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DIETARY SUPPLEMENTS: NATURE’S ANSWER TO

COST EFFECTIVE PREVENTATIVE MEDICINE

HEARING

BEFORE THE

SUBCOMMITTEE ON HUMAN RIGHTS AND

WELLNESS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

SEPTEMBER 22, 2004

Serial No. 108–270

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNET, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS

DAN BURTON, Indiana, Chairman

CHRIS CANNON, Utah

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

DIANE E. WATSON, California

BERNARD SANDERS, Vermont

(Independent)

ELIJAH E. CUMMINGS, Maryland

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

MARK WALKER, Chief of Staff

MINDI WALKER, Professional Staff Member

DANIELLE PERRAUT, Clerk

RICHARD BUTCHER, Minority Professional Staff Member

(III)

C O N T E N T S

Page

Hearing held on September 22, 2004 ..................................................................... 1

Statement of:

Coates, Paul, Ph.D., Director, Office of Dietary Supplements, National

Institutes of Health, U.S. Department of Health and Human Services ... 9

Dobson, Allen, Ph.D., senior vice president, the Lewin Group; Jeffrey

Blumberg, Ph.D., professor, Friedman School of Nutrition Science and

Policy, Tufts University; Barbara Levine, R.D, Ph.D., associate professor of nutrition in medicine, Weill College of Medicine; Elliott Balbert,

president, Dietary Supplements Education Alliance; and Marilu

Henner, actress, nutrition and diet expert ................................................. 22

Letters, statements, etc., submitted for the record by:

Balbert, Elliott, president, Dietary Supplements Education Alliance, prepared statement of ........................................................................................ 59

Blumberg, Jeffrey, Ph.D., professor, Friedman School of Nutrition Science

and Policy, Tufts University, prepared statement of ................................. 42

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 4

Coates, Paul, Ph.D., Director, Office of Dietary Supplements, National

Institutes of Health, U.S. Department of Health and Human Services,

prepared statement of ................................................................................... 12

Dobson, Allen, Ph.D., senior vice president, the Lewin Group, prepared

statement of ................................................................................................... 24

Henner, Marilu, actress, nutrition and diet expert, prepared statement

of ..................................................................................................................... 65

Levine, Barbara, R.D, Ph.D., associate professor of nutrition in medicine,

Weill College of Medicine, prepared statement of ...................................... 50

(1)

DIETARY SUPPLEMENTS: NATURE’S ANSWER

TO COST EFFECTIVE PREVENTATIVE MEDICINE

WEDNESDAY, SEPTEMBER 22, 2004

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:10 a.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the subcommittee) presiding.

Present: Representatives Burton and Watson.

Staff present: Mark Walker, chief of staff; Mindi Walker, Brian

Fauls, and Dan Getz, professional staff members; Nick Mutton,

press secretary; Danielle Perraut, clerk; Sarah Despres, minority

counsel; Richard Butcher, minority professional staff member; and

Cecelia Morton, minority office manager.

Mr. BURTON. Good morning. A quorum being present, the Subcommittee on Human Rights and Wellness will come to order. I ask

unanimous consent that all Members and witnesses’ written and

opening statements be included in the record. And without objection, so ordered.

I ask unanimous consent that all articles, exhibits, and extraneous or tabular materials referred to be included in the record.

Without objection, so ordered.

In the event of other Members attending the hearing, I ask

unanimous consent that they be permitted to serve as a member

of the subcommittee for today’s hearing. And without objection, so

ordered.

We have other Members that will be coming very shortly, Ms.

Watson in particular. And for those who aren’t here, they will get

transcripts of the hearing.

I, along with millions of Americans, firmly believe that dietary

supplements have been shown through credible scientific research

and historical use to be of immeasurable benefit to human health.

As a regular consumer, I know firsthand the health benefits of

using dietary supplements on a daily basis. Consequently I proudly

serve as cochairman of the Congressional Complementary and Alternative Medicine Caucus, the CAM Caucus, along with my colleague, Representative Dennis Kucinich of Ohio, in the House, and

Senators Orrin Hatch of Utah in the Senate, and Tom Harkin of

Iowa in the Senate. They have been true champions on these issues

for some time.

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Together we have worked hard, in a bipartisan fashion, for the

continued research and safety of all dietary supplements manufactured and sold in the United States. It remains our top priority to

ensure that only the highest quality of products are made available

to the American consumers.

Given my role as cochairman of the CAM Caucus, as well as my

duties as chairman of the Subcommittee on Human Rights and

Wellness, I am particularly concerned about how these products

can be used as preventatives, and preventative measures, to combat the multitude of life-threatening and debilitating medical conditions like cardiovascular disease, cancer, osteoporosis, and even

preventable birth defects in infants.

The subcommittee has invited some of the foremost experts on

nutrition to discuss the proven health benefits of regular supplement usage. Dr. Jeffrey Blumberg, professor at the Friedman

School of Nutrition Science and Policy at Tufts University is with

us today to explain the role of folic acid and other dietary supplements in the promotion of health and prevention of chronic diseases.

The subcommittee also has the pleasure of hearing testimony

from Dr. Barbara Levine, an associate professor of nutrition and

medicine at the Weill College of Medicine at Cornell University,

who will discuss two of the nutrients she has studied for a majority

of her career, Omega–3 fatty acids and calcium. Dr. Levine will

also explain how those two nutrients are needed throughout the entire life cycle in the development and growth of the human body,

in addition to their use for prevention and treatment of a variety

of diseases.

In addition to the scientifically proven health benefits of using dietary supplements correctly to promote a healthier lifestyle and

curb disease, these products can also offer substantial cost savings

for our long-term national health care expenditures. And that is

one of the things that isn’t talked about enough.

During our hearing today a new study will be released regarding

the cost savings of dietary supplements on the U.S. health care system. Dr. Allen Dobson, senior vice president of the Levin Group, an

independent health care consulting firm, is here with us today to

discuss the conclusions of his study, which demonstrates that certain supplements provide an inexpensive and safe way to improve

overall personal health and reduce health care expenditures.

A recent report published by the Institute of Medicine [IOM], estimates that American consumers spend over $18 billion annually

on the over 29,000 supplements sold in the United States. In 1994,

Congress passed, and the President signed into law, the Dietary

Supplement Health Education Act [DSHEA]. DSHEA prescribes

the framework for how the Federal Government ensures the safety

and the efficacy of dietary supplements sold in the United States.

Prior to DSHEA, dietary supplements were treated and regulated as traditional food products. Seeing a need for the Federal

Government to address the American consumer’s growing interest

in dietary products, in conjunction with public safety, Congress

overwhelming passed this legislation to make certain that all dietary health products sold in the United States are held to the highest and most stringent quality standards.

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DSHEA ensures the safety of dietary supplements by requiring

manufactures to follow standards called good manufacturing practices [GMPs]. Essentially all ingredients in supplements sold in the

United States must be previously approved by the Food and Drug

Administration and listed on the products bottle label. In addition,

distributors must follow strict guidelines on all claims that are

made in regard to a particular product. This ensures consumers are

equipped with the most accurate information regarding their supplements.

Dr. Paul Coates, the Director of the Office of Dietary Supplements at the National Institutes of Health [NIH], is here to talk

about the Federal Government’s research into dietary supplements

and how these products have been shown to provide for a healthier

lifestyle both in children and in adults.

In addition, Mr. Elliott Balbert, the president of the Dietary Supplement Education Alliance, will be testifying before the subcommittee to discuss the supplement industry’s efforts and continued support for the overwhelming need to ensure that consumers

have access to balanced, science-based facts about dietary supplements.

And, finally, we have the distinct pleasure of having a distinguished star of the stage and screen, whom I think is beautiful and

have admired her for a long, long time, testifying before our subcommittee today. I saw her in Taxi a long time ago, and she looks

so young, it just doesn’t seem possible. Marilu Henner is here to

talk about her personal experiences using dietary supplements in

attaining and maintaining optimal health. Ms. Henner has not only

personally benefited from supplement usage, but has also served as

a health advocate, and is the author of six books on how to live a

healthier lifestyle.

Whether taking a multivitamin, herbal product or a specialty

supplement, people can and do live healthier lives and save money

in long-term health care costs by supplementing their diets.

I would like to thank all of our witnesses for their participation

in this hearing, and I look forward to hearing their testimony.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. BURTON. With that, we will start with Dr. Coates.

Dr. Coates, if you would come forward and stand so I can swear

you in, please.

[Witness sworn.]

Mr. BURTON. Do you have an opening statement, Doctor?

Mr. COATES. I do.

Mr. BURTON. If we could, I would like to try to admonish the witnesses to try to keep their statements to 5 minutes so we would

have more time for questions if possible.

STATEMENT OF PAUL COATES, Ph.D., DIRECTOR, OFFICE OF

DIETARY SUPPLEMENTS, NATIONAL INSTITUTES OF

HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Mr. COATES. Thank you very much. Mr. Chairman, I am Paul

Coates. I direct the Office of Dietary Supplements at the National

Institutes of Health. I appreciate the opportunity to appear before

you today to talk about NIH efforts and research on dietary supplements.

