[Senate Hearing 107-619]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-619

  WHEN DIETS TURN DEADLY: CONSUMER SAFETY AND WEIGHT-LOSS SUPPLEMENTS

=======================================================================

                                HEARING

                               before the

                  OVERSIGHT OF GOVERNMENT MANAGEMENT,
              RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
                              SUBCOMMITTEE

                                 of the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE


                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 31, 2002

                               __________

      Printed for the use of the Committee on Governmental Affairs


81-314              U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2002
____________________________________________________________________________
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                   COMMITTEE ON GOVERNMENTAL AFFAIRS

               JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan                 FRED THOMPSON, Tennessee
DANIEL K. AKAKA, Hawaii              TED STEVENS, Alaska
RICHARD J. DURBIN, Illinois          SUSAN M. COLLINS, Maine
ROBERT G. TORRICELLI, New Jersey     GEORGE V. VOINOVICH, Ohio
MAX CLELAND, Georgia                 THAD COCHRAN, Mississippi
THOMAS R. CARPER, Delaware           ROBERT F. BENNETT, Utah
JEAN CARNAHAN, Missouri              JIM BUNNING, Kentucky
MARK DAYTON, Minnesota               PETER G. FITZGERALD, Illinois
           Joyce A. Rechtschaffen, Staff Director and Counsel
              Richard A. Hertling, Minority Staff Director
                     Darla D. Cassell, Chief Clerk

                                 ------                                

OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF 
                         COLUMBIA SUBCOMMITTEE

                 RICHARD J. DURBIN, Illinois, Chairman
DANIEL K. AKAKA, Hawaii              GEORGE V. VOINOVICH, Ohio
ROBERT G. TORRICELLI, New Jersey     TED STEVENS, Alaska
THOMAS R. CARPER, Delaware           SUSAN M. COLLINS, Maine
JEAN CARNAHAN, Missouri              THAD COCHRAN, Mississippi
MARK DAYTON, Minnesota               PETER G. FITZGERALD, Illinois
       Marianne Clifford Upton, Staff Director and Chief Counsel
         Melanie Leitner, Congressional Fellow, Senator Durbin
               Andrew Richardson, Minority Staff Director
           Theresa Prych, Minority Professional Staff Member
                   Brian McLaughlin, Staff Assistant


                            C O N T E N T S

                                 ------                                
Opening statement:
                                                                   Page
    Senator Durbin...............................................     1
Prepared statement:
    Senator Voinovich............................................    39

                               WITNESSES
                        Wednesday, July 31, 2002

Janet Heinrich, Director, Health Care--Public Health Issues, U.S. 
  General Accounting Office......................................     4
Michael F. Mangano, Principal Deputy Inspector General, Office of 
  Inspector General, Department of Health and Human Services.....     6
Joseph A. Levitt, Esq., Director, Center for Food Safety and 
  Applied Nutrition, Food and Drug Administration, Department of 
  Health and Human Services; accompanied by Dr. Christine Lewis 
  Taylor, Director, Office of Nutritional Products, Labeling and 
  Dietary Supplements (ONPLDS), Center for Food Safety and 
  Applied Nutrition (CFSAN), and John Taylor, Director, Office of 
  Enforcement, Office of Regulatory Affairs (ORA), Food and Drug 
  Administration (FDA)...........................................     8
Karen Ruiz, Consumer, San Clemente, California...................    19
Steven B. Heymsfield, M.D., Deputy Director, New York Obesity 
  Research Center, St. Luke's-Roosevelt Hosptial Center, 
  Professor of Medicine, Columbia University, College of 
  Physicians and Surgeons........................................    22
Michael McGuffin, President, American Herbal Products Association 
  (AHPA), Silver Spring, Maryland................................    25
Cynthia T. Culmo, R.Ph., Chairperson, Drugs, Devices, and 
  Cosmetics Committee, Association of Food and Drug Officials, 
  Austin, Texas..................................................    27

                     Alphabetical List of Witnesses

Culmo, Cynthia T., R.Ph.:
    Testimony....................................................    27
    Prepared statement with attachments..........................   160
Heinrich, Janet:
    Testimony....................................................     4
    Prepared statement with attachments..........................    40
Heymsfield, Steven B., M.D.:
    Testimony....................................................    22
    Prepared statement with attachments..........................   123
Levitt, Joseph A., Esq.:
    Testimony....................................................     8
    Prepared statement...........................................    86
Mangano, Michael F.:
    Testimony....................................................     6
    Prepared statement with attachments..........................    65
McGuffin, Michael:
    Testimony....................................................    25
    Prepared statement...........................................   139
Ruiz, Karen:
    Testimony....................................................    19
    Prepared statement...........................................   118

                                Appendix

``Code of Ethics & Business Conduct,'' June 2002, submitted by 
  Mr. McGuffin...................................................   146
``Ephedra-containing Supplements Produced by Members Of Leading 
  Trade Association Test Well in New Study,'' May 19, 2000, 
  submitted by Mr. McGuffin......................................   157
Consumer Healthcare Products Association (CHPA), prepared 
  statement......................................................   191
John Hathcock, Ph.D., Vice President, Nutritional and Regulatory 
  Science, Council for Responsible Nutrition (CRN), prepared 
  statement......................................................   195
Raymond L. Woosley, M.D., Ph.D., Vice President for Health 
  Sciences, University of Arizona, prepared statement............   197

 
  WHEN DIETS TURN DEADLY: CONSUMER SAFETY AND WEIGHT-LOSS SUPPLEMENTS

                              ----------                              


                        WEDNESDAY, JULY 31, 2002

                                       U.S. Senate,
       Oversight of Government Management, Restructuring,  
                 and the District of Columbia Subcommittee,
                  of the Committee on Governmental Affairs,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 10:01 a.m., in 
room SD-342, Dirksen Senate Office Building, Hon. Richard 
Durbin, Chairman of the Subcommittee, presiding.
    Present: Senators Durbin and Voinovich.

              OPENING STATEMENT OF SENATOR DURBIN

    Senator Durbin. I would like to welcome everyone to the 
hearing this morning. We will get under way, and I note people 
are still coming in. They are welcome to find a seat, since 
they are available. I would like to advise you that we 
anticipate some votes around 11 o'clock, so I am hoping that we 
can complete opening statements and the first panel. Then 
perhaps take a break for the voting, and return to complete the 
hearing.
    I am pleased to welcome you to today's hearing before the 
Senate Subcommittee on Oversight of Government Management, 
focusing on ``When Diets Turn Deadly: Consumer Safety and 
Weight-Loss Supplements.''
    There may be some argument across America about whether the 
great American pasttime is baseball. Last year nearly 50 
million people attended a major league baseball game, but 100 
million Americans are on a diet. It appears that we have spent 
a lot of our time as Americans thinking about weight loss. 
According to the Centers for Disease Control and Prevention, 25 
percent of adult men, 40 percent of adult women, and an even 
higher percentage of teenagers are currently trying to lose 
weight. Some will be inspired by medical professionals to 
follow a diet and exercise. Others will be convinced by 
infomercials to buy the latest exercise video or magic machine. 
Many will look for a pill to help make the pounds disappear.
    The purpose of this hearing is not to announce the new 
congressional diet or endorse the latest ab cruncher. The 
Federal Government should leave that to others. But there is 
one area of weight loss where the government, particularly the 
Food and Drug Administration, does have responsibility. 
Americans count on the FDA to make sure the drugs and 
nutritional supplements they take are safe. When it comes to 
drugs, the law is clear: no drug can be legally sold in America 
until the FDA certifies it is both safe and effective. This 
certification involves extensive testing before a drug comes to 
market, and after it has come to market, monitoring of that 
drug and its consequences.
    But when it comes to dietary supplements, everything from 
vitamins, minerals, herbal components, steroid precursors, 
animal derivatives and weight-loss supplements, we have a 
different standard. The Dietary Supplement Health and Education 
Act of 1994 said that in most cases supplements are considered 
safe. There is a presumption of safety. The product can be sold 
until the FDA can prove that it is unsafe.
    Let me inject a personal note here, so that if there is any 
question in your mind. When I got up this morning, I took my 
vitamin. I believe in them. I think people should have the 
right to make that choice, to take the vitamins and minerals 
that they think are important to their personal health. We are 
not calling for the sale of vitamins by prescription. That is 
not what this hearing is about. But the reason that we are 
holding this hearing is because there have been several events 
recently, when it comes to dietary supplements, which have 
caught everyone's attention.
    On January 9 of this year the Canadian Government issued a 
warning about a particular class of supplements containing the 
herb ephedra, sold for the purpose of weight loss. It is also 
sold for body building and to increase energy. The Canadian 
Government advised the people of Canada to avoid these products 
because they may, ``cause serious, possibly fatal adverse 
effects,'' when combined with caffeine or other stimulants. 
They announced reports of adverse health events involving these 
drugs, which range from dizziness to tremors, headaches, 
irregular heart rates, seizures, psychoses, heart attacks and 
stroke. Health Canada then issued a voluntary recall of these 
products containing ephedra or ephedrine nationwide. Many of 
the ephedra supplements recalled by the Canadian health 
authorities can be found today on the shelves of stores across 
America.
    Canada is not alone. A variety of athletic organizations 
including the International Olympic Committee, the National 
Football League and the National Collegiate Athletic 
Association have banned a variety of dietary supplements, 
including--and forgive me if I mispronounce this, I am a 
liberal arts lawyer--androstenedione, known as ``andro'' from 
this point forward in the hearing, a steroid precursor, and the 
weight-loss product ephedrine.
    Despite this ban, a 2001 NCAA study of ergogenic compounds, 
compounds that increase work output, found that 4 percent of 
the 21,000 athletes that completed the confidential survey have 
used ephedrine in the past 12 months. Even more disturbing, 
this number had increased since the ban went into effect in 
1997, especially among women's teams. According to the study 
most athletes reported using ergogenic products started in high 
school.
    The obvious questions are these: Whether the health 
concerns announced by Canada and athletic organizations in our 
country about ephedra supplements are valid? What action should 
be taken by the Department of Health and Human Services and the 
Food and Drug Administration in light of the Canadian recall, 
and whether the 1994 law which Congress enacted, protects 
American consumers from supplements that may be dangerous to 
their health?
    At this hearing we will ask these and other questions about 
whether the 1994 law is working when it comes to weight-loss 
supplements. The GAO, General Accounting Office, will tell us 
about the analysis they just completed about the safety and 
regulation of this industry. The Inspector General's Office and 
the Department of Health and Human Services will tell us about 
a report they turned in on the warning system that exists for 
problems with dietary supplements, and we will ask the Food and 
Drug Administration whether the current system is working to 
protect Americans from dangerous health results. We will hear 
from a woman who took one of those supplements, with a very 
negative health consequence. We will hear from a doctor who 
studies weight loss. We will hear from a spokesman for the 
trade organization representing the supplement industry, as 
well as public health officials, who have attempted to increase 
the standard of supplement regulation in their State. I might 
add that some 21 States or more have imposed stricter 
regulation on the sale of these supplements than is required by 
the Federal Government.
    To put this issue in some context, I want to first share 
some information on the supplement industry. There has been an 
explosion in the sale of dietary supplements since the 1994 law 
was enacted. As you can see from this slide,\1\ the supplement 
industry is currently estimated to be on track to have $19 
billion in sales in the year 2002. They have more than tripled 
their sales since the passage of the Federal law. Weight-loss 
products account for a significant part of supplement sales. So 
what do some of these weight-loss supplement manufacturers tell 
the consumers about their products? Here is an example of a 
supplement product produced by a company that has been in the 
supplement business for 20 years. I know it is a little hard to 
read, but it is a product called Pure Ephedrene. How is the 
consumer to distinguish between ephedra, which is marketed as 
an herbal product, and ephedrine HCl which is an over-the-
counter drug, especially as ephedrine alkaloids are the active 
ingredients found in ephedra? I am not sure.
---------------------------------------------------------------------------
    \1\ The slide appears in the Appendix on page 77.
---------------------------------------------------------------------------
    What kind of language is used to sell Pure Ephedrene? \2\ 
Well, it says, ``Pure Ephedrene is available all the time and 
in unlimited quantities, so you can have as much as you want 
whenever you want it.'' This is a strange claim for an all 
natural herbal product that is known to be a stimulant, 
especially given the fact that the safety range the industry 
claims for ephedrine alkaloids is 25 milligrams per individual 
dose up to a maximum of 100 milligrams a day, and the amount of 
ephedra per tablet in Pure Ephedrene appears to be 325 
milligrams. Allow me to put this in perspective. The Canadian 
Government has said that they have a much different dosage 
level, 8 milligrams per dose, no more than 32 milligrams a day. 
If we read this warning label or advisory correctly in this 
particular advertisement, they are offering a product that 
offers in one dose 10 times what the Canadians say is a safe 
daily dose in four separate dosages.
---------------------------------------------------------------------------
    \2\ The slide appears in the Appendix on page 78.
---------------------------------------------------------------------------
    The next slide is an example of a current warning label on 
a top-selling weight-loss product containing ephedra and 
caffeine.\1\ And here is what it says: ``This product is for 
adult use only, and should not be used by pregnant or nursing 
women or by anyone with any known medical condition.'' What 
does that mean? What does it mean to the consumer? While 
ephedrine and caffeine combinations were banned by the FDA in 
1983 for over-the-counter medications, many weight-loss 
supplements contained ephedra and some herbal form of caffeine, 
the combination, incidentally, which the Canadians have found 
to be highly dangerous.
---------------------------------------------------------------------------
    \1\ The slide appears in the Appendix on page 81.
---------------------------------------------------------------------------
    I am looking forward to our witnesses to help us understand 
this issue and the responsibility we have to protect the health 
of American consumers, and at the close of the hearing I will 
make an announcement concerning some action which I believe 
that we should be taking on Capitol Hill.
    Let me at this point welcome the first panel of witnesses. 
Janet Heinrich is the Director for Health Care--Public Health 
Issues with the General Accounting Office. Her office has 
produced several reports relating to dietary supplements, 
including a recent report titled ``Health Products for Seniors, 
Potential Harm from Anti-Aging Products.'' I am going to look 
for that one too.
    Second is Dr. Michael Mangano. He is the Principal Deputy 
Inspector General within the Office of the Inspector General 
for the Department of Health and Human Services. Thank you.
    Finally, Joseph Levitt, who is the Director of the Center 
for Food Safety and Applied Nutrition within the Food and Drug 
Administration.
    We thank you for coming this morning. It is customary for 
the Subcommittee to swear in all witnesses. Therefore I would 
like to ask you to stand and please raise your right hand.
    Do you swear that the testimony you are about to give is 
the truth, the whole truth and nothing but the truth, so help 
you, God?
    Ms. Heinrich. I do.
    Mr. Mangano. I do.
    Mr. Levitt. I do.
    Senator Durbin. Let it be noted for the record that the 
witnesses answered in the affirmative. We have your statements, 
and I have a number of questions which I would like to ask, and 
I would ask you if you would please summarize your statements 
in about 5 minutes. We will not hold you to that exactly. And 
then I will proceed with some questions.
    Ms. Heinrich, would you like to start?

