior employees,’’ those paid at an annual rate equivalent 

to level ES–5 in the Senior Executive Service, are subject to a one-year ‘‘cooling-off’’ 

period which precludes any contacts with their former agency on any matter for 

which official action is sought, even if the former employee had no involvement with 

the matter while in government service. For SGEs, this one-year ‘‘cooling-off’’ period 

does not apply if the SGE served less than 60 days in the one-year period prior to 

termination of senior employee status. 

18 U.S.C. § 208. Section 208(a), the main conflict of interest statute, prohibits an 

SGE from participating personally and substantially in any particular matter that 

could affect the financial interests of the SGE, the SGE’s spouse, minor child, general partner, an organization in which the SGE serves as an officer, director, trustee, general partner, or employee, or an organization with which the SGE is negotiating or with which the SGE has an arrangement for prospective employment. 

Under this statute, for example, an SGE would be prohibited from reviewing a 

grant application submitted by a researcher from the same university in which the 

SGE is employed, or a contract proposal from an association for which the SGE 

serves as a member of the board of directors. In these instances, the SGE would 

be required to recuse from participation in the reviews. 

Section 208 might also prohibit the SGE from participating in setting standards 

for grantees or contractors in general, to the extent that the SGE’s university (or 

any organization with which the SGE is affiliated as an officer or board member) 

would be affected by those standards. (Under this scenario, however, a waiver could 

be issued to permit the SGE to participate in such general policy matters. Also, a 

regulatory waiver might apply to this situation. See discussion below.) 

A waiver for advisory committee members may be granted under 18 U.S.C. 

§ 208(b)(3). Section 208(b)(3) authorizes issuance of a waiver to an SGE who serves 

on a committee subject to the Federal Advisory Committee Act if the official responsible for the individual’s appointment certifies in writing that the need for the individual’s services outweighs the potential for a conflict of interest created by the particular financial interest involved. The waiver granted is considered a ‘‘general’’ 

waiver, in that it allows participation in matters that affect all institutions, or types 

157 

of institutions, similarly. Even with a general waiver, however, SGEs must disqualify themselves from participation in all matters that specifically and uniquely 

affect their financial interests. 

The Designated Federal Official responsible for a committee will explain the procedures for disqualification. SGEs who do not serve on advisory committees are subject to more exacting waiver requirements in 18 U.S.C. § 208(b)(1), and a Deputy 

Ethics Counselor should be consulted. 

In addition, under regulations issued by the Office of Government Ethics, a regulatory (i.e., automatic) waiver of the disqualification requirement of 18 U.S.C. § 208 

is available under certain circumstances, including instances involving the following 

classes of financial interests: 

• interests held in broadly diversified investment funds; 

• publicly traded securities of $15,000 or less; 

• publicly traded securities of $25,000 or less if the matter is a general policy 

matter and the total value of all investments in the affected industry sector is 

no more than $50,000; 

• employment in one campus of a multi-campus state university if the matter affects only another campus and the employee does not have multi-campus responsibilities. 

In addition, there is an automatic exemption which allows SGEs serving on Federal advisory committees to participate in particular matters of general applicability 

where the otherwise disqualifying financial interest arises solely from the committee 

member’s non-Federal employment or prospective employment, provided that the 

matter will not have a special or distinct effect on the employee or employer other 

than as part of a class. This exemption is unavailable if the employee (or those persons whose interests are imputed to the employee) owns stock, stock options, or has 

some other financial interest in the employer other than his or her employment interest. 

18 U.S.C § 219. Section 219 prohibits an SGE from acting as an ‘‘agent of a foreign principal’’ as defined under the Foreign Agents Registration Act (FARA) or a 

‘‘lobbyist’’ on behalf of a foreign entity that is required to register under the Lobbying Disclosure Act of 1995 (LDA). 

The ban on participating in foreign agent activities covered by FARA prohibits 

representation of foreign governments or foreign political parties before the United 

States Government, as well as a number of other activities conducted within the 

United States on behalf of such entities: (1) political activities; (2) public relations 

counseling; (3) publicity agent activities; (4) information services; (5) political consulting; and (6) solicitation or disbursement of contributions, loans, money, or other 

things of value; where such services are rendered with the intent to influence the 

American public or the government, with reference to formulating the domestic or 

foreign policies of the United States, or with reference to the political or public interests, policies or relations of a government of a foreign country or a foreign political party. 