I appeared before this committee 2 years ago to give you details

about some key NIH initiatives and to highlight the opportunities

as well as the challenges associated with developing strong science

in the field of dietary supplements. These are products that are

used widely by American consumers for their potential health benefits, often in combination with other lifestyle measures such as diet

and physical activity. Their potential to improve health and to prevent disease has been realized when some have been put to modern

scientific testing. Clear examples of this are folic acid, in the prevention of neural tube defects, and calcium to reduce the risk of

osteoporosis.

It is important to keep in mind, though, that others have not undergone rigorous scientific testing to establish their efficacy and

safety. Some are currently under active investigation at the NIH,

as I will mention in a moment.

In the preamble, or in the invitation, you identified five supplements as being of particular interest today: folate, calcium, omega–

3 fatty acids, glucosamine, and saw palmetto. I would like to give

you a snapshot of some ongoing NIH-funded research efforts related to these ingredients.

With respect to folate, NIH has funded and continues to fund

considerable research examining its role in the prevention of chronic diseases such as cancer and heart disease. In addition to these

many projects, which I would be pleased to share with you in more

detail, I draw your attention to another current trial that looks at

the impact of folate and other B vitamins on slowing the rate of

cognitive decline in Alzheimer’s disease.

With respect to calcium, the NIH has a considerable investment

in clinical research. In addition to the many studies supported by

NIH over the years on calcium and bone health, one current trial

that I would like to draw to your attention is a trial called supplemental calcium in overweight people, currently under way at the

NIH to examine the effects of calcium supplementation on weight

reduction.

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With respect to omega–3 fatty acids, the Office of Dietary Supplements has sponsored a series of evidence reports in collaboration

with the Agency for Health Care Research and Quality, on the

health effects of omega–3s for a number of conditions. One report

in particular, the one on cardiovascular disease, concluded that

there was substantial evidence for benefit of omega–3 fatty acids

in the secondary prevention of heart disease, but that there was

considerably less evidence for an effect on primary prevention; that

is, in the general population.

We view that as an opportunity, not a barrier, and as a result

of this report, the National Heart-Lung and Blood Institute, along

with the Office of Dietary Supplements, convened a working group

earlier this year to assess future research needs related to coronary

disease prevention with omega–3s. The working group recently

made its recommendations, which are currently being pursued at

the NIH.

With respect to glucosamine, a clinical trial is currently under

way looking at the effect of glucosamine and chondroitin sulfate for

knee osteoarthritis. It has now met its recruitment goals of nearly

1,600 participants and scheduled to be completed within a year.

Finally, a clinical trial of saw palmetto and African plum for urinary symptoms in men was recently funded and should provide

some very informative results.

I would like to comment at this point that the evidence for benefit is stronger for some of these supplements than it is for others.

I would also like to point out that research efforts need to continue

apace in all of these areas, and that NIH remains committed to encouraging and supporting the best science in this area.

Between 1999 and 2003, the years for which we have these data, NIH invested roughly $770 million to support research related to

dietary supplements. About a quarter of that was devoted to studies of the five supplement ingredients that I have cited above.

Let me briefly tell you a little about the Office of Dietary Supplements. We were authorized by the Dietary Supplement Health and

Education Act of 1994, and came into existence at the NIH in 1995.

Our mission is to identify and foster research on the health benefits and the risks of supplements.

We have a strategic plan in place, and I am pleased to announce

that the strategic plan for the next 5 years has now been published, and it can be found on the Office of Dietary Supplements’

Web site.

As a result of increases in funding for the Office by Congress,

from $3.5 million in 1999 to about $26 million year, we have expanded our role in a number of important activities. This year we

cofund 90 research grants with other institutes at the NIH, and

among those a number of dietary supplement research centers that

we fund across the country that specialize in botanical dietary supplements.

Let me give you four brief examples of other efforts that we do

in collaboration with other agencies, both within and outside the

NIH. The National Health and Nutrition Examination Survey looks

at supplement use in a health context, and is conducted by the

CDC. We significantly support that, along with collaborators at the

FDA, the National Institute of Standards and Technology, and a

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number of private sector organizations, including the dietary supplement industry. We administer a program to develop, validate

and disseminate analytical methods and reference materials for dietary supplements.

And, finally, I wanted to mention that as part of our evidencebased review program, which we conduct in collaboration with the

Agency for Healthcare Research and Quality, we have two others

that are currently under way, two evidence reports, in addition to

the omega–3 ones I cited. One is on vitamin D adequacy in health,

and the other is on the role of antioxidants and B vitamins in the

age-related neurodegenerative disorders. These are all collaborative

efforts. It is a key way in which to get research done in this area,

in my opinion.

Mr. Chairman, I thank you for the opportunity to review the status of dietary supplement research at the NIH, and I would be

happy to answer your questions.

[The prepared statement of Mr. Coates follows:]

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Mr. BURTON. Do you take supplements?

Mr. COATES. That is a personal decision, and I do. But that

doesn’t extend beyond by personal decision.

Mr. BURTON. What does that mean?

Mr. COATES. I am not in a position to make recommendations to

others.

Mr. BURTON. I see. But you do take supplements.

Mr. COATES. I take a multivitamin.

Mr. BURTON. Can you tell us a little bit about the risks associated by using dietary supplements, from your point of view?

Mr. COATES. I can tell you some of the issues that are raised.

One in particular is the possible interaction of certain dietary supplement ingredients and other bioactive ingredients that people

take, either other supplements or drugs. Occasionally there have

been identified risks associated with that. People need to know

about the possible interaction among these biologically active constituents.

Mr. BURTON. But the labeling on the bottles pretty much tells

people who are taking those to be careful or consult a physician in

the event that they think that there might be some

counteractive——

Mr. COATES. Yes. That is certainly a goal for all of the potentially

harmful interactions. I venture to say that we don’t know everything that we need to know either about the benefits or the risks

of dietary supplements, and our job is to try to identify those so

that the best information can be made available to consumers.

Mr. BURTON. I see. But you don’t see the need for the health

agencies to take over complete control over supplements and all of

that?

Mr. COATES. I am not sure I understand that question.

Mr. BURTON. Well, there have been some people who thought

that DSHEA was something that we should not have passed in the

Congress, and some of our health agencies say that all supplements

should be regulated. You don’t agree with that?

Mr. COATES. They are regulated.

Mr. BURTON. No. What I mean is they are not reviewed on a regular basis by the health agencies; i.e., Health and Human Services

and FDA.

Mr. COATES. I think it is the FDA’s responsibility to regulate dietary supplements using the existing law.

Mr. BURTON. Using the existing law. But you don’t think there

needs to be any changes in that?

Mr. COATES. The last time I testified here, Mr. Chairman, I think

you asked me the same question, and I said that at the time that

DSHEA was passed, that it was an effective and appropriate way

to look at dietary supplements.

Sometimes things change. I think we have learned a lot about dietary supplements, and I am not advocating that there be any

change. But I do think that it is appropriate for people to examine

periodically what they are doing.

Mr. BURTON. But you are not advocating any change right now?

Mr. COATES. That is not my position.

Mr. BURTON. Good.

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In your opinion, how has the passage of the dietary supplement—or DSHEA affected the FDA’s enforcement powers over dietary supplements?

Mr. COATES. This is a tricky question for me to answer, since I

am not in the FDA, and I am in a sister agency, and I don’t know

that I have any information that I can bring to bear on your question.

Mr. BURTON. OK. Could you please inform the subcommittee

where you believe the issue of dietary supplements will be in 5

years if the funding for these research initiatives remain consistent

or constant?

Mr. COATES. Thank you for—there is a question that I am in a

much better position to be able to answer, since it relates to the

research efforts, which really is what I do.

I think we are in a position where we can provide an enormous

amount of information to American consumers about dietary supplements. There is a lot that still needs to be done.

What we understand about dietary supplements is quite variable. For some, we have very clear evidence of benefits. We also understand those circumstances in which individuals may be at risk,

given exposure to certain supplements under some conditions. It is

such a large body of knowledge that needs to be addressed. I think

you alluded to the idea that there are 29,000 or so products in the

marketplace. They are not, of course, all different from one another

in terms of the ingredients.

But there is a lot that remains to be done, and I think it is incumbent upon us as a research agency to invest as much as we can

in developing the right data set to inform consumers.

Mr. BURTON. Ms. Watson, I am sure, has questions. Would you

be willing to have her submit those to you for the record, because

she is not here. She had to go to a Democrat get-together, I guess,

and she is in the front row, and she can’t leave right now. But she

will be here shortly, so we will have her submit those to you.

Mr. COATES. Thank you. I will be here for the rest of the hearing.

Mr. BURTON. Oh, good. Thank you. I am glad you decided to stay.

I wish we had more government agencies that were willing to do

that.

Mr. BURTON. OK. Our next panel is Allen Dobson, Ph.D., senior

vice president of the Lewin Group. Would you come forward, Mr.

