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**DEPARTMENT OF HEALTH & HUMAN SERVICES** Public Health Service

Food and Drug Administration

Rockville MD 20857

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##### 

##### STATEMENT OF

**ROBERT E. BRACKETT, PH.D.**

**DIRECTOR**

**CENTER FOR FOOD SAFETY AND APPLIED NUTRITION**

**FOOD AND DRUG ADMINISTRATION**

**BEFORE THE**

**COMMITTEE ON GOVERNMENT REFORM**

**SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS**

**UNITED STATES HOUSE OF REPRESENTATIVES**

###### MARCH 24, 2004

[FOR RELEASE ONLY UPON DELIVERY]{.underline}

### INTRODUCTION

Thank you, Mr. Chairman for this opportunity to testify before your
Subcommittee at this hearing entitled, "Ten Years After the
Implementation of DSHEA: The Status of Dietary Supplements in the United
States."

### BACKGROUND ON REGULATION OF DIETARY SUPPLEMENTS

Many Americans take some type of dietary supplement, and in many cases,
there is either strong or suggestive evidence that many of these
vitamins and minerals and other naturally occurring products have
important health benefits. The Dietary Supplement Health and Education
Act of 1994 (DSHEA) (P.L. 103-417) amended the Federal Food, Drug, and
Cosmetic (FD&C) Act to set up a distinct regulatory framework for these
products in an attempt Number range CHAPTERto strike the right balance
between providing consumers access to dietary supplements that they may
choose to use to help maintain and improve their health, and giving the
Food and Drug Administration (FDA or the Agency) regulatory authorities
to take action against supplements or supplement ingredients that
present safety problems, have false or misleading claims, or are
otherwise adulterated or misbranded. Although dietary supplements are
regulated as foods, in that pre-market approval is not mandatory, DSHEA
and FDA's implementing regulations establish special requirements for
dietary supplements that differ in some respects from those covering
"conventional" foods, and that also differ from those that apply to drug
products (prescription and over-the-counter).

Congress defined the term "dietary supplement" as a product that, among
other things, is intended for ingestion, is intended to supplement the
diet, is labeled as a dietary supplement, is not represented as a
conventional food or as a sole item of a meal or diet, and contains a
"dietary ingredient." "Dietary ingredients" are defined as vitamins,
minerals, amino acid, herbs or other botanicals, dietary substances
(such as enzymes), and concentrates, metabolites, constituents,
extracts, or combinations of the preceding types of ingredients. Dietary
supplements may be found in many forms, such as tablets, capsules,
liquids, or bars.

**LABELING OF DIETARY SUPPLEMENTS**

Under the FD&C Act and FDA's implementing regulations, the label of a
dietary supplement must bear a statement of identity (product name) that
identifies the product as a dietary supplement; nutrition information in
the form of a Supplement Facts panel; a list of any ingredients not
listed in the Supplement Facts panel; the name and address of the
manufacturer, packager, or distributor; and the net quantity of
contents. In addition, if the labeling includes a claim to affect the
structure or function of the body, a claim of general well-being, or a
claim of a benefit related to a classical nutrient deficiency disease,
the product must bear a disclaimer stating that FDA has not evaluated
the claim and that the product is not intended to diagnose, treat, cure,
or prevent any disease. Furthermore, a manufacturer of a dietary
supplement making such a claim must have substantiation that the claim
is truthful and not misleading and must notify FDA that its product
bears such a claim within 30-days of marketing the product with the
claim.

### Dietary Supplement Safety

**[Statutory Framework]{.underline}**

As with most foods, there is no requirement for manufacturers of most
dietary supplements to provide evidence of product safety to FDA prior
to marketing. Accordingly, FDA regulates the safety of dietary
supplements primarily through a post-market evaluation of whether the
product is adulterated under one of the provisions of the FD&C Act.
However, there is a 75-day pre-market notification requirement for
manufacturers or distributors of dietary supplements that contain "new
dietary ingredients" that were not marketed in the U.S. before October
15, 1994, unless the supplement contains only ingredients that have been
present without chemical alteration in the food supply as an article
used for food. There must be a history of use or other evidence of
safety establishing that the dietary ingredient will reasonably be
expected to be safe when used as recommended in the labeling of the
supplement. In its notification to FDA, the manufacturer or distributor
of the supplement must submit information, including citation to
published articles, that forms the basis for concluding that the dietary
supplement containing the new dietary ingredient will reasonably be
expected to be safe.

