![](media/image1.png){width="0.84375in"
height="0.8229166666666666in"}**DEPARTMENT OF HEALTH & HUMAN SERVICES**
Public Health Service

> Food and Drug Administration

Rockville, MD 20857

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# STATEMENT OF

JOHN M. TAYLOR

ASSOCIATE COMMISSIONER

FOR

REGULATORY AFFAIRS

FOOD AND DRUG ADMINISTRATION

BEFORE THE

COMMITTEE ON COMMERCE

UNITED STATES SENATE

OCTOBER 28, 2003

####  [RELEASE ONLY UPON DELIVERY]{.underline}

####### INTRODUCTION

Thank you Mr. Chairman, for this opportunity to testify at this hearing
on dietary supplements and the current regulations to protect American
consumers from the potential adverse health risks associated with the
use of certain supplements. I am John M. Taylor, Associate Commissioner
for Regulatory Affairs at the Food and Drug Administration (FDA or the
Agency). In my statement today, I will address FDA actions to implement
DSHEA, especially our regulations development, adverse event monitoring,
and enforcement posture. I will also address FDA actions on two major
types of dietary supplements that are of current concern, ephedra and
steroid precursors. But first, let me provide you a short background on
dietary supplements.

**BACKGROUND ON REGULATION OF DIETARY SUPPLEMENTS**

Nearly half of the population of the United States uses "dietary
supplements."[^1] The Dietary Supplement Health and Education Act of
1994 (DSHEA) establish a unique regulatory framework in an attempt
Number range CHAPTERto strike the right balance between providing
consumers access to dietary supplements that they choose to use to help
maintain and improve their health, and giving the FDA the necessary
regulatory authority to take action against supplements or supplement
ingredients that present safety problems, make false or misleading
claims, or are otherwise adulterated or misbranded. Although dietary
supplements are generally regulated as foods, there are special
statutory provisions and implementing regulations for dietary
supplements that differ in some respects from those covering
conventional foods. Moreover, the regulatory requirements for dietary
supplements also differ from those that apply to prescription and
over-the-counter (OTC) drug products.

Congress defined the term dietary supplement as a product that, among
other things, is ingested, 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 the diet, and that contains at least
one dietary ingredient. The dietary ingredients in these products may
include vitamins, minerals, herbs or other botanicals, amino acids, and
dietary substances such as enzymes. Dietary ingredients also can be
metabolites, constituents, extracts, concentrates, or combinations of
the preceding types of ingredients. Dietary supplements may be found in
many forms, such as tablets, capsules, liquids, or bars. DSHEA placed
dietary supplements in a special sub-category under the general umbrella
of foods, but products that meet the drug definition are subject to
regulation as drugs.

**LABELING OF DIETARY SUPPLEMENTS**

Under the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA's
implementing regulations, the label of a dietary supplement must
include:

-   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, packer, or distributor

-   the net quantity of contents

In addition, if the labeling includes a claim that the product affects
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 also 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. If a product that is marketed as a
dietary supplement includes claims that the product is intended for the
use in the diagnosis, cure, mitigation, treatment, or prevention of a
disease, it is considered a drug within the meaning of the Act.

##### DIETARY SUPPLEMENTS CONTAINING STEROID PRECURSORS

Because of the Committee's interest in steroid precursors, let me
discuss them now. FDA is aware of a wide variety of products that
contain steroid precursors. Some consumers ingest steroid precursors
because they believe these products boost testosterone levels and speed
muscle growth.

Use of these products has grown dramatically in popularity in the United
States. We have heard from athletic organizations, health care
professionals and health organizations, and anti-drug abuse authorities
about potential health risks that may be associated with their use.
However, the scientific evidence about the benefits or adverse
consequences of steroid precursors appears to be inconclusive at this
time. These products are generally marketed as dietary supplements and
targeted to athletes and body builders as performance enhancers. Some of
these products are marketed for weight loss or as anti-aging products.
While the majority of products containing steroid precursors are not
promoted for disease treatment or prevention purposes, a minority of
products may be promoted for therapeutic purposes and therefore are
subject to regulation as drugs.