Dobson.

Jeffrey Blumberg, Ph.D., professor at Friedman School of Nutrition Science and Policy at Tufts University; Barbara Levine, R.D.,

Ph.D., associate professor, nutrition in medicine, Weill College of

Medicine, Cornell University; Elliott Balbert, president of the Dietary Supplement Education Alliance; and the ever popular Marilu

Henner, TV and movie star, actress, author, and health advocate,

and author of six books. I will have to read one of your books.

Would you all please rise so we can have you sworn.

[Witnesses sworn.]

Mr. BURTON. Dr. Dobson.

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STATEMENTS OF ALLEN DOBSON, Ph.D., SENIOR VICE PRESIDENT, THE LEWIN GROUP; JEFFREY BLUMBERG, Ph.D., PROFESSOR, FRIEDMAN SCHOOL OF NUTRITION SCIENCE AND

POLICY, TUFTS UNIVERSITY; BARBARA LEVINE, R.D, Ph.D.,

ASSOCIATE PROFESSOR OF NUTRITION IN MEDICINE, WEILL

COLLEGE OF MEDICINE; ELLIOTT BALBERT, PRESIDENT, DIETARY SUPPLEMENTS EDUCATION ALLIANCE; AND MARILU

HENNER, ACTRESS, NUTRITION AND DIET EXPERT

Mr. DOBSON. Mr Chairman, my name is Allen Dobson. I’m am

a senior vice president for the Lewin Group. Thank you for the opportunity to present key findings of a study that the Lewin Group

has conducted for the Dietary Supplement Education Alliance.

The purpose of the study was threefold: to critically review the

research evidence for five specific dietary supplements, to estimate

changes in health care utilization and the associated health care

expenditure savings that could result from the daily use of two of

these supplements, and then for the other three supplements to

recommend research that might be done in the future.

The five supplements that were covered in this study, calcium

with vitamin D, folic acid, omega–3 fatty acids, glucosamine and

saw palmetto, the Lewin Group developed estimates of potential

cost savings that could result from the daily use of only two of

these supplements for which the higher standard of evidence exists

at this time. In effect, what we are doing is we were moving beyond

the research and the literature, which speak to the efficacy of the

supplements, and speaking to their cost-effectiveness in society.

That is to say, if they are used appropriately, what savings might

accrue to both the individuals and society? So in that sense the

study results that we are presenting today are new.

Cost estimates were developed for calcium with vitamin D and

folic acid where in each case there is significant scientific agreement as to the improvement in health status. For these two supplements, conservative estimates for health care expenditure savings

were developed for specific relevant outcomes.

Dr. Devonso, my colleague, and I were very conservative in our

approach to building the cost estimates. We only went to those supplements that had the most strong scientific evidence, and when

we did our costing, we only looked at a few of the possible areas

where cost savings might exist.

As Dr. Coates has indicated, for instance, for calcium, there is

many areas where it will be effective, but we only looked at a few

specific areas where the evidence was strongest. That is to say for

calcium, we estimated savings for avoided hip fractures for over

age 65; and for folic acid, we looked at avoided incidences of babies

being born with neural tube defects.

In terms of our key findings for calcium, for a daily intake of

1,200 milligrams of calcium D, calcium with vitamin D, could result in 734,000 fewer hip fractures for the population aged 65 and

over. We estimated that would save about $13.9 billion over a 5-

year period. We used the CBO-type scoring procedures, which you

are familiar with, because CBO scores all of our budgetary items

for you. We tried to use their procedures because they are well

known and fairly conservative in their approach, and subject to

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much scrutiny, and we feel that those kinds of procedures are the

appropriate ones to use.

We looked at net savings in hospital, nursing facility and physician expenditures. There again, we could have added more expenditures to the list, but we felt we would take the biggest ones and

the least controversial with respect to hip fractures.

Over one-third of adults over age 65 experience falls each year.

Hip fractures caused the most severe health problems and the

greatest number of deaths. So not only are we looking at cost savings here, we are looking at improved health and people’s status

in terms of feeling better. When you have a broken hip and you are

over 65, it is not a good condition to be in. If we can avoid that,

not only do we save money, but we improve people’s health status

enormously.

In terms of folic acid, there are 64 million women of child-bearing

years in the United States. Again, we were conservative, and we

said if an additional 10.5 million, or 25 percent of those not currently taking folic acid, begin to take 400 micrograms of folic acid

on a daily basis, we estimated that 600 babies would be born without neural tube defects. Our savings over 5 years, using the CBO

estimates again, were about $1.3 billion. Again, these are conservative, because we only took 25 percent.

The problem here is not so much the effects of the supplement

itself, but getting people to take the supplements. And the recommendation here, of course, would be that we do a lot as a society, much more as a society, to get people to understand both the

benefits of taking the supplement and the risk of not taking it,

which are enormous.

For omega–3 fatty acids, we found that there was a lot of evidence. As we heard from Dr. Coates, a lot of it is good. But the evidence wasn’t quite strong enough to do our cost estimates. And as

Dr. Coates indicated, the government is under way taking studies

where perhaps we will have stronger evidence in the future.

Similarly with glucosamine and saw palmetto, we found that the

evidence was strong, it was encouraging, but it wasn’t quite up to

the rigor that we would like before we did our cost studies. So for

those two studies, we note that the government is undertaking

again, and already under way, very large double-blind, placebo controlled studies, which should provide us the evidence in the future

with which we can proceed with cost studies.

In closing, I would like to note that the typical American diet

does not always provide a sufficient level of nutrients to support

optimal health, very much as you said in your introductory comments, and then that would be the overall conclusion of this; that

is, in certain instances, supplements are an inexpensive and safe

way to improve health status and reduce health care expenditures,

and in these cases the role of public policy to support their use is

unambiguous.

I would thank you for the opportunity to present these findings

from the Lewin Group study. Thank you.

Mr. BURTON. Thank you, Doctor.

[The prepared statement of Mr. Dobson follows:]

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Mr. BURTON. We didn’t get into any other—they only asked you

about those five products?

Mr. DOBSON. Yes.

Mr. BURTON. Didn’t get into vitamin C or any of the others?

Mr. DOBSON. No. We took the five—we knew there was a great

deal of literature out there, and we wanted to look at those cases

where we thought we had the best case to move beyond the studies

of efficacy and impact on health and move into cost savings. So we

felt that we would look at those where the literature in come cases

is 30 and 40 years in length.

Mr. BURTON. OK.

Dr. Blumberg.

Mr. BLUMBERG. Good morning. I am a professor of nutrition at

the Friedman School of Nutrition Science and Policy, and the associate director of the Jean Mayer USDA Human Nutrition Research

Center on Aging at Tufts University in Boston. I also serve as a

nonpaid member of the Scientific Advisory Board of the Dietary

Supplement Education Alliance. I have been investigating the role

of dietary supplements in the promotion of health and prevention

of chronic disease for almost 25 years.

It is now indisputable that nutrition is a key component of any

disease-prevention strategy, and optimal intakes of vitamins, minerals, and other nutrients are critical to maintaining wellness. Virtually every nutrition-monitoring survey reveals that most Americans fail to achieve these intakes through their usual diets. Fortunately, dietary supplements represent an affordable, effective and

practical tool to help solve this problem, and thus ultimately reduce

health care costs.

This morning I will illustrate this principle with the example of

folic acid. Folic acid is a B vitamin essential to the activity of more

than a dozen enzymes, amino acid metabolism, and DNA formation. Inadequate intake of folic acid has been associated with anemia, some forms of cancer, heart disease, poor pregnancy outcomes,

and birth defects, most notably neural tube defects, but also including cleft lip and palate, limb deficiencies and defects of the heart.

The richest dietary sources of folic acid are liver, mushrooms,

dried beans, green leafy vegetables, and, since 1998, enriched

grains fortified with this vitamin.

The recommended dietary allowance for folic acid is 400

micrograms daily. Usual intakes of folic acid before fortification

were 200 micrograms, but are now estimated to be about 300

micrograms, with much lower intakes in people following low-carbohydrate diets and avoiding fortified breads and other cereals.

However, it is important to understand that many people have

a greater need for folic acid, including pregnant and lactating

women, people who consume alcoholic beverages or take certain

medications, patients with certain inflammatory conditions of the

intestines, and the elderly.

For the last 5 years, the Center for Disease Control and Prevention and the Institute of Medicine have recommended that all

women capable of becoming pregnant should consume 400

micrograms per day of synthetic folic acid from supplements or fortified foods, in addition to consuming food folate from a variety of

dietary sources. Nonetheless, two-thirds of American women of

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child-bearing age do not follow this advice, and 1 of every 1,000 babies in the United States is born with a neural tube defect.