There are certain FARA exceptions related to trade or commerce, legal representation, humanitarian fundraising, and religious, scholastic, or scientific pursuits. 

The head of an agency may authorize the employment of an agent for a foreign entity as a special government employee upon a certification that such action is in the 

national interest. The LDA ban prohibits certain lobbying of covered legislative and 

executive branch officials on behalf of foreign corporations, associations, or other organizations. 

Standards of Ethical Conduct 

In addition to criminal statutes, the conduct of SGEs is governed by a series of 

ethics rules that apply 24 hours per day and even on days during which the SGE 

provides no Federal services. The following are some of the major Standards of Ethical Conduct regulations (5 CFR Part 2635) that pertain to HHS SGE advisory committee members during the term of their appointment: 

I. Teaching, Speaking and Writing in a Personal Capacity (i.e., Other Than as a 

Government Employee) 

Generally, during their term of appointment, committee members may continue 

to receive fees, honoraria, and other compensation for teaching, speaking and writing undertaken in their personal or non-governmental capacities. However, there 

are some limitations: 

158 

(A) An SGE is prohibited from receiving compensation for teaching, speaking, 

and writing that ‘‘relates to the employee’s official duties.’’ 5 CFR § 2635.807. 

The ‘‘relatedness’’ test is met for an SGE if: 

(1) the activity is undertaken as an official government duty; 

(2) the circumstances indicate that the invitation to engage in the activity 

was extended to the SGE primarily because of the employee’s position in 

the government rather than the employee’s expertise in the particular subject matter; 

(3) the invitation to engage in the activity or the offer of compensation 

for the activity was extended to the employee, directly or indirectly, by a 

person who has interests that may be affected substantially by the performance or nonperformance of the employee’s official duties; or 

(4) the information conveyed through the activity draws substantially on 

ideas or official data that are confidential or not publicly-available. 

(B) Additionally, if a committee member serves for 60 days or less during a 

one-year period, the SGE may not accept compensation for teaching, speaking, 

and writing if the subject matter of the teaching, speaking or writing concerns 

a particular matter involving specific parties in which the SGE participated or 

is participating personally and substantially as a government employee. 

For example, an AIDS researcher has been appointed to a 4 year term as a 

member of an advisory committee established for the purpose of surveying and 

recommending modification of procedures that deter the development of treatments for HIV infection and HIV-related diseases. The committee member is 

not expected to serve more than 60 days each year during her 4 year term of 

appointment. 

The committee member may accept compensation for an article or speech 

about the deterrent effect of certain procedures required for clinical investigations and trial designs even though such issues are being discussed by the advisory committee. Clinical procedures in general are not a particular matter involving specific parties. The committee member could not accept compensation 

for an article or speech which recounts committee deliberations that took place 

in a closed meeting, or which relies upon other, non-public information. In addition, the committee member could not accept compensation for an article or 

speech about specific collaborations in the HIV drug development process which 

were discussed by the committee, since the collaborations are considered a particular matter involving specific parties. 

(C) If a committee member serves for more than 60 days, the SGE is additionally prohibited from receiving compensation for teaching, speaking, and 

writing if the subject of the activity deals in significant part with any matter 

to which the SGE is presently assigned or was assigned during the previous 

one-year period. 

Exceptions: 

1. This rule does not preclude a committee member from receiving compensation 

for teaching, speaking, or writing on a subject within the committee member’s 

discipline or inherent area of expertise based on the SGE’s educational background or experience. The outside activity must not be about or distinctly related to the work the SGE is providing to the government. 

2. These restrictions also do not apply to teaching a course requiring multiple 

presentations that is part of the regularly established curriculum of an institution of higher education, an elementary or secondary school, or a program 

of education or training sponsored and funded by the Federal, State, or local 

government. 

II. Gifts 

Any gift given to a committee member because of the member’s service on an 

HHS advisory committee would raise concerns. The Designated Federal Official responsible for the committee should be consulted should this situation arise. Gifts 

given to an SGE because of the SGE’s position or achievements in the private (nongovernment) sector generally are not problematic. 

