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95–187 PDF 2004

S. Hrg. 108–651

DIETARY SUPPLEMENT SAFETY ACT:

HOW IS THE FOOD AND DRUG ADMINISTRATION

DOING 10 YEARS LATER?

HEARING

BEFORE THE

OVERSIGHT OF GOVERNMENT MANAGEMENT, 

THE FEDERAL WORKFORCE, AND THE DISTRICT 

OF COLUMBIA SUBCOMMITTEE

OF THE

COMMITTEE ON 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JUNE 8, 2004

Printed for the use of the Committee on Governmental Affairs

(

(II)

COMMITTEE ON GOVERNMENTAL AFFAIRS 

SUSAN M. COLLINS, Maine, Chairman 

TED STEVENS, Alaska 

GEORGE V. VOINOVICH, Ohio 

NORM COLEMAN, Minnesota 

ARLEN SPECTER, Pennsylvania 

ROBERT F. BENNETT, Utah 

PETER G. FITZGERALD, Illinois 

JOHN E. SUNUNU, New Hampshire 

RICHARD C. SHELBY, Alabama 

JOSEPH I. LIEBERMAN, Connecticut 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

RICHARD J. DURBIN, Illinois 

THOMAS R. CARPER, Delaware 

MARK DAYTON, Minnesota 

FRANK LAUTENBERG, New Jersey 

MARK PRYOR, Arkansas

MICHAEL D. BOPP, Staff Director and Chief Counsel 

JOYCE A. RECHTSCHAFFEN, Minority Staff Director and Counsel 

AMY B. NEWHOUSE, Chief Clerk

OVERSIGHT OF GOVERNMENT MANAGEMENT, THE FEDERAL 

WORKFORCE, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE 

GEORGE V. VOINOVICH, Ohio, Chairman 

TED STEVENS, Alaska 

NORM COLEMAN, Minnesota 

ROBERT F. BENNETT, Utah 

PETER G. FITZGERALD, Illinois 

JOHN E. SUNUNU, New Hampshire 

RICHARD J. DURBIN, Illinois 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

FRANK LAUTENBERG, New Jersey 

MARK PRYOR, Arkansas

ANDREW RICHARDSON, Staff Director 

MARIANNE CLIFFORD UPTON, Minority Staff Director and Chief Counsel 

KEVIN R. DORAN, Chief Clerk 

(III)

C O N T E N T S 

Opening statements: Page 

Senator Voinovich ............................................................................................. 1 

Senator Durbin ................................................................................................. 2 

WITNESSES 

TUESDAY, JUNE 8, 2004

Hon. Robert E. Brackett, Ph.D., Director, Center for Food Safety and Applied 

Nutrition, U.S. Food and Drug Administration ................................................. 5

Alice M. Clark, Ph.D., Vice Chancellor for Research and Sponsored Programs, 

University of Mississippi, Oxford, Mississippi ................................................... 18

Ronald M. Davis, M.D., Member, Board of Trustees, American Medical Association (AMA) ....................................................................................................... 20

Charles W.F. Bell, Program Director, Consumers Union of U.S., Inc ................. 21

Anthony L. Young, General Counsel, American Herbal Products Association 

(AHPA) .................................................................................................................. 24

Bruce Silverglade, Director of Legal Affairs, Center for Science in the Public 

Interest .................................................................................................................. 25

Annette Dickinson, Ph.D., President, Council for Responsible Nutrition ........... 27

ALPHABETICAL LIST OF WITNESSES

Bell, Charles W.F.: 

Testimony .......................................................................................................... 21

Prepared statement .......................................................................................... 92

Brackett, Hon. Robert E., Ph.D.: 

Testimony .......................................................................................................... 5

Prepared statement with attachments ........................................................... 43

Clark, Alice M., Ph.D.: 

Testimony .......................................................................................................... 18

Prepared statement with attachments ........................................................... 75

Davis, Ronald M., M.D.: 

Testimony .......................................................................................................... 20

Prepared statement .......................................................................................... 85

Dickinson, Annette, Ph.D.: 

Testimony .......................................................................................................... 27

Prepared statement with attachments ........................................................... 123

Silverglade, Bruce: 

Testimony .......................................................................................................... 25

Prepared statement .......................................................................................... 115

Young, Anthony L.: 

Testimony .......................................................................................................... 24

Prepared statement .......................................................................................... 105

APPENDIX 

List of Manufacturers Receiving Androstenedione Warning Letters .................. 66

Sample Warning Letter on Androstenedione ........................................................ 68

Chart entitled ‘‘Time Line of Activities To Establish Current Good Manufacturing Practice Regulations (CGMPs) for Dietary Supplements,’’ submitted 

by Mr. Brackett .................................................................................................... 70

Chart entitled ‘‘CFSAN 2004 Program Priorities,’’ submitted by Mr. Brackett . 72

American Society For Pharmacology and Experimental Therapeutics 

(ASPET), prepared statement ............................................................................. 137

(1)

DIETARY SUPPLEMENT SAFETY ACT: HOW IS 

THE FOOD AND DRUG ADMINISTRATION 

DOING 10 YEARS LATER? 

TUESDAY, JUNE 8, 2004

U.S. SENATE, 

OVERSIGHT OF GOVERNMENT MANAGEMENT, THE FEDERAL

WORKFORCE, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE,

OF THE COMMITTEE ON GOVERNMENTAL AFFAIRS, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 2:36 p.m., in room 

SD–342 Dirksen Senate Office Building, Hon. George V. Voinovich, 

Chairman of the Subcommittee, presiding. 

Present: Senators Voinovich and Durbin. 

OPENING STATEMENT OF SENATOR VOINOVICH 

Senator VOINOVICH. The Subcommittee will come to order. 

Good afternoon, and thank you for coming. The Subcommittee is 

meeting this afternoon to discuss the Food and Drug Administration’s implementation of the Dietary Supplemental Health Education Act of 1994, also referred to as DSHEA. 

This hearing was requested by my friend and colleague, Senator 

Durbin. In the 51⁄2 years that I have been Chairman or Ranking 

Member on this Subcommittee, Senator Durbin and I have had an 

excellent working relationship. When I was Chairman of the Subcommittee during the 106th Congress, we held two hearings on 

food safety at Senator Durbin’s request, and during the last Congress, Senator Durbin held two hearings at my request on one of 

my top issues, human capital management, and today, I am happy 

to be hosting this hearing. 

Prior to this hearing, I was not familiar with the subject matter 

of dietary supplements. After I started researching the issue, I 

began to understand why Senator Durbin wanted to hold a hearing. I take vitamins daily and would like to be guaranteed that 

they are labeled correctly and that they are safe. I also have additional concerns with people mixing dietary supplements and prescription drugs. 

Millions of Americans buy and use dietary supplements on a 

daily basis and believe that the products that they are taking are 

safe and beneficial to their health. Now that we have reached the 

10th anniversary of the act, it is appropriate to examine whether 

the FDA and the dietary supplement industry have adhered to the 

intent of this law so that Congress might consider ways in which 

it could be improved and also to educate American consumers on 

2

the latest development in dietary supplement policies and practices. 

Recognizing the need for the Federal Government to address the 

American consumer’s growing interest in dietary products and public safety, Congress overwhelmingly passed DSHEA 10 years ago. 

And the purpose of the act was to provide the framework for ensuring that the Federal Government properly oversees the safety and 

efficacy of dietary supplements sold in the United States. 

Essentially, this legislation requires that all ingredients and supplements sold in the United States must be previously approved by 

the FDA and listed on the bottle label and that distributors must 

follow guidelines to demonstrate the veracity of any claims that are 

made in regard to the particular product. Additionally, an important aspect of DSHEA is the establishment of good manufacturing 

practices, GMPs, which are standards that could help ensure the 

safety of dietary supplements. 

In March 2003, the FDA published a proposed rule for dietary 

supplement GMPs, and the rule is currently under review. It is my 

understanding that the final rule on GMPs is expected by the end 

of the year. I applaud the Bush Administration and former FDA 

Commissioner McClellan for making this a priority. This is a positive step in the enforcement of DSHEA, and I hope these standards 

give American consumers of dietary supplements greater confidence in their safety. 

With that said, I would like to know why it took the regulations 

so long to be established. Responsible members of this industry 

have actively sought appropriate science-based regulations to ensure that consumers are well-educated through factual labeling and 

that dietary supplements are manufactured in a consistent manner 

to guarantee their safety and efficacy. 

Unfortunately, not all players in the market are responsible. It 

is these bad players that bring us here today. We need to ensure 

that they are held accountable and that Americans can depend on 

the existing regulatory agencies to protect and promote their 

wellbeing with regard to dietary supplements. 

To aid in this dialogue, the Subcommittee will be hearing from 

the U.S. Food and Drug Administration, policy researchers, medical 

professionals, consumer advocacy groups, and dietary supplement 

industry leaders, regarding the impact of the law. 

I now yield to our Ranking Member of the Subcommittee, my 

good friend, Senator Durbin, for an opening statement. 

OPENING STATEMENT OF SENATOR DURBIN 

Senator DURBIN. Thank you, Mr. Chairman. And this has been 

a very cooperative bipartisan relationship, and we each have our 

interests and priorities, and Senator Voinovich has allowed me to 

pursue this, and when I chaired this same Subcommittee, I offered 

the same opportunity to him. 

And I think this is the kind of bipartisan cooperation people expect of us, and I am glad that we have been able to achieve it in 

this Subcommittee. 

Mr. Chairman, 1994 was an important year in the history of the 

dietary supplement industry. After an overwhelming effort on Capitol Hill, the dietary supplement industry won the right to sell 

3

their products to the American public without testing them in advance for safety or establishing their efficacy. The Dietary Supplement Health Education Act of 1994, also known as DSHEA, exempted the industry from informing the FDA when their products 

caused harm or injury to the people who were buying them. 

The law that was passed in 1994 was opposed by all public 

health, medical, and professional nutrition groups, including the 

American Cancer Society, the American Dietetic Association and 

all of the major consumer groups in America, including the Consumer Federation of America. 

Since then, business has been very good for the supplement industry. The industry has grown more than fourfold since 1994, 

from $4 billion to $18 billion in sales. According to the Centers for 

Disease Control and Prevention, more than 38 million Americans 

used dietary supplements in the past 12 months. The Internet has 

now grown to 143 million users, and there are literally thousands, 

hundreds of thousands of Websites on the Internet that sell dietary 

supplements. 

But meanwhile, consumers have been endangered by the FDA’s 

inability to act on particular supplements, 155 people died after 

taking dietary supplements containing the stimulant ephedra, and 

thousands more suffered injury. Yet it took years, literally years, 

for the FDA to ban this substance under this law, DSHEA. The 

FDA’s action, though commendable, may have been a classic case 

of closing the barn door well after the horse had galloped away. 

By July 2003, 6 months before FDA acted, Walgreens, CVS, Rite 

Aid, and virtually all other major drug stores and specialty nutrition stores in this country had already removed products containing ephedra from their shelves. Why? They believed that 

ephedra was too risky and exposed their stores to legal liability if 

they continued to sell dangerous ephedra products. 

All the major American sports organizations and the International Olympic Committee had already banned ephedra before 

the FDA acted. Three of the most populous States, Illinois, New 

York, and California, had done the same, and the nation of Canada 

had banned the sale of ephedra. Ephedra products were banned for 

sale on military base exchanges around the world, because we had 

literally lost soldiers who had taken ephedra products and died. 

Why did it take the FDA, the agency created by President Theodore Roosevelt to protect the American public from mysterious elixirs claiming to cure diseases, so long to finally pull the plug on 

ephedra? The answer? DSHEA. The law has to be changed to protect consumers. Millions of Americans take vitamins safely every 

day, including this Senator and the Chairman. Vitamins taken in 

recommended doses are safe. 

It is the designer supplements that are worrisome. Supplement 

makers like to say their products are safe because they are natural. 

They have been used for years. But the truth is that many of today’s supplements contain concentrated extracts mixed with a myriad of other ingredients that can be harmful. Take the supplement 

Joint Ease, which was marketed as a natural remedy for arthritis. 

While the active ingredient, aristolochic acid, has been used for 

centuries in Europe and China, the supplement product contained 

4

the substance in concentrated form which was subsequently found 

to cause kidney failure and kidney cancer. 

The product was eventually recalled, but only after cases in the 

United Kingdom, Belgium, and France highlighted its toxicity. 

Until we fundamentally change the law governing how supplements are regulated, agencies responsible for public health will 

constantly fall short of monitoring the marketing practices of this 

industry. I do not believe that every natural substance needs to be 

subject to premarket safety testing. But at the very least, DSHEA 

should be changed so that stimulants are tested before marketed. 

When a supplement raises blood pressure, increases metabolism 

and constricts blood vessels, it is only prudent that we test this 

product before it is marketed. Otherwise, American consumers are 

going to be the laboratory test rats. 

Another change I would like to see made to DSHEA is making 

the adverse event reporting system mandatory for serious adverse 

events. I am not talking about someone getting dizzy from taking 

a supplement. I am talking about heart attacks, strokes, and death. 

It is absolutely necessary that we know when a product is seriously 

harming people. How can the FDA effectively protect the public if 

it does not know when the product is causing harm? 

Adverse event reporting is not a cumbersome process compared 

to the premarket safety and efficacy review prescription and overthe-counter drugs go through. Fixing DSHEA and keeping dietary 

supplements safe are challenging tasks. It is no assignment for the 

politically timid, I can tell you, having been on this issue for a couple years. Regardless, our responsibility to protect the health of the 

American consumer is clear. 

Thank you, Mr. Chairman. 

Senator VOINOVICH. Thank you, Senator Durbin. 

First, the Subcommittee has the pleasure of hearing testimony 

from Hon. Dr. Robert Brackett. Dr. Brackett is the Director of the 

Center for Food Safety and Applied Nutrition at the Food and Drug 

Administration. He will explain in greater detail the status of 

DSHEA’s implementation. 