 TESTIMONY OF JANET HEINRICH,\2\ DIRECTOR, HEALTH CARE--PUBLIC 
         HEALTH ISSUES, U.S. GENERAL ACCOUNTING OFFICE

    Ms. Heinrich. Mr. Chairman, I am pleased to have the 
opportunity to testify as the Subcommittee considers concerns 
about dietary supplements that are used for weight loss.
---------------------------------------------------------------------------
    \2\ The prepared statement of Ms. Heinrich with attachments appears 
in the Appendix on page 40.
---------------------------------------------------------------------------
    As you said, U.S. sales of weight-loss supplements have 
increased steadily. It is estimated that Americans spent almost 
$2 billion in weight-loss supplements in 2001. Obesity in the 
United States is reported to be a growing epidemic, and many 
people are trying to lose weight.
    As sales of weight-loss supplements have increased so have 
concerns associated with their marketing and use. Because of 
these concerns, you asked us to examine the safety and efficacy 
of weight-loss supplements, Federal oversight, research, and 
public education efforts, and State and local regulatory 
efforts aimed at consumer protection of these products.
    For most weight-loss supplements there is little scientific 
evidence to support their efficacy. Although there have been 
studies on specific ingredients, many of these studies were of 
short duration, involved small numbers of individuals, or use 
study approaches that limit the usefulness of their findings.
    There has been limited Federal research on weight-loss 
supplements. The Office of Dietary Supplements at the National 
Institutes of Health is working with other Federal agencies to 
develop a research agenda. However, none of the institutes and 
centers have made weight-loss supplements a priority at this 
time. Available research, again limited, also suggest that some 
supplements are associated with harmful side effects. Some side 
effects are minor, such as indigestion or rash, while others 
are very serious. For example, DHEA, a hormone associated with 
reduction in fat deposits may increase the risk of breast 
cancer. And ephedra, as you suggest, has been associated with 
seizures, heart attacks, and stroke. Supplements also may be 
contraindicated for individuals with certain medical conditions 
or may have dangerous interactions with prescription and over-
the-counter drugs.
    The amounts of active ingredients can vary from what is 
indicated in a product label. Products sometimes contain 
ingredients not listed on the label, or may have as many as 22 
active ingredients, all listed on the label, but with amounts 
unknown if the product contains a proprietary blend. Studies 
have also found supplements contaminated with pesticides or 
heavy metals known to damage the liver and kidneys.
    The Food and Drug Administration, FDA, and the Federal 
Trade Commission, FTC, have oversight responsibilities for 
safety and marketing. FDA has been hindered in its ability to 
address safety concerns with weight-loss supplements by 
weaknesses in its Adverse Event Reporting System, as well as 
the lack of scientific evidence from clinical trials.
    Senator Durbin. Can I interrupt you for a second? Would you 
explain what Adverse Event Reporting means?
    Ms. Heinrich. What that means is that on a voluntary basis, 
individuals or health care providers, can turn in information 
about medical conditions that they think are associated with a 
particular product. FDA has an Adverse Event Reporting System 
for all drugs as well as for dietary supplements.
    Senator Durbin. Thank you.
    Ms. Heinrich. Difficulty in obtaining and properly 
documenting these voluntary Adverse Event Reports has been a 
major problem in the past. Even with Adverse Event Reports, 
FDA's ability to respond is different for dietary supplements 
than for drugs. Dietary supplements are regulated more like 
foods, and FDA must meet a higher safety threshold to take 
regulatory action than for drugs that contain similar 
ingredients. While it is reasonable to assume that foods are 
safe, many supplements are more like synthetic drugs.
    FDA and FTC have taken enforcement actions against 
manufacturers for improper labeling and false advertising. FDA 
has taken 16 actions since 1995 against manufacturers of 
dietary supplements marketed with weight-loss claims almost 
entirely for products that are improperly labeled as dietary 
supplements. For example, in 2001 FDA took action against the 
manufacturer of AMP II Pro drops, an unapproved drug product 
that contained ephedrine for a non-herbal source, but was 
labeled as a dietary supplement. FTC has taken legal action in 
30 cases involving weight-loss substances in this time period. 
For example, in 2000 Enforma Natural Products agreed to a 
settlement with FTC regarding the products Fat Trapper and 
Exercise in a Bottle for deceptive claims such as ``You can eat 
what you want and never have to diet again.''
    FDA does have authority over good manufacturing practices, 
the GMPs, which could help in oversight of product dosage and 
contamination issues. FDA drafted GMP regulations for dietary 
supplements in 1997, but has been slow to finalize these 
regulations. GMPs would standardize manufacturing, packaging 
and holding practices, and improve FDA's enforcement 
capabilities since the law provides that dietary supplements 
not manufactured under conditions that meet GMPs would be 
considered adulterated.
    In summary, Federal activities related to weight-loss 
supplements have focused on oversight of marketing more than 
safety. Federal activity has focused less on safety in part 
because of the lack of scientific evidence and the weaknesses 
in the voluntary reporting system for adverse events. For FDA 
regulatory action there is a different standard of proof 
requiring a determination that a supplement causes significant 
or unreasonable risks. Further research on the efficacy and 
safety of dietary supplements is needed to guide consumers 
choice, especially as the upward trend in sales and use is 
expected to continue.
    Mr. Chairman, that completes my statement. I am happy to 
answer any questions.
    Senator Durbin. Thank you. Mr. Mangano.

TESTIMONY OF MICHAEL F. MANGANO,\1\ PRINCIPAL DEPUTY INSPECTOR 
GENERAL, OFFICE OF INSPECTOR GENERAL, DEPARTMENT OF HEALTH AND 
                         HUMAN SERVICES

    Mr. Mangano. Thank you, Mr. Chairman. I appreciate this 
opportunity to share with you the results of the work we have 
done on taking a look at the FDA's Adverse Event Reporting 
System for the dietary supplements.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Mangano with attachments appears 
in the Appendix on page 65.
---------------------------------------------------------------------------
    Unlike prescription drugs, the FDA lacks the authority to 
require dietary supplements to undergo premarket approval for 
safety and efficacy. Rather, they have to rely extensively on 
the Adverse Events Reporting System to give them signals of 
product problems with consumer safety. Our review found, 
however, that the Adverse Event Reporting System for dietary 
supplements was inadequate as a safeguard to protect consumer 
safety. We believe it is so because it has three major 
weaknesses. The first, the system detects relatively few 
adverse events. Like most Adverse Event Reporting Systems, it 
is a passive system, requiring somebody with an adverse event 
to link that event with the use of a dietary supplement and 
then report it to the appropriate authorities. Our study 
confirmed an earlier review that the FDA commissioned, which 
found that very few adverse events are ever reported for 
dietary supplements.
    In our study we found that from 1994 through 1999, only a 
little over 2,500 adverse events had ever been reported 
relating to dietary supplements. As a comparison, in the year 
1999 the Food and Drug Administration received about 460 
adverse events on dietary supplements. Over the same time 
period, the same year, the Poison Control Centers received over 
13,000 reports related to dietary supplements.
    The second weakness the FDA has with its Adverse Event 
Reporting System is its difficulty in generating signals that 
there may be a public problem with regard to a particular 
dietary supplement. The FDA lacks sufficient information such 
as consumer medical records, product ingredients and the 
identity of manufacturers so as to analyze the reported events 
and determine if they raise concerns regarding the public 
health.
    For example, we found that FDA could not obtain medical 
records for over half of the Adverse Event Reports where they 
had actually requested those records. With regard to product 
information, FDA was unable to determine the ingredients of one 
third of the dietary supplements that were indicated in an 
Adverse Event Report, and they had no product label information 
for three-quarters of the supplements that appeared in those 
Adverse Events Reports.
    So the agency really needs those labels in order to 
determine the supplement ingredients and whether they should 
take action in the future. Manufacturers have information that 
would also be very important for FDA to have regarding these 
supplements, yet they could not identify even the manufacturer 
for one-third of the products in the Adverse Events Reports. 
Finally, the database housing the Adverse Event Reports was 
wholly inadequate for analysis purposes.
    The third weakness of the Adverse Event Reporting System is 
that sufficient information is not available to assess whether 
action is actually required by the FDA to protect public 
safety. FDA relies very heavily on clinical research, 
scientific literature and laboratory testing to assess signals 
generated by the system, but because supplement manufacturers 
are not required to conduct those clinical trials, little of 
this information is actually known.
    The FDA lacks information on the size of the consumer 
population actually taking the dietary supplements and the 
dosage amounts they're taking. And as mentioned earlier, they 
suffer from too few Adverse Event Reports, inadequate Adverse 
Event Reports, and a limited computerized database to help them 
facilitate the analysis of that data.
    We estimate that FDA's taken about 32 actions between 1994 
and June 2000, and the two most common were voluntary product 
recalls and warnings to consumers.
    We recognize, however, that FDA faces significant 
legislative and resource barriers to improving the Adverse 
Event Reporting System.
    Our report offers a number of recommendations. I'll 
highlight just a few here this morning. We believe that FDA 
should seek authority to require manufacturers to report 
serious adverse events for some products, require manufacturer 
and product registration, contract with the Poison Control 
Centers to obtain their data and develop a new computerized 
database that helps track and analyze Adverse Event Reports.
    I am pleased to say that FDA has recently reported to us 
that they have taken a number of those recommendations and put 
them into action.
    Mr. Chairman, millions of consumers take supplements every 
day without any apparent problems and do receive health 
benefits. However, risks do exist, and the consumers need to be 
protected.
    This completes my oral testimony. I will be happy to answer 
any questions at the appropriate time.
    Senator Durbin. Thanks a lot.
    Our next witness is Joseph Levitt with the Food and Drug 
Administration. Please proceed.