The Lewin Group analysis which you just heard about calculated that over the next 5 years, $1.3 billion in health care costs could

be saved if these women took a daily supplement containing 400

micrograms of folic acid, but folic acid supplements are not just for

women. Observational studies consistently reveal that men and

women taking supplements containing folic acid have the lowest

blood levels of the amino acid homocysteine. Elevated levels of

homocysteine are a significant independent risk factor for atherosclerotic vascular disease and for thromboembolism. Some evidence

suggests that lowering homocysteine levels could reduce the risk of

heart disease by 20 percent. Many studies reveal that elevated

homocysteine may enhance the effect of other established vascular

risk factors such as hypertension and smoking.

Folate inadequacy also has a procarcinogenic effect by interfering

with normal DNA synthesis and regulation. An increased risk for

some forms of cancer has been associated with poor folate status

in several epidemiological studies, with the strong evidence linked

to colorectal cancer.

Studies have also suggested that the increased risk of breast cancer associated with regular alcohol consumption may be reduced by

an increased intake of folic acid from dietary supplements.

While many different factors contribute to the risk of poor health

and chronic disease, we know that diet and the intake of specific

nutrients play a key role in the prevention of cancer, diabetes,

heart disease, infectious diseases, macular degeneration,

osteoporosis and other conditions.

The power of nutrition to promote health is well established. We

need now to find ways to encourage Americans to choose helpful dietary patterns and increase their intake of key nutrients with fortified foods and dietary supplements. If we succeed in doing so,

both the personal burden of disease carried by Americans and the

associated enormous expenditure for their health care will be substantially reduced. Thank you.

Mr. BURTON. Thank you, Dr. Blumberg.

[The prepared statement of Mr. Blumberg follows:]

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Mr. BURTON. Dr. Levine.

Ms. LEVINE. Good morning, Chairman Burton. I am Barbara Levine, associate professor of medicine at Weill Cornell Medical College, as well as the head of clinical nutrition at Strang, which is

part of Cornell Medical College, as well as the Rockefeller University.

It is a great honor to be able to address you about the importance of the nutritional health of Americans. More specifically, I

will be discussing two nutrients I have studied for most of my career. The first nutrient is calcium, which is found in every cell of

the body. Calcium is essential for bone development and growth,

and in the protection of the human body through all stages of life.

Prolonged low calcium intake has been linked to the development

of several chronic diseases, including colon cancer, hypertension

and osteoporosis, and we have to remember that we reach our peak

bone mass really at around age 20, and then bone resorption will

really exceed bone formation, so that it is very important for us to

get enough calcium very early on in life, but continue to get the

calcium we need throughout our life so that we don’t lose more

bone than we make.

It is generally accepted that the ideal method for obtaining calcium is through regular dietary sources. Unfortunately, meeting

the recommended daily intake of calcium has proven to be difficult

for the average American, as evidenced by the low percentage of individuals actually meeting recommended calcium intake levels on

a continuing daily basis.

In the recent National Health and Nutrition Examination Survey, it was reported that the average intake of calcium for women,

for example, age 40 and over, was only 698 milligrams per day.

This is well blow the 1,200-milligrams-per-day calcium intake recommended for postmenopausal women, and illustrates the overall

need to encourage calcium supplementation.

And this is true for men as well, as we know that women generally experience fractures earlier on because of postmenopause,

but men catch up in the sixth decade of life and will experience hip

fractures as well.

Not only can calcium supplements help to increase the intake of

calcium among our population, but also the resultant disease prevention can help cut health care costs substantially.

The second nutrient I will discuss today is actually part of a

group of nutritional components, the much-heralded omega–3 fatty

acids. This group has a major role in the maintenance of cardiovascular health, development of the nervous system and other key

functions. As was mentioned today, there is more evidence in the

secondary prevention of the omega–3 fatty acids, which include

DHA, docosahexaenoic acid, and eicosapentaenoic acid.

But we just finished, and I will have the results at the Rockefeller University, a primary prevention study with DHA in patients

that are overweight and have the syndrome called metabolic syndrome. So they are overweight, they have high triglycerides, they

generally have insulin resistance, and we will get you that information as soon as possible.

But the role of omega–3 fatty acids and cardiovascular function

has been studied for the last 40 years. I would like to commend the

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American Heart Association for its recent Scientific Statement on

Fish Consumption, Fish Oil, Omega–3 Fatty Acids and Cardiovascular Disease. This statement confirms the importance of longchain omega–3 fatty acids, both DHA and EPA, for their significant

role in the reduction of cardiac death. DHA recommends that patients with coronary disease and hypertriglyceridemic patients,

that is with the high triglycerides, consume DHA and EPA as part

of their medical management.

As just another example of the importance of omega–3 fatty

acids, research has found that DHA is particularly vital for pregnant and lactating women because it plays a critical role in supporting brain and retinal development in infants. A recent workshop supported by NIH recommends 300 milligrams of DHA a day

for pregnant and nursing women to promote optimum neurological

development and visual acuity in their babies.

As I mentioned in my discussion of calcium, despite our best intentions, the nutritional health of our Nation remains suboptimal.

The principal dietary source of omega–3 fatty acids is coldwater

fish like salmon and trout. However, both the United States Food

and Drug Administration and the Environmental Protection Agency has recently scrutinized certain fish, such as shark, swordfish

and fresh frozen tuna, for having potentially high levels of methyl

mercury. And the Heart Association tempers its recommendations

to increase DHA and EPA intake by stating that the availability

of high-quality omega–3 fatty acid supplements, free of contaminants, is an important prerequisite to their extensive use. This is

even more important for pregnant and lactating women who would

benefit from DHA. These are a clear example of the benefits of supplementation which can provide high-quality omega–3 without contamination.

I thank you for the opportunity to speak to you about these important nutrition issues. Thank you, Mr. Chairman.

Mr. BURTON. Thank you.

[The prepared statement of Ms. Levine follows:]

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Mr. BURTON. You know, before we go to the next witness, I always find it very interesting that the EPA is talking about being

very careful about how much fish we eat that might have mercury

in it, because the environment has been contaminated with mercury, you know, and yet most of the adult shots that we get, where

we get a vaccination, contain mercury. They have that in there as

a preservative.

I mean, they will tell you not to eat it, but when you go to get

a tetanus shot or a flu shot, they are going to stick mercury in your

body. They say it doesn’t hurt anything. And we have a huge increase; we have gone from 1 in 10,000 children that are autistic to

1 in 166. We have an epidemic of Alzheimer’s. And we know that

mercury causes neurological problems, and yet our health agencies—I know the gentleman is here from a health agency. I don’t

know if he is going to carry this message back, but it just seems

reasonable to me that maybe we ought to get mercury out of these

shots. Just get it out of there. Hell, if we can’t eat it, we sure don’t

want to have it stuck in our bodies.

Anyhow, Mr. Balbert.

Mr. BALBERT. Chairman Burton and members of the committee,

thank you for the opportunity to address you as a representative

of the dietary supplement industry.

I am Elliot Balbert, CEO of Natrol, Inc. Natrol is a diversified

nutrition company and manufactures and markets premium-branded nutritional products for a wide range of consumer needs.

While running Natrol is obviously an important and central role

for me, I am here in another capacity, as chairman of a not-forprofit group, the Dietary Supplement Education Alliance [DSEA].

DSEA was created in 2001 as a way for my industry to help ensure

that the intent of the Dietary Supplement Health and Education

Act [DSHEA], is met by providing meaningful information about

the health benefits and responsible use of dietary supplements to

all Americans.

As you well know, Mr. Chairman, an important aspect of the passage of this critical law was to ensure that all of us as potential

consumers of dietary supplements were educated about them, the

very reason for the E in DSHEA. For that reason, those of us involved in DSEA have worked over the past 3 years to educate the

public, the media, and even Members of Congress and their staffs

through our Web site, supplementinfo.org, and other educational

activities and means.

In fact, one of our ongoing educational efforts is a monthly mailing to Members of Congress, where we strive to provide those of

you on the Hill with essential information on the benefits of supplements. This may be a familiar package that you have seen.

Mr. BURTON. Do those contain supplements?

Mr. BALBERT. Yes, they do. I can show you that if you would like

to see those.

Mr. BURTON. No, just keep sending them.

Mr. BALBERT. Our pleasure.

Mr. BURTON. I don’t want to interrupt your testimony, but something very humorous is I take so many supplements that I don’t

eat anymore. There is no more room for food. It is supplements and

more supplements. I wish somebody would tell me what I really—

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I know I need vitamin C and E and all of this, but I wish somebody

would say, Danny—that is me—this is what you ought to take

every day. But everybody that I know that knows that I am very

concerned and want to make sure that the supplement industry

does very well, because I believe very strongly in it, as you know,

as the chairman of the caucus, but there has to be a limit to how

much of this stuff I can take. I know I am going to live to be 170,

but I would like to know if I can cut down a little bit, because I

am afraid if I stop taking this, I am making a mistake and so forth.

So somebody needs to write me a letter and say, OK, this what

you ought to take. Marilu, maybe it is you.

Ms. HENNER. I have it.

Mr. BURTON. I may read your book. I want you to keep me

young. I am 29 now, but I want to stay there.

Ms. HENNER. You only look 27.

Mr. BURTON. I love you. I love you.

Go ahead, Mr. Balbert.