On the second panel, we will hear from Dr. Alice Clark, the Vice 

Chancellor for Research and Sponsored Programs at the University 

of Mississippi and a member of the National Academy of Sciences’ 

Task Force for Developing a Framework for Evaluating the Safety 

of Dietary Supplements. The Subcommittee will also hear testimony from Dr. Ron Davis, Member of the Board of Trustees of the 

American Medical Association to discuss the medical society’s view 

of DSHEA. And we will also hear from two consumer groups: 

Charles Bell, who is the Program Director for Consumer Reports; 

and Bruce Silverglade is the Director of Legal Affairs at the Center 

for Science in the Public Interest. And to provide insight into how 

DSHEA has affected the dietary supplementary industry, the Subcommittee will hear from Tony Young, General Counsel for the 

American Herbal Products Association, which represents the herbal 

supplement industry and Dr. Annette Dickinson, President of the 

Council for Responsible Nutrition, who represents many suppliers, 

manufacturers, and marketers of dietary supplements in the 

United States. 

5

1The prepared statement of Mr. Brackett with attachments appears in the Appendix on page 

43. 

I want to thank all of our witnesses for coming today. It is my 

sincere hope that this hearing will help point out the positive effects of the Dietary Supplement Health Education Act while at the 

same time providing suggestions from our witnesses that could further improve this law. 

Once again, we look forward to hearing from today’s witnesses. 

I would appreciate it if all of you could keep your statements to 5 

minutes and please be aware that your statements will be made a 

part of the official record of this Subcommittee. 

We have a custom here in this Subcommittee to swear in all witnesses. I would ask all of our witnesses today to stand and to raise 

your right hand, please. 

[Witnesses sworn.] 

Senator VOINOVICH. Let the record indicate they answered in the 

affirmative. 

Dr. Brackett, will you come forward? 

TESTIMONY OF HON. ROBERT BRACKETT, PH.D.,1 DIRECTOR, 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, U.S. 

FOOD AND DRUG ADMINISTRATION 

Mr. BRACKETT. Good afternoon, Mr. Chairman and Senator Durbin. 

I am Dr. Robert Brackett, Director of FDA Center for Food Safety and Applied Nutrition, and I am pleased today to testify before 

your Subcommittee on the Dietary Supplement Health and Education Act. 

Many Americans take some type of dietary supplement, and in 

many cases, there is either strong or suggestive evidence that 

many of the vitamins and minerals and other sorts of naturally-occurring products that we take have important health benefits. The 

Dietary Supplement Health and Education Act of 1994, as you 

said, DSHEA, amended the Federal Food, Drug and Cosmetic Act 

to set up a distinct regulatory framework for these products in an 

attempt to strike the right balance between providing consumers 

access to dietary supplements that they may choose to help to 

maintain and improve their health and giving the Food and Drug 

Administration regulatory authorities to take action against supplements or supplement ingredients that present safety problems, 

either having false or misleading claims or otherwise adulterated 

or misbranded. 

As with foods, there is no premarket FDA approval of safety for 

most dietary supplements. However, there is a 75-day premarket 

notification requirement for manufacturers of certain dietary supplements that contain so-called new dietary ingredients that were 

not marketed in the United States before October 15, 1994. In its 

new dietary ingredient notification to FDA, the manufacturer or 

distributor of the supplement must submit information that provides the basis on which it concludes that the dietary supplement 

containing the new dietary ingredient will reasonably be expected 

to be safe. 

6

FDA regulates the safety of dietary supplements primarily 

through a postmarket evaluation of whether the product is adulterated under the provisions of the Food, Drug and Cosmetic Act. In 

developing a comprehensive postmarket safety evaluation of 

dietary supplement products, FDA collaborates with consumer and 

industry stakeholders as well as other Federal partners and academic centers. 

An important tool that FDA uses for developing the so-called signal which might identify potential safety problems are adverse 

events reports. These reports are not mandatory and consist of voluntary reports from industry, health care providers and consumers. 

Under DSHEA, FDA was given authority to promulgate regulations for dietary supplement current good manufacturing practices, 

CGMPs, and such regulations could help ensure product quality 

and consistency. FDA published a proposed rule on March 13, 

2003; extended the comment period; convened two satellite 

downlink outreach meetings and attended three outreach meetings 

organized by the industry. 

Publishing the final rule is a priority for FDA. The FDA uses 

three principles: direct health risk, indirect health risk, and economic harm to guide the development of its risk-based enforcement 

strategy. Products that are not themselves hazardous can still 

present an indirect health hazard in that consumers may delay or 

forego proven medical treatments or drug therapies. Examples include unproven products promoted for the treatment of cancer, diabetes, arthritis, heart disease, and high blood pressure. 

This strategy provides a foundation for the agency’s enforcement 

activities. However, we continually reevaluate our actions and emphasis in light of emerging issues or products to ensure that our 

activities achieve compliance. 

Since October 2002, FDA has conducted 224 domestic inspections 

of dietary supplement manufacturers, issued more than 170 warning letters and cyberletters to marketers of dietary supplement 

products, seized products worth more than $9 million, supervised 

the voluntary destruction of more than $3 million worth of supplements with promoted and unsubstantiated dietary supplement 

claims or that were unapproved drugs and obtained permanent injunctions against five firms distributing misbranded or unapproved 

new drugs. 

FDA enforcement has extended to our Nation’s borders, where 

we have refused importation of more than 1,500 foreign shipments 

of potentially unsafe or misbranded dietary supplements offered for 

entry into the United States. The agency’s enforcement actions 

send a clear message that FDA will not tolerate fraudulent practices that victimize or endanger consumers. 

In April 2004, FDA sent a warning letter to 16 dietary supplement manufacturers making false and misleading claims for weight 

loss products promoted over the Internet. Many of these products 

claimed to block starch, carbohydrates, fats and calories while 

maintaining that consumers would lose weight without any 

changes in their lifestyle. On March 8, 2004, the producers and distributors of SEA-Silver signed a consent decree of permanent injunction in which they agreed to stop manufacturing and distributing violative products and agreed to destroy the seized products 

7

at their expense and pay liquidated damages of $10,000 per day for 

any future violations of the consent decree. 

Under a settlement with the Federal Trade Commission entered 

into on March 4, 2004, the SEA-Silver defendants and the individual distributors agreed to pay $4.5 million in consumer redress, 

and this consent decree followed a coordinated effort in June 2003 

that resulted in the seizure of $5.3 million worth of products. 

FDA will continue to use our available resources to fully implement DSHEA, and Mr. Chairman, I do thank you very much for 

this opportunity to testify today, and I would be very happy to take 

your questions. 

Senator VOINOVICH. Thank you, Dr. Brackett. 

Do you think that DSHEA gives the FDA the regulatory authority to supervise the dietary supplement industry? 

Mr. BRACKETT. It does give us the supervisory authority to supervise the dietary supplement industry. But what is important is 

that we take what all of the parts of DSHEA and implement it 

fully in order to get the most use out of it. 

Senator VOINOVICH. So it is your opinion that the law is adequate. Do you think that there are some improvements that could 

be made in the law that make it easier for you to get the job done? 

Mr. BRACKETT. Well, the administration has no plans at this 

time to make any changes or suggest any changes to DSHEA. 

There are a number of options that we could use that would improve our effectiveness, including, especially, more research that 

could be done on some of the supplements themselves so that we 

could better define what they are and what they do. 

Senator VOINOVICH. One issue that is of concern to this Subcommittee is the oversight of government management and restructuring, is the capacity of agencies to perform the jobs that they are 

asked to perform by Congress, in this particular case, DSHEA, the 

enforcement of it, I think in your testimony you said something 

about FDA does the job with ‘‘available resources.’’

Mr. BRACKETT. That is right. 

Senator VOINOVICH. I know that FDA has numerous responsibilities other than enforcing DSHEA. Do you believe that you have 

the resources necessary to enforce this law? 

Mr. BRACKETT. Well, we have the resources we need to do and 

enforce the top priorities. Part of our strategy is to look at all of 

the different issues that we have to deal with within DSHEA, 

prioritize them based on public health risks, as I had mentioned 

earlier and then to use our resources effectively towards those that 

have the biggest public health impact. 

Senator VOINOVICH. What are the top priorities? 

Mr. BRACKETT. The top priorities are looking at those ingredients 

that might cause some sort of injury or might otherwise cause 

human health effects. As I mentioned, we can also have indirect effects, where people are taking dietary supplements in lieu of taking 

medical treatments, but we are most interested in those ingredients that might actually have a direct public health impact; that 

is, make someone ill. 

Senator VOINOVICH. How do you find out about those ingredients? 

8

Mr. BRACKETT. Well, there are several different ways, one of 

which is the label. We look to see what is on the label and whether 

the ingredients listed on the label actually have characteristics, 

known pharmacological properties that——

Senator VOINOVICH. Do you have a regular policy of monitoring 

these supplements as they come onto the market? Or do you wait 

for these things to be brought to your attention by this adverse 

event reporting or from consumer groups that are out there monitoring new supplements? 

Mr. BRACKETT. Well, all of the above. We have, as I mentioned, 

the 75-day notification in which a manufacturer of a new dietary 

ingredient would send in an application for their product being listed as a new dietary ingredient, where they must show cause that 

they believe that this product is safe, so that is one way. 

Senator VOINOVICH. These are new ingredients. The law was 

passed 10 years ago and said that the ingredients prior to the passage of the law were grandfathered in. 

Mr. BRACKETT. That is correct. 

Senator VOINOVICH. So, if they come out with new ingredients 

that are different than what were grandfathered, they have an obligation to bring that to your attention? 

Mr. BRACKETT. That is correct. 

Senator VOINOVICH. If they do not do that, what is the penalty? 

Mr. BRACKETT. They are subject to prosecution, because they are 

marketing this product that is not an approved new dietary ingredient. The other things that we do in addition to looking at——

Senator VOINOVICH. Pardon me; do you have many of those that 

do that? 

Mr. BRACKETT. No, there are not many who do that. We have—

probably more than half the applications that come in, we will object to, because they have not provided enough information, enough 

scientific information to justify that they are safe, and so, we are 

not aware of many that do that. 

Some smaller items may, when we find out about them, we do 

take action for those. And as listed in my written testimony, there 

are a number of examples of those sorts of items that we have 

taken action on. 

Senator VOINOVICH. About how many prosecutions have you had 

for people who failed to come in and comply with that part of the 

law? 

Mr. BRACKETT. I am not sure of the exact numbers. I can find 

that out, and I would be happy to get back to you with the exact 

number.

INFORMATION PROVIDED FOR THE RECORD 

Response: In March 2004, FDA sent 23 warning letters to companies asking them 

to cease distributing products sold as dietary supplements that contain androstendione (andro) and warning them that they could face enforcement actions if they 

do not take appropriate actions. The warning letters state that FDA assumes that 

the firm has a basis to conclude that androstenedione is a dietary ingredient. If 

androstenedione is a dietary ingredient, FDA believes that it is also a new dietary 

ingredient for which a premarket safety notification is required. Because any manufacturer or distributor who has received a warning letter has submitted no such notification, these products are adulterated and their marketing is prohibited under 

the Federal Food, Drug, and Cosmetic Act. The letters further state that FDA is, 

based on what it knows now, aware of no history of use or other information estabVerDate 0ct 09 2002 10:40 Nov 18, 2004 Jkt 095187 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCS\95187.TXT SAFFAIRS PsN: PHOGAN
9

1List of Manufacturers Receiving Androstenedione Warning Letters and Sample Warning Letter on Androstenedione, submitted by Mr. Brackett, appear in the Appendix on pages 66 and 

68 respectively. 

lishing that a dietary supplement containing androstenedione will reasonably be expected to be safe. In the absence of such information, these products would be adulterated even if the required premarket safety notification were submitted. The attached list has the names of the firms and the products in question. A sample warning letter is also attached.1

The Agency has never conducted a prosecution for violations of the notification requirements for new dietary ingredients.

Senator VOINOVICH. I would like that. 

Mr. BRACKETT. OK. 

Senator VOINOVICH. As you know, under DSHEA, FDA can regulate dietary supplement good manufacturing practices. I understand that FDA will issue a final rule on GMPs possibly by the end 

of the year. Can you tell me why it has taken so long for these 

GMPs to be issued and if you feel they will bring about needed 

changes in the oversight of the dietary supplementary industry? 

Mr. BRACKETT. Well, I will answer your last part first, which is 

yes, absolutely; good manufacturing practices are essential to providing consistency and quality, and, as you mentioned earlier, to 

make sure that the consumers get what they think they are getting 

in an ingredient. There’s a number of reasons why it has taken a 

long time. First, in 1994, when DSHEA was published, it took a little bit of time for FDA to, in making a current good manufacturing 

practice rule, finding out all of the background on the industry, 

what needed to be changed, what did not need to be changed. 

And so, we spent a lot of time meeting with the industry in the 

intervening years. From that, we were able to propose the rule that 

you had mentioned earlier. 

Senator VOINOVICH. When was that rule proposed again? 

Mr. BRACKETT. In 1993. 

Senator VOINOVICH. No, I am talking about the rule that——

Mr. BRACKETT. Oh, in March 2003 is the current proposed good 

manufacturing practice rule. Since that time, we have gotten much 

comment from the industry. We have met with them; have extended the comment period; we have gotten over 1,600 pages of 

comments that we very thoughtfully went through; hundreds of 

substantive comments that we will address in the final rule. 

Senator VOINOVICH. I have run out of my time, but one question 

that I have got, and then, you can save it for the next one is that 

if the law was passed 10 years ago, it seems to me that is a long 

time to consider regulation. 

Mr. BRACKETT. It is a long time, and that is why it is one of our 

top priorities within the Center for Foods. 

Senator VOINOVICH. Thank you. Senator Durbin. 

Senator DURBIN. Thank you, Mr. Chairman. 

Dr. Brackett, I apologize. We are usually given biographies of the 

witnesses, and I do not have yours. Are you a medical doctor? 

Mr. BRACKETT. No, I am not. I have a Ph.D. in food microbiology. 

Senator DURBIN. I see. 

Let me ask you a few questions, if I might. First, on the reporting of new ingredients, the 75-day reporting, was there a list published of pre-1994, pre-DSHEA ingredients so that FDA knows if 

there is a new ingredient that is being used? 

10

Mr. BRACKETT. To my knowledge, there was no specific list given 

on those ingredients. 

Senator DURBIN. So how does that work? 