III. Charitable Fundraising 

A committee member may engage in charitable fundraising in a personal capacity 

as long as the committee member does not personally solicit funds or other support 

from any person or entity known to the committee member to be a person or entity 

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ance of the committee member’s Federal duties. 5 CFR § 2635.808. If specific questions concerning particular fundraising events or activities should arise, the Designated Federal Official responsible for the committee should be consulted. 

IV. Expert Witness 

A committee member cannot serve as an expert witness, in a proceeding before 

a United States court or agency in which the United States is a party or has a direct 

and substantial interest, except on behalf of the United States, if the committee 

member participated, while a Federal employee, in the particular proceeding, unless 

authorized by the HHS Designated Agency Ethics Official (DAEO), who can be 

reached at (202) 690–7258. 

In addition, a committee member who was appointed by the President, serves on 

a commission established by statute, or has served or is expected to serve for more 

than 60 days in a period of 365 consecutive days, cannot serve, other than on behalf 

of the United States, as an expert witness, with or without compensation, in any 

proceeding before a United States court or agency in which the committee 

members’s employing agency is a party or has a direct and substantial interest unless authorized by the DAEO. 5 CFR § 2635.805. 

V. Impartiality 

Although committee members are prohibited under 18 U.S.C. § 208(a) from participating in matters in which they have a financial interest, there may be other 

circumstances in which a committee member’s participation in a particular matter 

involving specific parties would raise a question regarding the member’s impartiality 

in the matter. For example, a committee member asked to review a grant application submitted by the SGE’s mentor, or someone with whom the SGE has a close 

personal or professional relationship, would raise a concern about the committee 

member’s impartiality in the review. In such circumstances, the committee member 

should discuss the relationship with the Designated Federal Official responsible for 

the committee and a determination will be made as to whether the member should 

be disqualified from participation in the specific party matter, or should be granted 

an ‘‘authorization’’ to permit the member to participate in such matter. 5 CFR 

§ 2635.502. 

VI. Misuse of Position 

Committee members are subject to a number of prohibitions intended to address 

the use, or appearance of use, of ‘‘public office for private gain.’’ 5 CFR Part 2635, 

Subpart G. These prohibitions include: 

(A) Using their HHS titles or referring to their government positions for their 

own private gain, the private gain of friends, relatives, or anyone with whom 

they are affiliated in a non-governmental capacity (including nonprofit organizations which they serve as officers, members, employees, or in any other 

business relationship), or for the endorsement of any product, service, or enterprise. 

(B) Using their HHS titles or government positions to coerce or induce another 

person to provide any benefit to themselves or another person. 

(C) Using non-public government information in a financial transaction to further their private interests or those of another, or disclosing confidential or 

non-public information without authorization. 

(D) Using government property for unauthorized purposes. 

Employment by, or Gifts from, Foreign Governments 

The Constitution prohibits a committee member’s employment by a foreign government, including political subdivisions of a foreign government. For SGEs, this 

provision has particular relevance to positions with foreign universities that are government-operated, as opposed to private institutions. United States Constitution, 

art. I § 9, cl. 8. There are also statutory provisions restricting acceptance of gifts 

from foreign governments. 5 U.S.C. § 7342. Committee members should consult with 

the Designated Federal Official responsible for their committee for details about 

these restrictions. Employment or consultation with a foreign entity for the purpose 

of providing foreign agent representation or lobbying is barred by a criminal statute; 

see the discussion above concerning 18 U.S.C. § 219. All SGEs are required to complete HHS Form 697, Foreign Activities Questionnaire, for the purpose of determining whether a committee member’s foreign connections are incompatible with 

Federal service. 

160 

Lobbying Activities 

In their official capacities or as a group, committee members are prohibited from 

engaging in any activity which directly or indirectly encourages or directs any person or organization to lobby one or more members of Congress. 18 U.S.C. § 1913. 

When authorized, committee members may appear before any individual or group 

for the purpose of informing or educating the public about a particular policy or legislative proposal. Committee members also may communicate to Members of Congress at the request of any Representative or Senator. Communications to Members 

of Congress initiated by committee members, in their official capacity as members 

of the committee, should be coordinated through the Office of the Assistant Secretary for Legislation. 