Mr. BALBERT. Well, before I continue, Mr. Chairman, we want to

thank you on behalf of the industry for single-handedly supporting

the ongoing efforts to help educate folks.

As a representative of DSHEA, I have three important points to

make here, and I will be brief. First, as you have heard from Dr.

Blumberg and Dr. Levine, dietary supplements have been shown to

be safe and effective aids for maintaining health and supporting

overall wellness.

Just think about the implications of this on the human level. Dietary supplements can help prevent a life of disability due to neural tube defects. Dietary supplements can enable senior citizens to

live fuller lives without the disability of a broken hip. Dietary supplements can help active adults have less discomfort from arthritic

knees.

The potential goes on and on. And how do you put a dollar and

cents value on the quality of life? You simply cannot. This isn’t a

matter of statistics. It is the ability to lead healthy, happy lives.

Second, these relatively inexpensive supplements can help our

country with the critical issue of managing health care costs. One

of the most pressing problems confronting the United States today

is the spiraling cost of medical health care. That is no mystery, and

as you heard from Dr. Dobson, just two dietary supplements examined in the study could provide—I don’t know if we fully grasped

his statement—just two, just two dietary supplements examined in

this study could provide over $15 billion in savings over the next

5 years. That is two.

We have a critical crisis going on in our health care system, and

we are talking about food supplements that can help reduce health

care costs, and we are not even talking about the value of the quality of life.

Third, to take advantage of health-promoting and cost-savings

potential of supplements, people need accurate, science-based information about dietary supplements and access to them. To ensure

that dietary supplements get the research attention they deserve,

ongoing support from the Office of Dietary Supplements [ODS], Mr.

Coates’s office, and the National Center for Complementary and Alternative Medicine [NCCAM], is essential.

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We would urge members of your committee to strive to find ways

to increase funding to these government bodies. We are confident

that more extensive research will only further support the benefits,

safety, effectiveness, and cost savings we are hearing about in this

panel today.

To promote education about supplements, full implementation of

the Dietary Supplement Education Act is important. Chairman

Burton, we applaud your recognition of this critical aspect; on behalf of the industry, praise your efforts to achieve this goal by your

introduction of H.R. 4760, which I wholeheartedly support.

I believe there is more that can and should be done to ensure

that consumers have access to balanced, science-based facts about

dietary supplements so they may make informed decisions about

achieving and maintaining optimum health. That is really what

this is all about.

To ensure even greater access to supplements, bills like your Tax

Fairness Act are critical and represent legislation we endorse. The

Tax Fairness Act would allow taxpayers to deduct amounts paid for

foods for specialty dietary uses, dietary supplements or medical

foods as medical expenses, thereby fairly putting supplements on

par with other health benefits.

Likewise, the ability of food stamp recipients to use their benefits

to purchase dietary supplements. Food stamps can be used to buy

Twinkies, but they can’t be used to buy dietary supplements.

As you and others have proposed in the past, Mr. Chairman, this

is an idea we hope you and others will pursue.

In closing, I would like to point out although many congressional

hearings focus on what is wrong, hearings like this provide encouragement to continue doing what is not only right, but cost-effective,

too. I want to thank the chairman and others on the subcommittee

for taking the time address to the positive aspects of dietary supplements. Thank you, sir.

Mr. BURTON. Thank you.

[The prepared statement of Mr. Balbert follows:]

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Mr. BURTON. And I do take a myriad of supplements, but, like

I said, I think that might be one of the problems with a lot of people, because there are so many supplements that are available in

the marketplace to take care of a myriad of problems that you

sometimes wonder, you know, if you are—if you are taking too

many, or if you are not taking enough.

So I am going to read Ms. Henner’s book, I have it right here.

She looks awful nice. Does this tell me how to do that?

Ms. HENNER. Sure. If not, I will give you my e-mail address, and

I can send you a lot of information.

Mr. BURTON. Gosh, that would be great. I would love just to converse with you. You are a lovely lady. OK.

Ms. HENNER. Well, thank you so much.

Well, Chairman Burton, good morning, and members of the committee. I am Marilu Henner, actress, author, concerned mother,

and health advocate. As a consumer who recognizes the value of dietary supplements, I thank you for the opportunity to speak here

today.

I would like to provide testimony on why I believe it is important

for consumers to have information about dietary supplements and

to have access to supplements through their government and private health plans. The information and access is important in order

to help people make better decisions and lead healthier lives than

is possible through a healthy diet alone. I mean, that is why I believe dietary supplements should be part of a campaign to improve

our Nation’s health.

Now, I feel qualified to say that, because I am not only the author of six best-selling books promoting health and nutrition and

a healthy lifestyle, but I am also one of the healthiest eaters in

Hollywood; that is, according to a few magazines. Which isn’t saying much, because everybody is on that crazy low-carb phase except

me.

Anyway, I believe that healthy food without dietary supplements

is not enough, because it is not always possible to get everything

we need from our food, no matter how carefully we plan our diet.

We eat in restaurants, we eat on airplanes, we eat in school lunch

programs, etc.

But before I get into my personal story, I would like to talk first

about the need for information. According to the Centers for Disease Control, approximately 400,000 Americans a year die as a result of an unhealthy diet and a sedentary lifestyle. While I personally think the estimate is low, it is high enough for us to recognize

that something must be done to get people moving and eating better.

As the waistline of the average American continues to expand,

illnesses related to obesity, such as diabetes and heart disease, are

reaching epidemic proportions. People are stuffing themselves with

processed foods and fast foods and junk foods, while they are literally starving their bodies of the nutrients they need.

The solution for too many people is fad diets that only perpetuate

their unhealthy eating habits. As I have described in several of my

books, I was raised on the standard American diet and spent many

years dieting as I tried to control my weight. I actually weighed 54

pounds heavier than I do right now. Big change. The result, of

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course, was that I was consistently in bad health and never could

control my weight eating that way. Both of my parents died in

their fifties of diseases associated with poor diet. As I have since

learned, my father’s heart disease could have probably been mitigated using vitamin E and omega–3 fatty acids, and the severity

of my mother’s arthritis could have been alleviated using calcium

and/or glucosamine.

I have had my own experiences with calcium. I have not had a

dairy product in 26 years. I take a calcium supplement. I had a

bone density test recently. I am the 104th percentile for a woman

my age. I am 52. I was in the 97th to 99th percentile for a woman

18 to 25, and this is—I had a mother who died of arthritis. So I

know that a calcium supplement can definitely help, and, you

know, coupled with a very healthy diet of leafy greens, etc., salmon.

My parents’ deaths were the impetus for my never-ending quest

for better health for myself, my siblings, my children and anyone

else who would listen. My journey to good health took many years.

Mine was a story of trial and error, because it was so difficult in

the 1970’s and 1980’s to find information about optimizing health

through diet and supplements. There is more information now than

ever before about health, but unfortunately the same chatter about

fad diets and miracle drugs drowns out the sound information that

people should be getting.

I believe that people are ready to take the right steps toward becoming healthy, but without the proper guidance and the support

of their insurance providers, health organizations and the Federal

Government, they will continue to be led into to seeking false solutions. One of my goals as an author is to show people the way to

optimize their health by encouraging them to disregard false solutions such as drastic weight loss with no sacrifice, or better health

through miracle pills. I really do believe it is about changing the

palate of America.

Through my many personal appearances advocating good health,

my books and my Web site at marilu.com, I come into contact with

and mentor thousands or people who are on their own quest for

good health. I hear many personal accounts of how people have

turned their lives around from debilitating illness to vibrant health

when they get information needed to make choices, to make good

choices, and by good choices I mean specifically rejecting the manufactured foods of our society with their overreliance on sugar, meat

and dairy, and the chemical, hormones and steroids that usually

accompany these products. Instead we should be moving toward an

organic, plant-based diet that produces a sense of physical wellbeing, and also a healthy diet that includes the use of appropriate

dietary supplements.

Finally, I would like to describe why I think it is important to

have access to dietary supplements. Eleven years ago when I was

pregnant with my first son, I began to take prenatal vitamins and

supplements and found that I felt better than ever before. I continued to take dietary supplements after my pregnancy to benefit

from the essential nutrients that I knew I couldn’t get from food

alone, even though I am very committed to a healthy way of eating.

But I was lucky enough to have a doctor who not only understood

the value of dietary supplements, he also encouraged me to use

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them to maintain my health. Not everyone is that lucky, however,

and many doctors have no idea what supplements are best for their

patient’s individual needs.

Since then I have taken dietary supplements every day, and I

would recommend them to my family and friends as well as in my

books and classes. The general public needs more access to dietary

supplements to maintain good health. Supplements are the result

of American research and development, but for some reason they

have been stigmatized by the American Medical Association and

the drug companies, and, as a result, most Americans do not have

access to those supplements because they are not covered by their

health plans, nor recognized as effective by the Federal Government.

I think this needs to be changed. People need to be able to find

the supplements to target their specific needs. They need good information. They need to be able to find quality products, and the

product needs to be cost-effective. They can’t have any of these

things without your help.