Mr. BRACKETT. What FDA does, then, is goes back to look to see 

whether certain of the dietary supplements that we know were sold 

before that time were marketed, and of course, those we can rule 

out. Otherwise, it takes research to go back and find out whether 

there is any evidence that they were, and we also request from the 

industry to show whether or not they were marketed before that 

period. 

Senator DURBIN. That seems like a very unusual approach, that 

FDA did not start off with a list of pre-1994 ingredients so the 

agency would have some knowledge as to whether an ingredient is 

new. Is it possible that some ingredients were benign in some combinations but dangerous in other combinations? 

Mr. BRACKETT. Yes, that is true. 

Senator DURBIN. So if you had an ingredient that perhaps was 

viewed as an old ingredient, had been used before 1994, now combined with another old ingredient, the combination itself could turn 

out to be dangerous; is that possible? 

Mr. BRACKETT. It would be possible. I do not know of any specific 

examples, but that goes back to one of the important gaps that I 

think we have, which is do we actually characterize many of these 

ingredients to find out individually what they do and what their 

characteristics are? And then, when you also have the evidencebased reviews of these compounds, see if there is any evidence of 

cross-reaction with other compounds. 

Senator DURBIN. So to protect American consumers, would not 

our government and your agency want to know a lot more about 

the ingredients used before 1994, particularly in what combinations 

they were used, and whether you are not only seeing new ingredients but new combinations of old ingredients? Are not all of those 

important questions if your mission is to protect the consumers? 

Mr. BRACKETT. They are excellent questions, and that is information that we would like to have. That is true. 

Senator DURBIN. And you do not have the right to establish that 

information under DSHEA, do you? 

Mr. BRACKETT. Well, what we are doing is working with academic centers such as the University of Mississippi’s National Center for Natural Product Research, with the National Institutes of 

Health, to try to get those answers. 

Senator DURBIN. We are 10 years after the fact, and I am glad 

we are still working to try to get those answers as the industry has 

grown from $4 billion in sales to $18 billion in sales. 

Now, let me speak about the GMPs, the manufacturing practices. 

How many years has the FDA been working on these regulations 

to establish good manufacturing practices in the dietary supplement industry? 

Mr. BRACKETT. Well, I would say at some level, we have been 

working since DSHEA was passed. It has been the most active 

probably in the last 4 or 5 years. 

Senator DURBIN. So for 10 years, the FDA has been trying to establish basic standards of manufacture and purity of the products 

themselves, not looking into specific questions about whether this 

11

is a product that might be of some danger to an individual; is that 

correct? 

Mr. BRACKETT. That is correct. Well, as I mentioned earlier in 

the testimony, one of the things we did early on was to go back and 

check what were manufacturers doing at that time? What were the 

industry norms within the industry themselves? Which sorts of operations would cause products to be either contaminated or whether they would be reduced, or perhaps the amount of an ingredient 

might not match what was on the label. 

So we tried to learn as much about this industry as we could before we actually started writing. 

Senator DURBIN. Are you familiar with a group called Consumer 

Lab, Dr. Cooperman and Dr. Obermeyer? 

Mr. BRACKETT. I have heard the name, yes. 

Senator DURBIN. I believe Dr. Obermeyer was a former employee 

of the Food and Drug Administration. In Oprah Magazine, they 

just published the fact that Theragran-M, which is a very common 

multivitamin, advanced formula, high potency multivitamin, multimineral contained 3.65 micrograms of lead, which exceeded the 

limit for supplements used by adults. Are you familiar with that? 

Mr. BRACKETT. I have not read the article, and I have heard rumors about it but no personal knowledge of that issue. 

Senator DURBIN. Now, going to Chairman Voinovich’s question, 

Stuart Prenatal, a multivitamin, multimineral supplement, advertises that it has 4,000 IUs of Vitamin A. It turns out, after testing, 

it has 75 percent of the vitamin A that is claimed. Again, that is 

in the article which you are familiar with—or at least have heard 

of—but have not read. These are things which go to the question 

of good manufacturing practices, are they not? 

Mr. BRACKETT. That is exactly what good manufacturing practices are for, and in addition to having too little vitamins, it is 

sometimes quite dangerous to have too much as well, so that is also 

covered. 

Senator DURBIN. And we are still, after 10 years, trying to establish basic standards on good manufacturing practices. 

Let me go to March 11, 2004, this year, where your agency announced a crackdown on companies selling androstenedione 

(andro), a steroid precursor. Acting FDA Commissioner Lester 

Crawford said we are using the DSHEA authority to supervise dietary supplements put on the market after the law was passed. For 

example, he said, we sent letters to 23 companies directing them 

to cease distributing dietary supplements containing andro. 

Doctor, are you familiar with a company known as GNC? 

Mr. BRACKETT. Yes, I am. 

Senator DURBIN. Pretty widespread, large company with a lot of 

stores all over the United States. 

This morning, I asked my staff to go over to the local GNC. They 

went over and purchased this product called Skuplt. It is a topical 

fat loss product containing androstenedione. It also contains yohimbine, a substance the FDA announced 11 years ago causes serious 

adverse effects, including renal failure, seizures and deaths. 

Since the FDA has taken a specific action against this dietary 

supplement, and we still find it on the shelves of one of the most 

12

prominent supplement retailers in the United States, what does it 

tell us about your enforcement actions? 

Mr. BRACKETT. Well, with the letters that we sent out on 

androstenedione, I think all but five have withdrawn their products. 

Senator DURBIN. Out of how many? 

Mr. BRACKETT. Out of, I believe, 23. 

Senator DURBIN. Twenty three. 

Mr. BRACKETT. In this particular instance, did you say this was 

a topical? 

Senator DURBIN. Yes. 

Mr. BRACKETT. So this may not be covered under what we were 

looking at, which were oral dietary supplements. 

Senator DURBIN. All right; now, let me ask you about the adverse 

event reporting. You said one of the things that you feel is your responsibility is to establish the risk of a dietary supplement product; 

is that correct? 

Mr. BRACKETT. Yes. 

Senator DURBIN. We ask the makers of prescription drugs—in 

fact, we do not ask; we require them to report adverse events so 

that the Food and Drug Administration will know if there is a 

warning sign. If someone gets seriously sick, hospitalized, dies from 

a prescription drug, the FDA is put on notice immediately. Did you 

not testify earlier that DSHEA makes this reporting by supplement 

manufacturers strictly voluntary? 

Mr. BRACKETT. That is correct. It is voluntary. 

Senator DURBIN. So how can you protect the American consumer 

from risk if you are not even receiving from these companies, the 

dietary supplement companies, notice that their products are hurting, injuring or even killing American consumers? 

Mr. BRACKETT. Well, I think that the answer to that is that adverse event reporting, it is an important signal, but it is not the 

only thing that we use. Equally important are some of our knowledge of the pharmacology of some of the ingredients that might be 

in there with, even in the absence of an adverse event, whether we 

have used it against evidence-based reviews to see if there has 

been any reporting in the scientific literature and what the science 

actually points to on those ingredients as well as perhaps the 

chemical nature of the compounds themselves, whether they are 

similar to other sorts of ingredients that we know might cause public health problems. 

Senator DURBIN. So it comes down to a basic question I will ask 

you: Either you are asking for too much information from the pharmaceutical companies on adverse event reporting, or you are not 

asking for enough information from the dietary supplement manufacturers, who have a voluntary reporting standard. Which is it? 

Mr. BRACKETT. Well, we would welcome a lot more information 

from the dietary supplement manufacturers or, I think, information 

in general from wherever, whether it be physicians or the public 

as well, as again, as one of the parts of the signals that we use. 

Senator DURBIN. Thank you for your tolerance. Exactly how 

many people at the FDA are monitoring the dietary supplement industry? How many employees? 

13

Mr. BRACKETT. In total, I do not know the exact answer to that, 

because many of them in the field—again, I could be happy to get 

back with you to find the appropriate answer. 

Senator DURBIN. Is it a matter of hundreds or dozens or fewer 

than 20? Just give me a rough estimate. 

Mr. BRACKETT. I do not want to speculate. We will find out. It 

is not probably hundreds, I do not think, but I can find out what 

the exact allocation of people to this task is for you and get back.

INFORMATION PROVIDED FOR THE RECORD 

In Fiscal Year 2003, FDA had 58 people, i.e., full-time equivalents (FTE), in various parts of the Agency, monitoring the dietary supplement industry. 

In Fiscal Year 2004, 59 people (FTE), in various parts of the Agency, were monitoring the dietary supplement industry.

Senator DURBIN. Thank you very much, Mr. Chairman. 

Senator VOINOVICH. It is my understanding that if a manufacturer has a defective product, they have the ability to recall this 

product. I am not sure if there is a law that requires manufacturers to report the defective product, or they are doing it because 

they want to protect themselves from a lawsuit. Would it not make 

sense to make it mandatory for these companies to submit adverse 

event reports? 

Mr. BRACKETT. Well, again, that would be one thing that could 

be done, but again, that is just a small part of the whole or at least 

an equal part of the many different factors that would factor in. So 

if we were to have adverse event reporting mandatory, and right 

now, the administration has no position on this, again, that would 

not solve the whole problem. We would still need to look very closely at the science, at our knowledge of what has been done pharmacologically, many other things. 

Senator VOINOVICH. You said that with the new ingredients, they 

have to submit it so that you can look at the product, or if that 

is mandatory, and if they do not do that, then, they can be prosecuted. 

Mr. BRACKETT. They are in violation, yes. 

Senator VOINOVICH. Subject to penalties, right. 

Would it not make a lot of sense to make it mandatory that they 

at least report these adverse events and provide a penalty that 

says if they do not do it, they are subject to the same kind of sanctions or worse or whatever that you have on not submitting a product for review prior to putting it on the market if it is new ingredients? 

Mr. BRACKETT. Well, that would be helpful, but again, that is not 

the whole story. And another difficult part of that is many of the 

dietary supplements today are a combination of many ingredients, 

unlike many of the pharmaceuticals. So quite often, when you have 

an adverse event reported, it may not necessarily be caused by the 

ingredient that you think it is. So it is complicated. 

Senator VOINOVICH. When ephedra came out on the market there 

were some incidents that were claimed to be as a result of taking 

ephedra that might have been due to something else. It seems to 

me that even if the event reports showed that the incidents were 

not caused by ephedra that you would investigate ephedra further. 

14

Mr. BRACKETT. Oh, absolutely. When we have adverse events reports, we do look into it. But again, standing on the pillars of the 

pharmacology, the evidence-based research, the scientific literature, 

all of that has to stand together. 

Senator VOINOVICH. Well, my common sense tells me that it 

would be good if we required them to do it. And I think it would 

probably be very helpful to you also. I suspect that some manufacturers who did have adverse event reports did not submit them to 

you. 

Additionally, I am concerned with people mixing over-the-counter 

medicine or prescription drugs with dietary supplements. As you 

know this is a growing industry and consumption is only going to 

increase. In 2006, 680,000 people in Ohio are going to start getting 

prescription drug coverage to improve their quality of life. Is there 

a concern within the FDA that the mixing of prescription drugs 

and dietary supplements could cause adverse effects? 

Mr. BRACKETT. Well, certainly, Mr. Chairman, that is a concern, 

and that is one of the recommendations we always make is that patients discuss their medications and any other foods as well as dietary supplements that they may be consuming. 

Senator VOINOVICH. I take coumadin, and in the disclosure that 

comes along with coumadin, they talk about vegetables that are 

strong in vitamin K, and if you consume high levels of vitamin K, 

it could make the drug less effective. 

It would seem to me that a dietary supplement, should carry the 

same type of information. Individuals ought to be informed that if 

they are taking a drug like coumadin, a blood thinner, that these 

kinds of interacting could dilute the product, and therefore, the 

drug they are taking may not be as effective as it should be. 

Do you think the dietary supplement should be required to put 

the same kind of warnings on their labels? 

Mr. BRACKETT. Well, I think that would be good for them to do 

if they knew what the interactions were. Quite often, the manufacturers of the drugs have a better understanding of what interactions have been studied in much more depth. 

Senator VOINOVICH. You have to wonder how much real thought 

is going into labeling dietary supplements. 

One reason for such huge growth in the dietary supplement industry is the ability to purchase them over the Internet. Many of 

these supplements have big claims on their Websites. 

Mr. BRACKETT. Well, I agree. And this goes back to my earlier 

statement. We simply have to know more about the ingredients we 

are taking, and that is why we do appreciate our colleagues at the 

University of Mississippi and at the National Institutes of Health 

actually doing research on both the properties of these ingredients 

and the beneficial aspects of the ingredients as well. 

But again, one of the issues that we have to deal with is finding 

out exactly what the ingredient is in the first place, and sometimes, 

that is the first challenge. 

Senator VOINOVICH. Senator Durbin. 

Senator DURBIN. Dr. Brackett, when Dr. McClellan was Commissioner, he promised enforcement action against some of the 

ephedra substitutes. This product here, Stacker-2, which is advertised on television, this is now advertised as ephedra free, and if 

15

you will look at the operative ingredients, they include cola nut and 

citrus aurantium, which is also known as bitter orange. 

Now, Dr. McClellan said that he was going to take enforcement 

action against products containing bitter orange and usnic acid, 

which are now ephedra substitutes. Can you tell me what has been 

done so far in that enforcement action? 

Mr. BRACKETT. Sure, actually, what Dr. McClellan’s intent was 

anything, any of those stimulant products that were to be used in 

place of ephedra were to get a much closer scrutiny to find out, in 

fact, if they were of danger, and that is something that we have 

been doing. We have been looking at ephedra substitutes; again, to 

characterize them, to find out specifically what is in the products 

that are on the market; in some cases, you may have parts of dietary supplement come in from one part of the plant versus another 

part of the plant, and they may have different amounts entirely of, 

in this case, citrus aurantium. So we are trying to get all of the 

scientific data that we need, and if it looks like there is something 

that is at risk, we will take action. 

Senator DURBIN. This is an unusual assignment for the FDA, because when it comes to other products that you monitor, for instance, prescription drugs, is it not true that the burden is on the 

manufacturer of the drug to establish its safety and efficacy, and 

in the case of dietary supplements, we are talking about the FDA 

scrambling to find the personnel, the time and the resources to do 

the research on the product that is already on the market; is not 

that true? 