As private citizens, committee members may express their personal views (but not 

the views of the committee as a whole or the opinions of HHS) to anyone. In doing 

so, committee members may state their affiliation with the committee, may factually 

state the committee’s official position on the matter (to the extent that non-public 

information is not used), but may not take new positions and represent those views 

as the committee’s position on the matter. Moreover, in expressing their private 

views, as with all other personal (non-governmental) activities, committee members 

are not permitted to use government computers, copiers, telephones, letterhead, 

staff resources, or other appropriated funds. All personal activities must occur ‘‘off 

duty time.’’ 

Committee members are prohibited in their personal capacities from making representations on behalf of others, to the government, on particular matters involving 

specific parties in which they were involved as Federal employees. (See discussion 

above under 18 U.S.C. §§ 203 and 205.) 

Political Activities 

The Hatch Act (5 U.S.C. §§ 7321–7326) prescribes the restrictions on certain political activities of Federal employees (see the explanatory chart on the following 

page). Unlike the criminal conflict of interest statutes and the ethics rules which 

are fully applicable to an SGE throughout the SGE’s entire term of appointment, 

the Hatch Act restrictions apply only during the period of any day in which the SGE 

actually is performing government business. For example, if an SGE attends an advisory committee meeting from 8:00 a.m.–1:00 p.m., the SGE could attend a political 

fund raiser at 3:00 p.m. and even solicit political contributions from the attendees. 

A series of criminal political statutes (18 U.S.C. §§ 595, 600–603, 606–607, 

610) applies to SGEs even on non-duty hours. These sections, which focus 

on patronage crimes and election offenses, prohibit coercive ‘‘political 

shakedowns,’’ intimidation regarding political activities, campaign fundraising on Federal property, and the use of public office or authority for 

the purpose of affecting the outcome of an election. 

Hatch Act Political Activity Restrictions 

Permissible Activities Prohibited Activities (while on duty) 

• May be candidates for public office in nonpartisan 

elections 

• May not use their official authority to interfere with 

an election. 

• May register and vote as they choose. 

• May assist in voter registration drives. 

• May express opinions about candidates and issues. 

• May contribute money to political organizations. 

• May not collect political contributions, unless both individuals are members of the same Federal labor organization and the one solicited is not a subordinate 

employee. 

• May attend and be active at political rallies and 

meetings. 

• May attend political fund raising functions. 

• May not knowingly solicit or discourage the political 

activity of any person who has business before the 

agency. 

• May join and be an active member of a political 

party or club. 

• May sign nominating petitions. 

• May not engage in political activity while on duty. 

• May not engage in political activity in any government 

office. 

• May campaign for or against referendum questions, 

constitutional amendments, municipal ordinances. 

• May not engage in political activity while wearing an 

official uniform. 

• May campaign for or against candidates in partisan 

elections. 

• May not engage in political activity while using a government vehicle. 

• May distribute campaign literature in partisan elections. • May not solicit political contributions from the general 

public. 

• May hold office in political clubs or parties (except 

Treasurer). 

• May not actively participate as a candidate for public 

office in a partisan election. 

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ATTACHMENT 4

Initial Meeting Materials 

Charge to the 2015 Dietary Guidelines Advisory Committee 

The Dietary Guidelines for Americans provide science-based advice on how nutrition and physical activity can help promote health and reduce the risk for major 

chronic diseases. The Guidelines form the basis of Federal nutrition policy, standards, programs, and education for the general public. The Dietary Guidelines are 

published jointly by the U.S. Department of Health and Human Services and the 

U.S. Department of Agriculture every 5 years. 

The Dietary Guidelines Advisory Committee (DGAC), whose duties are time-limited and solely advisory in nature, will: 

• Examine the Dietary Guidelines for Americans, 2010 and determine topics for 

which new scientific evidence is likely to be available that may inform revisions 

to the current guidance or suggest new guidance. 

• Place its primary focus on the systematic review and analysis of the evidence 

published since the last DGAC deliberations. 

• Place its primary emphasis on the development of food-based recommendations 

that are of public health importance for Americans ages 2 years and older. 

• Prepare and submit to the Secretary of Health and Human Services and the 

Secretary of Agriculture a report of technical recommendations, with rationales, 

to inform the development of the 2015 Dietary Guidelines for Americans. DGAC 

responsibilities include providing authorship for this report; however, responsibilities do not include translating the recommendations into policy or into 

communication and outreach documents or programs. 