# Scientific Research

In order to be informed about the safety of dietary supplements, in
addition to assessing known reported adverse events, FDA evaluates
published literature, evidence-based reports, and the known pharmacology
of a compound in order to assist in the evaluation of dietary supplement
products. Collaboration with academic centers such as the National
Center for Natural Products Research (NCNPR), Federal partners such as
the National Institutes of Health and the National Center for
Toxicological Research, and our consumer and industry stakeholders is
important in developing a comprehensive safety evaluation of dietary
supplement products. For example, the partnership that FDA has with
NCNPR at the University of Mississippi is valuable in order to find
practical solutions to practical scientific problems. For dietary
supplements containing botanical ingredients, development of such a
science-base can be especially difficult because of several unique
factors, such as the complexity of the chemicals that make up these
products and the variability between one product and another.

**[CFSAN Adverse Event Reporting System (CAERS)]{.underline}**

Adverse event reports (AERs) are an important tool for developing a
"signal" which can help FDA to identify potential safety problems with
dietary supplements. Last year, FDA's Center for Food Safety and Applied
Nutrition (CFSAN) put in place the CFSAN Adverse Event Reporting System
(CAERS) to monitor adverse event reports on CFSAN-regulated products,
i.e. food (including dietary supplements) and cosmetics. Adverse event
reporting for dietary supplements is not mandatory and consists of
voluntary reporting from industry, health care providers, and consumers.
CAERS is a computerized system that records voluntarily received reports
and separates them into product problems and adverse events. This system
started collecting reports after June 15, 2003, and unifies CFSAN's
adverse event reporting through one common portal. Future planned
capabilities include transitioning data from older systems into the
CAERS portal, developing a botanical thesaurus to enable sophisticated
search strategies, and electronic links to other databases such as
MedWatch and poison control centers.

DIETARY SUPPLEMENT CURRENT GOOD MANUFACTURING PRACTICES (CGMPs)

Under DSHEA, another important arm of FDA's regulatory and surveillance
activities used to help ensure the safety of dietary supplement products
is the Agency's authority to promulgate regulations for dietary
supplement current good manufacturing practices (CGMPs). Such
regulations will help ensure product quality and consistency. FDA
published a proposed rule for dietary supplement CGMPs on March 13,
2003, which would establish standards to ensure that dietary supplements
and dietary ingredients are not adulterated with contaminants or
impurities, and are labeled to accurately reflect the active ingredients
and other ingredients in the product.

Examples of product quality problems the proposed dietary supplement
CGMPs would help prevent are: superpotent and subpotent products, wrong
ingredients, presence of contaminants (e.g., bacteria, pesticide, glass,
and lead), under-filled containers, foreign material in a dietary
supplement container, improper packaging, and mislabeling. The
publication of the final rule on dietary supplement CGMPs remains a high
priority for FDA. A 90-day public comment period on the proposed rule
was extended 60-days and closed on August 11, 2003. During the comment
period, FDA staff participated in two outreach meetings and an
FDA-sponsored satellite downlink, as well as three outreach meetings
organized by industry groups to ensure that dietary supplement
manufacturers (especially small manufacturers) and other interested
parties were familiar with the proposal.

Due to the volume of comments and requests by commenters, FDA extended
the time period in order to receive additional public comments. We are
currently reviewing over 1600 pages of comments, which include more than
400 substantive comments that are being carefully analyzed. We plan to
publish a final rule once this evaluation is completed. We recognize the
importance of having dietary supplement CGMPs in place and we are moving
forward to complete this regulatory priority under DSHEA. This rule will
give consumers greater confidence that the dietary supplements that they
choose to use will have the identity, strength, purity and composition
that they are represented to have.