Mr. BRACKETT. That is true. This is a little bit different than 

pharmaceuticals. In this case, the law is almost ahead of the 

science. In the case of pharmaceuticals, they are specifically developed with a chemical structure that people know about. In this 

case, people are taking common ingredients for which we often do 

not understand what the active ingredient in it is. And so, it is taking some basic research to just define and characterize what the 

products we are dealing with are. 

Senator DURBIN. We are trying to take a look back at DSHEA, 

and as you take a look back, is not this an extraordinary if not impossible burden for the FDA to handle, to try to look at each new 

ingredient and then try to do enough research to determine that 

even on the market, it is not dangerous? 

Mr. BRACKETT. Well, it is impossible for FDA to do. This is why 

we partner with NIH. There are specifically in DSHEA the Office 

of Dietary Supplements that was established to help with this in 

addition to our academic partners as well. So it is a large-scale effort. 

Senator DURBIN. Do you have the specific responsibility within 

FDA for monitoring the dietary supplement industry? 

Mr. BRACKETT. We have the specific authority, yes, to oversee the 

dietary supplement industry. 

Senator DURBIN. And as the director of the Center for Food Safety and Applied Nutrition, that is your responsibility. 

Mr. BRACKETT. That is correct. 

Senator DURBIN. I mentioned the article in Oprah Magazine

about specific problems, and you said you were familiar with it. Is 

this the kind of thing, having been brought to your attention, that 

16

would result in activity by the FDA to establish whether or not the 

assertions in here are true and that some products currently on the 

shelf are dangerous? 

Mr. BRACKETT. Yes, and in fact, this article was brought to my 

knowledge by my staff who, in fact, is actually checking into those 

assertions. 

Senator DURBIN. And let me ask the same thing about the Consumer Reports story. This Consumer Reports story from May of 

this year lists some 12 different supplements, starting with some 

that they have identified by testing as definitely hazardous to likely hazardous. Have you undertaken in the FDA any kind of investigation or study of these dietary supplements which have been 

identified as dangerous? 

Mr. BRACKETT. Yes; in fact, much of the information in the Consumer Reports article was not new to us. We did know about that. 

We have, in fact, done some surveillance since that time to look for 

certain ingredients that were listed in there as well so——

Senator DURBIN. Have any of these products been taken off the 

shelf, like ephedra? 

Mr. BRACKETT. Well, ephedra has been off, unless it is there illegally. 

Senator DURBIN. Any other products on the Consumer Reports 

list? 

Mr. BRACKETT. We have listed or sent out warning letters, for instance, for aristolochic acid. In fact, that was one of the items for 

which we did surveillance and to this point have not found them 

in products marketed as dietary supplements. 

Senator DURBIN. Let me just conclude, Mr. Chairman, by thanking you and also to say this: If the object of this law is to protect 

American consumers, I think it fails on its face. Take a look at the 

obvious here: 10 years after passing the law, we still have not established standards so we can even identify what is in these products. And I think, by the nod of the head, you agree with me. We 

do not know what is in them, to start with. We do not know if it 

is 4,000 IUs or 3,000 IUs. We have no idea whether there is lead 

contained in multivitamins or not. 

That is a starting point. The second thing we have not established is the responsibility of the industry. Ten years after the law 

is passed, we have not come up with a list of pre-1994 ingredients. 

And even if we did, you have conceded in your testimony it is of 

little value, because a combination of old ingredients could be dangerous, as dangerous as any new ingredient. 

And finally, we do not have any requirement that these companies selling products worth lots of money to them in profits even 

report to the Food and Drug Administration when people get seriously ill from having taken these products. So that is why I am 

kind of troubled by your conclusion. Having said these things, having heard these things, you have concluded by saying and therefore, we do not want to change the law. 

How can you possibly meet your responsibility to consumers to 

say to them if you buy a dietary supplement for yourself or somebody in your family, it is safe? How can you meet that responsibility with a law that is so weak? 

17

1The information entitled ‘‘Time Line of Activities To Establish Current Good Manufacturing 

Practice Regulations (CGMPs) for Dietary Supplements,’’ submitted by Mr. Brackett appears in 

the Appendix on page 70. 

Mr. BRACKETT. Well, the safety and health of the consumers is 

our utmost concern. That is the thing that we most want to protect. 

What we are doing is trying to work, to maximize our activities 

under the current DSHEA before we would go out and sort of look 

for new authorities. There are many parts of DSHEA that we think 

have not been explored, that we can use to protect the public, and 

that is one of the things that we are going to do, which is why we 

do want to use DSHEA to its maximum, completely. 

Senator DURBIN. Dr. Brackett, that approach is so timid that 

even the industry is ahead of you. We are going to have testimony 

later from someone from the dietary supplement industry. They 

have conceded that adverse event reporting is necessary. And yet, 

you are afraid to say those words. I think we are in trouble here. 

I think your watchdog responsibility includes being ahead of the 

problem and not behind it. If you are stuck with this 10-year-old 

law that is so deficient, you are never going to get ahead of it. 

Thanks for your testimony. 

Mr. BRACKETT. Thank you. 

Senator VOINOVICH. Thank you. I would like to make one point, 

and that is I would like to have, in writing from you, the chronology of going forward with this rule for these GMPs. I cannot believe that it has taken that long for it to happen. This law passed 

10 years ago, and it is unacceptable. 

Mr. BRACKETT. We will be happy to provide that.1

Senator VOINOVICH. Unacceptable that it takes 10 years to get 

something done. I would like to have some assurance from you 

today this is going to get done at least by the end of this year. 

Mr. BRACKETT. We will do our very best to get it done as soon 

as possible. That is our goal. 

Senator VOINOVICH. Is the problem that you do not have enough 

people? 

Mr. BRACKETT. Well, the problem has been partly going through 

many of the comments that we have to address, as you know, in 

rulemaking. 

Senator VOINOVICH. I would like to know how many people you 

have working on this. I also would like to know what other responsibilities that you have? So often, we ask agencies to do work, and 

then, we do not provide them the resources necessary to get the job 

done. So often we pass the law and forget about the fact that it has 

to be enforced. 

I am really interested in knowing, in getting a candid appraisal 

from you whether or not you have the number of people you need 

to get the job done in your agency to implement these laws that 

we have passed over the years. 

Mr. BRACKETT. We will be happy to get that to you.

INFORMATION PROVIDED FOR THE RECORD 

Approximately five full-time-equivalent employees (three people full-time, two 

people at 75 percent, one person at 50 percent) and approximately nine others as 

necessary, are working on preparing the final rule for publication with dietary supplement GMP’s as their first priority. We are also soliciting input on development 

18

1The information entitled ‘‘CFSAN 2004 Program Priorities,’’ appears in the Appendix on page 

72.2The prepared statement of Ms. Clark, with attachments, appears in the Appendix on page 

75. 

of the final rule from two external expert consultants and one GMP expert in FDA’s 

Center for Drug Evaluation and Research (CDER). In addition, when the final rule 

has been drafted, there will be additional people involved in the review/clearance/

publication process. 

Over 400 comment letters, approximately 1,600 pages, were received on the proposal, most of which raised substantive issues that need to be addressed in the preamble to the final rule. Accordingly, the bulk of the effort is in reviewing and responding to the comments. 

CFSAN, in conjunction with the Agency’s field staff, regulates 80 percent of the 

nation’s food supply and is responsible for protecting the public’s health by ensuring 

that the nation’s food supply, except for meat, poultry and certain egg products 

which are the responsibility of the Department of Agriculture, is safe and secure, 

and honestly labeled. CFSAN has similar responsibilities for cosmetic products. Attached is a May 4, 2004, transmittal letter to our Colleagues in the FDA Foods 

Community forwarding our projected workload for Fiscal Year 2004 in accordance 

with the Agency’s Strategic Action Plan. You will note that the plan includes 168 

‘‘A-list’’ goals, of which we anticipate at least 90 percent completion this year.1

Senator VOINOVICH. Any other comments, Senator? 

Senator DURBIN. No. 

Senator VOINOVICH. Thanks very much. We really appreciate 

your coming here today. 

Mr. BRACKETT. Thank you, Mr. Chairman. 

Senator VOINOVICH. Our next witnesses to testify are Alice M. 

Clark, Ph.D., Vice Chancellor for Research and Sponsored Programs, from the University of Mississippi; Ronald M. Davis, M.D., 

member of the Board of Trustees of the American Medical Association; Charles Bell, Program Director, Executive Office, Consumer 

Reports; Anthony L. Young, General Counsel, American Herbal 

Products Association; Bruce Silverglade, Director of Legal Affairs, 

Center for Science in the Public Interest; and Annette Dickinson, 

Ph.D., President, Council for Responsible Nutrition. 

This is a large second panel, so I would appreciate your adhering 

to the 5-minute rule. I appreciate you testifying today, and again 

remind you that your testimony will be made a part of the record 

along with your written statement. 

We will begin the testimony with Dr. Clark. 

TESTIMONY OF ALICE M. CLARK, PH.D.,2 VICE CHANCELLOR 

FOR RESEARCH AND SPONSORED PROGRAMS, THE UNIVERSITY OF MISSISSIPPI 

Ms. CLARK. Good afternoon, Mr. Chairman, and Senator Durbin. 

My name is Alice Clark. I am Vice Chancellor for Research and 

Sponsored Programs at the University of Mississippi and a professor of pharmacognosy. I also served as a member of the Committee on the Framework for Evaluating the Safety of Dietary Supplements at the Institute of Medicine and National Research Council. 

I am here today to talk about our report, which is entitled ‘‘Dietary Supplements: A Framework for Evaluating Safety,’’ which was 

released in April of this year, and my comments today will focus 

on some key findings and recommendations of the report. 

In 1994, of course, Congress passed DSHEA in order to define 

FDA’s authority to regulate dietary supplements. In the fall of 

19

2000, the FDA approached the Institute of Medicine with a request 

to devise a science-based framework that it could use to evaluate 

dietary supplements under the authority of the current statutes. 

In short, DSHEA states that supplements are to supplement the 

diet and are therefore regulated like foods, meaning that they are 

assumed to be safe. Many of the products on the market are probably safe. However, to identify and take action on the occasional 

problem product, the FDA must rely on available evidence to evaluate whether an ingredient poses an unreasonable risk. 

According to DSHEA, the agency can act to protect the public’s 

health when an ingredient poses a significant or unreasonable risk. 

In this report, we offer a science-based approach that allows the 

FDA to use available data to better identify supplements of concern 

and then evaluate the safety of those ingredients. This framework 

consists of three major steps: Signal detection, an initial review of 

that signal, and an in-depth evaluation of the ingredient. 

In the framework’s first step, the FDA becomes aware of a signal, a notification or an event that raises concern about a particular ingredient. In the framework’s second step, that signal is reviewed to determine if the ingredient should be investigated further. And in the framework’s third step, the totality of available 

scientific data is evaluated to determine if the ingredient poses an 

unreasonable risk. 

This approach works within the parameters of the current law 

governing how dietary supplements are regulated. One of the key 

points of this report is that the FDA does not have to find direct 

evidence of actual harm from use of a supplement ingredient to determine that the product poses an unreasonable risk. Another key 

point of the report is that historical use of an ingredient is often 

insufficient to demonstrate that an ingredient does no harm. 

The report also describes the significance of other kinds of data 

the agency can use in its safety evaluation, such as data from animal studies, tests done in laboratories or toxicity of similar or related substances. Some of these types of data may be sufficient by 

themselves for the FDA to determine that a supplement ingredient 

poses an unreasonable risk. 

With the approach devised by the committee, it is possible for the 

FDA to conduct effective safety evaluations within the current regulatory framework. However, in the process of devising this approach and reviewing the science, the committee noted that constraints imposed by aspects of DSHEA limit the agency’s ability to 

conduct these evaluations as effectively and efficiently as possible. 

We have recommended some changes that could mitigate these 

constraints and make the law more effective in meeting the goal 

of protecting public health. I will mention just a few of those key 

recommendations now: For example, we recommend that supplement manufacturers and distributors be required to notify FDA 

about health problems that they discover related to the use of their 

products, and recognizing that other parties also bear responsibility 

for ensuring that health problems related to supplement use are 

brought to the FDA’s attention, we recommend that health professionals be educated about ways to report health concerns and encouraged to use them. 

20

1The prepared statement of Dr. Davis appears in the Appendix on page 85. 

We also recommend that the toll-free number for FDA’s 

Medwatch be printed on all supplements’ packaging so that consumers have a clear way to relay any health concerns. And finally, 

while the committee did not do a cost analysis of implementing the 

framework, we recognize that implementing any framework will require additional resources. Therefore, we recommend that FDA be 

provided adequate resources to implement the framework and more 

effectively protect the public’s health. 

Thank you for the opportunity to address you on this important 

topic, and I would be pleased to answer questions. 

Senator VOINOVICH. Thank you. Dr. Davis. 

TESTIMONY OF RONALD M. DAVIS, M.D.,1 MEMBER, BOARD OF 

TRUSTEES, AMERICAN MEDICAL ASSOCIATION (AMA) 

Dr. DAVIS. Chairman Voinovich, Ranking Member Durbin, good 

afternoon. My name is Ron Davis. I am a preventive medicine physician from Detroit and a Member of the Board of Trustees of the 

American Medical Association. 

On behalf of the AMA, I am pleased to be here to discuss the 

dangers of dietary supplements and whether DSHEA is working. 

The AMA has been concerned for years about the use and abuse 

of dietary supplements. These include herbal products and those 

containing anabolic steroid-like ingredients and their precursors. 

Precursors are substances that the body can convert into testosterone or other anabolic steroids. 

DSHEA does not provide FDA with enough authority over dietary supplements to adequately protect consumers. What are the 

problems with DSHEA? First, DSHEA treats a wide variety of socalled natural substances as foods, but the fact of the matter is 

that herbal remedies, anabolic steroids or their precursors are not 

foods, and neither are megadose vitamins. 

These supplements are biologically active compounds that act 

like drugs. They also have risks and side effects that can be serious 

and, unfortunately, sometimes fatal. Therefore, many dietary supplements are really drugs. 

Second, because existing law treats these products as foods, people think they are safe. In fact, surveys show that most consumers 

believe that these products have been approved by the government. 