 TESTIMONY OF JOSEPH A. LEVITT, ESQ.,\1\ DIRECTOR, CENTER FOR 
       FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG 
   ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 
ACCOMPANIED BY DR. CHRISTINE LEWIS TAYLOR, DIRECTOR, OFFICE OF 
    NUTRITIONAL PRODUCTS, LABELING AND DIETARY SUPPLEMENTS 
(ONPLDS), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), 
  AND JOHN TAYLOR, DIRECTOR, OFFICE OF ENFORCEMENT, OFFICE OF 
  REGULATORY AFFAIRS (ORA), FOOD AND DRUG ADMINISTRATION (FDA)

    Mr. Levitt. Thank you very much, Mr. Chairman. It's a 
pleasure to be here. Let me first introduce two colleagues that 
are here with me. The first is Dr. Christine Taylor, Director 
of our Office of Nutritional Products, Labeling and Dietary 
Supplements in the Center I direct. And the second is John 
Taylor, Director of the Office of Enforcement, Office of 
Regulatory Affairs at the FDA level, so he has responsibility 
across all the regulated products.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Levitt appears in the Appendix on 
page 86.
---------------------------------------------------------------------------
    I would summarize my testimony, Mr. Chairman, with five 
main points. Point No. 1, with which I think everybody here 
will agree, is that dietary supplements present a significant 
challenge worthy of our attention. As you pointed out, Mr. 
Chairman, in your opening statement, there is widespread use in 
this country of dietary supplements, clearly increased since 
passage of DSHEA in 1994, and DSHEA looks to FDA to step in if 
there is a problem and to be vigilant on behalf of the public. 
We welcome reports from GAO, IG, and others that can help us 
meet this challenge.
    Point No. 2 is we do have a plan. We spent, in fact, an 
entire year developing a strategic plan on how we would 
implement DSHEA. I have a copy here, and copies have been 
provided to the Subcommittee. The goals of this plan are clear. 
We need to fully implement this law. In doing so we need to 
provide consumers with a high level of confidence in the 
safety, composition, and labeling of these products. We need to 
do so in a science-based way, consistent with all of FDA's 
successful programs, and we need to recognize that 
implementation of this law is going to take sustained time and 
effort.
    Now, we developed this plan with broad public import and 
support. The major theme we heard from stakeholders was safety 
first. As you've already heard, look at the Adverse Event 
Reporting System, make it functional, develop good 
manufacturing practices, get them implemented, but I will also 
tell you that fundamentally, long term, this program will not 
be successful unless there is a much stronger scientific 
underpinning to the products, and I think that has been 
reinforced by both speakers already.
    Point No. 3. Congress has asked us what it would take 
resource-wise to implement the strategic plan, and I am pleased 
to say that we submitted a report to Congress this past May 
which outlines that. That report concludes that our needs would 
be in the range of $40 to $65 million over 5 years. That would 
be compared to $9 million that we had allocated in fiscal year 
2002, the current fiscal year we're in. The plan also describes 
how we would prioritize those resources, how we would implement 
them over time, starting with safety issues, moving on to 
inspectional issues, and so forth. I think the bottom line is, 
you'll agree, that it does take time, money and people to 
operate and implement an effective program.
    Point No. 4. We are making progress, admittedly 
incrementally. Each year across our entire center we publish 
our annual priorities for what we accomplish, or intend to 
accomplish that year. One section of that report includes 
dietary supplements. And at the end of each year, we publish 
our report on what we have been able to accomplish, and we have 
been averaging a good 85 to 90 percent completion rate of what 
we set out to accomplish. We're also pleased that Congress has 
started to appropriate funds earmarked for dietary supplements. 
We've received funds recently in the area of Adverse Event 
Reporting and academic collaborations on the science-based and 
on enforcement, and we are seeing progress in each of these 
areas. We also were able to fund a study to be conducted by the 
National Academy of Sciences Institute of Medicine to develop a 
framework for evaluation of the safety of dietary supplements, 
and you may have seen some press this week on an interim report 
from that group. My testimony also outlines a number of 
enforcement actions which we have taken.
    Point No. 5 though, again of which I think every speaker 
will agree, we have a lot more to do in this area. As just one 
example, on the product ephedra that you have mentioned, 
Secretary Tommy Thompson issued a statement in June which 
outlined a two-prong approach. Prong one is that we need better 
research. There is an ongoing evidence-based review being 
conducted by the Rand Corporation under the auspices of the NIH 
to determine what is known about ephedra and what research 
needs to be done, and that the NIH is committed, the Department 
is committed to using that report as a guide to future research 
needs.
    Concurrently FDA has already initiated a number of 
enforcement actions against products that are synthetic 
ephedrine, and therefore they're not botanical and they fall 
outside the scope of DSHEA.
    Summarizing then and wrapping up with my five main points, 
dietary supplements, of which weight-loss supplements are an 
important part, and probably illustrative of the broader group 
of herbal supplements at large, presents significant 
challenges, something we clearly need to devote our attention 
to. Point 2 is that FDA has developed a strategic plan on a 
blueprint of how we would implement this with broad stakeholder 
import and support. No. 3, we thank Congress for asking for our 
funding needs, and we have issued that report. No. 4, we are 
making incremental progress consistent with the resources that 
have been allocated. And No. 5, we recognize this as a long-
term effort. There's a lot more we have to do. We welcome the 
input you have, the visibility this hearing provides to helping 
us achieve those goals.
    Thank you very much, Mr. Chairman. I know in your letter of 
invitation you had a number of specific questions, and I'll be 
happy to try and answer those during the question period.
    Senator Durbin. Great. Let us start with a few questions, 
and some of these are very basic, but I think we ought to put 
them on the record.
    From the Food and Drug Administration's viewpoint, is it 
safe to say that the chemical properties of ephedrine can be 
found in a variety of ways in both natural, botanic sources as 
well as synthetic sources?
    Mr. Levitt. That's right.
    Senator Durbin. And is it also true that the Food and Drug 
Administration, over the years, has regulated the synthetic 
sources of ephedrine and how they can be sold in America?
    Mr. Levitt. Yes.
    Senator Durbin. For prescription drugs as well as over-the-
counter?
    Mr. Levitt. Yes.
    Senator Durbin. Is it also true that when it comes to the 
combination of ephedrine with, for example, either a stimulant 
or an analgesic, that there have been limitations on the 
products that can be offered for sale as prescription drugs and 
as over-the-counter products?
    Mr. Levitt. I think any product that is regulated as a 
pharmaceutical, whether it's as a prescription or as an over-
the-counter drug under our monograph system, regulated by 
another part of FDA, not the part I direct, that there are 
boundaries associated with claims, with dosages and so on and 
so forth.
    Senator Durbin. But in terms of the limitation of sale, are 
there any forms of ephedrine that have been prohibited by the 
FDA from sale, either as an over-the-counter drug or as a 
prescription drug?
    Mr. Levitt. Well, the history is such--I'm not sure I can 
answer that with the specificity you're looking for--but any 
time there's a monograph that lists the boundaries, and so 
anything outside that boundary is not permitted.
    Senator Durbin. And so from the consumers' point of view, 
if the Food and Drug Administration has decided that when 
ephedrine is in a drug, a prescription drug, or in an over-the-
counter product, that it has to have some limitations in terms 
of how it can be prescribed and dosage and that sort of thing. 
From the consumers' point of view, that same drug could be 
available through a supplement in a botanical form without the 
FDA limitations.
    Mr. Levitt. The one distinction I would draw, as we have 
pointed out, if an ephedrine product is a synthetic-derived 
product, then that product is not permitted to come under the 
dietary supplement provisions. Ephedra comes under the part of 
the definition of dietary supplements for botanicals.
    Senator Durbin. Understood.
    Mr. Levitt. So if there is synthetic derived--and I think 
you'll find that a lot of the pharmaceutical products that 
you're referring to are synthetic derived----
    Senator Durbin. I understand that. This is really basic. I 
go into my neighborhood drugstore in Springfield, Illinois, and 
I look at the pharmacy and I look at what is on the shelf. And 
I know that if I am going to get some form of ephedrine through 
a prescription drug, I need a doctor's prescription, and the 
pharmacy will fill it with instructions on how I am to take it.
    Mr. Levitt. Right, for certain uses.
    Senator Durbin. I also know if there is an over-the-counter 
drug for sale there, according to the FDA, it is going to have 
instructions on the back of it as to dosage, contraindications, 
warnings and that sort of thing.
    Mr. Levitt. That is correct.
    Senator Durbin. If I move----
    Mr. Levitt. There is now a new standardized format for that 
which is very good.
    Senator Durbin. Then I move to the third counter and I see 
a dietary supplement. It contains the same drug. Maybe it is 
called ephedra, maybe it is ephedrine, but it contains the same 
drug, but what is on the label of that product as a matter of 
warning or recommended dosage is really not determined by the 
Food and Drug Administration. That is determined by the 
manufacturer of the product.
    Mr. Levitt. That is correct.
    Senator Durbin. OK.
    Mr. Levitt. That is because, as you pointed out in your 
opening statement, when Congress passed the law there was a 
presumption that these were natural ingredients with a history 
of safe use, and therefore, that was an appropriate way for 
them to be marketed.
    Senator Durbin. But if you blindfolded a chemist and walked 
him in and said, ``I have got ephedra or ephedrine coming at 
you in three different forms,'' it is still that drug, whether 
it is from a botanical source or from a prescription drug or 
from an over-the-counter, it is still that basic chemical 
compound coming into your body?
    Mr. Levitt. There are clear similarities.
    Senator Durbin. Now, when it comes to the manufacturing 
practices of these drugs and over-the-counter products and 
supplements, I understand the Food and Drug Administration 
monitors very carefully how drugs are manufactured in terms of 
foreign matter as Ms. Heinrich and others have said, and in 
terms of its purity. The same thing would be true for over-the-
counter drugs, is it not?
    Mr. Levitt. Yes.
    Senator Durbin. But when it comes to dietary supplements, 
what standards, when it comes to manufacturing practices, would 
the FDA impose on the supplement industry?
    Mr. Levitt. Well, the law does explicitly authorize FDA to 
issue good manufacturing practice regulations. We did issue, 
some years ago, what's called an advance notice of proposed 
rule making. We do have a proposed rule which we hope to get 
out very shortly that would elicit public comment, but really 
take us a major step towards getting those kinds of regulations 
in place. Again, I think there was a broad support for getting 
those kinds of regulations in place. Everybody recognizes the 
need for them.
    Senator Durbin. I have been around Washington long enough 
to know that things do take some time, but we are talking about 
a 1994 law, are we not?
    Mr. Levitt. That is correct.
    Senator Durbin. And we are talking about the fact as we sit 
here today in 2002, we are talking about public hearings on 
good manufacturing practices for dietary supplements.
    Mr. Levitt. That is correct.
    Senator Durbin. They have not been established?
    Mr. Levitt. Yes, correct.
    Senator Durbin. The products that are currently on the 
market, the dietary supplements, for example, that are 
currently on the market are not being manufactured according to 
any standards that have been established by the Federal 
Government or the Food and Drug Administration?
    Mr. Levitt. That is right.
    Senator Durbin. It is up to----
    Mr. Levitt. That's why we think it's important to do it.
    Senator Durbin. I think it is too. That is why it is really 
up to every individual manufacturer to call their own 
standards, call their own shots in terms of what they put in 
that bottle and how they label it.
    Mr. Levitt. At this point in time, that is correct.
    Senator Durbin. And, Ms. Heinrich, what have you found, as 
you have looked into these products?
    Ms. Heinrich. Well, certainly the reports in the literature 
are that there is contamination, that there is variability in 
terms of the dose, that you can't assume that what the label 
says is what you'll find in the product. And the other area 
that is of growing concern is the fact that many supplements, 
the dietary supplements for weight loss especially, have 
multiple ingredients, as I said, up to 22 ingredients, and they 
may not--you may not have the information about what dose is in 
the product.
    Senator Durbin. Mr. Levitt, I mentioned in the opening 
statement the action taken by Canada, which basically has 
recalled these products, ephedrine products, particularly those 
combined with a stimulant, and said that they are a danger, and 
they are very explicit in terms of the danger that they see 
here, in terms of heart attack, stroke, psychotic episodes, 
seizures. What kind of notice does the FDA take of that action 
in Canada; what kind of reaction has the FDA had to that 
Canadian decision?
    Mr. Levitt. I think there were two reflections upon that 
action. No. 1 is that action closely resembles a proposed 
regulation that FDA issued several years ago, and therefore is 
consistent with some of the steps FDA historically has sought 
to take.
    No. 2, as I understand the Canadian framework, they have a 
different legal framework, and that these products are 
generally not lawfully available in the country as they are 
here. And so they're operating within a different framework, 
but actually looking to this country for what actions have been 
taken in the past.
    Senator Durbin. Well, I do not quarrel with that. I 
understand that our 1994 law is different from the Canadian 
law. But what I am asking for is not from the legal 
interpretation, although I know you come to this as a lawyer, 
but I am looking from the medical and scientific side. If we 
have a neighbor to the north which is considered very similar 
to the United States in its culture and values, which shares 
our pharmaceutical products on a regular basis because of the 
trust we have engendered between the two countries, and they 
have taken a product which we have for sale in drug stores and 
nutrition stores across America, and announced that it is 
unsafe for Canadians, so unsafe that they recalled it from the 
shelves, what I am really driving at is from the medical and 
scientific viewpoint, did that not raise a red flag at the FDA 
that perhaps we are not moving quickly enough or not taking 
this concern seriously?
    Mr. Levitt. Well, let me read to you from the HHS press 
release of June 14, which I think speaks directly to that 
point. It says very clearly, and I quote from our deputy 
commissioner, ``These products are not for everyone.'' 
``Consumers should read labels carefully to ensure their proper 
use.'' It goes on to state that consumers should not use these 
products if they are under the age of 18 or if they are 
pregnant or nursing women. It further states that adult 
consumers should consult health care providers prior to use of 
such products if they have current or previous history of high 
blood pressure, heart or thyroid disease, a seizure disorder, 
depression, diabetes, difficulty urinating, prostate 
enlargement, glaucoma, or are using any prescription drugs. It 
goes on to alert consumers that this is a product we have 
concerns about, and that consumers should be vigilant as they 
take these products for possible side effects, and that 
specifically, ``Consumers should discontinue use if any of the 
following symptoms are experienced: Rapid or irregular 
heartbeat, chest pain, severe headache, shortness of breath, 
dizziness, loss of consciousness, sleeplessness or nausea.''
    So I think that we clearly have recognized some of the 
potential concerns with this product, have tried to alert 
consumers to that, and we reinforce that message whenever 
possible, and I thank you for the opportunity to reinforce that 