### Consumer Health Information for Better Nutrition Initiative 

As part of FDA's efforts on dietary supplements, the Agency has been
working to inform consumers about these products and their uses. On
December 18, 2002, the FDA Commissioner announced the Consumer Health
Information for Better Nutrition Initiative. The focus of this effort is
to make available more and better scientifically accurate information
about foods and dietary supplements so Americans know the health
consequences of what they consume. This Better Health initiative is
designed to foster two complementary goals concerning the labeling of
food and dietary supplements:

-   encouraging makers of conventional foods and dietary supplements to
    make accurate, science-based claims about the health benefits of
    their products, and

-   bringing enforcement actions against those dietary supplement
    marketers who make false or misleading claims.

In a July 10, 2003, status report on the Better Health Initiative, FDA
unveiled a process to review health claims. In addition, the Agency
announced enhanced enforcement activity against dietary supplement
manufacturers and others who make misleading claims about health
benefits that are not based on science. These enforcement activities are
described below.

### 

### ENFORCEMENT ACTIONS 

At the core of FDA's DSHEA enforcement efforts is our commitment to work
with industry in order to enhance the legitimate manufacture, sale, and
use of dietary supplements while enforcing the law aggressively against
fraudulent product claims and other illegal practices. Dietary
supplement enforcement actions include inspections that have resulted in
voluntary compliance, voluntary recalls, warning letters, seizures and
injunctions, criminal enforcement and joint enforcement actions with the
Federal Trade Commission (FTC) and the Department of Justice.

FDA shares Federal oversight of dietary supplements with the FTC. FDA
regulates the safety, manufacturing, and labeling of dietary
supplements, while the FTC has primary responsibility for regulating the
advertising of these products. Over the last few years, the FDA and the
FTC have worked well together to ensure that there is a seamless
assertion of our jurisdiction over these products. With the mutual goal
of consumer protection, FDA and FTC chair an interagency health fraud
steering committee that includes Federal agencies in the U.S., Canada,
and Mexico. Also, as part of FDA's effort to curb Internet health fraud,
the Agency has conducted several "surfs" to identify fraudulent
marketing of health care products over the Internet. These actions were
carried out in partnership with the FTC and other law enforcement and
public health authorities in the U.S. and abroad.

Since October 1, 2003, FDA has conducted 180 domestic inspections of
dietary supplement manufacturers, issued 103 warning letters and "cyber
letters" to marketers of dietary supplement products, seized products
worth almost \$9.65 million, supervised the voluntary destruction of
almost \$8 million worth of products promoted with unsubstantiated
dietary supplement claims or that were unapproved drugs, and obtained
permanent injunctions against 3 firms distributing misbranded or
unapproved drugs.

FDA enforcement has extended to our nation's borders, where we have
refused importation for 1171 foreign shipments of potentially unsafe or
misbranded dietary supplements offered for entry in the U.S. The
Agency's enforcement actions send a clear message that FDA will not
tolerate fraudulent practices that victimize or endanger consumers.

As with all of FDA's activities, priorities are established based upon
the direct impact upon public health. Products that present a direct
health hazard to consumers are the Agency's highest priority. When the
Agency encounters such products, FDA will use all available civil and
administrative remedies to assure that the product is quickly removed
from the market. We also aggressively publicize our actions to warn
consumers and health professionals about such products. In some cases,
the Agency may initiate a criminal prosecution against manufacturers or
distributors of violative products.

######## HIGHLIGHTS OF RECENT ENFORCEMENT ACTIONS

# Royal Tongan Limu

In October 2003, FDA witnessed the voluntary destruction of 90,000
bottles worth \$2.7 million of Royal Tongan Limu, a liquid dietary
supplement distributed by Dynamic Essentials, a subsidiary of NBTY, Inc.
The firm was initially warned in a 2002 FDA "cyber letter" that website
claims to treat various diseases such as cancer, arthritis, and
Attention Deficit Disorder caused their products to be in violation of
the law. Despite the warning, the product remained in distribution
channels and, therefore, FDA recommended the seizure action. Dynamic
Essentials ceased operation and no longer promotes or sells the products
on its website.