But such protections do not exist for dietary supplements. Prescription and over-the-counter medications must be proved safe and effective and receive FDA approval before being sold. There is no 

such approval for dietary supplements. 

For the most part, supplement manufacturers do not have to provide premarket data to FDA: No safety data, no efficacy data, no 

quality data. They do not have to include warnings, precautions or 

side effects on their product labels, even for products with known 

serious hazards. So consumers are not told that many supplements 

can counteract their prescription medications or cause adverse reactions. 

Manufacturers also do not have to provide adverse event reports 

to the FDA. The bottom line? Consumers cannot be sure that dieVerDate 0ct 09 2002 10:40 Nov 18, 2004 Jkt 095187 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 C:\DOCS\95187.TXT SAFFAIRS PsN: PHOGAN
21

1The prepared statement of Mr. Bell appears in the Appendix on page 92. 

tary supplements work, are safe and that the bottle actually contains what the label says it does. 

Third, under DSHEA, the burden is on the FDA, not the manufacturer, to prove that a dietary supplement is unsafe or adulterated. This is very difficult. Ephedra is probably the best example 

of how hard it is to regulate unsafe dietary supplements. Ephedra 

causes a number of well-documented adverse reactions, including 

heart attacks, strokes, seizures, and death. 

For several years, the AMA asked FDA to ban ephedra products 

from the U.S. market. Yet even for a substance as dangerous as 

ephedra, it took FDA 7 years to ban the product. Although ephedra 

has been banned, we are concerned about other dietary supplements containing so-called natural stimulants that still are being 

sold. These products, labeled ephedra-free, often contain bitter orange, as you mentioned, Senator Durbin. Bitter orange contains 

ephedra-like substances and may be associated with high blood 

pressure, irregular heartbeat, heart attack, and stroke. 

My written statement provides additional examples of the dangers of other supplements. 

The AMA has supported changing DSHEA for the past 6 years. 

Many dietary supplements, especially herbal products, need to be 

regulated like drugs. We urge Congress to make four changes in 

the law: (1) Require premarket approval by FDA of all dietary supplements for evidence of safety and efficacy. As with drugs, manufacturers should have the burden of proving their products are safe 

and beneficial. 

(2) Require dietary supplements to meet U.S. Pharmacopeia 

standards for identity, strength, quality, purity, packaging and labeling. (3) Require manufacturers to monitor their products for 

safety and to submit adverse event reports to FDA. And (4) reclassify dietary supplements that contain anabolic steroids or their precursors as drugs, subject to the Controlled Substances Act. 

The AMA supports pending legislation such as S. 1722, sponsored by you, Senator Durbin. We were pleased that last week, the 

House of Representatives passed, by an overwhelming margin, H.R. 

3866. We encourage the Senate to pass its companion bill, S. 2195. 

These bills would make some of the changes that we have recommended. 

We appreciate the opportunity to present our views. 

Senator VOINOVICH. Thank you, Doctor. Mr. Bell. 

TESTIMONY OF CHARLES W.F. BELL,1 PROGRAM DIRECTOR, 

CONSUMERS UNION OF U.S., INC 

Mr. BELL. Good afternoon, Chairman Voinovich, Ranking Member Durbin and other Members of the Subcommittee. I am Charles 

Bell, Programs Director for Consumer’s Union, the nonprofit publisher of Consumer Reports and consumerreports.org. 

Since 1936, our mission has been to test products, inform the 

public and protect consumers, and today, I offer this testimony on 

dietary supplements as part of our consumer protection function. 

The Dietary Supplement Health and Education Act of 1994 has 

opened the floodgates to thousands of untested dietary supplement 

22

products. While many dietary supplements including most vitamins 

and minerals taken within recommended limits are generally safe 

and can have important health benefits for consumers, there is a 

significant and growing number of highly questionable products 

that would probably not be allowed on the market if they were subject to premarket safety testing. 

As has been noted, under DSHEA, the burden of proof for removing unsafe products has been inappropriately shifted from manufacturers to the government. As former FDA Director David 

Kessler has stated, Congress put the FDA in the position of being 

able to act only after the fact and after substantial harm has already occurred. 

In the aftermath of DSHEA, new dietary supplement products 

can be introduced overnight, as can novel combinations of new or 

existing supplement ingredients. Further, unsafe dietary supplement products can remain on the market for many years, in the 

same stream of commerce as products approved by the FDA as safe 

and effective for their intended use. 

As an example, in 1995, Consumer Reports published this list of 

five supplements that, according to FDA, could cause serious harm 

to consumers: Ephedra, chaparral, comfrey, lobelia and yohimbe, 

and 9 years later, ephedra is the only one of these supplements 

that has finally been removed from the marketplace, many years 

after the FDA received reports of serious consumer health problems, including deaths and disabling injuries. But the other four 

hazardous supplements that we named in 1995 are all still being 

marketed and sold in retail stores and on the Internet. 

In May 2004, Consumer Reports published a major article called 

‘‘Dangerous Supplements Still at Large’’ with a new, more comprehensive list but not necessarily exhaustive list, but this includes 

12 hazardous dietary supplements including the four herbs earlier 

named that we believe are too dangerous to be on the market based 

on government warnings, adverse event reports and medical experts. 

These dirty dozen unsafe supplements, which we purchased in 

stores and online in February, include aristolochia, an herb conclusively linked to kidney failure and cancer; yohimbe, a sexual stimulant linked to heart and respiratory problems; chaparral, comfrey, 

germander and kava, all known or likely causes of liver failure; 

and bitter orange, its ingredients having effects similar to the 

banned weight loss supplement ephedra. 

The potentially dangerous effects of most of these products have 

been known for more than a decade, and at least five of them have 

been banned in Asia, Europe, and/or Canada. Now, we believe that 

consumers want additional protections to ensure that supplements 

are safe. Last month, Consumer’s Union conducted an online survey of a random sample of over 1,200 adults regarding dietary supplements as part of a regular national consumer survey that we 

perform. 

The survey found that more than eight in ten respondents agreed 

that poor regulation of supplements posed a personal risk to themselves and their families. More than nine in ten want the sale of 

supplements to be conditioned on safety and efficacy. Virtually everyone, 96 percent, agreed that supplement producers should be reVerDate 0ct 09 2002 10:40 Nov 18, 2004 Jkt 095187 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 C:\DOCS\95187.TXT SAFFAIRS PsN: PHOGAN
23

quired to report adverse events, as is required for prescription 

drugs. 

Similarly, 96 percent want product risk information to be included on dietary supplement labels, and fewer than one in five respondents feel that supplements are already sufficiently regulated. 

The current serious gaps in consumer protection in DSHEA are 

not in the interests of dietary supplement consumers. Consumers 

turn to dietary supplements because they think these products will 

promote health and wellness. So it is very important to ensure that 

these products are safe and do not themselves pose serious health 

problems. 

We are pleased that the FDA finally did take action to remove 

ephedra from the marketplace in January 2004, finally coming off 

in April, but we are very concerned that the action came too late 

for many consumers, who experienced unacceptable health damage, 

including stroke, seizures, heart attacks, and deaths. And despite 

numerous warning signals, the agency failed to take action in a 

timely way to remove that product from the marketplace. 

Ephedra is a poster child for a failed policy. We need to understand why the signals of an urgent public health problem failed to 

trigger prompt action by the Federal Government. 

Many consumers are surprised to learn that the government does 

not evaluate the safety of dietary supplements before they are sold. 

Joseph Levitt, who was the Director of FDA’s Center for Food Safety and Applied Nutrition, has testified that the current regulation 

of dietary supplements is, for the most part, a postmarketing program, but we cannot even run the postmarketing aspect of that 

program effectively without the authority to require mandatory reporting of adverse events, and we find this to be one of the most 

disturbing aspects of the entire ephedra debacle. 

The fact is that voluntary reporting of adverse events by manufacturers has failed. From 1994 to 1999, fewer than 10 of the 2,500 

reports that the FDA received about serious consumer health complaints actually came from manufacturers, and we are very concerned that evidence has emerged that at least two manufacturers 

suppressed thousands of adverse event complaints relating to supplements containing ephedra: Metabolife and E’ola, as detailed in 

my written testimony. 

We wonder as we sit here today what else manufacturers may 

have known about the dangers of ephedra and other supplements, 

including those on our dietary dirty dozen list. Unless Congress 

acts now to tighten requirements from adverse event reporting by 

manufacturers, FDA will continue to lack vital information that is 

needed to ensure the safety of dietary supplements. 

So we would recommend that Congress make appropriate modifications to DSHEA to create a sensible preventive safety system 

that ensures that supplement products are reviewed for safety 

prior to marketing and sale. The safety system should also include 

effective postmarketing surveillance so the government can take 

prompt safety actions as needed, including recalls, warnings and 

import alerts. Labels of dietary supplements should clearly indicate 

what and how much is in the package and provide explicit warning 

of possible adverse effects, including herb-drug interactions. 

24

1The prepared statement of Mr. Young appears in the Appendix on page 105. 

We strongly support the provisions in the Durbin bill, the Dietary Supplement Safety Act of 2003, S. 722, that would enable the 

FDA to take unsafe products off the market more quickly. We also 

strongly believe that dietary supplement makers should be required to report adverse events to the FDA. And in particular, on 

this point, I would note there is broad consensus among many parties that adverse event reporting is critical to ensuring supplement 

safety. As the Institute of Medicine in April urged Congress to 

amend DSHEA to require mandatory reporting; the AMA supports 

this position; the Inspector General of the Department of Health 

and Human Services has called for it. Even Secretary of Health 

and Human Services Tommy Thompson stated in his press conference in December it would be nice to have the authority to require mandatory adverse event reporting. 

And so, we think that is a critical step for us to take to learn 

from the experience with ephedra. 

Thank you, and I look forward to the opportunity to respond to 

questions. 

Senator VOINOVICH. Thank you very much. Mr. Young. 

TESTIMONY OF ANTHONY L. YOUNG,1 GENERAL COUNSEL, 

AMERICAN HERBAL PRODUCTS ASSOCIATION 

Mr. YOUNG. Chairman Voinovich and Ranking Member Durbin, 

my name is Anthony Young. I am General Counsel to the American 

Herbal Products Association or AHPA. I appear here because 

AHPA’s president, Michael McGuffin, who was here 2 years ago, 

had a preexisting commitment with the FDA’s Food Advisory Committee. 

AHPA’s prepared testimony addresses in some detail the issues 

you have raised with respect to the purpose of this hearing. With 

respect to FDA and DSHEA, AHPA is pleased with FDA’s recent 

dietary supplement regulatory activities. Under the leadership of 

Dr. Mark McClellan, FDA began seriously to enforce DSHEA, and 

these efforts are detailed in enforcement reports found on FDA’s 

Website and in Dr. Brackett’s testimony today. 

In addition, FDA has now come to closure on how to regulate 

ephedrine alkaloid-containing dietary supplements and 

androstenedione, and they have done so. All of these enforcement 

activities were supported by the supplement industry’s effort to assure that the funds necessary for dietary supplement enforcement 

were earmarked in FDA’s budget, and that was a unified position 

of the supplement industry that those funds were needed. 

In addition to enforcement, FDA proposed last year current 

GMPs for dietary supplements. AHPA was one of the industry 

trade associations that presented FDA with an industry draft for 

GMPs in late 1995. While a long time coming and controversial in 

part, AHPA looks forward as you do to FDA making Dr. 

McClellan’s 2004 year end deadline for the promulgation of GMP 

regulations a reality. 

It is AHPA’s view that DSHEA can be strengthened in one important aspect, and that is with a requirement for serious adverse 

event reporting for dietary supplements. AHPA’s Board of Trustees 

25

1The prepared statement of Mr. Silverglade appears in the Appendix on page 115. 

reached this conclusion in October 2002, and AHPA petitioned FDA 

the next year for serious AER reporting regulations. Both Commissioner McClellan and Deputy Commissioner Crawford had said 

FDA does not have the authority to do this. 

Accordingly, the time has come for Congress to provide that authority. Any serious adverse event reporting for dietary supplements should have the same protections for privacy of subjects and 

reporters and nonadmission of causation that FDA and the law accords to drugs, medical devices and biologics. In addition, FDA 

needs to fairly report and correct AER information that is demonstrably wrong. All of these protections are detailed in our written 

statement. 

As you both noted earlier, DSHEA treats new dietary ingredients 

differently than old ingredients. This is the same approach followed 

by Congress when it passed the new drug approval provisions of 

the law in 1938, the food additive provisions in 1958 and the medical device amendments in 1976. Dietary supplements with old ingredients, like old drugs, old food ingredients and old medical devices are to be proceeded against under the law’s adulteration and 

misbranding provisions, and these are the tools used by FDA to 

regulate ephedrine alkaloid-containing dietary supplements. 

For new dietary ingredients, DSHEA makes FDA the gatekeeper. 

Only about 45 percent of the new dietary ingredients submitted to 

FDA go onto the market. The gate is narrow. The requirements for 

safety substantiation imposed by the FDA are substantial, and the 

FDA applies the law to those companies that make the required 

premarket notification. 

But it is clear that FDA needs to monitor the dietary supplement 

market to enforce this valuable provision with respect to those obviously new dietary ingredients that have not passed through 

FDA’s gate. To do otherwise is unfair and disrespectful of the law. 

Not enforcing DSHEA’s new dietary ingredient provision rewards 

lawbreakers at the expense of those who observe the law, and this 

is one of DSHEA’s most important provisions. 

Let me close by saying that AHPA is committed to providing benefits to American consumers through our members’ products. 

Thank you for the opportunity to appear before you here today. 

Senator VOINOVICH. Thank you, Mr. Young. Mr. Silverglade. 

TESTIMONY OF BRUCE SILVERGLADE,1 DIRECTOR OF LEGAL 

AFFAIRS, CENTER FOR SCIENCE IN THE PUBLIC INTEREST 

Mr. SILVERGLADE. Thank you very much, Mr. Chairman and Senator Durbin. 

I am Bruce Silverglade, Director of Legal Affairs from the Center 

for Science in the Public Interest. It is certainly appropriate to review the impact of DSHEA on consumers and discuss the need for 

reforms such as those included in S. 722. We support this legislation, and we urge that Congress enact it this year. 