• Disband upon the submittal of the Committee’s recommendations via the Report 

of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for 

Americans, 2015 to the Secretaries. 

• Complete all work within the required 2 year charter time frame. 

(Accessed December 10, 2015.) 

ATTACHMENT 5

Charter 

2015 Dietary Guidelines Advisory Committee Authority 

The 2015 Dietary Guidelines Advisory Committee (the Committee or 2015 DGAC) 

is authorized under 42 U.S.C. 217a, Section 222 of the Public Health Service Act, 

as amended. The Committee is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C., App.), which sets 

forth standards for the formation and use of advisory committees. 

Objectives and Scope of Activities 

Under Section 301 of Public Law 101–445 (7 U.S.C. 5341, the National Nutrition 

Monitoring and Related Research Act of 1990, Title III) the Secretaries of Health 

and Human Services (HHS) and Agriculture (USDA) are directed to jointly issue at 

least every 5 years a report entitled Dietary Guidelines for Americans. The law instructs that this publication shall contain nutritional and dietary information and 

guidelines for the general public, shall be based on the preponderance of scientific 

and medical knowledge current at the time of publication, and shall be promoted 

by each Federal agency in carrying out any Federal food, nutrition, or health program. The Dietary Guidelines for Americans was issued voluntarily by HHS and 

USDA in 1980, 1985, and 1990; the 1995 edition was the first statutorily mandated 

report, followed by subsequent editions at the appropriate intervals. 

The 2015 DGAC is established to provide independent, science-based advice and 

recommendations for development of the Dietary Guidelines for Americans, 2015, 

which forms the basis of Federal nutrition programs, nutrition standards, and nutrition education for the general public. A variety of services and tools will be made 

available to the Committee to support development of recommendations that promote health and reduce chronic disease risk for Americans. The USDA Nutrition 

Evidence Library will assist the Committee in conducting and creating a transparent database of systematic reviews reflecting the most current research available 

on a wide range of food and nutrition-related topics to inform its recommendations. 

162 

Description of Duties 

The work of the Committee will be solely advisory in nature and time-limited. The 

Committee will examine the current Dietary Guidelines for Americans, take into 

consideration new scientific evidence and current resource documents, and then develop a report to be submitted to the Secretaries that outlines its science-based recommendations and rationale which will serve as a basis for developing the eighth 

edition of Dietary Guidelines for Americans. 

Agencies or Officials to Whom the Committee Reports 

The HHS Assistant Secretary for Health and USDA Under Secretaries of the 

Food, Nutrition, and Consumer Services (FNCS) and Research, Education and Economics (REE) will provide guidance and oversight for the Committee’s function and 

activities. 

Support 

Management and support services for the 2015 DGAC primarily will be provided 

by the Office of Disease Prevention and Health Promotion (ODPHP) within the Department of Health and Human Services. The ODPHP is a program office within 

Office of the Assistant Secretary for Health (OASH), which is a staff division in 

HHS Office of the Secretary. Responsibility for administrative services will be 

shared with staffs of the USDA FNCS and REE. USDA administrative leadership 

and Nutrition Evidence Library support will come from the Center for Nutrition Policy and Promotion within FNCS. REE agencies will provide administrative and data 

analysis support. 

Estimated Annual Operating Costs and Staff Years 

The estimated annual HHS cost for operating the DGAC, including travel and per 

diem expenses for members, but excluding staff support is $400,000. It is estimated 

that the annual person-years of HHS staff support required is 4.4 FTEs, at an estimated cost of $430,000. 

Designated Federal Officer 

The HHS Assistant Secretary for Health will appoint two Co-Executive Secretaries from HHS, one of whom will serve as the Designated Federal Officer (DFO). 

USDA Under Secretaries of FNCS and REE will appoint two Co-Executive Secretaries from USDA, one from the Center for Nutrition Policy and Promotion, who will 

serve as the lead for USDA, and the other from the Agricultural Research Service. 