# 

### [Germanium Sesqioxide]{.underline}

In October 2003, FDA refused an entry of 20 kilograms of bulk germanium
sesquioxide valued at \$16,500, destined for use in human dietary
supplements. Germanium has caused nephrotoxicity (kidney injury) and
death when used chronically by humans, even at recommended levels of
use.

# Jean's Greens

In September 2003, at FDA's request, the U.S. Marshal seized herbal tea
products known as Forticel and Forticel Mix from Jean's Greens in
Norway, New York. The products claimed to treat and cure various
life-threatening and serious illnesses such as cancer, thus causing the
products to be unapproved drugs. FDA warned Jean's Greens in November
2001 to change its labeling for the products. The firm failed to comply.
The value of the seized goods was more than \$4000.

# Seasilver

In June 2003, U.S. Marshals seized \$7 million worth of Seasilver, a
liquid multi-vitamin/mineral/amino acid dietary supplement. The
marketer, SeasilverUSA, promoted Seasilver, on the Internet and in
marketing materials, as a safe and effective treatment for 650 serious
diseases, including AIDS, cancer, diabetes, hepatitis, and arthritis. On
March 8, 2004, Seasilver USA, Inc., and Americaloe, Inc., of Carlsbad,
California, and their principals, signed a consent decree of permanent
injunction in which they agreed to stop manufacturing and distributing
violative products, including "Seasilver." In addition, Seasilver USA,
Inc. and Americaloe, Inc. will destroy the seized products at their
expense and will pay liquidated damages for \$10,000 per day for any
future violation of the consent decree. Under a settlement with the FTC,
entered on March 4, 2004, the Seasilver defendants and the individual
distributors agreed to pay \$4.5 million in consumer redress.

# Coral Calcium

In June 2003, FDA issued warning letters to 18 firms, which operate 24
websites marketing multiple coral calcium products as effective
treatments or cures for a variety of diseases and conditions including
cancer, multiple sclerosis, lupus and heart disease. One product, Coral
Calcium Supreme, was promoted in nationally televised 30-minute
infomercials featuring Kevin Trudeau and Robert Barefoot. In June, on
FDA's behalf, U.S. Marshals seized \$2.6 million worth of Coral Calcium
Supreme. In a separate action, FTC charged the marketers of Coral
Calcium Supreme with making false and unsubstantiated claims that the
product can treat or cure diseases and stipulated preliminary
injunctions were entered against Trudeau, Barefoot, Shop America LLC and
Deonna Enterprises, Inc. In December 2003, a U.S. District Court entered
a Consent Decree of Condemnation and Permanent Injunction against Shop
America prohibiting Shop America and its directors, officers, agents,
representatives from promoting any products as a treatment for disease.

######## [SIGRA]{.underline}

In June 2003, FDA warned consumers not to purchase or consume SIGRA,
STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin,
manufactured by NVE Pharmaceuticals, Inc., in Newton, New Jersey and
distributed by Hi-Tech in Norcross, Georgia. These products, which were
marketed as dietary supplements for sexual enhancement, were found to
contain the prescription drug ingredient tadalafil, which could cause a
drastic lowering of blood pressure when combined with prescription drugs
containing nitrates. Tadalafil is the active ingredient in Cialis, an
Eli Lilly product approved in Europe to treat male erectile dysfunction.
Despite FDA's warnings, the defendant and his related businesses
repeatedly sold dietary supplements that claimed to treat obesity and
erectile dysfunction. Hi-Tech recalled the products and in September
2003, a U.S. District Court Judge entered a Consent Decree of Permanent
Injunction enjoining Hi-Tech Pharmaceuticals, National Urological Group,
National Institute for Clinical Weight Loss, American Weight Loss
Clinic, United Metabolic Research Center, and the President of these
corporations, from distributing unapproved new drugs and misbranded
drugs.