In addition, some steroid precursors are clearly outside the scope of
the dietary supplement definition and are subject to regulation as drugs
because they are intended to affect the structure or function of the
body. For example, FDA considers tetrahydrogestrinone, or THG, the
subject of what is rapidly becoming a major sports controversy, a new
drug under FD&C. Our analysis demonstrates that this is a purely
synthetic, non-naturally occurring, highly potent anabolic steroid. It
is a designer steroid in the truest sense. It is directly derived, by
simple chemical modification, from an anabolic drug that is explicitly
banned by the U.S. Anti- Doping Agency. That drug, gestrinone, a
synthetic product, is approved in Europe for the treatment of
endometriosis, a painful condition of pre-menopausal women. Furthermore,
THG is closely related, structurally, to trenbolone, a strong veterinary
anabolic steroid approved in the U.S. to increase rate of weight gain
and/or improved feed efficiency in beef cattle. Trenbolone is a
controlled substance.

Steroid precursors marketed as dietary supplements present complex
regulatory issues for FDA regarding the scope of the dietary supplement
and drug definitions. FDA is still examining these issues and has not
reached any formal conclusion about the status of steroid precursors as
dietary supplements under the FD&C Act. Nevertheless, we understand that
this is a public health issue that warrants our close attention. FDA is
currently pursuing an evaluation of the legal and scientific uses that
bear on the status of these kinds of substances and we hope to be able
to address this matter more authoritatively in the future.

### ADVERSE EVENT REPORTING

Now, let me turn to our discussion of dietary supplements. DSHEA's
regulatory framework is primarily a post-market program, like much of
food regulation. There is no pre-market approval requirement for dietary
supplements. Further, there is no requirement for manufacturers to
provide evidence of product safety to FDA prior to marketing a dietary
supplement, unless the supplement contains a "new dietary ingredient" (a
dietary ingredient that was not marketed in the United States before
October 15, 1994) that has not been "present in the food supply as an
article used for food in a form in which the food has not been
chemically altered" (21 U.S.C. 350b(a)). In contrast, drug regulation
involves an extensive premarket evaluation of safety and effectiveness
with explicit standards of evidence. This evidence provides a basis to
guide not only approval decisions but also conditions of use to manage
benefits and risks. In addition, there are post-market reporting
requirements for drugs to support product safety monitoring. These
requirements do not exist for dietary supplements.

As a result, voluntary adverse event reports (AERs) are the primary
means FDA has for identifying potential safety problems with dietary
supplements. Under DSHEA, FDA must rely on AERs as a major component of
its post-market regulatory surveillance efforts. Also, unlike drug
regulation, FDA cannot compel reporting of adverse events by dietary
supplement manufacturers.

In June 2003, 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 for foods, cosmetics, and dietary supplements.
This state-of-the-art system compiles and analyzes any reports of
consumer complaints and adverse events related to CFSAN-regulated
products presented to FDA. Health care professionals and consumers
voluntarily send submissions to CAERS. While voluntary reporting systems
are estimated to capture only one percent of adverse events, they
provide valuable signals of potential problems.

**ENFORCEMENT**

Protecting the public health has always been the Agency's first
responsibility. Consumers need to have confidence in the safety and
effectiveness of the products they use. Therefore, unsafe, ineffective,
or fraudulent products are a threat to the public health.

FDA is serious about its responsibility of ensuring that there is access
to effective, safe, scientifically-based health products for our
nation's citizens. U. S. citizens must have access to truthfully
labeled, safe, effective, and non-misleading health products.

At the core of FDA's enforcement efforts is our commitment to enhance
the legitimate manufacture, sale, and use of dietary supplements while
protecting consumers against unsafe products, fraudulent labeling
claims, and other illegal practices. Achieving these goals utilizes a
number of strategies, including cooperation and coordination with other
state, Federal, and international law enforcement agencies in protecting
consumers against unapproved and potentially harmful products offered by
Internet outlets, some of which are based abroad.

On December 18, 2002, FDA announced its "Better Health Information for
Better Nutrition" initiative. The purpose of the initiative is to
improve the health of consumers by providing them with scientifically
accurate, FDA-approved information about the health effects of foods and
dietary supplements. In undertaking this initiative, FDA recognized that
false claims that mislead Americans both endanger the public health and
undermine the goals of the FDA. Because FDA recognizes that efficient,
effective enforcement is an essential component to ensure that such
false and misleading claims do not take root in commercial distribution
channels, FDA is prepared to take aggressive enforcement action to
ensure that consumers have access to truthful and non-misleading
information about products related to their health.