As I will explain in a moment, however, Congress needs to extend additional protections to consumers that are not included in 

this legislation. 

26

Dietary supplements can play an important role in maintaining 

good health and can sometimes provide a valuable adjunct to traditional medical treatment. We certainly recognize that. Unfortunately, the safety and effectiveness of all dietary supplements has 

not been established, and there are many products which are hazardous or no more than 21st Century snake oil. 

The problem stems from the passage of the Dietary Supplement 

Health and Education Act of 1994, and as it has been said, history 

repeats itself, so it might be useful to look just for a moment at 

the history of this law. This is a blowup of the lobbying materials 

used by the industry in 1993 that urged consumers at health food 

stores to, ‘‘write Congress today or kiss your vitamins goodbye.’’

These kinds of scare tactics were used by the industry to get consumers to write Congress to persuade this body to enact the Dietary Supplement Health and Education Act of 1994. And the reason I bring it up is because the same tactics are being used today 

to oppose S. 722. 

Here, we have another poster: It asks, ‘‘Could these products be 

banned: vitamin C, multivitamins, calcium?’’ This is a current poster at health food stores. And as the Senate offices on this Subcommittee and throughout this body receive mail from consumers, 

I want you to know that the mail is being generated by phony 

scare campaigns being generated not necessarily by these trade associations testifying here today but by many other segments of the 

dietary supplement industry. 

Now, the problems with DSHEA in the area of safety are rooted 

in that that Act changed the assumptions we make about the safety of products that FDA regulates. The Act changed the prevailing 

approach that the FDA takes. Food manufacturers do not have to 

demonstrate their products are safe before they are sold, so if you 

are selling lettuce, you can just sell it without FDA approval. 

But the manufacturers of food additives, drugs and medical devices must prove that their products are safe before they can be 

sold. Well, what are dietary supplements more like? Drugs and 

medical devices or lettuce? I think the answer is obvious. But the 

problem with the law is that DSHEA regulates these products like 

this kind of product—lettuce. 

Although the FDA still has the authority to take dangerous dietary supplements off store shelves, it must first prove that the 

product pose a significant or unreasonable risk. Well, that is difficult to do if there is no requirement that adverse event reports 

be submitted to the agency. Such information is essential to 

ascertaining whether a product poses a significant or unreasonable 

risk, especially in the absence of a premarket approval system. 

Thus, as a practical matter, the FDA has not been able to effectively utilize the authority granted to it by DSHEA. Consequently, 

the agency has been forced to rely on woefully inadequate remedies, such as issuing press releases, public warnings, medical 

alerts, voluntary recall requests, and so forth. 

Here is one such effort from 1993. This came from a report FDA 

issued called Unsubstantiated Claims and Documented Health 

Hazards in the Dietary Supplement Marketplace. It is out of print 

(it was issued in 1993), but it is available on the FDA Website as 

of today. 

27

1The prepared statement of Ms. Dickinson, with attachments, appears in the Appendix on 

page 123. 

It lists Yohimbe, for example, as a product that has, in the agency’s own words, ‘‘health hazards,’’ many different types of health 

hazards. The supplement bottle I just held up before was yohimbe. 

We bought it today at a health food store. So more than 10 years 

later, after FDA is issuing press releases and alerts and warnings, 

this product is still available. Clearly, a more effective regulatory 

approach must be found if consumers are to be protected. 

Now, we all know that FDA banned ephedra, but as the Washington Post stated, DSHEA is truly a ‘‘terrible law.’’ The New York 

Times called the ephedra ban ‘‘not enough’’ and urged Congress to, 

‘‘revise the ill-conceived 1994 legislation.’’ S. 722 would help address some of these problems by requiring that manufacturers report serious adverse reactions to the agency. The legislation would 

also require agency approval of stimulants, one category of dietary 

supplements that pose some of the most severe hazards. 

These are useful steps, and we support the legislation. But we 

urge Congress to go further. Safety standards for dietary supplements that are used by children, pregnant women, the elderly, and 

other vulnerable groups determined by the FDA to be at particular 

risk should be raised higher than is now provided for in the law, 

and manufacturers should be required to submit evidence of safety 

before such products are sold. 

These steps, together with the provisions already incorporated in 

S. 722, would go a long way to ensuring that supplements in the 

United States are safe. Thank you. 

Senator VOINOVICH. Thank you. Dr. Dickinson. 

TESTIMONY OF ANNETTE DICKINSON, PH.D.,1 PRESIDENT, 

COUNCIL FOR RESPONSIBLE NUTRITION 

Ms. DICKINSON. Senator Durbin, Senator Voinovich, thank you 

for giving us the opportunity to testify here today. 

The Council for Responsible Nutrition is a trade association of dietary supplement manufacturers, and I am the president of CRN. 

Our members include manufacturers and marketers of national 

brands as well as store brands of dietary supplements available to 

consumers through the mass market, through natural product 

stores, direct sales and mail order. 

Our members include not only the manufacturers of finished 

products but also the suppliers of the bulk ingredients such as vitamins, minerals and botanicals that are contained in these ingredients. DSHEA was passed 10 years ago for two reasons: One was 

to ensure that consumers would continue to be able to choose safe 

and beneficial dietary supplements of a wide variety of products. 

The second was to increase the information available to consumers 

about the purposes and uses of those dietary supplements. 

The past 10 years have demonstrated that these purposes are 

being fulfilled, as are other goals established by the law, which I 

would like to address briefly. I think it is important to recognize 

that dietary supplements have always been considered as a subcategory of foods. This official categorization was not, as some of 

our witnesses would have you believe, created by DSHEA. 

28

In fact, it precedes DSHEA by about 56 years. The Food, Drug 

and Cosmetic Act of 1938 included dietary supplements within a 

category of foods called foods for special dietary use. In 1941, FDA 

established definitions for this category of products, and in 1976, 

that definition was added to the Food, Drug and Cosmetic Act in 

Section 411, the vitamin and mineral amendments. 

That definition is extremely broad, covering vitamins and minerals but also all ‘‘other ingredients intended for use in supplementing the diet.’’ DSHEA reconfirmed that dietary supplements 

were to continue to be regulated as foods and established a specific 

definition to clarify the categories of ingredients that were to be 

permitted in those dietary supplements. 

As has already been noted, it grandfathered ingredients that 

were already on the market at the time the act was passed, just 

as was done with food ingredients when the food additive amendments were passed and just as was done with old drugs when the 

drug amendments were passed. 

DSHEA grandfathered those ingredients in the same way that 

this was done in other food categories. At the same time, DSHEA 

established a premarket notification requirement for new ingredients much in the same way that new GRAS substances (substances 

generally recognized as safe) put on the market today for use in 

foods are evaluated by their manufacturers for safety before they 

are put on the market. There is no requirement for FDA evaluation 

of new GRAS ingredients. 

FDA has been seriously reviewing and evaluating these 75-day 

notices that have been submitted for these new ingredients, and 

this is one of the many ways in which FDA under the recent Commissioner, Dr. Mark McClellan and the current acting Commissioner, Dr. Lester Crawford, have been vigorously implementing 

the act. 

As you all know, FDA issued a final regulation this year that 

banned ephedra in dietary supplements as of April 12, 2004. That 

rule is currently undergoing judicial review and has survived the 

first phase, in which the court denied a preliminary injunction. 

This is generally viewed as an indication that the rule is likely to 

survive the entire review process. 

It is sometimes said that FDA took 10 years to take definitive 

action against ephedra, but this is not, in fact, an accurate description of the process. From the time former Commissioner McClellan 

took office and decided to resolve this ongoing issue, which has 

been a serious problem for everybody involved, for industry, for 

consumers and for FDA, from the time Commissioner McClellan 

took office, it took the agency less than 2 years, which, as you well 

know, is lightning speed in terms of the regulatory process, to issue 

a final ban on ephedra. 

The earlier delays that occurred in FDA enforcement were not 

due to inadequate authority but were due to false starts, wrong 

turns and a frank unwillingness to actually use the new provisions 

of DSHEA that were provided and that were ultimately used as 

Congress intended. 

Another issue that has been troubling to the industry is the issue 

of andro. CRN and other industry trade associations are supporting 

Congressional legislation that will place andro on a long list of 

29

similar ingredients that are to be placed under the Controlled Substances Act, which effectively removes them from the dietary supplement category. That legislation passed the House on June 3 and 

is expected to pass the Senate during this session. 

FDA has also taken separate action against andro, as was mentioned here today, sending warning letters to a number of manufacturers arguing that andro is an unsafe ingredient and is, moreover, 

a new dietary ingredient for which a 75-day notification has not 

been submitted. Between the Congressional and FDA action, andro 

should be off the table as an issue of concern by the time the next 

Congress convenes. 

There has been much talk about adverse event reporting. If there 

were to be an adverse event reporting requirement, it would be important for it to at least contain protections for reporting companies 

and for individuals that are included in regulations applicable to 

other FDA-regulated categories, including prescription drugs. The 

legislative proposals currently on the table tend to actually exceed 

the requirements that currently exist for pharmaceuticals and thus 

are not provisions we can support. 

We support the need for more resources for FDA to implement 

the law and are in support of the Hatch-Harkin bill, which would 

provide FDA with very substantial new resources. We also support——

Senator VOINOVICH. Ms. Dickinson, your time is up. 

Ms. DICKINSON. Yes, I am concluding. 

We also supported the provisions in DSHEA which created the 

Office of Dietary Supplements, which the Congress has very appropriately given significant resources. 

With all of these changes, Senators, we hope that when you come 

back in January 2005 to the next session of Congress, we will be 

able to return to hearing rooms such as this one and discuss the 

role of dietary supplements in improving the health of the population and ultimately in reducing health care costs. 

Senator VOINOVICH. Thank you very much. 

According to a recent poll, most Americans believe that dietary 

supplements are safe and are approved by the FDA before they can 

be made available to the public. 

Should this, in fact, be the case, and do you believe that the 

FDA’s authority to regulate dietary supplements is sufficient to 

protect the health of the American public? I have heard from all 

of you that adverse event reports should be made mandatory. What 

else beyond that? Dr. Dickinson. 

Ms. DICKINSON. I would say the primary thing that is needed is 

exactly what FDA has been doing in the past couple of years, which 

is to actively enforce and implement the law. I think that it is not 

possible to say that the law has not worked until FDA has actually 

seriously attempted to implement it, which they are now doing. 

And I think they need a little bit more time to demonstrate the effectiveness of that approach, as has been demonstrated in the case 

of ephedra. 

Senator VOINOVICH. I would like to ask the panel the same question I asked Dr. Brackett from the FDA. Is it your observation that 

the FDA has the resources needed to enforce DSHEA. Dr. Davis. 

30

Dr. DAVIS. Well, our position would be that the FDA does need 

more resources to address this issue. I think the fact that it took 

the agency so long to get the ephedra-containing products off the 

market and the fact that it has taken so long to finalize promulgation of standards for good manufacturing practices are pieces of 

evidence that the agency is not able to act as promptly and effectively as it could. 

Senator VOINOVICH. So even if we did require mandatory adverse 

event reporting, we have to make sure that they have the people 

necessary to follow up on the reports, correct? 

Dr. DAVIS. That is correct. And sometimes, the agency can work 

on a problem with in-house staff, and sometimes, it would need to 

contract out and get some expert assistance from the outside, like 

in the case of the ephedra study, where they brought in the RAND 

Corporation. 

Senator VOINOVICH. Mr. Silverglade. 

Mr. SILVERGLADE. Yes, thanks very much, Mr. Chairman. 

It is our position that, of course, while all government agencies 

could use more resources, we do not like throwing good money after 

a bad law. And the way DSHEA is set up, and I think the witnesses attested to this, and Senator Durbin’s questions to the witnesses illustrated this, is that the burden is on FDA, for example, 

to investigate each of these market notifications for these new 

products to determine if the product is safe. 

That expense should be borne by the manufacturer and then 

turned over to the FDA for a quick review by the agency. The 

whole burden should not be on the FDA. It is extremely costly, and 

the agency did say about 2 years ago that it would require $90 million over 5 years, I believe, from Congress to fully implement 

DSHEA. Last year, Congress gave the FDA an additional $1.5 million. That is not anywhere close to the $90 million the agency says 

it needs to implement DSHEA. 

So what should really happen is the law should be changed so 

that the expense of investigating the safety of these products is put 

on the manufacturers who profit from their sale. 

Senator VOINOVICH. You suggest that before the products be put 

on the market, the manufacturer has to do the same thing that one 

has to do with a prescription drug and prove that it is not harmful 

to the public? 

Mr. SILVERGLADE. No, we do not favor an across the board requirement of that sort. Ordinary vitamins and minerals are generally recognized as safe and do not need to undergo an FDA review. On the other hand, a product like this, yohimbe, which is 

from tree bark, and is known by FDA to be hazardous, this should 

not be on the market until manufacturers can demonstrate to the 

agency that it is safe. 

The agency itself has said since 1993 that it is unsafe. 

Senator VOINOVICH. How do they know that it is unsafe. How 

does the FDA find out about unsafe products if manufacturers do 

not have to submit it to the FDA before they can put it on the market? 

Mr. SILVERGLADE. Well, on this kind of product, which is an 

herb, not an ordinary vitamin or mineral, the manufacturers, the 

31

distributors, the sellers of this product should have to go to the 

FDA first to get approval before selling it. 

Senator VOINOVICH. So it is more specific? 

Mr. SILVERGLADE. Right; dietary supplements fall into three 

major categories: There are ordinary vitamins and minerals, which 

are presumed safe for the most part. There are just one or two exceptions. Herbal products comprise a second category, and then we 

have a miscellaneous group of products, a third category. These 

products could be anything from shark cartilage to cow organs, bull 

testicles; believe it or not, it is all out for sale on the market. 

Ordinary vitamins and minerals do not now have to be reviewed 

by FDA, but products in these other two categories probably should 

be reviewed by the agency, as the American Medical Association 

has suggested, before they are sold to ensure that they are safe. 

Senator VOINOVICH. You are saying all of them should be or just 

some of them? 

Mr. SILVERGLADE. Just certain categories that are known by the 

medical community to be more likely to pose health hazards. 

Senator VOINOVICH. Are you at all concerned about the outrageous claims that you see on the packaging and advertising of 

some of these products that lead you to believe that they are going 

to do this and that? 