today.
    Senator Durbin. Well, I am glad you did reinforce it. With 
all due respect, that is a press release, is it not?
    Mr. Levitt. Yes.
    Senator Durbin. Yes. And I do not know how many people read 
it when you issued it, but when I go into my corner drugstore 
in Springfield and buy a dietary supplement with ephedra in 
there, am I going to find that warning on the label?
    Mr. Levitt. You will find a number of warnings that are 
voluntarily put on by the manufacturers, and they tend to be of 
the first kind of language I read on the kinds of consumers 
that should avoid using the product or consult a physician 
before using the product. But that is consistent with what 
you'll find on a lot of products.
    Senator Durbin. But it is a voluntary label.
    Mr. Levitt. That is correct.
    Senator Durbin. We have seen some disclosures already that 
do not get even close to the warnings which you have just 
outlined, which are lengthy. It sounds like the end of one of 
these ads on television about the little purple pill. But what 
I am saying to you is it is voluntary, and from a consumers' 
viewpoint, unless you happen to be on the mailing list from the 
FDA and got a copy of that press release, you may never see the 
warnings which you have laid out here; is that not correct?
    Mr. Levitt. It is correct that the warnings are voluntary, 
and we do try to get this message out as broadly as we can.
    Senator Durbin. Let me ask you about the dosage level if I 
can, and we apparently have some difference of opinion between 
the United States and Canada as to safe dosage, and I might go 
further to say that when you look at the actual products being 
sold, it appears that some of the companies are paying little 
or no attention to either standard as announced. Is there a 
safe dosage standard for products containing ephedrine 
supplement products that the FDA has announced?
    Mr. Levitt. Let me share with you the brief history on this 
subject. In the earlier part of the 1990's, FDA had a Public 
Advisory Committee meeting addressing the safety of ephedra 
products, and the recommendation of the Advisory Committee was 
to see if FDA could determine a safe dose or an acceptable 
dose. FDA went back to the existing body of information that 
the agency had, which was the Adverse Event Reports, and used 
those reports as best as we could, consistent with what's known 
in the literature and about the product in general and proposed 
a dose level. A study was done following that by the General 
Accounting Office. I will let them speak if I say anything 
incorrectly and correct. But their conclusion was that those 
Adverse Event Reports, while important in signalling a 
potential problem with this product, were not designed to 
establish a dose level, and it was not appropriate to use them 
for that purpose. And so where we stand today is that we don't 
have a good scientific foundation--goes back to my opening 
comments--a strong scientific foundation. We don't have a 
strong scientific foundation establishing what is the best dose 
to use.
    Senator Durbin. We certainly do not, and I think the 
conclusion from your statement is the following: The Food and 
Drug Administration since 1994 has not established a standard 
for safe dosage of this product.
    Mr. Levitt. That is correct.
    Senator Durbin. The Canadians have reached a conclusion 
that resulted in their withdrawal of this product from sale in 
Canada, and we have seen other actions taken by other 
organizations, but our government has not taken an action to 
either withdraw the product or even to establish a safe dosage. 
Is it not also true that the American Medical Association, 
after this Canadian action, wrote to the Food and Drug 
Administration and made a recommendation concerning ephedrine 
products?
    Mr. Levitt. They have written to us.
    Senator Durbin. Do you recall what they asked?
    Mr. Levitt. In an earlier letter I believe they recommended 
that the products be removed from the market.
    Senator Durbin. Letter of January 28, 2002 to Dr. Bernard 
Schwetz, and this is from Dr. Michael Maves of the American 
Medical Association, first sentence, ``On behalf of the 
American Medical Association, I am writing to reiterate our 
call for the Food and Drug Administration to initiate 
proceedings to remove dietary supplements containing ephedrine 
alkaloids from the United States market.'' He goes on to spell 
out the reasoning based on Adverse Event Reports, and they are 
concerned about the danger of this product as against its value 
to the American consumer.
    The point I am getting to, Mr. Levitt, is it appears that 
the evidence keeps piling on to the Department of HHS and FDA 
about the danger of this product, and as you come today to 
testify, 8 years after the law has been passed and as this 
evidence accumulates, it appears that nothing has been done. 
The proposed rules are good and we will talk about when they 
might come about but from the consumers' viewpoint, neither a 
required warning label, an established dosage, or any 
consideration as to whether some of these products should be 
removed from commerce, none of this has been taken despite the 
clear danger that was perceived in Canada when it made this 
decision.
    Now, is this for lack of resources at the FDA? Is it 
because your hands are tied by legislation, or is there some 
other element at work here?
    Mr. Levitt. It is because the data are not--there's not a 
consensus on the clarity of the data to the point that you 
describe. We held a public meeting with government officials on 
the panel a couple summers ago--I guess it was 2 years ago by 
now--and the outcome--and we presented all the Adverse Event 
Reports; we brought our consultants. Some of the people 
testifying today testified at that meeting. The report coming 
out of that meeting reinforced that the Adverse Event Reports 
generate a strong signal, but we did not have the kind of 
stronger clinical data that they would like to have seen. We 
took that to the NIH and they commenced what they call--because 
we said if we need more research, then we need it--and what 
they call an evidence-based review. That is what was in the HHS 
press release of June 14.
    Senator Durbin. Which we are hoping some consumers saw. Let 
me ask this----
    Mr. Levitt. We are hoping it will result in firm 
recommendations and identification of the research we need to 
get to the bottom of it.
    Senator Durbin. Well, I hope you get to the bottom of it 
soon too because you have had over 1,000 Adverse Event Reports 
which led the AMA to say take this product off the shelf. Mr. 
Mangano has made it clear--and I will return to him and ask 
this question--the Adverse Event reporting for supplements in 
this country is woefully inadequate because it is voluntary. 
13,000 adverse events were reported to the Poison Control 
Centers in the year 1999 for dietary supplements, and only 460 
or 480 were reported to the FDA. So clearly, this system of 
reporting is not giving the information from consumers to the 
industry to the FDA for them to make a decision. And when we 
hear Mr. Levitt and the FDA say, well, we just do not have 
enough information from Adverse Event Reports, this is 
circular, and frankly, it is leading to some disastrous 
results.
    Mr. Mangano, you have talked about changing this Adverse 
Event reporting system. Would you comment on that?
    Mr. Mangano. Sure. The system itself is inadequate as a 
system to collect data. I'm talking about the computerized 
system that actually houses all of the events reports 
themselves. It was not a system that could either house all the 
information or be used fully in terms of analyzing the 
necessary information. So that needs to be changed. I know that 
FDA has put about $2.5 million into that process itself, but 
there are a whole lot of other things that have to go on at the 
same time. The voluntary system just is not going to work for 
the kinds of products that can cause risk through human 
consumption.
    We need to have reporting by the manufacturers of what the 
ingredients are in their individual products. We need to have 
mandatory reporting by the manufacturers of adverse events for 
some products, products like ephedrine, that could cause 
problems. Right now it's voluntary. We need to complete the 
good manufacturing practice standards, etc.
    They need to learn a little bit more from the Poison 
Control Centers about the kinds of information they're getting 
from that source. They need to do all the kinds of research 
that Dr. Levitt has just talked about.
    The resources haven't been there in the past for them, but 
they need to really try and ratchet up developing the clinical 
studies that will help them when they do get a signal that 
there might be something wrong with a product. They need to 
have the clinical research that's available to them to tell 
them whether they need to act on it immediately.
    So those are just a few of the things that need to happen.
    Senator Durbin. Ms. Heinrich, the GAO and the Inspector 
General have both looked into this Adverse Event Report 
situation here, and I would like to ask you what role do you 
believe that this adverse event reporting should play in 
protecting consumers from potentially harmful weight-loss 
supplements?
    Ms. Heinrich. I think we have to be very thoughtful about 
the design of this Adverse Event Reporting System. The fact of 
the matter is you have to have good and complete data going 
into the system. Then you have to have people that are able to 
look at those events and decipher patterns or early warning 
signals that there may be a problem. And then you have to have 
the ability to go further where there is a problem and do 
thorough investigations and be able to link the clinical 
outcomes to the ingestion of one of these dietary supplements.
    The problem is that it is voluntary. In this instance 
industry, manufacturers are not required to report adverse 
events that they know about, and so with dietary supplements, 
you don't have complete information on which to determine these 
patterns.
    More to the point, when FDA does see a pattern as they have 
said that they see in ephedrine, for example, they really have 
a higher threshold of evidence that they have to have in order 
to prove harm and possible public health safety concerns.
    Senator Durbin. I guess, Mr. Levitt, that is a point I am 
going to come to here, and maybe that is a question for the 
FDA. I know there are many doctors who work the FDA, and I do 
not believe you are a medical doctor?
    Mr. Levitt. That is correct.
    Senator Durbin. I am not either. But--and I do not play one 
on TV, even on C-SPAN. But I would say to you that it would 
seem that the first obligation of the Food and Drug 
Administration is to protect American consumers. When in doubt, 
err on the side of protecting American consumers. We have a 
situation here where you have said the FDA just cannot reach a 
conclusion on warning labels, on dosage and the like, because 
we just do not have enough information. We do not have enough 
statistical data on Adverse Event Reports. We know the system 
is stacked against you. The law that was passed in 1994 makes 
those reports voluntary. The industry is not rushing to your 
door to saying, ``Oh, listen, there are some more reports on 
bad outcomes with our product.'' In fact, they are holding back 
on that information. And so you do not have the information to 
deal with. The Poison Control Centers are learning a lot more 
than the FDA. What is wrong with this picture? And so you do 
not have the statistical information coming in to make an 
ordinary decision about how to protect American consumers, but 
you do know something. You know that the Canadians have come to 
the conclusion already that this is unsafe to be sold in their 
country. You know as well that 21 States or more have 
established stricter standards than the Federal Government when 
it comes to the sale of these products. You know as well that 
the American Medical Association, which is not considered a 
fly-by-night operation, has notified the Food and Drug 
Administration that there is a real danger in the sale of these 
products. You know that three football players dropped dead 
after taking these supplements and the NFL has banned it, as 
well as the International Olympic Committee and the NCAA.
    When all of this accumulates, does not the Secretary of 
Health and Human Services come to the conclusion that I should 
err on the side of protecting Americans? These products are 
killing people and hurting people, and we should err on the 
side of helping them, rather than waiting for statistical 
evidence which by this law will never appear.
    Mr. Levitt. Mr. Chairman, we agree with you that in this 
product area in general, this product in particular, is an area 
that we need to be doing more.
    Senator Durbin. This has been 8 years.
    Mr. Levitt. We agree that our Adverse Event Reporting 
System needs to be upgraded. We're in the process of doing 
that. We thank you for the funds to do that. I also want to 
reinforce a point made by my colleagues. The Adverse Event 
Reporting System needs to be an effective tool for an early 
warning of problems, but that early warning system, once a 
problem or potential problem is identified, needs to be 
complemented with a broader, stronger, scientific foundation of 
information. We will continue to search for ways to get that 
information, and to meet our responsibilities under the law as 
best as we can.
    Senator Durbin. I do not want to assign the blame to you 
personally, and I do not. I do not necessarily want to assign 
it to the FDA because I respect this agency more than you can 
imagine. But either the law is bad, the resources are not being 
given to you, or there is no will to deal with a clear threat 
to the American consumers. It may be all three. I hope not. And 
I hope that we can make some steps to resolve it.
    Now, let me ask you about one particular bill before I draw 
this panel to a conclusion. When we passed the Bioterrorism 
Bill, we called for the registration of food manufacturers, 
distributors and importers. So can I conclude from that that at 
least now the most basic information about the identity of 
supplement manufacturers will now be available to the Federal 
Government?
    Mr. Levitt. That is correct. Dietary supplement 
manufacturers are clearly included under the law. In fact we 
had our first outreach meeting with industry in general on 
these provisions just yesterday. A number of dietary supplement 
representatives were there. And I think everybody accepts and 
recognizes that as a very positive step.
    Senator Durbin. Now, let me also add, too, is it not a fact 
that some businesses within the supplement industry have tried 
to create their own code of good conduct and manufacturing 
practices to try to establish some standards that have not been 
imposed by the government?
    Mr. Levitt. That is correct.
    Senator Durbin. But there are some companies that are not 
part of that code.
    Mr. Levitt. That is correct also.
    Senator Durbin. Well, this raises another question as to 
whether or not the industry itself perceives a problem. Can any 
of the witnesses at this table testify about the question of 
lawsuits and claims against the supplement industry? Did that 
come up during the course of the GAO investigation?
    Ms. Heinrich. We did indeed try to document the types of 
claims that have been filed, and there are several. And 
certainly ephedra is involved in several lawsuits. You've had 
claims brought by State Attorneys General, and then you have 
also had liability claims from individuals.
    Senator Durbin. Thank you.
    If there is anything else that any of the panel members 
would like to say at this point, I will give you this 
opportunity. If not, thank you very much for your testimony. I 
appreciate it.
    I think we will go ahead and bring on the second panel. We 
may have to interrupt it if there is a vote. Let me invite 
Cynthia Culmo, who is Chairperson for Drugs, Devices, and 
Cosmetics with the Association of Food and Drug officials in 
Austin, Texas; Dr. Steven Heymsfield, Deputy Director at the 
Obesity Research Center, St. Luke's-Roosevelt Hospital Center, 
Professor of Medicine, Columbia University, College of 
Physicians and Surgeons in New York; Michael McGuffin, 
President of the American Herbal Products Association from 
Silver Spring, Maryland; and Karen Ruiz, a consumer from San 
Clemente, California.
    As you probably noted before, we do ask our witnesses to 
take an oath, and if you will please stand.
    Do you solemnly swear the testimony you are about to give 
is the truth, the whole truth and nothing but the truth, so 
help you, God?
    Ms. Culmo. I do.
    Dr. Heymsfield. I do.
    Mr. McGuffin. I do.
    Ms. Ruiz. I do.
    Senator Durbin. Let the record indicate that all four of 
the witnesses answered in the affirmative, and we will start 
with testimony.
    And let me begin with Mrs. Ruiz. Thank you for joining us 
from California today. We have your statement for the record, 
and if you would like to give us a summary of your experience 
for the record, I would appreciate that.