FDA's commitment to continue its efforts to ensure that there is access
to safe, scientifically sound medical products is demonstrated by the
Agency's enforcement actions to combat fraudulent, misbranded, and
misleading dietary supplements. For example, over the last 15 months,
FDA has witnessed the voluntary destruction of approximately \$7.7
million of dietary supplements that were determined to be non-compliant
with the FD&C Act and has monitored two voluntary recalls of dietary
supplement products.

FDA also sent numerous Warning Letters to marketers of products
represented as dietary supplements but whose products did not qualify as
such because claims on them caused them to be misbranded and/or
unapproved drugs. At least two of these Warning Letters were sent to
firms whose products were marketed in lieu of approved drugs that were
available to the public. For example, one made claims that its products
were alternatives to vaccinations/immunizations against anthrax,
measles, smallpox, and encephalitis; the other promoted its product as a
natural alternative to Ritalin for ADHD. This calendar year, FDA also
issued Warning Letters to 18 firms marketing coral calcium products as
effective treatments or cures for a variety of disease conditions. In
addition, FDA and the FTC warned website operators, manufacturers, and
distributors who were making misleading or deceptive claims on the
Internet regarding their products ability to prevent, treat, or cure
SARS that they must cease making these impermissible claims. FDA also
issued Warning Letters to 8 firms marketing "dietary supplements" as
street drug alternatives and warned 26 firms to stop making unproven
claims that ephedrine-containing dietary supplements could enhance
athletic performance.

Lastly, over the course of the course of the last 15 months FDA utilized
its judicial and administrative enforcement tools to take one injunction
action and 8 seizure actions against marketers of, and/or fraudulent
dietary supplements. Six of the seizure actions occurred in FY 2003
alone, including 3 that were undertaken in cooperation with FTC.

### Health Fraud

Traditionally, FDA has taken action against violative dietary
supplements as part of its health fraud efforts. Generally, FDA defines
health fraud as the deceptive promotion, advertising, distribution, or
sale of articles that are represented as being effective to diagnose,
prevent, cure, treat, or mitigate an illness or condition, or provide a
beneficial effect on health where the product has not been
scientifically proven safe and effective for such purposes.

The Internet is one avenue by which fraudulent products have been
promoted. The use of the Internet by our nation\'s citizens, from school
age children to seniors, has opened up vast new opportunities for the
exchange of information and for enhancing commerce in all types of
consumer products. The Internet is rapidly transforming the way we live,
work, and shop in all sectors of the economy. In the health sector,
tele-medicine allows people in remote areas to access the expertise of
doctors in the nation\'s finest academic health centers. The Internet
also permits an increasing number of individuals to obtaining meaningful
medical information that helps them understand health issues and
treatment options. As beneficial as this technology can be, it also
creates a new marketplace for activity that is illegal, such as the sale
of unapproved new drugs, prescription drugs dispensed without a
prescription, and products marketed with fraudulent claims about health
benefits. Also, because the Internet is a worldwide communications
system, U.S. citizens are now more directly susceptible to fraud from
sources both foreign and domestic.

Consumers respond to these promotions by spending billions of dollars a
year on fraudulent health products. They hope to find a cure for their
illness or improve their well-being or appearance. Yet, consumers often
fall victim to products and devices that do nothing more than cheat them
out of their money, steer them away from useful proven treatments, and
possibly do more harm than good.

**FDA Web Site Triage Process**

In June 1999, FDA established a case assessment or "triage" team with
representatives from the Offices of Criminal Investigation within the
Office of Regulatory Affairs, the Center for Drug Evaluation and
Research, the Office of Chief Counsel, and the Office of Policy. The
scope of this group has been expanded to cover all FDA Centers and
regulated products including the CFSAN's Office of Nutritional Products,
Labeling and Dietary Supplements.

Under the triage process, FDA identifies web sites that potentially
violate the FD&C Act from the Agency's Internet monitoring activity,
other Federal or foreign law enforcement agencies including our joint
partnership with the Federal Trade Commission (FTC), and from states and
the public. The triage team evaluates each case to determine whether or
not it should be pursued through a civil or criminal investigation.
Using this information, we give priority to cases involving unapproved
new drugs, health fraud, prescription drugs sold without a valid
prescription, and products with the potential for causing serious or
life-threatening reactions.