Dr. DAVIS. Could I comment on that, Mr. Chairman? 

Senator VOINOVICH. Yes, Doctor. 

Dr. DAVIS. You are referring to structure and function claims, 

and I think that is an example of how DSHEA is not working. And 

I just found five products on the market today that are making 

some rather unbelievable claims, and just to read a few of those: 

Provides dietary support for a healthy nervous system. Provides dietary support for normal, healthy, cerebral blood vessel tone. Promotes healthy immune system by supporting T and B cell function, 

protecting against cellular damage and introducing beneficial enzymes. Optimal support for allergies and sinuses. Helps cleanse the 

liver from impurities in the diet and environment. And then, the 

last one is, may help manage hot flashes and night sweats associated with menopause. 

Now, these are structure and function claims. The manufacturers 

are required under DSHEA to be able to substantiate the truthfulness of those claims, but they are not required to provide data to 

the FDA to prove that. They are required to put a disclaimer on 

the product that says this statement has not been evaluated by the 

FDA. This product is not intended to treat, cure or prevent disease. 

So on the one hand, you have these claims that I just read for 

you, and then, right underneath, there is the claim that this is not 

a claim. It is not a health claim; it is a structure and function 

claim. And can the ordinary consumer distinguish between ‘‘a 

structure and function claim and a health claim?’’ As I read this 

as a physician and putting myself in my patients’ shoes, those 

claims that I read sound awfully like health claims, which should 

put them under the authority of the FDA, and the manufacturers 

should be required to prove that those claims are correct at their 

own expense. 

Senator VOINOVICH. My time is up. 

32

And I will give you a chance on my next round to—I am sorry. 

Senator Durbin. 

Senator DURBIN. Please let her go ahead. 

Senator VOINOVICH. Go ahead, Dr. Dickinson. 

Ms. DICKINSON. In response to your question about the claims, 

it is our belief that false and misleading claims are not only a disservice to the consumer but are actually an unfair trade practice. 

We worked with the Federal Trade Commission and the FDA to get 

action taken on coral calcium products a year ago, which were 

claiming to prevent and treat at least 400 different diseases. 

These claims simply should not be allowed on the marketplace. 

And I think part of the answer to your previous question as well 

is that industry should be cooperating with FDA, responsible industry should be cooperating with FDA and FTC to see that these 

issues are taken care of, and that is one of the ways that the resources of FDA can be stretched and made more effective. 

Senator VOINOVICH. I will let Senator Durbin take over. 

Senator DURBIN. Mr. Young, I want to make sure I understand 

what your association has decided. You agree, then, that there 

should be adverse event reporting of all dietary supplement products. 

Mr. YOUNG. Reporting of serious adverse events for all dietary 

supplement products, that is correct. 

Senator DURBIN. Whether they are characterized as pre-1994 

products or post-1994 products. 

Mr. YOUNG. That is correct. 

Senator DURBIN. Regardless of combinations, whether they are 

old or new. 

Mr. YOUNG. All dietary supplements, all serious adverse events 

associated with them. 

Senator DURBIN. And I assume from what you have added in 

your testimony here that you are asking for the same basic protection when it comes to privacy and legal admissions as currently 

exist on AERs for pharmaceuticals, for example. 

Mr. YOUNG. That is correct, Senator. 

Senator DURBIN. What is your position on premarket testing of 

your products, particularly of stimulants? 

Mr. YOUNG. I think that our view is that stimulants can be regulated under the current law, and I think we have provided that information to your staff, but we think they can be regulated under 

current law. FDA has the authority to look into these various ingredients. Some of the stimulants mentioned in the Consumer Reports article have been known about for years. 

Our trade association has had positions with respect to the labeling of the yohimbe for a long time. It is set out in the Botanical 

Safety Handbook. And if these matters rise to a level of concern, 

FDA has the tools, we believe, to take the action they feel is necessary, whether it is to ban an ingredient, as they did with ephedrine alkaloid-containing supplements or whether it is to require labeling, which is another option FDA has. 

Senator DURBIN. Many years ago, when we were having trouble 

with approval of medical devices, the FDA did not have the resources to approve devices, the industry decided to agree to pay a 

user fee to the FDA to provide them with the resources and staff 

33

necessary so that these approvals could take place. Is your association prepared to pay a user fee to the FDA to make certain there 

is adequate review and testing of your products before they are 

marketed? 

Mr. YOUNG. I would assume that you are talking about new dietary ingredients, and let me clarify something that Mr. Silverglade 

said. 

Senator DURBIN. No, I am talking about all. 

Mr. YOUNG. All ingredients? No, because I think at that point, 

with respect to the older ingredients, we believe that they can be 

assessed under the law; that there is information available on old 

ingredients, and that FDA has the tools necessary to evaluate that. 

Senator DURBIN. Mr. Young, I suspect that we are both doctors 

of the law. I know I am not a medical doctor; perhaps you happen 

to have that in your resume. But you heard Dr. Brackett say earlier that even new combinations of old ingredients could be dangerous. So how can you draw this distinction, as the law does, and 

say that we are going to make this apply only to new ingredients? 

Mr. YOUNG. Well, it is a distinction that the law does make, and 

I think if we can effectively deal with new ingredients under the 

new dietary ingredient provision, which is a provision where the 

manufacturer submits the information, by the way, and FDA only 

evaluates what is submitted, FDA does not go out and do independent research on new ingredients. 

The manufacturer must present the data for review, and that 

data must pass muster or not. But with respect to old ingredients, 

there is information out there. It is readily available. The Botanical 

Safety Handbook where we talk about the safety, the cautions, etc., 

associated with various herbs was not written in a vacuum. There 

is a lot of information available to FDA and to others to evaluate 

the safety of these materials. 

Senator DURBIN. So, Dr. Davis, if we are talking about old ingredients in the Botanical Handbook, and we are dealing with products that present these ingredients in new concentrations and new 

combinations, do you accept the premise that they are still benign? 

Dr. DAVIS. No, I do not. I think we may discover that there are 

harms that we did not know about before. There may be new interactions between an old dietary supplement and a new prescription 

medication that has just come on the market. There may be combinations, as you have pointed out, with an old dietary supplement 

and a newer one or new combinations. We talked during the 

ephedra hearings about ephedra being combined with caffeine, for 

example. So I would not accept that premise. 

Senator DURBIN. Let me ask Dr. Dickinson a question, if I might, 

and I am going to go to your testimony here, because I think you 

were rather explicit when it came to the issue of ephedra, in which 

I can find it quickly here. I apologize. I had it underlined. You said 

delays were due to false starts, wrong turns, and an unwillingness 

to actually use the provisions of DSHEA as Congress intended 

when it came to the banning of ephedra, and you credited Commissioner McClellan with having taken control of the agency and, in 

less than 2 years, as you say, lightning speed in terms of the regulatory process, responded to this issue. 

34

Did you include in your false turns the statement by the largest 

manufacturer and retailer of ephedra, Metabolife, to the FDA in 

1999 that, ‘‘Metabolife has never been made aware of any adverse 

health events by consumers of its products. Metabolife has never 

received a notice from a consumer that any serious adverse health 

event has occurred because of ingestion of Metabolife 356?’’

A statement by Metabolife in 1999, and then, after lawsuits were 

filed by the Department of Justice and individuals, here is what 

came out: Metabolife had deliberately misrepresented this fact to 

the FDA. Metabolife had 16,500 adverse event reports for 

Metabolife 356, including almost 2,000 significant cardiac, neurological and psychiatric reports. 

So when you are saying the problem was false starts at the agency, and Dr. McClellan finally straightened it out, what kind of responsibility do you accept as an industry for this kind of concealment and obfuscation of adverse event reports by Metabolife? 

Ms. DICKINSON. I think this kind of concealment and obfuscation 

is just as outrageous as you think it is. But this is one company’s 

activities. 

Senator DURBIN. The largest company. 

Ms. DICKINSON. A large company that is not, in my view, characteristic of the industry as a whole. When I spoke of false starts, 

I refer to the fact that FDA, after having first started begun to receive reports of adverse events on ephedra in 1993, held two advisory committee meetings, one in 1995, one in 1996, at which they 

failed to come to a unanimous conclusion about how to act; produced a rule in 1997 which overtly attempted to use the adverse 

event reports for purposes that FDA has always recognized and 

still recognizes they cannot be used for. 

The Government Accounting Office found that rule to be inadequately supported in terms of the specific actions FDA took. Following that event, FDA then did not take further action until 

McClellan’s action in 2003. So there is a period of time there where 

FDA started off in one direction, was found not to be on good 

ground in going in that direction, and it really took Commissioner 

McClellan to put them in another direction. 

Senator DURBIN. That was during the same time that the largest 

retailer of ephedra products in America was deliberately lying to 

the Government about adverse events. 

Ms. DICKINSON. I understand that, I understand that, and I 

think it is outrageous. 

Senator DURBIN. And that outrage also made it more complicated, did it not, for FDA to evaluate the danger of the product. 

Ms. DICKINSON. I do not think it did, and let me explain why I 

do not think it did. As outrageous as that event was, I think the 

reality is that FDA knew everything they ever learned about the 

pattern of events associated with ephedra within the first couple of 

years that they were receiving adverse events. I think that from a 

scientific and public health point of view, it is a fact that one does 

not have to know about every event that occurred in order to understand what pattern is occurring. 

There were millions of people using ephedra, and FDA had a 

very extensive sample of the events that were occurring. I think 

from a scientific and public health point of view, they knew exactly 

35

what was happening, even if they did not know the actual number. 

And I think that is the same information that FDA eventually used 

in finalizing the rule. 

Senator DURBIN. I think the fact that it took so long, and so 

many people died while we were waiting for this to occur is a suggestion about the inadequacy of the law. 

Mr. Chairman, I will wait and do another round of questions 

when you are finished. 

Senator VOINOVICH. Is there a fee that a manufacturer must pay 

when they intoroduce a new ingredient? 

Mr. YOUNG. No, Mr. Chairman. 

Senator VOINOVICH. So the cost of this is all being borne by the 

FDA; is that right? 

Mr. YOUNG. That is correct. FDA evaluates the data that is presented to them by the company coming to them with the new dietary ingredient. 

Ms. DICKINSON. But the company does the work of preparing the 

data, so they help. 

Senator VOINOVICH. The fact is that there is no fee for the FDA 

to review the data the company prepares. How about prescription 

drugs? Is it the same situation with prescription drugs? Is there a 

fee for the FDA to review the data the company submits? 

Ms. DICKINSON. With drugs, there is, but not with food additives 

and not with GRAS ingredients. On the food side, there is no fee 

associated with the review of a GRAS notification. 

Senator VOINOVICH. That is because the definition of a dietary 

supplement is still in the food category. I got the impression here 

that it should be defined as something other than a food product. 

Ms. DICKINSON. No, absolutely not, not from us. 

Senator VOINOVICH. How about the other witnesses? 

Mr. SILVERGLADE. Thank you, Mr. Chairman. 

I would define it a little differently than a food product. It does 

not look like food to me. 

Ms. DICKINSON. Does saccharin look like food to you? 

Mr. SILVERGLADE. It comes from tree bark. I would not eat it as 

food. 

Senator VOINOVICH. Mr. Young. 

Mr. YOUNG. There are user fees for new drugs, and there are 

user fees for medical devices. I do not know the degree to which 

user fees in this industry would be appropriate. There have only 

been 188 new dietary ingredient notifications submitted to FDA in 

the 10 years that this law has been in effect. I think we have a 

lot greater concern as an industry with those people who are not 

going through the toll booth and paying the toll or at least gathering the information together and having it reviewed by FDA. 

It is like an 8-lane highway with a toll booth on one lane. Responsible manufacturers are going through that door. I do not 

think they ought to have to pay in order to go there and have a 

45 percent success rate of getting through until this agency is able 

to deal with those who ignore the law entirely. 

So I do not believe that it is something that would really facilitate the proper and timely review of these notifications. 

Senator VOINOVICH. You are saying 188 in a 10-year period have 

come through the door? 

36

Mr. YOUNG. That is correct. We believe about 45 percent of those 

were allowed by FDA to go to market. FDA does not approve; they 

simply allow these products to go to market without objection. 

Senator VOINOVICH. Of the 188 new ingredient projects, only 45 

percent were allowed to go to the marketplace? 

Mr. YOUNG. That is correct, Mr. Chairman. 

Senator VOINOVICH. What percentage of dietary supplement 

manufacturers are avoiding this requirement that the FDA review 

their product? 

Mr. YOUNG. It is very difficult to say how many there are, but 

I have been to a lot of trade shows, and I have read trade magazines that can be read by FDA as well, and there are a lot of folks 

out there offering new ingredients, new, this is the first time ever, 

and in the enforcement context, my own view is these would be 

low-hanging fruit, easy targets. And this is an important part of 

the law to enforce. 

Senator VOINOVICH. One problem that I have, whether it is 

Enron or Global Crossings, is that you have some bad apples out 

there, and it seems to me that the industry itself, in order to protect itself, should become a lot more aggressive in bringing these 

matters to the attention of the Food and Drug Administration. How 

do you feel about that? 

Mr. YOUNG. I know it has been done, that these matters have 

been brought to FDA’s attention. I do not know that any of them 

have been acted upon. However, certainly, it was part of the decision FDA made with respect to androstenedione. FDA said on the 

one hand, it is not a dietary ingredient at all; it is illegal as a dietary supplement, and second of all, no notification has been filed 

if it is a dietary ingredient. So you are off the market. That is the 

only instance I am aware of, and industry and others urged FDA 

to do that, and it did so. 

Senator VOINOVICH. Does your organization, the American Herbal Products Association, take the initiative to police your own industry? 

Mr. YOUNG. I think our association has brought matters to the 

attention of the Federal Trade Commission. I am not certain about 

the FDA. I know individual competitors in the industry have 

brought matters to the attention of FDA with respect to new dietary ingredients, and I think it is something that should be done 

more, because we do have a role, obviously, an important role in 

protecting the integrity of this industry. 

Senator VOINOVICH. Dr. Dickinson, how does your organization 

feel about acting as a watchdog and trying to police your own industry? 

Ms. DICKINSON. I agree with Mr. Young that it is very important 

for us to be strong in taking some initiatives in self-regulation. 