 TESTIMONY OF KAREN RUIZ,\1\ CONSUMER, SAN CLEMENTE, CALIFORNIA

    Ms. Ruiz. This is amazing, and I want to thank you for 
having me here. Senator Durbin, I would like to thank you for 
taking the time to hear my testimony, and it is my hope that by 
sharing with you that others will be spared the serious and 
life-changing effects of taking unregulated diet supplements, 
specifically containing ephedra and guarana.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Ruiz appears in the Appendix on 
page 118.
---------------------------------------------------------------------------
    I would like to just read to you a journal entry I wrote. I 
grabbed this at the last minute. But it's impacted my life, 
it's impacted it a lot, and I wanted to read this to you. I 
wrote: ``I'm 32-years-old now and determined to journal a lot 
more consistently. Today I feel good. About 4 months ago I had 
my third manic episode. It baffles me how my mind can 
completely take me to non-reality and I am completely helpless 
when it happens. It just happens. And when it does, it seems so 
wonderful and perfect, and everything seems to come together 
and make such perfect sense. But always only to me. Once Donny, 
my husband, realized I was manic again, he took me to the 
doctor. Three weeks of heavy sedation and lots of sleep brought 
me down, but then comes the depression. And so horrible is this 
hopelessness that I don't know how I survived it again. But 
today I feel good and I thank my God for restoring my mind to 
me today. It is my biggest prayer these days that my medication 
will work and keep me from getting sick again.''
    ``My story and how I first developed this illness with 
these ephedra supplements will be in `Self Magazine' next 
month.'' This was back in April 2000. ``And I'm a little 
nervous about seeing it. I hope it doesn't make me sound 
crazy.''
    It was in February 1996 that I first took these supplements 
containing ephedra and guarana. The ephedra was listed as ``ma 
huang'' on my bottle. That's the Chinese herbal name, and I 
just think that it's important to note that many of the dietary 
supplements out there do say ma huang. They don't say ephedra. 
But it's the same thing.
    I had two small children and I was looking to lose post-
pregnancy weight, also get a little extra energy. I was tired 
from getting up at night with the kids. I was drawn in by 
claims that it was all natural, and that it was safe. I had 
attended a meeting and asked questions about this product, and 
I was given brochures that used words like ``doctor 
recommended,'' ``scientific approach,'' and ``quality 
assurance.'' I was very impressed with the entire presentation, 
and I found myself feeling very comfortable about taking these 
products. And I was pretty cautious. I didn't want to take 
anything that wasn't legal or drugs. I never had.
    When I first started taking the products, I want to just 
tell you I immediately felt the lift in my energy. They said I 
would and I did. And for the first time in months, when my 
children took their naps, I didn't have to nap along with them. 
On day 3 after starting the product I woke up early and 
actually went to the gym before daybreak, and I came home and 
completely cleaned my house before the kids woke up.
    My days were full and every minute was being used, and I 
felt very productive. There seemed to be no limit to my energy, 
and by day 4 I had come up with a new marketing plan for this 
company and was seeking legal advice on how to patent it. I had 
a lot of friends and a lot of moms who I knew needed this 
product. The energy was amazing.
    But it was around day 5 that I began to feel something big 
was happening to me, and I still made no connection to the 
product. I was not getting as much sleep, and when I asked my 
direct distributor, and told him I was not getting as much 
sleep, his response was, ``Isn't that great. You are getting so 
much healthier, you do not need as much sleep.'' That was not a 
red flag to him, it was not a warning, and if he was not 
concerned, I was not concerned.
    I remember I was suddenly feeling very aware of a spiritual 
realm, and at one point I felt that I was being watched, and I 
remember thinking my neighbor was demonically possessed. I was 
flipping in and out of paranoia, but then followed by thoughts 
of what I presumed were divine and coming from God. I somehow 
was convinced that I was being chosen, initially to warn people 
that it was the end of the world. I went to my bank account, 
pulled out twenties and started handing them out to homeless 
people and saying, ``We are almost there. We are going home.''
    Later, I thought I was being chosen to be God's wife, and 
eventually I just felt so euphoric and so in tune with the 
cosmic around us that I just thought I was God myself. It was 
an incredible way to feel, and I want you to know that I think 
I understand why people do drugs now. I had never experienced 
anything like that, and it does not surprise me to learn that 
teenagers and kids are using these products to get high. It is 
called herbal ecstacy on the streets.
    By day 5 and 6, my husband knew something was wrong, and he 
took me to the hospital. They admitted me, and I was fortunate 
to have a psychiatrist who had been an emergency room physician 
prior to being here on this ward, and he took the supplements 
from my husband. (My husband believed they were responsible.) 
The psychiatrist immediately identified the ephedra, the ma 
huang. There were some additional stimulants in the product, 
and he said, ``She is on amphetamines. She is high.''
    I was there for 10 days, and after 10 days, a lot of 
medication, my mind did start to slow down, but I had a very 
hard time believing the things I was seeing, and hearing, and 
feelings were not real. I mean, I was seeing visions in the 
clouds. So, when you are seeing them, the person next to you 
cannot tell you that they are not there, because I was seeing 
them.
    So I did eventually get well. It took 9 months, and 
following the initial incident--we did report it to the people 
who had sold it to me. Basically, they said, ``Oh, gosh. We are 
really sorry. We have never seen that before. Bye.'' They never 
called or followed up or tried to get any kind of reaction. We 
felt lucky that we did have an attorney who knew me personally, 
knew that was very abnormal and had not happened to me before. 
He took our case on a contingency basis, and with lab tests, we 
realized that the products had no quality assurance. I had 
additional sources of ephedra in the product, in addition to 
the ma huang that was listed on the label. There were multiple 
kinds.
    There was also guarana in the product not listed on the 
label, and I was taking it with another drink that was a 
guarana caffeinated drink so----
    Senator Durbin. Guarana is basically a stimulant?
    Ms. Ruiz. Yes. The guarana is the herbal equivalent to 
caffeine, but there were no specifications of how much or 
anything like that. My cautions label said, ``Don't take if you 
are a nursing or lactating mother or you are having high blood 
pressure,'' and that was about it, nothing else.
    The doctors concluded that I had one of two things happen. 
I somehow had a predisposition toward mental illness which had 
never shown up before, and the supplements triggered its 
appearance or the supplements actually altered my natural brain 
activity and caused me to have symptoms similar to bipolar 
illness. Either conclusion is scary.
    I know for a fact I am not alone. I have been fortunate 
enough to do some news clips and some media. It has been 
written up a few times, and I am amazed how many people 
actually see the article, make the connection of what is 
happening in their life, and they call me or it is the spouse 
of someone who calls me or it is a mother, and their daughter 
has been in the psychiatric hospital for 3 months, and she is 
just making the connection that she was taking Metabolife for 3 
months before that.
    And they are calling me looking for hope. They want to know 
what doctor I went to. They want to know how I got well, and 
they are lost. I always do my best to tell them how I got to a 
place where I could handle it and tell them to call the FDA.
    So I would like to just conclude with my thoughts on what 
would have helped. Even those extensive labeling conditions 
would not have applied to me. I was completely healthy. I had 
no preexisting conditions, and so those warning labels did not 
apply to me.
    I have seen them now in grocery stores. I did not use to 
see them so much, but now I can go to my coffee shop. They are 
all on the counters. ``Here, take this. Drink it with your 
coffee,'' you are out the door. They are everywhere.
    Before I came, I walked into a Wal-Mart and bought three 
herbal products with no posted warnings anywhere. I would 
recommend posted warnings be required, at the very least. I 
also would recommend that number, the FDA's number, be put on 
all labels of these supplements immediately. We tried to report 
it to the FDA. We got lost in the phone loop, and I do not know 
if I am part of those statistics.
    I would just like to conclude with saying that in articles 
I read, representatives for the industry repeated claim that 
cases like mine cannot be scientifically proven, and yet it is 
the industry which should have the requirement to prove that 
their products are scientifically safe. I did not abuse this 
product. I did not take more than was recommended. Until that 
can be done, and the medical communities agree, and the 
manufacturers, they both agree on some kind of safety standard, 
then I would like to see it pulled off the market.
    So please use your influence and power to make a 
difference. Thank you.
    Senator Durbin. Thank you very much, Ms. Ruiz. Dr. 
Heymsfield, thank you for joining us.
    Dr. Heymsfield. Thank you very much.
    Senator Durbin. Your testimony will be part of the record, 
and we invite you to summarize it at this point.

 TESTIMONY OF STEVEN B. HEYMSFIELD, M.D.,\1\ DEPUTY DIRECTOR, 
NEW YORK OBESITY RESEARCH CENTER, ST. LUKE'S-ROOSEVELT HOSPITAL 
CENTER, PROFESSOR OF MEDICINE, COLUMBIA UNIVERSITY, COLLEGE OF 
                    PHYSICIAN'S AND SURGEONS