I have the benefits of 26 years of research and experimentation,

and I have never been afraid to think outside the box when it

comes to my health, but I only wish I had that information when

my parents were alive, because I know I could have helped them

and saved their lives.

In closing, I want to thank the committee for examining the

issue and inviting me to speak here today. I would like to encourage you to make this information on dietary supplements available

to all Americans so that the health of the American public can be

improved. And I wish you the best of health.

[The prepared statement of Ms. Henner follows:]

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Mr. BURTON. You know, I am going to use a different kind of

metaphor to make this next statement. That is, you know, when we

were attacked on September 11, we at that point didn’t have the

ability to arrest and hold a suspected terrorist before the act took

place. There had to be probable cause, you know, all of the things

that you do. And we ended up passing what was called the Patriot

Act, so that if we saw a terrorist, we could get him and hold him

until we checked him out to make sure that he didn’t kill 10,000

or 12,000 people.

And that brings me to the issue we are talking about here today,

and that is health. My son-in-law is a doctor, and most doctors are

taught to take care of people who become sick. But they don’t move

in advance to help them with preventive medicine, because they

are not trained that way. They are not trained to say take these

supplements, take these things, and you probably won’t have the

kind of maladies that you may be heading for.

And it seems to me in our medical schools, in addition to what

we have been talking about here today, and we talked about this

at other hearings, that the medical colleges and universities around

the country ought to be teaching diet, supplements, nutrition and

everything right along with the medical studies so that they minimize the amount of people that have to come to them in the first

place. And I think we would have a much healthier Nation.

Unfortunately, that’s not the case. We have the cart before the

horse. You get sick, then you go to the doctor and he gives you prescription drugs, many of which help but don’t solve the problem,

because the problem started earlier. So I agree with what you said,

and that’s why we are sponsoring all of the legislation we are to

try to give people the ability to get vitamins and minerals and supplements that will help them in a preventive way from getting

these diseases.

Dr. Dobson, you provided us with some very significant cost savings in the findings of your studies. Would you say that the cost

savings for calcium and folic acid are conservative? And would you

also agree that even more savings could be achieved by people

using them?

Mr. DOBSON. Yes, they are very conservative estimates, for two

reasons, No. 1, we assumed that most people wouldn’t take either

the calcium they should or the folic acid they should. If more people took each of those supplements, our estimates would rise.

If we had public policies that encourage people, as Marilu has

suggested, to get more people to take more folic acid, we would reduce more neural tubes defect than we estimated in our studies,

which would increase the savings similarly with the calcium.

Second, we only took the major healthcare savings associated

with both calcium and folic acid. And as you have heard from your

panel, there are many other potential savings that one might have.

We didn’t cost those, because the research isn’t quite there yet, but

it may very well be in the future. So I think for those two reasons

at least, our estimates are very, very conservative.

Mr. BURTON. You also stated that omega 3 fatty acids, glucosamine and saw palmetto, that there’s emerging evidence that

suggests there’s going to be significant cost savings for those as

well. What types of research would have to be conducted to help

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determine if there would be economic benefits from those supplements?

Mr. DOBSON. I think that the research already in place, the clinical trials under way by FDA and others at other Federal agencies,

may be powerful enough in the next couple of years to allow the

cost estimates to be made. We won’t know until we get the studies,

of course, but it’s these very carefully controlled studies that take

time and money to put in place. We need more of those for our supplements.

The government is, as we heard from Dr. Coates, is well on its

way to providing those types of studies. We are focusing now in

those areas where there’s a long trail already of evidence that’s out

there, and a few additional studies may be what we need to take

us over the top to be able to say, yes, these are supplements that

we can now have confidence that they do improve health to the

point where we can calculate cost benefits.

Mr. BURTON. Let’s see, Dr. Blumberg, in your testimony, you

state that all women capable of becoming pregnant need to consume folic acid on a daily basis. What would you recommend is the

best method of obtaining folic acid besides eating liver, mushrooms,

dried greens or green leafy vegetables. Would just taking a folic

acid pill be sufficient?

Mr. BLUMBERG. Well, I would point out—it’s not nearly my view,

but the view of the Institutes of Medicine and the CDC—that the

most effective, reliable and practical way to insure that enough

folic acid is consumed to reduce the risk for neural tube defects is

to take a dietary supplement containing 400 micrograms of folic

acid.

It’s just, hands down, the most realistic way to do it. The reason

that many women don’t, indeed as I stated, two-thirds of American

women in this group do not use supplements containing folic acid,

is they are not getting the recommendations from their health care

providers that this is an appropriate thing for them to do. It’s really part of the preventive nutrition issue that you were raising. This

advice, which is actually official government advice, is still not

being picked up by health care providers by physicians, dieticians,

pharmacists and others to encourage women to do this.

Mr. BURTON. Is folic acid one of the most practical ways to insure

good health?

Mr. BLUMBERG. Well, folic acid, I like to think, is a very important vitamin, but it’s certainly not the only one. I would point out,

for example, that folic acid works in conjunction with other B vitamins, like vitamin B6 and vitamin B12 to lower homocysteine,

which I mentioned is an independent risk factor for cardiovascular

disease.

As Dr. Coates mentioned, there’s some exciting new research

that suggests that increasing our intake of folic acid may reduce

the risk for age-related dementias like Alzheimer’s disease. Recent

research studies at Tufts University have shown that people with

elevated homocysteine levels which can be lowered by folic acid

supplements, have fourfold higher rates of Alzheimer’s disease

than people with low homocysteine levels. So I think the promise

of folic acid, together with other essential vitamins and minerals,

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holds tremendous promise for promoting health and reducing our

risk for many chronic diseases.

Mr. BURTON. Well, I would like for all of you, as I said before—

I would like for all of you, if you would, to give me a list of the

essential vitamins that people should take so that they—I personally would like to know.

I have drawers of items. I can’t possibly take them all. I think

that’s one of the shortcomings that people have when they start deciding what is best for them. Because every article that you read

says this does this, this does this, and this does this. And clarity

in your health, I think, providing for your health, I think is very

important. So I would like some advice from you folks, and I have

been taking these things for a long time.

Dr. Levine, as part of your both written and oral testimony, you

stated that Americans are not getting the recommended daily intake of calcium that they need on a daily basis, just through the

foods they eat, that they are eating. Can you tell us the benefits

that we are getting as a society, how it could reap more benefits

if individuals supplemented their diets with calcium and what kind

of calcium are we talking about, are you talking about CalMax or

things like that?

Ms. LEVINE. Well, they are. Well, first some people should get

some calcium from their diet. Typically they get it from dairy foods,

certain leafy vegetables like cal-fortified foods, such as fortified orange juice. They can get it from fortified cereals. But really most

people are unwilling or unable to get the 1,200 milligrams they

need, and that’s for both men and women.

That’s if you translate it into dairy products, that’s four glasses

of milk a day—and most of us are saying low fat or skim milk a

day—but most of us are unwilling or unable to do that. So you can

get it from calcium carbonate, calcium citrate. You really do not

want to go to bone meal or dolomite that are contaminated with

things like lead or arsenic.

And the coral calcium issue is one that I don’t even want to go

into.

Mr. BURTON. Why not? Wait a minute. I want you to go into the

coral calcium issue.

Ms. LEVINE. Because they were advertising that as having a high

absorption rate of 69 percent. We know that most calcium, like carbonate or citrate, according to Dr. Heeney, who is a calcium expert,

shows that most calcium is absorbed like milk at about 30 percent.

So they did not do the calcium studies on coral calcium.

Mr. BURTON. Well, you are not saying coral calcium is not good,

it is just——

Ms. LEVINE. There is no way that it has an absorption rate of

69 percent.

Mr. BURTON. But it’s not bad?

Ms. LEVINE. I don’t think we have the studies. We really need

good double blind placebo-controlled studies. Most of the studies

that I am involved in, either at Cornell or the Rockefeller or

Strand, are in our clinical research center where we typically—I

should say it this way—incarcerate our patients. They stay in the

hospital. We control everything that they eat and drink.

Mr. BURTON. But you haven’t studied coral calcium yet?

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Ms. LEVINE. We do. We just finished a study on calcium, using

calcium carbonate in patients that were at high risk for colon cancer.

Mr. BURTON. Uh-huh.

Ms. LEVINE. Those data are not quite complete yet, so we will

have——

Mr. BURTON. What about the coral calcium?

Ms. LEVINE. We didn’t use coral calcium.

Mr. BURTON. You haven’t studied it?

Ms. LEVINE. No, we haven’t studied it.

Mr. BURTON. All right. Could you further explain the benefits of

omega 3 fatty acids for all Americans?

Ms. LEVINE. Yes. As I mentioned with children, it starts at the

very beginning. Mom gives DHA by the placenta in the third trimester of pregnancy to her baby, and then if she is nursing her

baby, she will give DHA to her baby.

However, as Americans, we have the lowest levels of DHA in our

breast milk. That’s because we do not eat fish, and we don’t eat

organ meats—and you mentioned you don’t like liver. Typically, we

used to eat more organ meats.