CRN has just recently established a task force to look at some of 

the things that we might do more proactively to address some of 

these issues. 

Senator VOINOVICH. I do not know where this legislation is going. 

I can tell you one thing that if this bill comes up, I am certainly 

going to give it a great deal of thought. The fact of the matter is 

that so often the only reason why we get into legislation is because 

the industries responsible close their eyes to the problems facing 

37

their industry. I think that you all have to be a lot more aggressive 

in policing your own industry. 

Ms. DICKINSON. Let me say that we have been very aggressive 

in some of these areas like GMPs. The fact that it has taken 10 

years is not because we have not been pushing it. In fact, CRN and 

the other associations took the initiative in 1995, in just 1 year 

after DSHEA was passed, of going to FDA with draft language 

which we had already shared with USP that formed the basis of 

their——

Senator VOINOVICH. What happened? It does not make sense. It 

is almost illogical. If you are a member of the public, and it is a 

requirement of the law, and here, it is 10 years later, and it has 

not happened? How can you explain that it did not happen? 

Ms. DICKINSON. Well, it actually was not a requirement of the 

law. They were permitted by the law to do this. In the meantime, 

until we have unique dietary supplement GMPs, we are fully subject to food GMPs, so it is not that there are not any. It is that 

there is an opportunity to ratchet up the level of quality that would 

be required, and industry was fully supportive of that. FDA has a 

lot of stuff on its plate, including the new bioterrorism act, which 

we have also all had to be complying with and which, in fact, has 

brought a very significant amount of new resources to the agency 

which it can use for all of its regulatory activities. 

Senator VOINOVICH. So in this case, you would say that because 

of September 11 and the new additional money that is helping the 

agency overall, it is not a situation of where they have new responsibilities, but they have been given more money, and therefore, you 

think that they are better off than they were before. 

Ms. DICKINSON. It is a mix, but they got about 700 or 800 new 

inspectors as a result of the new bioterrorism law. They got requirements for registration. Companies had to register as of December 12 of last year, so they now have resources that they did 

not have before. There are also provisions related to advance notice 

of imports and the review of records which strengthen their overall 

position. 

Senator VOINOVICH. Mr. Silverglade. 

Mr. SILVERGLADE. Thank you, Mr. Chairman. 

With respect to GMPs, it is really kind of a black box. We do not 

know exactly what happened, but a few things are a matter of 

record that we do know. One thing we do know is that the FDA 

sent its proposed rule for GMPs to the Office of Management and 

Budget for approval on November 8, 2000, right after the election. 

After President Bush took office, the proposed rule for GMPs was 

sent back from OMB to the FDA. Then Commissioner McClellan 

took charge, but now, we had several more years of delay. So instead of doing a very good job, I would submit that the Clinton Administration had finished the job. Then, the GMP rule was sent 

back by OMB after the inauguration of President Bush. And then, 

Commissioner McClellan took several more years dealing with it. 

Now, the FDA finally proposed a rule last year. And what is 

holding it up now? I will give you the answer: The industry. The 

industry has filed hundreds of comments claiming that this has to 

be changed, that this provision is too strong, and that provision is 

too strong, and that is why FDA has not issued a final rule. 

38

Senator VOINOVICH. Senator Durbin. 

Senator DURBIN. And that is what Dr. Brackett said, 400 substantive comments. So is it any wonder why this GMP is dragging 

on as long as it has? 

I would like to make sure I understand a few of the things that 

have been said. Mr. Young, are you saying that in the 10 years of 

DSHEA, there have been 188 new ingredients submitted to the 

FDA of dietary supplements? 

Mr. YOUNG. That is what is noted on their Website. That is correct. 

Senator DURBIN. OK; is it correct that there are some 30,000 different dietary supplement products on the market today? 

Mr. YOUNG. I have no numbers, but I would not be surprised 

that is the number of what they call SKUs, the selling units. 

Senator DURBIN. That may have been in Dr. Brackett’s testimony 

or in one of the others, but I believe that 30,000 was the number. 

Ms. DICKINSON. But the definition——

Senator DURBIN. Excuse me a second, please. 

Does not it strike us as odd? Thirty thousand products on the 

market, and over a 10-year period of time, we average about 19 a 

year that come before the FDA to test a new ingredient? And going 

back to Dr. Davis’ point, combinations of old ingredients can also 

raise some concerns here as to new concentrations and new combinations. And I think it is proof positive that this current law is 

not giving the FDA the authority it needs. 

In fact, recall when Dr. Brackett was asked, well, did you have 

a listing of the old ingredients so you knew where your starting 

point was? No, it does not exist. 

Mr. YOUNG. Well, Senator, the industry did provide lists of old 

ingredients to FDA. FDA has those lists from the industry. They 

do not give them legal significance, but I do believe they read those 

lists when they look at things. There were lists given by, I think, 

all three of the major trade associations to kind of record, as you 

suggested earlier, what was in place in 1994. 

Senator DURBIN. It also is a fact, is it not, testimony here that 

fewer than or less than 1 percent of the AERs that have been filed 

with the FDA came from the industry. Ten out of 2,500, so the voluntary program for dietary supplements to self-report adverse 

events has generated 10 out of 2,500 adverse event reports in the 

life of this act. 

Is that your understanding, too, Mr. Young? 

Mr. YOUNG. I do not know how many have come from manufacturers, but I do not know that there is a voluntary program for 

manufacturers to send in adverse events other than that FDA 

would like it. There has been no organized industry activity that 

I am aware of in that regard. 

Senator DURBIN. So how can we take your industry seriously if 

they do not report products on the market that are causing adverse 

health events? How can consumers take the industry as seriously 

interested in the health of America? 

Mr. YOUNG. Well, I think the industry evaluates those reports. 

Our members evaluate those reports, and they make adjustments 

as necessary in response to those reports. They look at them as signals, and I think one of the reasons we support mandatory adverse 

39

event reporting is so that FDA, with all of its expertise, can aggregate that information and determine whether signals received by 

one company are similar to those received by other companies and 

begin with the process that the——

Senator DURBIN. Mr. Young——

Mr. YOUNG [continuing]. IOM has established. 

Senator DURBIN [continuing]. How can they aggregate what they 

never receive? 

Mr. YOUNG. They can if there is a mandatory reporting system. 

Senator DURBIN. A change in the law. 

Mr. YOUNG. That is correct. 

Senator DURBIN. Dr. Dickinson, you have said that we should 

view grandfathering of old ingredients like the grandfathering of 

food. 

Ms. DICKINSON. The grandfathering of GRAS ingredients, which 

are food additives ‘‘Generally Recognized as Safe.’’

Senator DURBIN. So if we had common foods that cause no problem, and people decided to cook them together, carrots and cauliflower, and that caused no problem, we should not be hauling in 

the FDA to analyze it. Is that your take on this? 

Ms. DICKINSON. With regard to carrots and tomatoes, yes. Not 

necessarily with regard to the dietary supplement ingredients. In 

fact, I think it is important to recognize, and I am sure Mr. Young 

would comment on this as well, FDA, in its review of these new 

ingredient notifications is, in fact, doing some of the things that 

you suggest. FDA is determining, on the basis of concentration, different types of extracts, different types of processing, that certain 

ingredients that companies might have thought were old ingredients are, indeed, new ingredients. 

Senator DURBIN. How many old ingredients are there? How 

many are we talking about? 

Ms. DICKINSON. I think we are talking about several thousand. 

I do not think we are talking about 30,000. And the reason for that 

is that the number of 30,000 was an FDA number that came about 

when FDA was proposing nutrition labeling, and the cost of that 

they——

Senator DURBIN. But do you see that if you take several thousand starting old ingredients and consider just combinations, not 

concentrations, that you could be ranging into the millions of possibilities here? 

Ms. DICKINSON. Well, one can speculate about a lot of things. A 

large number of those ingredients are essential nutrients or recognized nutrients. A large number of the additional ones are the 

chemicals that are reviewed in a large number of monographs published by organizations like USP and WHO. 

Senator DURBIN. OK; let us start with citrus aurantium, the 

most popular, I believe, substitute for ephedra. I wrote to the seven 

largest dietary supplement companies and asked them: Did you 

test your citrus aurantium product before you marketed it? How 

many do you think tested it ahead of time? 

Ms. DICKINSON. How many of them responded? 

Senator DURBIN. Well, of those who responded. It is a good point, 

but how many do you think tested it? 

40

Ms. DICKINSON. None of them may have tested it in the way that 

a drug is tested, but they certainly had information from their supplier of the ingredient and from other information that——

Senator DURBIN. Sure did. Let me read you some of the replies. 

NVE Pharmaceutical. 

Ms. DICKINSON. Oh, not them; come on. 

Senator DURBIN. Robert Ochifento. Are you familiar with him? 

Ms. DICKINSON. I am. 

Senator DURBIN. OK. He makes this beautiful little product, 

Stacker-2. He says: ‘‘In my experience, it is unusual for companies 

to conduct in-house testing for nutraceutical compounds.’’ But then, 

he referred me to a study involving Seville orange juice, a study 

that had been published in the Journal of Clinical Pharmacology, 

as evidence that this was not a dangerous product, citrus 

aurantium. 

And so, we contacted the people who actually authored the study, 

and here is what they said: Mr. Ochifento, president of NVE, making Stacker-2, who says that this study is the reason why he can 

sell this product safely, ‘‘I do not consider our study using Seville 

orange juice even remotely sufficient to assess the safety of synephrine-containing dietary supplements. If the industry is doing 

that, then, in my opinion, they are committing an egregious error.’’

Do you understand that we are not dealing with benign products 

here? 

Ms. DICKINSON. We are not dealing——

Senator DURBIN. Excuse me. I will finish, and then, you get your 

chance. 

We are dealing with products which can be in lethal concentration with no testing, going on the market making the consumer 

walking into that store the laboratory test rat. Now, is that what 

you want to see in the America that you live in? 

Ms. DICKINSON. No, it is not. 

Senator DURBIN. Is that where you think the FDA should be in 

allowing these products to be sold without testing, without review 

of adverse events? You think they should be grandfathered and 

treated like food. I do not believe that this is a food situation. 

Ms. DICKINSON. I think that this is also not a responsible company and a responsible individual that we are referring to here. 

The fact that this guy does not know one end from the other does 

not necessarily mean that other companies in the industry do not 

have better information about these products. 

Senator DURBIN. Would you like to give us a list of those companies that we should not buy products from? 

Ms. DICKINSON. I would love to, but I do not think I can. I do 

not think my counsel will allow me to do that. 

Senator DURBIN. Well, that sure is reassuring. 

Ms. DICKINSON. I certainly can provide you a list of our members, and I think you can be perfectly confident buying from these 

members or from members of Mr. Young’s association or some of 

the other major associations. 

Senator DURBIN. Well, Mr. Young, it turns out that NVE is a 

member of your association. So what do you want to tell us about 

him? 

41

Mr. YOUNG. I believe they are a member of our association, and 

I believe they are the ones that have challenged the FDA’s ban on 

ephedrine alkaloid containing dietary supplements. I have not seen 

that letter before. I am surprised at his response. 

Senator DURBIN. Would the word troubled also be included? 

Mr. YOUNG. Troubled? 

Senator DURBIN. Are you troubled by his response? 

Mr. YOUNG. Yes, because there is a lot more information, I think, 

available about citrus aurantium, about the—there may be other 

ingredients that are in that product. I do not know how that product is labeled. There are various cautions that are recommended for 

these kinds of products or ingredients. 

Senator DURBIN. Well it has been labeled by a lawyer for a cure, 

because it says this product is not intended to diagnose, treat, cure 

or prevent any disease. 

Mr. YOUNG. Well, that is the statement for structure and function I think for the FDA that—but also, there may be cautions on 

there as well. 

Senator DURBIN. It is also pictured on cable, because it is the 

world’s strongest fat burner. How about that? 

Mr. Chairman, I think we have achieved what we wanted to in 

this hearing. Although it has taken awhile, I think we have 

reached the point where it is clear that DSHEA, which was written 

10 years ago as an experiment, is an experiment that has failed the 

consumers of this country. I do not believe that we collect enough 

information about these products to say to any unsuspecting consumer of any age in America be safe, by these products. 

We have to say buy them at your risk. Your government has not 

established standards about what is included in the products. We 

have not established any standards about whether they are lethal, 

whether they are safe, whether they can achieve the things that 

they are advertised to do, and we do not even require the makers 

of the product when they are killer products, causing people’s 

death, to report it to the government. 

We have failed miserably, and to think that the FDA’s testimony 

today is that they are satisfied with this law and see no need for 

change is troubling to me. I think we have a greater responsibility, 

and I thank you for this hearing. 

Senator VOINOVICH. You are more than welcome, Senator Durbin, and I am pleased that you asked me to hold this hearing 

today. I have learned a great deal, and I am just as concerned 

about this issue as you are. 

I would like to reiterate that the responsible organizations that 

are represented here and some that are not should take very seriously the fact that this hearing has been held. They need to start 

doing a better job of policing their own industry. 

Last but not least, I do not know if this hearing is going to be 

on C–SPAN or not, but I can assure you that if it is, the people 

watching this are going to be a lot more reluctance to purchase any 

of these dietary supplements because of the information that has 

been brought out today at this hearing. 

I am personally very concerned about this, because I had a brother who took all kinds of dietary supplements and kept urging them 

upon me. He died from a massive stroke 2 years ago. I am not sayVerDate 0ct 09 2002 10:40 Nov 18, 2004 Jkt 095187 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 C:\DOCS\95187.TXT SAFFAIRS PsN: PHOGAN
42

ing these supplements caused his stroke but there is reason to be 

concerned. I think there are a lot of Americans out there that for 

one reason or another think that these pills are going to be the 

thing that is going to keep them going, and they really are not. 

Thank you very much. 

Senator DURBIN. Mr. Chairman, if I might say before we close, 

give thanks to the staff people who worked so hard: On your staff, 

David Cole and our clerk, Kevin Doran, and on my staff, Krista 

Donohue, Myrece Johnson and Mindy Mannlein. This was a very 

challenging issue, and they did a great job on it. 

[Whereupon, at 4:46 p.m., the Subcommittee adjourned.] 

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Æ


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