    Dr. Heymsfield. Thank you very much.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Heymsfield with attachments 
appears in the Appendix on page 123.
---------------------------------------------------------------------------
    More than half of adult Americans suffer from overweight or 
obesity, and rates are skyrocketing in children and 
adolescents. Overweight and obesity are just spectrums of being 
overly fat.
    Many of those who are overweight or obese suffer from 
related illnesses such as diabetes and cardiovascular diseases. 
The obese are discriminated against in all aspects of their 
lives--social, professional, and economic. Strong societal 
forces, along with the medical establishment, encourage 
overweight Americans to lose weight. A large percentage of 
overweight and obese individuals are currently dieting for 
weight loss at any point in time, as you had mentioned earlier.
    While advances are rapid, almost breathtaking, scientists 
still do not have a complete fundamental understanding of why 
some people are prone to gain excess weight. Moreover, our 
nutritional medical treatments have limited effectiveness for 
the population as a whole. This creates a highly volatile 
combination: Tremendous consumer need and demand for weight-
loss treatments, and yet a general lack of very effective 
nutritional and medical therapies. That is a very volatile 
combination.
    The vulnerability of overweight and obese Americans to 
purchasing magic bullets or untested and unproven treatments 
has long been recognized by the FDA. The past is littered with 
unsafe weight-loss treatments ranging from nostrums in the 19th 
Century to amphetamines and Fen-Phen in the 20th Century.
    Given the millions of Americans seeking weight-loss 
treatments, some of whom harbor silent and potentially lethal 
diseases, the FDA has set in place a rigorous system for two 
types of drug approval--prescription and over-the-counter, as 
we have already heard today. A critical issue is that drugs in 
either of these categories must not only be effective, but also 
be very safe so that benefits outweigh risks. Moreover, diet 
and exercise are always considered safe and inexpensive 
alternatives to pharmacologic treatments.
    In 1994, as we know, a third category of weight-loss 
treatments emerged with the passage of DSHEA. An important 
concept inherent in the use of dietary supplements for weight 
loss is that beneficial effects would tend to be small, that 
is, less than that of a potent drug, and that by virtue of 
their presence in foods or herbs ingested by millions of humans 
over many, many centuries, they are inherently safe.
    The very stringent safety and effectiveness standards set 
for weight-loss drugs by the FDA should, in theory, therefore, 
not need to apply to products marketed under DSHEA. Most 
overweight consumers view dietary supplements, as Ms. Ruiz told 
us, often consisting of herbs and other natural ingredients, as 
inherently safe.
    As we will see shortly, this regulatory position opened the 
window for the marketing of ineffective and/or unsafe products 
to highly vulnerable populations. The available dietary 
supplements for weight loss purportedly suppress appetite, 
decrease hunger, limit nutrient absorption, alter the 
partitioning of fat and muscle or speed up metabolism.
    Claims are that chitosan reduces fat absorption and 
promotes weight loss. Hydroxy citric acid, also known as 
garcina cambogia, blocks fat storage. Ma huang or ephedra 
suppresses appetite while speeding up metabolism, and chromium 
picolinate promotes muscle over fat formation.
    Whether or not these dietary supplements work as proposed, 
to a large extent, remains uncertain. We lack adequate numbers 
or rigorous, mechanistic studies, and the benchmark for 
effectiveness, randomized, double-blind controlled trials.
    To highlight the current concerns related to dietary 
supplements for weight loss, we can look at two groups of 
compounds, one that is inherently safe, but appears to be 
ineffective so far, and the other that is modestly effective, 
but appears to be inherently unsafe.
    Garcinia cambogia, also known as hydroxy citric acid or 
HCA, is found widely in dietary supplements for weight loss and 
purportedly blocks the synthesis of body fat. However, our 
group, and no other scientist so far, have shown in well-
designed clinical trials that HCA either promotes meaningful, 
long-term weight loss or reduces body fat beyond that of a 
placebo or dummy pill.
    HCA has very minimal side effects, and the risk to 
consumers of ingesting these products appears to be negligible. 
The real risk is to bypass a medical evaluation that might 
detect an underlying serious, and even life-threatening, 
medical condition.
    The second example is based on the family of compounds that 
we have been discussing today that are extracted from plants 
referred to as ma huang or ephedra. Dietary supplements with 
ephedra are widely used by consumers for weight loss and to 
enhance athletic performance.
    Ephedra alkaloids include ephedrine, the main ingredient in 
small amounts of pseudoephedrine, phenylpropanolamine, and 
other related molecules. Phenylpropanolamine or PPA was widely 
used in over-the-counter weight-loss products until recently 
when a commission study supported a significant link between 
hemorrhagic strokes and PPA.
    As shown in the figure, which you can see up there, 
ephedrine and PPA bear strong structural similarities to 
amphetamines. Amphetamines were marketed for weight control 
beginning in the 1950's, but were addicting, had other serious 
medical side effects and were ultimately restricted by the FDA 
for weight-loss treatment. I should add, in the 1950's, I was 
told that there were very clean homes in the United States 
because amphetamines were strong stimulants, and we have heard 
from Ms. Ruiz, a very similar story about ephedra.
    Most of the evidence we have so far is that ephedra 
alkaloids, notably ephedrine, act in the body in a manner 
nearly identical to that of the synthetic drug ephedrine. 
Dietary supplements with ephedra are usually sold in 
combination with an herbal source of caffeine. Caffeine, also a 
stimulant, amplifies the actions of ephedrine in the body.
    The ephedra alkaloids and amphetamines are similar to the 
natural ``fight and flight'' hormone adrenaline. Like 
adrenalin, ephedrine speeds the heartbeat, increases blood 
pressure and stimulates respiration. These agents, their 
actions well understood at the molecular level, are termed 
sympathomimetics, and their actions center both in the brain 
and peripheral tissues.
    Most of the high-quality research in this area was carried 
out using synthetic sources of ephedrine and caffeine in 
Europe, where the combination is usually used under medical 
supervision. Studies of dietary supplements with ma huang or 
ephedra are limited to short-term evaluations, usually less 
than 6 months. These studies, including some that I have 
participated in, reveal to us that ephedra with caffeine or 
dietary supplement counterparts produced a modest weight loss 
above that of placebo by roughly 2 pounds per month. These 
trials also reveal the expected stimulant effects of ephedra, 
palpitations, jitteriness and blood pressure elevations, to 
name a few. In our own study at the New York Obesity Research 
Center, an inordinate number of subjects dropped out of the 
protocol due to these stimulant side effects.
    Although no heart attacks or strokes were reported in any 
of the previous controlled trials, we need to recognize that 
subjects are carefully screened. Those very individuals who 
harbor serious illnesses are usually eliminated from the study 
beforehand so as not to place them at risk. The subjects in 
these studies, thus, do not represent the consumer population. 
They are healthier.
    Also, rare side effects would likely not be observed in the 
clinical trials that collectively to date have studied fewer 
than a thousand subjects.
    While clinical trials confirmed the stimulant effects of 
ephedrine-caffeine combinations, the real safety concern comes 
from the untoward effects reported by individual consumers, 
like Ms. Ruiz, or their families to the FDA and from cases 
reported in the medical literature. While causality is hard to 
establish in many of these cases, we have strong evidence of an 
association between ephedra use for weight loss or physical 
activity enhancement and strokes, heart attacks and death.
    Most of the individuals in these reported and analyzed 
cases were not taking excessive or inordinate amounts of 
product. These injuries are a predictable outcome of the known 
physiological actions of sympathomimetic agents such as ephedra 
alkaloids. These are not weakly effective agents to which 
humans have been exposed for thousands of years in the food 
supply.
    As DSHEA now exists, the vulnerable, overweight and obese 
American public is exposed to an unfiltered and seemingly 
endless source of dietary supplements of questionable safety 
and effectiveness.
    I implore you and other Federal officials to appropriately 
and ethically tighten this law.
    Senator Durbin. Thank you, Dr. Heymsfield.
    As I mentioned at the outset of this hearing, there are a 
series of votes that are now underway, and I have a few minutes 
to get to the floor for the first of four. It could take 45 
minutes before all of those votes are completed. I assure you I 
will return just as quickly as I can, but the hearing will 
stand in recess until the call of the Chair.
    [Recess.]
    Senator Durbin. My apologies to everyone for the lengthy 
recess, but we had four votes, and on the Senate floor that can 
take some time.
    I believe that the next witness is Mr. McGuffin. Please 
proceed.

 TESTIMONY OF MICHAEL McGUFFIN,\1\ PRESIDENT, AMERICAN HERBAL 
      PRODUCTS ASSOCIATION (AHPA), SILVER SPRING, MARYLAND

    Mr. McGuffin. Thank you. Good, I guess it is afternoon now, 
and thank you for inviting me to testify here today. My name is 
Michael McGuffin, and I am President of the American Herbal 
Products Association or AHPA.
---------------------------------------------------------------------------
    \1\ The questions and answers included in the prepared statement of 
Mr. McGuffin from AHPA appears in the Appendix on page 139.
---------------------------------------------------------------------------
    Prior to this hearing, this Subcommittee asked AHPA to 
provide responses to eight questions related to dietary 
supplements, and I do ask that AHPA's written responses be 
entered into the record.
    Senator Durbin. Without objection.
    Mr. McGruffin. Six of the questions were directed to 
industry practices and self-regulation. AHPA has been actively 
involved in such efforts, and I want to describe two of them.
    Many of our earliest self-regulatory efforts relate to 
herbs that must be used with caution. AHPA established several 
trade recommendations, and those also are in my written 
testimony. One example of these self-regulations is AHPA's 
policy on ephedra.
    In 1994, AHPA established a label policy that ephedra 
products are not for use by children and that provides cautions 
for certain populations with preexisting conditions such as 
high blood pressure or diabetes. We revised this policy in 1995 
to recommend dosage limits.
    AHPA testified before FDA's Food Advisory Committee in both 
1995 and 1996 and told them of our policies and urged them to 
recommend that FDA adopt them. In the meantime, the AHPA 
labeling has been adopted in several States.
    In 1997, FDA proposed ephedra labeling and dosage limits, a 
proposal that was controversial and has, for the most part, 
been withdrawn. In May 1999, AHPA and other trade associations 
again recommended that AHPA's labeling and dosage guidance be 
adopted by FDA. This was repeated in October 2000 in the form 
of a citizen petition. There has been no action on the citizen 
petition, but the Department of Health and Human Services 
issued a statement last month regarding ephedra, and Mr. Levitt 
referred to that. The language that Mr. Levitt read very much 
models the industry labeling language as important information 
for consumers.
    I want to give another example of AHPA's self-regulation 
that occurred in 1992, when we published a document called 
``Herbs of Commerce'' to establish a single standardized common 
name for each of nearly 600 herbs. This was done to address 
potential consumer confusion because of the many different ways 
herbs are named.
    In 1997, the Food and Drug Administration incorporated 
Herbs of Commerce into the Code of Federal Regulations so that 
the names established by AHPA now have the force of law. FDA's 
adoption of AHPA's Herbs of Commerce is an example of how 
government and consumers can benefit from industry's self-
regulatory activities. The handling of the ephedra issue shows 
what can happen when positions become entrenched.
    While there have been differences of opinion over the label 
language, these have been minor, and the principal 
controversies have been over dosage levels. Stepping back from 
the fray, I believe consumers would have been better served if 
FDA had promptly sought labeling while addressing dosage issues 
at a later date.
    I want to address the common misperception that dietary 
supplements are unregulated. In fact the law requires dietary 
supplements to meet label claims, and these laws empower FDA to 
take enforcement action if a product fails to do so.
    The law requires all dietary supplement labeling and 
advertising to be truthful and not misleading, and these laws 
provide FDA and the Federal Trade Commission with authority to 
enforce them.
    The law places the responsibility for product safety 
squarely on the manufacturer, and it is a crime to introduce an 
adulterated product into the market.
    AHPA believes that there is not enough FDA enforcement of 
the law and that the Agency's priorities are sometimes ill 
advised. When FDA does send warning letters, they are seldom 
followed up with more aggressive enforcement when companies are 
not responsive. We have joined with other trade groups to 
successfully recommend an increase in FDA dietary supplement 
enforcement funding. I must say it is difficult for trade 
groups to urge members' compliance, when those members must 
confront unfair and unlawful competition on a day-to-day basis 
and not see FDA enforcing the law. It is time to see FDA take 
full responsibility for the implementation and enforcement of a 
law that is almost a decade old.
    Let me close by saying that we are an industry that is 
committed to providing benefits to American consumers through 
our products, including products for those who are overweight 
at a time that the medical community has declared an epidemic 
of overweight in our country. ``When Diets Turn Deadly'' is a 
sensational title for today's hearing, and perhaps it evolves 
from recent history, not just in our industry, but also with 
drugs and problems in other countries.
    The title is not, however, substantiated by any balanced, 
unbiased and thorough review of the body of science and 
experience for any of the dietary supplement agreements that 
are broadly available in the market, and that are manufactured, 
labeled and consumed according to established industry 
policies.
    Thank you very much.
    Senator Durbin. Thank you, Mr. McGuffin. Ms. Culmo.

 TESTIMONY OF CYNTHIA T. CULMO, R.Ph.,\1\ CHAIRPERSON, DRUGS, 
DEVICES, AND COSMETICS COMMITTEE, ASSOCIATION OF FOOD AND DRUG 
                    OFFICIALS, AUSTIN, TEXAS