It’s in liver, it’s in brain. Remember that brain is made up of 60

percent fatty acids and 30 percent of which is DHA or

decosahexaenoic acid, and it’s also very concentrated in the retina.

So, babies that get DHA have better cognitive function and visual

acuity. And it’s also in the heart muscle. So that we really need to

have it throughout all stages of life.

And now, through the Framingham study, you mentioned that

too, it’s been shown that patients that have low DHA levels in their

serum and then on autopsy in their brain have higher, higher incidence of Alzheimer’s disease or dementia. So we need it throughout

our life cycle. So it’s very, very important. And I mentioned, we

soon will have results in a primary—prevention trial with DHA.

And that, again, is in a study that we gave everything that the patients had to eat and drink in our clinical research center.

The only thing that was different is that they were either on placebo or on DHA supplementation while in the hospital for 6

months. So it was a long-term study, and we will have the results

shortly.

Mr. BURTON. Well, if I have to choose from eating a supplement

that contains DHA or eating brains——

Ms. LEVINE. I’m sorry.

Mr. BURTON. I said if I have to choose between eating a supplement that has DHA or eating brains, there’s not going to be any

question.

Ms. LEVINE. Me too.

Mr. BURTON. Mr. Balbert, were you surprised by the $15 billion

in cost savings and healthcare expenditures that were derived from

the results of the study conducted by the Lewin Group?

Mr. BALBERT. I was delighted with the cost savings.

Mr. BURTON. Were you surprised?

Mr. BALBERT. Not really. Just putting a number to something

that we have, I think, intuitively understood in the industry, was

a pleasure and a relief. The fact of the matter is that’s just a quanVerDate 11-MAY-2000 11:22 Feb 08, 2005 Jkt 000000 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 D:\DOCS\98293.TXT HGOVREF1 PsN: HGOVREF1
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tification of a specific ailment, and I happened to put a great deal

of value in the quality of life of dietary supplements.

One other comment, chairman, you have expressed a number of

times in your comments about the angst that you have with the

volumes of dietary supplements that you take and the difficulty

that you have in finding out what is right for you. The industry has

a very simple guideline on that. We suggest that everybody should

take one multivitamin and mineral formula as a base of any

healthy nutritional program, and then based upon the additional

body functions that you are looking for sufficient nutritional support from—whether it be eye health such as lutein or insulin balance, which is chromium—you would then build around your multivitamin formula.

That, along with a good healthy life-style with plenty of sleep

and rest, and you will live to that 170 that you were talking about.

Ms. LEVINE. And laughter.

Mr. BALBERT. Oh, yes, and laughter.

Mr. BURTON. OK. All right.

Your organization, the Dietary Suupplements Education Alliance,

in your Web site and mailings to Capitol Hill have helped to educate Members of Congress on the benefits of taking dietary supplements.

Do I then assume correctly that it is critical that the DSHEA be

preserved and not amended?

Mr. BALBERT. Absolutely, Mr. Chairman. We don’t believe that

there needs to be any modification for DSHEA. The Federal Food

and Drug Administration has all the authority that they need.

What they need to do is to encourage and implement the DSHEA,

all the grounds that are necessary at this time. DSHEA does not

need to be modified.

Mr. BURTON. Our health agencies have the tools necessary to police that?

Mr. BALBERT. By their open admission and testimony——

Mr. BURTON. I think they have the tools today, yes. Well there

are those in Congress and in health agencies that want to junk

DSHEA, as you probably know. I just want to admonish those that

are interested in the health care field and the supplement field,

and that they stay vigilant in contacting their Congressmen and

Senators, not just Representative Kucinich, myself and Hatch and

others. But contacting them and telling them how important it is,

we don’t tinker with DSHEA.

Ms. Henner, you stated in your testimony—you just stated that

eating healthy is not enough and that you believe that dietary supplements need to be a part of your and everyone else’s daily regimen.

Tell us a little bit about what you take and why you think supplements are so important to you?

Ms. HENNER. I take a multivitamin called Comprehensive Formula that I actually helped develop. I take vitamin E, I take calcium. I do take coral calcium. And I do take a calcium called BoneUp and I—because it’s vegetarian.

Mr. BURTON. You are vegetarian?

Ms. HENNER. I am what is known as pesca vegetarian. Because

I eat some fish, although I have been, I eat, you know, a little bit

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of fish, but I mainly eat whole grains, fruits, vegetables, legumes.

So I have a very strong plant-based diet. I have just a——

Mr. BURTON. You don’t drink a lot of milk?

Ms. HENNER. No, I never drink milk. My children have never

had milk. They are 8 and 10 years old. They are both in a gifted

school. They have both skipped a grade. And they have strong

bones. They are both athletes. They are incredible. My children

have never had a dairy product in their life. And I haven’t had one

for 26 years. So——

Mr. BURTON. Why is that?

Ms. HENNER. Because the only thing dairy is supposed to do is

turn a 50-pound calf into a 350-pound cow in 6 months. It’s true.

I always tell people if those are your aspirations, knock yourself

out.

I mean, we have a 27-foot long intestinal track in a very small

stomach. A baby calf has four stomachs and 9 feet of intestines,

and they have nothing to do with each other. So we are not even,

you know, I think that dairy is one of the worst calcium carriers

ever. Now, it doesn’t even, you know, resemble the milk of old. It

is really just a white bovine slime, as far as I am concerned.

Mr. BURTON. Wait a minute, I will get there. White bovine slime.

Ms. HENNER. Bovine slime, it’s—you know, I read people’s faces,

I go up and I can always tell somebody who has an overconsumption of dairy products. Because that was my problem.

I always ate a lot of dairy products, and when I gave them up,

my digestion changed, my skin changed, my weight changed. Everything changed about my body.

So I am a big advocate of people looking to alternatives to dairy

products. Because two-thirds of the country doesn’t even eat dairy.

So, anyway, the other things that I take are I take pycnogenol,

which is an antioxidant. And I also take—but I work with a nutritionist in Los Angeles, who tests me from time to time, and also

note from, based on my schedule, and based on if I am traveling,

etc., I need to make adjustments along the way.

So, you know, I am lucky enough to have found someone to work

with who puts me on different programs from time to time. Excuse

me. Does that answer your question?

Mr. BURTON. I think so. Bovine slime.

As an author of six books promoting a healthy lifestyle, what recommendations would you make to Americans so that they can

make better healthy choices?

Ms. HENNER. You mean in terms of food or supplements or both?

Mr. BURTON. Both.

Ms. HENNER. Well, I think definitely think, you know, you are

a real person, eat real food. They should start reading labels.

That’s always where I start with people. Because anything that

takes a paragraph, you know, this big to describe, or says continued on the next can, you probably shouldn’t be eating it.

With my children, I always say if you can’t read it, don’t eat it.

I always start there. And so I always have people start there. I also

think that you should—the American public really needs to change

their palate, because it’s really not about counting, it’s not about

measuring, counting, you know, it’s not about measuring, weighing,

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counting the points, grams, carbs, etc., of the same old food. That

is not going to make somebody healthy or thin or fit.

And the other thing is, I think that everyone needs a good daily

multivitamin to start. And as Mr. Balbert said, you start there and

then you build from there.

And then depending on your genetic hand. I knew that my parents—having died of arthritis and heart attack, that I had to, I

looked into those diseases thoroughly and started taking the calcium and vitamin E and, you know, Pro-EPA is the fish oil, the one

that I take.

Mr. BURTON. Besides buying your book what other things can we

do to educate the public?

Ms. HENNER. Well, that’s an excellent start. You know what. I

always say I educated myself. I started this in 1978 after my mother died, and I went to medical libraries and research departments

and took human anatomy classes and went to health food stores.

And there was not a lot of information.

I think what we have to do is we have to get the information out

there to people, because once you know, you can’t choose not to

know anymore. And this is why I am, you know, an actress who

goes out talking as much as I do about health. Because I think people need to be educated.

So I think what people also need to do is also get off their butts

and stop stuffing their faces but starving their bodies with the

same old junk over and over again. Because that’s exactly what is

happening. Their bodies can’t even ignore the nutrients in the food,

and there’s no nutrients in the foods, they choose so they keep

overeating and overeating and overeating.

I always look at someone who has either a weight or skin problem, and I always say that’s a natural healer. Because their body

is telling them that they are doing something wrong. So I really

think that what people have to do is rediscover the child in themselves, get out there and exercise, find a good doctor who can work

you, know enough about your body so that you can help your doctor

help you and educate yourself as much as possible. And eat lots of

fruits and vegetables.

Mr. BALBERT. Mr. Chairman, the DSEA has created a very comprehensive Web site called supplementinfo.org, which is extremely

exhaustive in providing information to the American public and access.

Mr. BURTON. Give me that again.

Mr. BALBERT. Supplementinfo.org contains over 2 million pages

of information on the use of dietary supplements. It is ad nauseam

in terms of—the information is there.