This triage process results in improved coordination of criminal and
civil enforcement actions within the Agency, reduces overlapping
efforts, and helps the Agency appropriately achieve a maximum deterrent
effect when taking action to remove harmful products from the market.

### Oversight of Dietary Supplements 

FDA shares Federal oversight of dietary supplements with the Federal
Trade Commission (FTC). FDA regulates the safety, manufacturing, and
labeling of dietary supplements, while 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.

As with all of FDA\'s activities, priorities are established based on
benefit/risk to public health. The Agency\'s enforcement of fraudulent
health products is based on a priority

system that is often driven by whether a fraudulent product poses a
direct or indirect risk to public health. The susceptibility of the
population is also an element that we consider when determining risk.
For example, cancer patients are considered a highly susceptible
population, as many have exhausted conventional or standard care
treatments, and may be desperate to try anything that offers hope of a
cure.

Products that present a direct health hazard to consumers are the
Agency's highest priority. These are products that have a reasonable
potential for causing direct serious adverse effects, or for which there
is documentation of injury or death. 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.

Products that are not themselves hazardous can still present an indirect
health hazard in that the consumer may delay or forego proven medical
treatments or drug therapies, or rely on these products for benefits
that simply are never going to materialize. Examples include unproven
products promoted for the treatment of cancer, Alzheimer\'s disease,
arthritis, heart disease, and high blood pressure.

In addition to these direct and indirect health risks, we also give
priority to products that undermine the integrity of the new drug
application (NDA) and Over-the-Counter (OTC) drug review processes. The
NDA and OTC drug review procedures provide consumers with assurance that
prescription and OTC drugs are both safe and effective. To avoid
undermining these procedures, it is essential for FDA to maintain
vigorous surveillance, provide prompt industry guidance and outreach,
and take enforcement action regarding fraudulent products. Such actions
help ensure that manufacturers comply with the requirement to submit an
NDA to the Agency for their product and that the playing field is fair
and equitable for those who do.

**Initiation of Enforcement Activity**

When a problem arises with a product, or the Agency receives information
that a product may violate the FD&C Act or regulations, FDA can take a
number of enforcement actions to protect the public. For example, FDA
may initially work with a product's manufacturer or marketer to correct
the problem voluntarily. If that fails, the Agency may bring a lawsuit
to seize the product and/or enjoin the firm marketing or distributing
the product. When warranted, FDA may also seek criminal penalties,
including prison sentences, against parties who break the law.

In the appendix attached to my testimony, I describe some of FDA's
recent dietary supplement enforcement activities. As you will see, our
enforcement actions are wide-ranging and diverse and take full advantage
of the entire breadth of enforcement tools that are available to FDA.
You will also see that the type of cases that we have brought have
evolved over time. We hope that they also illustrate to the public and
the industry that we will take action when warranted, and that FDA also
remains committed to consumer and industry education about the proper
labeling and use of dietary supplements.

### Outreach and Education

FDA recognizes that traditional enforcement actions and coordinated
efforts with other agencies are necessary, but these steps are not the
only components of a thoughtful enforcement strategy. We fully
appreciate that the dietary supplement industry has a vested interest in
curbing fraudulent operators and practices and that most of FDA's
regulated industries are interested in complying with the Act -- and do
so. For this reason, FDA will continue in its efforts to complement
these measures with industry and consumer education and will continue to
assist the industry by issuing regulations and guidance documents
addressing the manufacture, labeling, and sale of dietary supplements.

Examples of prominent FDA outreach activities in this area include:

-   continuing to develop mechanisms, including expanded use of our Web
    site, to communicate critical information and useful strategies
    about dietary supplements to industry and consumers. Coordination
    with groups like the Better Business Bureau, and with professional
    groups like the American Medical Association, will help FDA to reach
    the broadest possible audience;

-   continuing to encourage consumers to involve their health care
    practitioners in their health care decisions. Ultimately, however,
    consumers must be able to evaluate the accuracy of labeling claims,
    and with the assistance of health professionals when appropriate,
    determine which dietary supplements are right for them. Accordingly,
    through written materials and Web-based resources, FDA has provided
    consumers with the means to make informed choices about dietary
    supplements. Examples include [FDA Talk Papers]{.underline},
    articles in the *FDA Consumer* magazine, and information on FDA's
    web site to educate consumers about safely purchasing FDA regulated
    products. Other examples of these materials include CFSAN's
    "Overview of Dietary Supplements" and "Tips for the Savvy Supplement
    User." CFSAN has also published consumer advisories concerning
    dangerous products, such as the advisory that the Agency issued
    about dietary supplements containing kava, a botanical ingredient;