[]{.mark}

[]{.mark}

**[Global Source and Consulting, Inc.]{.underline}**

In June 2003, a U.S. District Court entered a Consent Decree of
Condemnation and Destruction for the seized products from Global Source
and Consulting, Inc., which included 450 bottles and 57,000 bulk
capsules of 20 dietary supplement products worth \$19,000. Global Source
agreed to destroy the products and to cease manufacture and marketing of
"Vitamin Hut Scientific Cholesterol Support Program" or any similar red
yeast rice product containing lovastatin, or any other drug product that
is a new drug unless and until an approved new drug application is in
effect for such product.

[]{.mark}

**[Severe Acute Respiratory Syndrome (SARS)]{.underline}**

In May 2003, in an immediate response, FDA and FTC warned website
operators, manufacturers and distributors to remove misleading or
deceptive Internet claims that their products may prevent, treat or cure
SARS. An internet "surf"\" conducted by FTC, FDA and the Ontario
Consumer and Business Services, found over 40 sites promoting a variety
of SARS treatment and/or prevention products. The products include
dietary supplements containing ingredients such as colloidal silver,
ascorbic acid, beta glucan, pycnogenol, and oregano oil. FDA sent
warning letters to 8 Internet firms promoting dietary supplement
products to treat or prevent SARS. FTC also notified violative firms
that they were subject to possible civil or criminal actions under the
FTC Act.

**[Gero-Vita International, Inc.]{.underline}**

In May 2003, the FTC filed a complaint against Glenn Braswell and four
of his corporations for making false and unsubstantiated claims that
several products marketed as dietary supplements are "scientific
breakthroughs" to treat or cure numerous serious medical conditions. FDA
provided technical assistance and scientific support to FTC for this
action. Products identified in the complaint were: Lung Support Formula,
which claimed to cure or ameliorate asthma, emphysema, smoking damage
and other respiratory problems; Antibetic Pancreas Tonic, which claimed
to treat or cure diabetes and to lower blood sugar levels; and GH3 and
GH3 Romanian Youth Formula, which claimed to extend life and prevent or
treat Alzheimer\'s disease and other forms of dementia; Chitoplex to
promote weight loss and reverse obesity without diet or exercise; and
Testerex, which claimed to treat erectile dysfunction.

[]{.mark}

######## [Nature's Youth]{.underline}

In April 2003, FDA announced that Nature's Youth, LLC, of Centerville,
Massachusetts, voluntarily destroyed approximately 5700 boxes of its
misbranded product, "Nature's Youth hGH" worth \$515,000. The action
followed FDA's advisory that the products appeared to be misbranded by
labeling that included unsubstantiated "structure and function" claims
that the product would, among other things, "improve physical
performance, speed recovery from training, increase cardiac output, and
increase immune functions."

[]{.mark}

# Street Drug Alternatives

On March 31, 2003, FDA sent Warning Letters to 8 firms after an
investigation revealed that the firms sold "street drug alternative"
products marketed for "recreational" purposes with claims that they
would produce such effects as euphoria, a "high", or hallucinations.
These street drug alternatives cannot meet the legal definition of a
dietary supplement because they are not intended to supplement the diet,
to promote health or to reduce the risk of disease. The 8 letters were
targeted primarily to manufacturers of products that contained ephedrine
or norephedrine hydrochloride.

[]{.mark}

In 2001, FDA brought a seizure and injunction action against a purported
supplement manufacturer that marketed its products as illegal street
drugs. The case, *U.S.* v. *Undetermined Quantities of Articles of Drug,
Street Drug Alternatives . . . et al.* showed that Hit Products, Inc.,
and Organic Diversions, Inc., marketed products made from a mixture of
herbs that promised users effects comparable to illegal street drugs.
FDA categorized these products as "street drug alternatives" and seized
them as misbranded and unapproved new drugs in violation of the FD&C
Act. FDA sought the destruction of the seized goods and an injunction
barring defendants from future FD &C Act violations. In granting this
relief, the court found FDA's position on street drug alternatives
"highly persuasive" and criticized the defendants' characterization of
the products as dietary supplements as a "veiled attempt to circumvent"
the FD&C Act. The court "declined to carve out a statutory loophole for
drug manufacturers attempting to profit from the illegal drug epidemic
by masquerading potentially dangerous substances as legitimate dietary
supplements."