Since HHS has responsibility for providing management support for the 2015 

DGAC, the HHS Co-Executive Secretaries will, in collaboration with the USDA CoExecutive Secretaries, schedule and approve all meetings of the 2015 DGAC, and 

make logistical arrangements that are necessary for public meetings of the 2015 

DGAC, including meetings of any established subgroups. The DFO, in collaboration 

with the USDA Co-Executive Secretaries, will prepare and approve all meeting 

agendas; development of the meeting agenda also can include consultation with the 

Committee Chair. 

The DFO or other official to whom the authority has been delegated will be 

present at all meetings of the full Committee and any subgroups that have been 

established to assist the Committee. The DFO has authority to adjourn meetings, 

when it is determined to be in the public interest, and may also chair the committee 

meetings when directed to do so by the Assistant Secretary for Health and/or other 

authorized official. 

Estimated Number and Frequency of Meetings 

It is estimated that the 2015 DGAC will meet approximately five times during 

the projected period for its operation. More meetings will be held if it is necessary 

to accomplish the mission of the Committee and funds are available to support additional meetings. It is required that 2⁄3 of the appointed members be present for the 

Committee to meet to conduct business. Meetings will be open to the public, except 

as determined otherwise by the Secretaries of HHS and USDA or other official to 

whom this authority has been delegated, in accordance with guidelines under Government in the Sunshine Act at 5 U.S.C. 552b(c) and the FACA. Notice of all meetings will be provided to the public. Meetings will be conducted and records of the 

proceedings will be kept, as required by applicable laws and Departmental policies. 

Duration 

The 2015 DGAC is established to accomplish a single, time-limited task. It is expected that the Committee will complete the mission for which it was established 

within two years from the date this charter is filed. 

163 

Termination 

Unless renewed by appropriate action prior to its expiration, the 2015 DGAC will 

terminate after delivery of its final report to the Secretaries of HHS and USDA or 

2 years from the date this charter is filed, whichever comes first. 

Membership and Designation 

The 2015 DGAC will consist of not more than 17 members, with the minimum 

number being 13; one or more members will be selected to serve as the Chair, Vice 

Chair, and/or Co-Chairs. Individuals will be selected to serve as members of the 

Committee who are familiar with current scientific knowledge in the field of human 

nutrition and chronic disease. Expertise will be sought in specific specialty areas 

that may include but are not limited to cardiovascular disease; type 2 diabetes; overweight and obesity; osteoporosis; cancer; pediatrics; gerontology; maternal/gestational nutrition; epidemiology; general medicine; energy balance, which includes 

physical activity; nutrient bioavailability; nutrition biochemistry and physiology; 

food processing science, safety and technology; public health; nutrition education 

and behavior change; and/or nutrition-related systematic review methodology. 

Members will be invited to serve for the duration of the Committee. Individuals 

who are appointed to serve as members of the Committee will be jointly agreed 

upon by the Secretaries of HHS and USDA. All appointed members of the 2015 

DGAC will be classified as special government employees (SGEs). 

Pursuant to an advance written agreement, the appointed members will receive 

no compensation for the advisory service they render during their tenure on the 

2015 DGAC. However, as authorized by law and in accordance with Federal travel 

regulations, members of the 2015 DGAC will receive per diem and reimbursement 

for travel expenses incurred while performing duties and/or conducting business related to the Committee. 

Subcommittees/Working Groups 

To accomplish its mission, and with approval of the official to whom authority has 

been given, the 2015 DGAC may establish subcommittees and/or working groups 

that are composed of members of the parent committee and non-member special 

consultants and/or individuals with demonstrated expertise in the specialty areas 

designated for the Committee membership. 

The established subgroups will provide advice and/or make recommendations to 

the parent committee. All reports and recommendations developed by an established 

subgroup of the 2015 DGAC must be submitted to the parent committee for the appropriate action to be taken. An established subgroup may not report its findings 

to any Federal official unless there is specific statutory authority for such reporting. 

The Department Committee Management Officer will be notified if any subgroup 

is established for the 2015 DGAC, and will be provided information regarding the 

name of the subgroup, function, membership, and estimated frequency of meetings. 

Recordkeeping 

Records of the Committee and any established subgroup will be handled in accordance with General Records Schedule 26, Item 2 or other approved agency records 

disposition schedule. These records will be made available to the public for inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552. 

Filing Date: February 19, 2013 

Approved 

January 9, 2013 //s// 

Date KATHLEEN SEBELIUS

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