-   continuing to communicate with industry regarding those practices
    that are permissible under DSHEA. We will continue our practice of
    providing this information through guidance documents and
    information posted on the Agency's web site. For example, FDA's
    "Statement of Identity, Nutrition Labeling, and Ingredient Labeling
    of Dietary Supplements Small Entity Compliance Guide" discusses
    compliance with the Agency's regulations implementing DSHEA's
    labeling provisions; and

-   leveraging resources by continuing to coordinate mutually effective
    relationships with other Federal and state entities involved in
    combating health fraud. For example, in 1992, FDA began sponsoring a
    National Health Fraud Working Group. This working group is comprised
    of representatives from the Association of Food and Drug Officials,
    State Attorneys General, FTC, Health Canada, and FDA representatives
    from headquarters and field offices. The group meets on a regular
    basis to facilitate the coordination of regulatory activities,
    information exchange, and leveraging the efforts of each member
    agency.

    Partnership with Federal Trade Commission (FTC)

As discussed earlier, FTC and FDA have a long-standing history of
working together to combat health fraud. This partnership was formed out
a recognition that although protection of the public health may be FDA's
primary goal, other can contribute to achieving this goal. To further
their mutual interest in consumer protection, FDA and FTC formed a
Dietary Supplement Enforcement Group to closely coordinate their
enforcement efforts against health care fraud. A major activity includes
Operation

Cure-All, which is aimed at halting the Internet promotion of products,
including dietary supplements, that make false or misleading disease
claims In addition, FDA and FTC chair an Interagency Health Fraud
Steering Committee that meets regularly to coordinate activity on these
issues. The workgroup includes Federal agencies in the U.S. and Canada,
and Mexico also has been invited to join the group. As part of its
effort to curb Internet health fraud, FDA 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. These efforts have led to many successful actions that have
protected the public health. Together, we have succeeded in
accomplishing goals that neither one of our agencies could accomplish
individually.

##### DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS

A number of plant genera, including ephedra, are known to contain
ephedrine alkaloids. Ma huang is a common name given to Chinese Ephedra,
which is used in traditional Chinese medicine. Ephedra has been shown to
contain various chemical stimulants, including the alkaloids ephedrine,
pseudoephedrine, phenylpropanolamine and norpseudoephedrine, as well as
various tannins and related chemicals. The concentrations of these
alkaloids depend upon many factors, such as the species, parts of the
plant used, time of harvest, growing location, and production methods.
Ephedrine and pseudoephedrine are used in some OTC and prescription
drugs, where they have been demonstrated to be safe and effective for
the labeled use.

Dietary supplements containing ephedrine alkaloids have known, and
potentially serious, side effects. While ephedra has been used in herbal
medicine preparations for thousands of years, in recent years ephedra
has been sold primarily in dietary supplement products for weight
control, as well as in products promoted to boost energy levels or to
enhance athletic performance. Some ephedra-containing products have been
marketed as herbal alternatives to illicit street drugs.
Ephedra-containing products often contain other stimulants, such as
caffeine, that may have synergistic effects and increase the potential
for adverse effects.

A number of adverse effects associated with ephedrine
alkaloid-containing dietary supplements have been reported to FDA. These
include elevated blood pressure, rapid heartbeat, nerve damage, muscle
injury, psychosis, and memory loss. More serious effects have also been
reported, including heart attack, stroke, seizure, and death.

As the tragic deaths of the Baltimore Orioles' pitching prospect Steve
Bechler and of Sean Riggins, the sixteen year-old from Illinois have
reminded us that use of ephedra, particularly in sports, raises serious
concerns about safety and has long posed difficult issues for health
care professionals, regulators, and consumers. These concerns stem from
both the mechanism of action of ephedrine alkaloids on the sympathetic
nervous system, and accumulating evidence of potentially serious adverse
events after use of ephedra-containing products.