Mr. BURTON. I want a one-page, one pager.

Mr. BALBERT. We will have it prepared for you, Mr. Chairman.

I can assure you.

Mr. BURTON. I want you to write down something for me saying

Dan, you can do this, and you are going be all right. All right?

Mr. BALBERT. Mr. Chairman, consider it done.

Ms. LEVINE. I think other responsibilities organizations, such as

the Heart Association, American Diabetes Association, of course

the NIH Web site, they are excellent Web sites to go to.

76

Mr. BURTON. Sure. Do you know how many pieces of paper. Representative Watson and I, how many documents we have to look

at a day. Do you know how many pieces of documents we get each

day and constituents asking us to pass to the White House and

people asking us to get their kids appointed to the Air Force Academy or West Point or God only knows, Social Security, veterans

problem, we really, I am not asking for sympathy. I asked for this

darn job a long time ago, but we really don’t have time to go into

a million pages here.

Mr. BALBERT. Of course not.

Mr. BURTON. But I will say give me the KIS principle, keep it

simple.

Mr. BALBERT. I will kiss you, Mr. Chairman.

Mr. BURTON. No, thank you. Maybe Marilu Henner.

I just want to say first of all, your enthusiasm, Ms. Henner is

very helpful, very nice.

Ms. HENNER. Thank you, this is my true passion, I was there

yesterday at the dietary guidelines open public forum talking

about—you know.

Mr. BURTON. Yes. I appreciate all of you panelists, I just want

to tell you, we had a hearing about a week ago, was it, on obesity

in America, and 31 percent of the people of this country are overweight. No. 65, 65 percent of the people of America are overweight

and 31 percent, almost 1 out of 3 people, are considered to be

obese.

I just got back from Guam and Saipan not too long ago, and they

have an absolute epidemic of diabetes over there. I think we had

a doctor before us at our last hearing and he said if we don’t

change our dietary habits in this country, one out of three children

will develop diabetes in their life, newly born, one out of three.

I mean, we are looking at an absolute epidemic if we don’t educate the public about eating habits, junk food—and then they start

saying that the average child in a year sees about 10,000 commercials—and I started watching children’s commercials and my God,

Little Benny’s chocolate wafers, you know, and all the stuff you see

is nothing but junk food, junk food, junk food. And a bit of that is

all right. But somehow, we have to educate the public, that they

ought to create better food products and advertise them the way

that make people want to eat them so that they get healthy. Otherwise, we are going to be paying so much money in health care cost,

it’s not even funny.

Ms. Watson is with us, she is my ranking democrat and a very

fine lady who is really concerned about health foods. Would you

like to make a comment?

Ms. WATSON. I thank you, Mr. Chairman. I am going to give my

opening statement, because I think it frames my interest and concern. Natural foods and supplements are very important to a

healthy population. If one understands what should go into the

body, then it is possible to live a healthier and more productive life.

Breast milk nurtures an infant and promotes accelerated learning.

Vitamins and minerals give cells and organs the proper building

block for optimal performance. There are some supplements that

have been proven to be very effective, for example, pregnant

women are advised to take folic acid to reduce the risk of certain

77

birth defects. And calcium supplements have been demonstrated to

reduce the risk of osteoporosis. Certain herbs and trace elements

also have medicinal values and sickness-preventing properties.

Mr. Chairman, I am encouraged with the aggressive outreach

and research initiated by the natural food and supplemental industry.

But there is room to do much more. The natural foods and supplement industry can help increasing numbers of Americans to

take charge of their own health. They can assist our constituents

in adopting healthier lifestyles that include a good diet, exercise,

supplementation and becoming more educated about all of these.

The Dietary Supplement Health and Education Act is a very important piece of legislation, and prior to its enactment, the FDA

regulated dietary supplements as food. Because manufacturers

claims are often promising and completely positive, Congress created guidelines to address supplement definition, safety concerns,

ingredient and nutrition labels, supplement claims, good manufacturing practices and new dietary ingredients. In addition, the

DSHEA created a supplement Commission and an office of dietary

supplements at the National Institutes of Health. Over the past

few years, there have been several media stories of supplements

causing adverse effects.

Natural nutrients are nothing to be scared of, but they should be

respected, treated with care and used properly. Since the enactment of DSHEA, the FDA has issued alerts on several supplements

to warn consumers of possible safety problems.

In other examples, the FDA has issued alerts about a possible

liver toxicity with kava-containing dietary supplements, dangerous

interactions between Saint John’s Wort and a number of prescription drugs and serious kidney disease and some cancers from herbal supplements containing aristolic acid.

Until recently, the FDA has only invoked its authority to declare

a supplement altered. In December 2003, the FDA declared that

Efedra, a dietary supplement that was marketed for weight loss

and was associated with serious adverse events, including heart attack, stroke and death, presented an unreasonable risk of injury.

The courts are currently reviewing this action, and courts should

not decide the risks and the efficacies of a dietary supplement at

all.

On the contrary, the scientific community should reach a wellfounded conclusion.

And, Mr. Chairman, you mentioned that several of the island,

Guam and other areas of the north Pacific and South Pacific are

now seeing the rapid development of being diabetic.

Mr. BURTON. Diabetes.

Ms. WATSON. I am thinking of so many other things. And I remember going to the Far East early—earlier on, and there wasn’t

a dentist around, and going back decades later, now there’s a dentist on every corner. Why? Because they have started consuming

western DSHEA style foods. And I think that is a sad commentary

on how we are promoting our bad dietary habits around the world.

And so I hope that we will have other hearings on this issue, because I do believe that of dietary supplements have an essential

role to play in today’s world. And I look forward to other hearings.

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I’m sorry I am late. I am sitting in another committee at the same

time. So thank you very much, Mr. Chairman, for this opportunity.

Mr. BURTON. You are welcome. Before we adjourn, let me say we

regret Ken Venturi wasn’t here with us. Ken Venturi won the U.S.

Open here at congressional under very stressful conditions years

ago, he is one of my heroes, I have had a chance to get to know

him and meet him a little bit. So I hope somebody will convey to

Mr. Venturi our sorrow that he couldn’t be with us. He has a book

out, and I am hoping I get a copy of it. I would like to read it, not

only on supplements but golf. I am a golf nut.

We have had some other people who are very interested in

health care issues and supplements. Arnold Schwarzenegger—I

talked to him on the phone—we were going to have him testify at

one time, shortly after he had open heart surgery, and I asked him,

this might be interesting to a lot of people who are interested in

the supplement field. I asked him if he thought that supplements

benefited him in the course of his surgery and his recovery. He said

that he recovered much more rapidly than anybody anticipated,

and he was absolutely certain it was because of not only his physical conditioning, but because of the supplements that he had been

taking for years that helped him heal quicker.

Of course, we have Ms. Henner here, another celebrity, we appreciate you being here. You are very beautiful and useful.

Ms. HENNER. Thank you very much.

Mr. BURTON. Just like when I saw you on TV.

Jane Seymour is a very good friend of mine. In fact I think I am

going to have lunch with Jane and James Keach, her husband, tomorrow. I think you know both of them. But she is a very, very

physical culturalist, if you will, and she is also big on supplements

as well as her sister, who I think teaches supplements.

And of course, we had one lady here, who I am sure would be

recognized as a person of great physical stature, Raquel Welch, and

just thought that you might like to know that she takes supplements as well. So this isn’t just limited to the plain people like me.

I mean, you have a lot of beautiful people who take that stuff as

well.

Ms. WATSON. Mr. Chairman, would you yield just 1 second?

Mr. BURTON. What piqued your interest there, was it Raquel

Welch or——

Ms. WATSON. This morning, on CNN, they were talking about the

Greek diet, and I was in Greece for the Olympics, and I noted that

every time you went into a restaurant, there was a Greek salad.

And I also noticed that everyone smoked there.

And I was asking, why is it that they don’t develop the kinds of

cancers related to smoking? Lung cancer and etc.? And they said

because of olive oil. So there are some medicinal properties in olive

oil that we all should be looking into.

They also talked about couscous in place of white rice, and they

talked about the fresh vegetables. They have the best tomatoes in

the world. So I think there are a lot of natural products that we

get through the supplements, and they tend to—they say they live

longer because of the olive oil. So I think we ought to try that and,

you know, stop using butter, dip our bread in olive oil. Thank you,

I just had to get that in.

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Mr. BURTON. Put that on my list, will you?

Ms. HENNER. I am half Greek, I just want you to know. My book

has exactly what they were talking about today.

Mr. BURTON. A lot of olive oil.

Ms. HENNER. A lot of olive oil. I was raised on olive oil too.

Mr. BURTON. Send me your list, kid.

Ms. HENNER. I will.

Mr. BURTON. Thank you, this has been very, very interesting. We

will have more panels on this, health and wellness and supplements. And you have been very helpful today.

We will send some questions to you. If you wouldn’t mind answering them and sending them back to us for our record. Thank

you very much. We stand adjourned.

[Whereupon, at 11:40 a.m., the subcommittee was adjourned.]

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