    Ms. Culmo. Good afternoon. I am Cynthia Culmo. I am here as 
the chairperson for the Drugs, Devices and Cosmetics Committee 
with the Association of Food and Drug Officials. The points 
that I am making, as well as those in my written comments, are 
a compilation of comments that were submitted from multiple-
State AFDO members. For the complete version of our position, 
please refer to those written comments.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Culmo with attachments appears in 
the Appendix on page 160.
---------------------------------------------------------------------------
    We thank you, Mr. Chairman, for the opportunity to 
participate in this important and critical discussion. It is 
extremely difficult to roll in 8 years of experience, knowledge 
and information into 5 minutes, but for time's sake, I will try 
and summarize most of our concerning points.
    There have been more serious adverse-event reports for 
dietary supplements containing ephedrine alkaloids than for any 
other type of dietary supplement or over-the-counter 
phenylpropanolamine drug products, which were recently 
withdrawn from all U.S. markets due to the increased risk of 
hemorrhagic stroke in young women.
    These serious adverse-event reports included psychoses, 
seizures, strokes, heart attacks, and death. These are known 
and expected consequences on the use of ephedrine. 
Pharmacologically, as what has been discussed, in the body 
there is no difference between natural and synthetic ephedrine. 
They act the same in the body.
    By regulation, drug products containing ephedrine cannot be 
combined with other stimulants. This is based upon the 
potential for abuse and safety concerns. However, currently 
marketed dietary supplements for weight loss do contain 
ephedrine plus other stimulants.
    Almost all of the products on the market are multi-
ingredient products. They are ephedrine combined with other 
stimulants, diuretics, laxatives and other active ingredients. 
This explains the high number of adverse-event reports for 
these products.
    You can see how well it is demonstrated--I believe the 
chart is up \1\--in the American Association of Poison Control 
Center data, as shown on this table, how the incidence of 
adverse-event reports has increased since the Dietary 
Supplement Health and Education Act.
---------------------------------------------------------------------------
    \1\ The chart appears in the Appendix on page 173.
---------------------------------------------------------------------------
    These multi ingredients can interact with each other, with 
other products, being drugs and/or foods, and there are drug 
disease interactions. Studies are beginning to identify these 
complex interactions, which have definite effects on the safety 
of the products.
    These products are also marketed for a disease--obesity. 
Although the industry routinely claims that their products are 
not drugs, they are posed to the consumer as drug products by 
their claims, the manner that they are advertised, as many of 
them are advertised in the Physician's Desk Reference for 
Nonprescription Drugs and Dietary Supplements now, as well as 
the way that the information is shared with health 
professionals and other consumer information, all of which 
results in misled consumers and medical professionals.
    The studies that industry uses to support safety comes from 
foreign data on prescription drugs, using pharmaceutical 
ephedrine. None of these studies can be used to support the 
safety of dietary supplements. These products are not the same. 
There are numerous methodology problems with the relative few 
studies in the United States, which include, one, being too 
small; they are not using the marketed products. For instance, 
the industry-touted Boozer study, the 6-month study, it did not 
use Metabolife 356 as that company elaborates. So the results 
of these studies cannot be applied to the general population 
for weight loss.
    DSHEA shifted the requirements proving a product is unsafe 
to the government. Many States have picked up this tremendous 
burden because of the apparent inability of the Federal 
Government to effectively address safety issues associated with 
these products.
    The enforcement actions by the States are labor- and time-
intensive. They are done with great difficulty and fierce 
battles with the industry and their political supporters. 
Politics and bureaucratic entanglements have prevented FDA and 
FTC from accomplishing their responsibilities.
    Under DSHEA, safety is addressed after the harm has already 
occurred. The standards and the criteria of safety have never 
been defined by FDA or the courts. A major question that is yet 
to be answered is what is questionable or unreasonable risk 
that causes a product to be adulterated?
    The most egregious safety problems with the dietary 
supplement for weight loss are the products containing 
ephedrine. The situation is not a scientific issue any longer. 
It is a political issue run by a political agenda. There are 
ongoing conflicts between good public health and the industry's 
economic needs, with politics frequently serving as the 
referee.
    Consumers are being misled, and they are not getting the 
full story about the risk associated with these products. They 
cannot make an informed decision about appropriate use. So 
labeling and warnings cannot solve safety issues. The warnings 
and the labels will not help when you do not know you have a 
condition that places you at increased risk.
    This has been our most concerning point, and please refer 
to our written comments for a complete summary. But as you can 
see, the States have indicated that there are numerous problems 
associated with dietary supplements for weight loss, and they 
have recommended a number of solutions:
    Except for traditional nutrients, such as vitamins, 
minerals, etc., prohibit or limit botanicals and other natural 
products to a single ingredient. I am sure that has made 
several in the room gasp, but this is exactly what Health 
Canada has done with ephedra. If you are going to retain a 
combination of products as a dietary supplement, then they 
should be required to have premarket review for safety;
    Require manufacturers and distributors to register with the 
FDA and to list their products. This will enable FDA to develop 
appropriate product databases, to evaluate the product adverse-
event reports, and the interactions;
    Institute mandatory adverse-event reporting, which is 
analogous to what is required for drugs, biologics, and medical 
devices;
    Implement a single adverse-event reporting system within 
FDA;
    Adverse-event report evaluations and risk management is 
best directed by the regulatory agencies. Therefore, 
communications and interactions should be enhanced between 
State and Federal agencies and the general public;
    Define the criteria for the DSHEA standard of significant 
or unreasonable risk. What is the standard to prove a product 
is unsafe? From a science perspective, if what is currently 
known about ephedra supplements cannot meet the standard, 
nothing else ever will;
    Create a specific center within FDA for traditional 
medicines and dietary supplements for the regulatory oversight;
    And last, and certainly not least, appropriate funding is 
necessary for all of the above.
    In conclusion, we appreciate this opportunity to provide 
you with our comments. AFDO believes that products current 
marketed as dietary supplements for weight-loss purposes are 
either not safe or are of unknown safety, and the public health 
is not being adequately protected. Thank you very much.
    Senator Durbin. Thank you very much, Ms. Culmo.
    Mrs. Ruiz, have you encountered individuals who continued 
to use these weight-loss supplements even though they told you 
they had had some bad side effects?
    Ms. Ruiz. Actually, yes, and the reason for that is because 
they do not attribute the supplements to the problem.
    I have been in contact with one family and he was training 
as an athlete. He was taking a product he bought at a bicycle 
shop. And when he had heart palpitations, (he was running), 
they took him to the hospital. They told him he was low on 
electrolytes, so he went home and took more of the product to 
help with his electrolytes. He then had a full-blown psychosis 
after that.
    So usually they do, but because they do not know it is 
causing the problem.
    Senator Durbin. Can you tell me how many individuals you 
estimate you have spoken to who have had negative experiences 
with ephedra-based dietary supplements?
    Ms. Ruiz. Over the last 6 years, I have probably spoken 
with 10 very serious cases, and then quite a few individuals on 
a daily basis. I spoke at one recovery group with about 100 
individuals in the room, and they were recovering from all 
kinds of things. I was talking about bipolar specifically, but 
I had talked about what triggered the event. After that 
meeting, I had six or seven different individuals come up to me 
who were dealing with depression, dealing with psychosis 
issues, and they were like, ``I was taking this product and 
this product. And does this have ephedra in it?''
    And all of them I was like, ``Yep, yep, yep.'' I was 
amazed.
    And then when I go to talk with my psychiatrist. (I have to 
see him for regular check-ups.) He explains how now he always 
asks more questions of new patients. Instead of just, ``Are you 
on any prescriptions or illegal substances,'' now he goes 
beyond, and he says, ``Are you taking any supplements, any 
vitamins? Have you been doing anything new lately?'' And what 
he usually uncovers is that there is this supplement they have 
started. They think they are taking a vitamin but he has them 
bring them in. His cupboards are packed with Xenadrine and 
Metabolife, and Pure Ephedrene from GNC. And he is amazed how 
many people come in to see him.
    So it is a daily thing for me to run into people like this.
    Senator Durbin. Dr. Heymsfield, have you had any patients 
in your practice who have had problems with dietary 
supplements?
    Dr. Heymsfield. Well, I have, particularly in the studies 
that we have done. When people go through the protocols, we 
have found that a number of them get side effects--jitteriness, 
headaches, palpitations, elevations in blood pressure. And when 
we take them off the study and break the code, we find that 
invariably they are on the active treatment which are ephedra 
alkaloids.
    Senator Durbin. We talked a little bit, Ms. Culmo spoke a 
little bit about combinations, and it appears that, unlike many 
products, some of these dietary supplements and herbal products 
have a range of different drugs in botanical form that are 
combined into these supplements. What kind of challenge does 
this create?
    Dr. Heymsfield. Well, it creates a number of challenges. 
First, those combinations usually amplify one another, so the 
effects can be fairly potent. Also, in the case of caffeine, 
many people continue to ingest caffeine in their daily lives 
out of colas, coffee, teas, and so on. So they can get a very 
high dose of caffeine. That amplifies the actions of ephedra 
alkaloids.
    But the real challenge is we do not know how to assess the 
safety and efficacy of these combinations because they are so 
variable. One product might have a lot of one component and 
less of another, so it is virtually impossible to make global 
statements about the efficacy and safety of products as a whole 
because they are so variable in these combinations.
    Senator Durbin. As Ms. Culmo said, whether it is synthetic 
or botanical, it is still the drug that is being ingested into 
your system with the drug's impact.
    Dr. Heymsfield. Your body does not really know the source 
of where that molecule came from. It sees ephedrine, as either 
a botanical or a synthetic component, is identical.
    Senator Durbin. I guess it bears repeating that under the 
law we treat that entirely differently.
    Dr. Heymsfield. That is right.
    Senator Durbin. Whether you are dealing with a synthetic 
that is being prescribed or over-the-counter, it is subject to 
strict regulation in terms of how it is manufactured, how it is 
marketed, the quality of the drug, the dosage, the warnings, 
they are extensive. On the supplement side, there is very 
little, if any, regulation, in terms of those elements as I see 
them.
    Now I would like to address the issue that Mr. McGuffin has 
raised. He has taken issue with my reference to the fact that 
the title of this hearing is ``When Diets Turn Deadly.'' That 
was based on the Canadian situation where, in fact, they warned 
the people of Canada of possible fatal effects of these 
ephedrine dietary supplements, and so the title was chosen 
based on the experience of Canada.
    Do you have any knowledge or any impression of this 
Canadian decision relative to these products, Dr. Heymsfield?
    Dr. Heymsfield. Do I have an opinion?
    Senator Durbin. Any knowledge or impression of this 
Canadian decision.
    Dr. Heymsfield. No, I do not, but it seems very well-
founded, in my personal opinion, and it would seem, based on 
the same literature that I have reviewed, in the United States 
there have been a number of studies in very prominent journals 
showing the very high risk of ephedra alkaloids and ephedrine.
    Senator Durbin. The Canadians came to the conclusion that 
these products pose a significant threat of danger to the 
public health of their citizens. Do you believe that these 
products for sale in the United States pose a significant 
threat of danger to public health?
    Dr. Heymsfield. I do, and I will tell you why I feel that 
way, and that is because many of the people who take these 
products are just like Mrs. Ruiz, who do not really read the 
labels carefully, who harbor silent diseases, and that can be 
triggered by ingestion of these products. So I think it poses a 
very significant risk to people.
    Senator Durbin. Before asking Mr. McGuffin, I am going to 
ask the same question of Ms. Culmo. Do you feel, as a 
registered pharmacist, that these ephedra-based dietary 
supplements pose a significant threat of danger to the health 
of American citizens?
    Ms. Culmo. Yes, definitely, and I believe the association 
would support the position as well. We are of the opinion that 
the evidence is there. The data and the information is 
available, and it is a conclusion that has been made by our 
association several times.
    We would also venture to say that your title, ``When Diets 
Turn Deadly,'' is appropriate, as I am sure that the families 
of the 100-plus people that allegedly died due to the 
association of these products supports the position that Canada 
took as well.
    Senator Durbin. Mr. McGuffin, I am not going to back off 
the title of this hearing. I think, based on what you have just 
heard from witnesses sitting on either side of you, and based 
on the decision of Canada, based on the letter you sent to the 
American Medical Association and the Food and Drug 
Administration, this is not a casual or minor problem. It is 
life-threatening in many instances.
    Mrs. Ruiz was lucky enough to survive the situation. Thank 
goodness you are here today, and raising your family, and doing 
well. Hers was a terrible episode, but she survived it.
    You have talked to me about industry standards. These are 
voluntary standards, are they not, within your industry?
    Mr. McGuffin. They are today. We have asked that they 
become the law.
    Senator Durbin. And those companies which market these 
products and do not belong to your association or do not 
subscribe to these standards may ignore completely the dosage 
requirements, the warning labels, the marketing, trying to keep 
these out of the hands of children; is that not true?
    Mr. McGuffin. It is true. We believe we have had an 
influence beyond our membership, but you know we have seen 
examples here today of products that would not conform with the 
labeling recommendations of our trade.
    Senator Durbin. Well, it strikes me that we are in a 
situation which is very strange, where your industry is coming 
forward and saying to the government, ``Regulate us more. We 
want more regulation.''
    Mr. McGuffin. Enforce these regulations.
    Senator Durbin. I think that is certainly overdue--8 years 
overdue. But before we reach that question of how we properly 
regulate these products so they are available, we have to ask, 
and answer, the threshold question, are they safe, and if they 
are not safe, there is no amount of regulation that could 
really cure the problem.
    I guess that is a question I would ask, let us start with 
Dr. Heymsfield. In terms of dosage, there seems to be a wide 
variance of opinion here. The Canadians limit it to 32 
milligrams a day. We hear 100 milligrams a day from many people 
in the dietary supplement industry.
    You have done some studies on this subject. What can you 
tell me about dosage levels?
    Dr. Heymsfield. Well, the dosage levels that we used in our 
studies were those that are commonly used in these products as 
a whole, and certainly at those levels I would not say that we 
could assert these products are safe. The question of whether 
or not they might be safer at lower doses would have to be 
studied, and I have questions about that for the following 
reason, and that is if you lower the dose far enough, then you 
reduce the efficacy, the weight-loss efficacy, to the point 
where it would hardly be worth taking it. So I have questions 
about whether or not a dose reduction would totally solve the 
problem.
    Senator Durbin. So, if I were asking you to establish, 
based on a reasonable degree of medical certainty, as they say, 
a safe dosing regimen for a dietary supplement that still would 
provide the benefit of suppressed appetite, increased energy, 
are you saying that you would have a tough time finding that 
number?
    Dr. Heymsfield. A very hard time finding that number 
because when you got down to the levels I am hearing, the 
numbers I am hearing, you would get virtually negligible weight 
loss. The weight loss effects of ephedra alkaloids are already 
only two pounds a month at the current dosage, which I think is 
unsafe. If you, say, cut the dose in half or a third, you would 
almost wonder why you would want to take the drug, which is 
what I will call it.
    Senator Durbin. This is obviously a question which 
Secretary Thompson and the FDA has to resolve, whether on a 
public benefit basis, the risk that you are encountering is 
worth the benefit. If you can lose a pound a month or two 
pounds a month--is that based on some study, incidently, that 
two pounds a month that you have come with?
    Dr. Heymsfield. Well, there are growing numbers of 
collective analyses called, meta-alyses, that are looking at 
the efficacy of ephedra products, and the trend that I am 
seeing, including the studies we have done at our center, are 
in the range of about two pounds a month, and that varies a 
little. If you add the caffeine, you get a bit more.
    Senator Durbin. Of course, according to the Canadian 
standard, adding a stimulant or an analgesic, I think there has 
been some evidence that adding aspirin or some other form of 
analgesic could also create some complications with ephedra.
    Dr. Heymsfield. That is correct.
    Senator Durbin. Mr. McGuffin, you said that what you are 
looking for is a balanced, unbiased, and thorough review. Do 
you feel that Canada made a balanced, unbiased, and thorough 
review of dietary supplements that contain ephedrine?
    Mr. McGuffin. No, I do not, because my understanding is 
that the Canadian rule was based on the FDA proposal, which was 
based on Adverse Event Reports, and as the GAO has told us, 
they do not believe that that is a good way to get to a dosage 
recommendation.
    I am concerned. If I can, I would like to repeat something 
that Mr. Levitt said earlier. He said that there is not a 
consensus on the meaning of the adverse event data that is as 
clear as you have described, sir; that it is not a black-and-
white that we know that there is--that these adverse events 
point out a danger, and I think that it is important to 
remember that, and I am concerned that some of the information 
is not included.
    If I may, I would like to ask that two other documents be 
entered into the record.\1\
---------------------------------------------------------------------------
    \1\ The information submitted by Mr. McGuffin appear in the 
Appendix on pages 146 and 157 respectively.
---------------------------------------------------------------------------
    Senator Durbin. Without objection, certainly, it will be.
    Mr. McGuffin. There is a report called the ``Safety 
Assessment and Determination of a Tolerable Upper Limit for 
Ephedra'' that was prepared for the Council for Responsible 
Nutrition by Cantox Health Sciences International and published 
in December 2000, that came to a conclusion that a dosage of 25 
milligrams per serving and 90 milligrams per day is safe when 
used in accordance with standard industry labeling.
    And there is a compilation of documents, comments of the 
expert panel of the Ephedra Education Council on the Safety of 
Dietary Supplements Containing Ephedrine Alkaloids, and it goes 
on for another two lines. This was presented in April 2000 at 
the hearing at the Office of Women's Health.
    I think it is that document or these documents that Mr. 
Levitt was referring to, when we do not have a clear consensus. 
I appreciate greatly what these two scientists to either side 
of me are saying, and I do not believe any of us say that their 
points of view are crazy or unfounded, but there is not a 
consensus. There are other scientists who look at the same data 
and come to remarkably different conclusions by a very 
sophisticated scientific process, and that needs to be 
considered.
    Senator Durbin. I will readily concede that there are areas 
of science that are not precise. Certainly, political science 
is not precise. [Laughter.]
    Mr. McGuffin. Did you win all four votes? [Laughter.]
    Senator Durbin. But I can tell you this, I have spent a 
career on this Hill listening to the scientific analyses of the 
tobacco companies. They always found a doctor, they always 
found a scientist who could just prove to you that it could not 
possibly cause heart disease, and cancer, and stroke and all of 
the rest.
    And so I think what we have to do is ask what is a 
reasonable scientific basis acknowledged by most, if not all, 
to base our conclusions.
    I am troubled by the adverse event reporting that we heard 
of earlier. To think how few, some estimate that only 1 percent 
of the adverse events relating to dietary supplements ever 
reach the FDA, and you heard the examples of the Poison Control 
Centers. Ms. Culmo made that point as well. In 1 year they had 
13,000 reported events, and in that same year, fewer than 500 
were reported to the FDA.
    That suggests to me, Mr. McGuffin, that you cannot really 
get into the circular argument of the FDA that we would really 
like to establish standards, but we need more adverse events 
reported to do that. We do not have enough adverse events 
reported, and therefore there will be no standards. Meanwhile, 
we seem to be, as we stand here, watching group after group, 
State after State, organization after organization, and now 
countries saying the United States is completely out of control 
here.
    Mr. McGuffin. Again, we have assisted many of those States 
in adopting our policy. You pointed out 21 States. I was not 
aware of that many, but we worked hard in several States to 
assist a process that would put our recommended labeling and 
dosage limit in place and make it the law in those States. We 
are very supportive of that.
    Senator Durbin. Was that part of your effort recently in 
Texas?
    Mr. McGuffin. We were involved in the communication with 
Texas. We were concerned, at least an initial stage, on the 
inclusion of the 800 number because we think that system needs 
to be patched up some. There are problems with the system, but 
we were involved in that, and their warning label is very 
similar to the one that we have been using for some years.
    Senator Durbin. You have all been very patient, but I want 
to conclude the hearing, if I can, by asking an open-ended 
question.
    It strikes me that we have two extremes here in terms of 
Federal regulation. We have the regulation of drugs, which 
clearly involves extensive testing and determination of safety 
and efficacy before it can ever be sold in the United States. 
Then it is sold only with a doctor's supervision, by his 
prescription, her prescription, and of course dosage and 
everything is being carefully monitored.
    Circulars are sent to the doctors, to the pharmacy with all 
sorts of information. Ms. Culmo, I bet you are called on from 
time-to-time by patients who say, ``Look at all of these 
medicines I am taking. Do they work together?'' That is part of 
the people in pharmacology.
    So we have a very thorough system of regulation, approval 
and monitoring when it comes to drugs.
    Then, when we get into the supplements and food area, it is 
totally the opposite, where you have a situation where the 
company that makes the product decides what to put in it, the 
manufacturing practices to follow, in terms of making certain 
that it is unadulterated and is what it says on the label, the 
representations on the label have to stand some tests, at least 
by the Federal Trade Commission, maybe by the FDA. Ultimately, 
the whole question of dosage and warning labels is still 
voluntary. The adverse event reporting, still completely 
voluntary on the part of the manufacturer. So we have this wide 
chasm between these two approaches.
    It strikes me that most people would concede that when it 
comes to basic things like Vitamin C, and folic acid, that this 
supplement in food approach is not to be quarreled with. I 
mean, we are talking about something that is fundamentally 
safe. You would have to have hyper dosages to have very bad 
results. But now we have got a middle category. We have a 
middle category of supplements that are combinations of 
naturally occurring chemicals that are life-threatening, in 
some instances, and certainly can create terrible medical 
situations. I think Congress has defined the extremes, and now 
has to come to the center.
    I would like to ask you, Dr. Heymsfield, do we need to come 
up with a new regimen of regulation for supplements, let us 
start with dietary supplements, that perhaps does not go as far 
as drugs, but takes us forward in terms of protecting American 
consumers?
    Dr. Heymsfield. Well, for one thing, we might consider 
changing the name. Dietary supplement certainly gives the 
impression that it is something normally in the diet or that it 
is supplementing something normally in the diet. If products 
are specifically, say, for body building, and they are anabolic 
steroid derivatives or if they are for weight loss and they are 
ephedra alkaloids, we might want to name them a little more 
specifically so consumers really understand what they are 
getting.
    I also feel strongly that these regulations should be 
tightened and that we should have much clearer guidelines for 
safety and efficacy of these products, and we should seek 
experts out like National Academy of Sciences and other 
esteemed bodies that can help us with these.
    Senator Durbin. Ms. Culmo, what is your feeling about 
establishing some new category of regulation?
    Ms. Culmo. Well, I believe that was part of our position 
through our comments. I think it is also evidence from what 
other countries do. The industry here is pretty quick to point 
out that these are dietary supplements that have been used for 
thousands of years in other countries, are currently used in 
other countries, when the truth of the matter is they are 
actually addressed more commonly as prescription drugs or 
prescription products in these countries, and the traditional 
use is very different from what the commercialized use is right 
now.
    So, definitely, it needs to be changed.
    Senator Durbin. Mr. McGuffin, what is your reaction?
    Mr. McGuffin. I would be very troubled by the idea of 
creating a new regulatory category as much as anything because, 
as you have pointed out, it is 8 years in, and we have not 
figured out how to properly implement this one.
    You have heard my testimony. What we believe needs to occur 
is that the current law needs to be enforced. There may be some 
refinements that would be appropriate for discussion. But the 
idea of just wholesale starting a new category, just off the 
top of my head here, sir, with no consultation with any of my 
Members, concerns me.
    Senator Durbin. I would say to you that you can argue that 
if the current law were properly funded and enforced, we might 
not be facing the problems we are today. The fact is that the 
government has not met its obligation and, as Ms. Culmo has 
suggested, there has been extraordinary political involvement 
in terms of decisionmaking when it comes to dietary 
supplements. That is a fact of political life.
    I have been around here 20 years. The reaction to this 
hearing on Capitol Hill, and off Capitol Hill, has been 
stronger than virtually any issue I have raised, including my 
hearings on tobacco. So I know that there are a lot of strongly 
held views by consumers, as well as the representatives of the 
industry in this town.
    But I honestly believe that we have to come up with a 
better answer. I do not think what we have today is adequate. 
The first thing that we have to do is establish whether these 
products are safe, and if they are not safe, then, frankly, 
that is the end of the story, as far as I am concerned.
    I am going to be calling on the Department of Health and 
Human Services and the Food and Drug Administration to make a 
timely determination whether the continued sale of dietary 
supplements containing ephedra create an imminent hazard to 
public health in our Nation, and if such a determination is 
made, whether the sale of these products should be restricted 
or regulated to protect consumers.
    I am also going to work on legislation to develop a 
commission for a scientific study to conclusively address the 
question of the safety of dietary supplements. I believe, as 
well, that we need to establish an effective mechanism for 
banning the sale of dietary supplemental products, particularly 
ephedra and ephedrine-containing supplements to minors. We 
should draw this line and draw it clearly.
    I want to work as well with consumers, industry and Federal 
agencies to establish a mandatory--mandatory--Adverse Event 
Reporting System that will effectively inform the FDA, 
consumers, companies and health care professionals when 
dangerous products have been identified.
    I believe we should modify the current definition of 
dietary supplement categories so as to highlight the difference 
between vitamins and minerals, potent herbal products that act 
like drugs, and animal derivatives, as well as exclude steroid 
precursors, like andro, from the dietary supplement category.
    I am going to press the FDA for the immediate release of 
good manufacturing practices and pursue with the Federal Trade 
Commission ways to further their efforts to eliminate deceptive 
supplement marketing claims.
    I would like to close this hearing by thanking this panel 
for your cooperation and your patience as I went off to vote. I 
want to particularly thank my staff that has been involved in 
this, Dr. Melanie Leitner, a congressional science policy 
fellow, who has worked harder on this than anybody on my staff. 
Thank you, Melanie, for all you have done.
    Anne Marie Murphy, Brian McLaughlin, Tom Faletti, Emily 
Kirk, Joe Shoemaker, Maria Domanskis, Marianne Upton, and a 
team of intrepid interns, thank you all very much for this 
hearing.
    [Whereupon, at 1:18 p.m., the Subcommittee was adjourned.]