While there has been considerable debate about the safety and
effectiveness of dietary supplements like ephedra, as well as the most
effective approach to regulating them, one thing is clear: although
dietary supplements are regulated as foods and not drugs, the consumer
should not assume they are always safe to use. "Natural" does not
necessarily mean safe. In particular, botanical and herbal products may
have active ingredients with pharmacologic properties similar to, or in
the case of ephedra identical to, drug products. They have the potential
to cause adverse effects, as well as interactions with prescription and
OTC drugs and with ingredients in other dietary supplements.

**USE OF EPHEDRA BY ATHLETES**

Although FDA is reviewing ephedrine alkaloids under DSHEA to assess the
safety concerns, FDA has particular concerns about the use of ephedra by
persons engaged in strenuous exercise. A recent study by RAND, discussed
in more detail below, concluded that ephedra has minimal if any proven
benefit for enhancing sports performance. Yet ephedra acts like an
adrenaline boost, stressing the heart, raising blood pressure, and
increasing metabolism. Moreover, the stimulating effects of ephedra may
mask the signs of fatigue, causing even the most well conditioned
athletes to push beyond their physical limits.[^2] Thus, ephedra's risks
are potentially much more serious for competitive athletes than for the
general population. As FDA has said before, ephedra should not be used
by people who engage in strenuous activity.

Because of the special risks of ephedra use in athletes, sports leagues
that have acted to restrict ephedra use are making a prudent decision.
Even as the Agency evaluates the safety of ephedra use in the population
more generally, including its use for weight loss, we see that ephedra
poses special risks in the context of sports performance with little or
no identified benefit for athletes.

### FDA's ACTIONS ON EPHEDRINE ALKALOIDS

The Agency's professional, scientific and legal staffs are currently
working hard to address the extraordinary challenges presented by these
products. Earlier this year, the Agency published a *Federal Register*
notice reopening the comment period on its 1997 proposed rule on dietary
supplements containing ephedrine alkaloids to seek comment on new
scientific evidence about the risks of these products and on a proposed
warning statement for the labels of these products. Our *Federal
Register* announcement also sought comments on whether, in light of
current information, FDA should determine that dietary supplements
containing ephedrine alkaloids present a significant or unreasonable
risk of illness or injury under the conditions of use recommended or
suggested in labeling, or under ordinary conditions of use if the
labeling is silent.

We are currently in the process of analyzing the over 30,000 public
comments we received earlier this summer as well as adverse event
information and the best available scientific evidence of ephedra\'s
pharmacology and mechanism of action**.** We are in the final stages of
our deliberative review, so I cannot discuss the specifics of that
process or the anticipated outcome. However, I want to emphasize that we
are committed to moving forward expeditiously to make a determination
that is well grounded in all available scientific evidence and that is
protective of the public health in accordance with DSHEA.

While we are undertaking these reviews, the Agency has dramatically
increased its enforcement actions against ephedrine alkaloids and other
dietary supplement products making false or misleading claims. These
actions, many of which have been undertaken in collaboration with the
FTC, are having an impact on the marketing of dietary supplements in
general and ephedra in particular.

### Sports Uses of Ephedra

On February 28, 2003, based on the conclusions of the RAND study, FDA
warned 26 firms to cease making unproven claims that
ephedrine-containing dietary supplements enhance athletic
performance.[^3] The actions were primarily a result of the Agency's
surveillance of the firms' web sites. Fourteen of the firms responded to
the warning letters by discontinuing the product or the claim. The
remaining twelve firms were inspected by FDA. Of those twelve inspected
firms, all but one either discontinued the product or the objectionable
claims. Investigation for consideration of regulatory action against the
remaining firm is ongoing. Since performance enhancement was one of the
two principal ways in which ephedra has been marketed, the impact of
these warning letters has been substantial. FDA continues to monitor the
compliance of products on the Internet.

### DIETARY SUPPLEMENT CURRENT GOOD MANUFACTURING PRACTICES

Another important aspect of FDA's regulatory and surveillance programs
is to help ensure that dietary supplements are manufactured in a manner
that will not result in adulteration. DSHEA gave FDA the authority to
promulgate regulations for dietary supplement current good manufacturing
practices (CGMPs).

On March 13, 2003, FDA published a proposed rule to establish CGMPs for
dietary supplements. FDA\'s proposed rule, if finalized as proposed,
will give consumers greater confidence that the dietary supplements they
choose to use will have the identity, strength, purity, quality or
composition claimed on the label. The CGMPs will help prevent product
quality problems such as superpotency, subpotency, contamination,
improper packaging, and mislabeling.