[]{.mark}

**[Ancom Anti-Hypertensive]{.underline}**

In February 2003, FDA investigators found that Ancom Anti-Hypertensive
Compound tablets, which were marketed on the Internet and in retail
stores as dietary supplements, contained several prescription drug
ingredients, including reserpine, diazepam (Valium), promethazine, and
hydrochlorothiazide. Best Life International, the manufacturer, ceased
distribution and recalled the product. Subsequently in May 2003, Best
Life International issued a voluntary recall and warned consumers not to
buy or consume its product called, Viga. Viga, marketed as a dietary
supplement, was found to contain sildenafil, the active ingredient in
Pfizer's Viagra. Sildenafil can cause life-threatening lowering of blood
pressure when taken with nitrates.

[]{.mark}

**[Unsubstantiated Claims for Enhanced Athletic
Performance]{.underline}**

In February 2003, based upon the conclusions of the RAND study, FDA
warned 26 firms to cease making unproven claims that
ephedrine-containing dietary supplements enhance athletic performance.
Since performance enhancement was one of the two principal ways in which
ephedra products have been marketed, the impact of these warning letters
was substantial. On February 5, 2004, FDA officials accompanied U.S.
Marshals in a seizure of ephedra-containing dietary supplements
Betatrim, Thermbuterol, and Stacker 2, from *Musclemaster.com* in
Northboro, Massachusetts. The firm failed to comply with FDA's warning
to stop making unsubstantiated athletic performance claims on its
websites. The value of the 900 bottles of seized goods was approximately
\$19,308.

[]{.mark}

# Yellow Jackets and Black Beauties

In January 2003, FDA and the U.S. Marshal's Service served an inspection
warrant that would allow FDA to witness the voluntary destruction of
\$4 - 5 million worth of products known as "Yellow Jackets" and "Black
Beauties." The warrant was served at NVE Pharmaceuticals, Inc., the
manufacturer of the products, located in New Jersey. A distributor in
the Netherlands promoted the products on the Internet as alternatives to
street drugs. Yellow Jackets and Black Beauties are "street terms" for
controlled substances and were sold as herbal street drug alternatives.
In September 2002, FDA became aware of the tragic death of a 16-year old
high school football player who had taken Yellow Jackets. FDA placed the
products on Import Alert on October 7, 2002.

**[EverCLR]{.underline}**

On December 16, 2002, U.S. Marshals seized approximately 3,000 bottles
of EverCLR, a dietary supplement, valued at more than \$100,000. EverCLR
was marketed by Halo Supply Company of San Diego, California, a
"natural" treatment for viruses such as the herpes virus and "cold and
flu protection." None of these claims were substantiated. FDA charged
that EverCLR was an unapproved and therefore, illegal, new drug because
it was promoted to treat and prevent specific diseases and conditions.
Because EverCLR's labeling lacked adequate directions for use, FDA also
charged that it was misbranded

# Calm Focus 

In August 2002, FDA issued a Warning Letter to Better Way Kids. This
firm distributed "Calm Focus," a product promoted to treat Attention
Deficit Disorder and Hyperactivity Disorder. The firm characterized its
product as a "natural alternative to Ritalin" and claimed that it was
"formulated to energize neurotransmitters in the brain." The Warning
Letter made clear that dietary supplements may not make disease claims
or unsubstantiated structure/function claims. The firm corrected its
product claims.