                            A P P E N D I X

                              ----------                              


            PREPARED OPENING STATEMENT OF SENATOR VOINOVICH
    Good morning, and thank you Mr. Chairman for holding this hearing 
on this topic which directly impacts the lives of millions of 
Americans.
    While Governor of Ohio, I signed the first law in the Nation 
establishing a balanced and fair approach to the sale of ephedra. Since 
then, other States have passed similar laws, including Hawaii, 
Michigan, Nebraska, and Washington. In 2000 California passed a similar 
law, but Governor Grey Davis vetoed the measure because he believed 
that the Federal Government should set the standard.
    It is my understanding that although the FDA is required by a 1994 
law to issue Good Manufacturing Practice (GMP) standards for the 
supplements industry; the agency has yet to finalize these standards. 
Let me repeat that, 8 years after Congress passed the law, the FDA has 
not issued the regulations. This is an action the agency can and must 
take.
    Responsible members of this industry have actively sought 
appropriate, science-based regulation to ensure that consumers are well 
educated through factual labeling and that dietary supplements are 
manufactured in a consistent and quality manner. Additionally, industry 
has agreed to a ban on the sale of ephedra products to minors. 
Unfortunately, not all players in the market are responsible. It is 
these bad players that bring us here today.
    In our oversight role, we need to ensure that Americans are able to 
count on existing regulatory agencies to protect and promote their 
well-being. I hope the work being done by the National Institutes of 
Health, even as this hearing takes place, will help us to understand 
just where we need to go on this important issue.
    Thank you, Mr. Chairman.

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