The proposed rule would:

-   include requirements on the design and construction of physical
    plants, to facilitate maintenance, cleaning, and proper
    manufacturing operations;

-   include requirements for production and process controls with the
    use of a quality control unit in the manufacturing, packaging and
    label operations;

-   include requirements for product testing and handling of consumer
    complaints; and

-   apply to all firms that manufacture, package, or hold dietary
    ingredients or dietary supplements, including those involved with
    testing, quality control, packaging, labeling, and distribution. The
    proposed regulations also would apply to both domestic and foreign
    firms that manufacture, package, or hold dietary ingredients and
    dietary supplements for distribution into the U.S.

The public comment period on this proposed rule closed on August 11,
2003. The Agency is carefully reviewing all of the comments.

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

# Enforcement Strategies Used to Enforce DSHEA

## 

## Inspections That Resulted in Voluntary Compliance 

-   In October 2003, FDA witnessed the voluntary destruction of Royal
    Tongan Limu, a liquid dietary supplement distributed by NBTY, Inc.,
    in Murphysboro, Illinois. This destruction concluded a series of
    Agency actions that started with the issuance of a Cyber Letter to
    Dynamic Essentials of Lake Mary, Florida for health claims
    associated with the product that were made on the firm's website.
    Subsequent follow up revealed that Dynamic Essentials was a
    subsidiary of NBTY, and that the product was being distributed from
    NBTY's Illinois location. Even after the issuance of the Cyber
    Letter, the product remained in distribution channels and,
    therefore, FDA recommended a seizure action. However, in lieu of
    seizure, the firm chose to voluntarily destroy its inventory of
    approximately 90,000 bottles of Royal Tongan Limu, along with the
    product's related literature and materials. Approximately 188 tons
    of material was destroyed with an estimated value of \$2.7 million.

-   On April 30, 2003, Nature's Youth, LLC, of Centerville,
    Massachusetts, voluntarily destroyed approximately 5700 boxes of its
    misbranded product, "Nature's Youth hGH." This destruction occurred
    at locations in Massachusetts and Florida, and involved
    approximately \$515,000 worth of the product. The firm's action was
    the result of an FDA advisory that the products appeared to be
    misbranded by virtue of unsubstantiated "structure and function"
    statements that claimed that the product would, among other things,
    "improve physical performance, speed recovery from training,
    increase cardiac output, and increase immune functions." The product
    also claimed to be "your body\'s best defense against aging."

-   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 to 5 million worth of products known as "Yellow
    Jackets" and "Black Beauties." The warrant was served at NVE
    Pharmaceuticals, 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. An attempt by FDA to
    inspect the manufacturer of the products on October 8, 2002,
    resulted in an inspection refusal, forcing FDA to obtain an
    inspection warrant. FDA obtained an additional inspection warrant in
    January 2003. After NVE stopped marketing Yellow Jackets and Black
    Beauties, it began marketing "Yellow Swarm" and "Midnight Stallion"
    as replacement products. Although these products appear to be almost
    identical in formulation and appearance to the previous products,
    they no longer bear street drug names or claims.

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-   FDA conducted a May 2002 inspection of Fresh Vitamins, a
    manufacturer of Noni Fresh Juice. Fresh Vitamins marketed its
    product to treat conditions ranging from immune system disorders to
    arthritis, malaria, and alcohol addiction. Following the inspection,
    the firm's president stated that he had removed impermissible claims
    from the firm's website and that he was educating himself on FDA
    policy regarding dietary supplement claims.

-   Following a May 2002 inspection of Health Ventures, a manufacturer
    of Miracle Bust, a FDA investigator witnessed the destruction of the
    company's inventory. The company signed an affidavit stating that it
    would voluntarily stop the sale and distribution of Miracle Bust,
    delete references to it on its website, and refrain from placing
    future orders from its contract manufacturer.

####  [Voluntary Recalls]{.underline}

-   On May 23, 2003, Best Life International, Mayaguez, Puerto Rico,
    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.

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-   On February 11, 2003, Best Life International recalled Ancom
    Anti-Hypertensive Compound tablets. Although these products claimed
    to be dietary supplements, they were found to contain several
    prescription drug ingredients, including reserpine, diazepam,
    promethazine, and hydrochlorothiazide. The product was sold on the
    Internet and at retail stores.