# U.S. v. Syntrax Innovations, Inc., et. al

*U.S.* v. *Syntrax Innovations, Inc., et al*, involved a substance
called Triax, marketed by Syntrax as a dietary supplement for the
treatment of obesity and to promote weight loss. FDA scientists
determined that the product contained a potent thyroid hormone called,
tiratricol, that if taken in sufficient quantity can cause heart attacks
and strokes. FDA alleged that Triax could not be a dietary supplement
because it was promoted to treat a disease (obesity) and because it did
not contain any of the dietary ingredients identified in DSHEA. In
February 2001, the court entered an injunction barring the distribution
of Triax.

[]{.mark}

######### U.S. v. Lane Labs USA, Inc. and Andrew Lane

[]{.mark}

FDA brought an injunction action against Lane Labs USA, Inc., Andrew
Lane and against three of Lane Labs' products, including its shark
cartilage product, BeneFin. Lane Labs claimed that two of these products
were dietary supplements, but the company promoted those products for
the treatment of cancer and HIV. The third product is a skin cream
promoted for the treatment of skin cancer. FDA contended that the
disease claims caused all three of these products to be an unapproved,
and therefore illegal, new drugs and misbranded drugs.

######### Brain Nutrient Capsule

*United States* v. *Undetermined Quantities of Cases of an Article of
Food and Drug Labeled in Part: Brain Nutrient Capsule*, involved a
dietary supplement product offered as a supplementary treatment for
mental retardation, cerebral palsy, and epilepsy. The product's
distributor claimed that it "has the function of increasing the
intelligence, elevat\[ing\] the intelligence quotient (IQ) and promoting
growth." FDA alleged that these claims were baseless.

RULE REMOVING DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS
(EPHEDRA) FROM THE MARKET

Under DSHEA, a dietary supplement is adulterated if, among other
reasons, it presents a significant or unreasonable risk of illness or
injury under the conditions of use recommended in the labeling, or if
the labeling is silent, under ordinary conditions of use.

On February 11, 2004, FDA applied DSHEA's unreasonable risk standard and
issued a final rule declaring dietary supplements containing ephedrine
alkaloids (ephedra) adulterated. The rule will have the effect of
removing dietary supplements containing ephedrine alkaloids from the
marketplace and will become effective April 12, 2004.

Last winter, FDA issued letters to manufacturers of dietary supplement
containing ephedra to notify them of its planned action. The Agency's
history in reviewing ephedra under DSHEA is substantial. FDA has had
long-standing concerns about potential risks associated with dietary
supplements containing ephedra.

### 

### 

### FDA ACTION ON SUPPLEMENTS CONTAINING ANDROSTENEDIONE

On March 11, 2004, FDA announced action on androstenedione ("andro"), as
a result of the Agency's concerns about its safety. Andro acts like a
steroid once it is metabolized by the body and therefore can pose
similar kinds of health risks as steroids. These products are generally
marketed as dietary supplements to enhance athletic performance based on
their claimed anabolic and androgenic properties to stimulate muscle
growth and increase production of testosterone.

FDA sent warning letters to 23 companies asking them to cease
distributing products sold as dietary supplements that contain
androstenedione and warning them that they could face enforcement action
if they do not take appropriate actions. The letters stated that FDA is
not aware of any information demonstrating that androstenedione was
lawfully marketed as a dietary ingredient in the U.S. before October 15,
1994, nor is FDA aware of any information demonstrating that this
ingredient has been present in the food supply as an article used for
food in a form in which the food has not been chemically altered. In the
absence of such information, dietary supplements containing "andro" are
subject to the pre-market notification requirement for a new dietary
ingredient. Because no notification was submitted for "andro", dietary
supplements containing "andro" are considered adulterated.

The warning letters further state that, based on what FDA knows now, the
Agency is aware of no history of use or other information establishing
that a dietary supplement containing androstenedione will reasonably be
expected to be safe. There is existing evidence that the use of
androgenic steroid precursors such as androstenedione may have long-term
adverse health consequences. If a manufacturer files a new dietary
ingredient notification to the Agency, FDA will evaluate whether
specific products are adulterated.

Mr. Chairman, thank you for this opportunity to testify. I am happy to
answer your questions.