## Warning Letters 

-   On September 30, 2003, FDA issued a Warning Letter to Dr. Gordon
    Joseph, Chelationcare Centers U.S.A., Scottsdale, Arizona. Dr.
    Joseph's websites, *http://www.anti-thrax.com* and
    *http://www.homeovax.com* marketed an anthrax vaccine alternative
    and viral immune alternative immunizations and vaccinations. The
    anti-anthrax vaccine contained *Bacillus anthracis* and other
    ingredients that are recognized in the Homeopathic Pharmacopeia of
    the United States (HPUS). The "Viral Immune" product made claims
    that it was a defense against smallpox, measles, and encephalitis
    viruses. These statements, and the therapeutic claims establishing
    the intended use of the products, caused them to be misbranded
    drugs.

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-   A Warning Letter was issued to Michael Peng, President of
    Greenvalley, LLC, located in Farmingdale, New York on September 26,
    2003, for offering trans-dermal products intended for the treatment
    of diabetes and prostate disease-related symptoms via a website,
    *http://gyconline.com*. Moreover, although the products were
    represented as dietary supplements, they did not qualify as dietary
    supplements since they were not intended for ingestion as set forth
    in the Act. Additionally, FDA had no information to indicate that
    the products were generally recognized as safe and effective for
    their intended use; and the products were misbranded because the
    labeling failed to bear adequate directions for use.

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-   On July 22, 2003, FDA issued a Warning Letter to Ayoula Dublin, New
    York, New York, for marketing and distributing "Lipostabil," an
    injectable product that claimed to break down and dissolve fat "for
    the person who wants to lose those last 5-10 extra pounds." Although
    the product claimed to be a dietary supplement, its route of
    administration disqualified it as a dietary supplement (since it was
    not intended for ingestion). Moreover, the product's
    structure/function claims and lack of substantiation to show that
    the product was generally recognized as safe and effective for its
    intended use made it a new drug without an approved drug
    application.

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-   On June 9 and 10, 2003, FDA issued Warning Letters to 18 firms that
    operated 24 websites marketing multiple coral calcium products as
    effective treatments or cures for a variety of diseases and
    conditions. Many of these coral calcium products also made
    unsubstantiated structure/function claims. Coral Calcium Supreme was
    promoted in nationally televised 30-minute infomercials featuring
    Kevin Trudeau and Robert Barefoot on cable channels such as
    Discovery Channel, Comedy Central, and Bravo.

-   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. The 8 letters were targeted primarily to manufacturers of
    products that contained ephedrine or norephedrine hydrochloride and
    whose products were labeled as dietary supplements for use in weight
    loss, suppression of appetite, and enhanced libido.

-   On February 28, 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. These warnings were issued primarily as a result of the
    Agency's surveillance of the firms' websites. Fourteen of the firms
    responded to the Warning Letters by discontinuing the violative
    products and/or fraudulent claims. FDA inspected the twelve
    remaining firms. Since performance enhancement is one of the two
    principal ways in which ephedra products have been marketed, the
    impact of these Warning Letters was substantial. FDA continues to
    monitor the firms/websites/products to ensure their compliance with
    applicable regulations.

-   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.

-   In mid-June, 2002, FDA sent seven Warning Letters to manufacturers
    of products containing synthetic ephedrine.

-   In 2002, the Agency issued 17 Dietary Supplement Warning Letters,
    with products containing synthetic ephedrine receiving particular
    attention. Marketers promoted these products for use in weight loss,
    energy enhancement, and to increase libido. However, the presence of
    synthetic ephedrine placed the products outside the definition of a
    dietary supplement.

## Seizures and Injunctions 

-   On September 22, 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. Despite FDA's warnings,
    the defendant and his related businesses repeatedly sold dietary
    supplements that claimed to treat obesity and erectile dysfunction.
    Earlier in June 2003, FDA had issued a "Public Health Alert" warning
    consumers not to purchase or consume certain dietary supplements
    sold by Hi-Tech Pharmaceuticals, Inc., and related businesses
    because FDA test results had found that the supplements were
    adulterated with the prescription-strength drug ingredient
    taldalafil. An interaction between certain prescription drugs
    containing nitrates (such as nitroglycerin) and taldalafil could
    cause a drastic lowering of blood pressure. The possibility that
    patients who did, indeed, take nitrates could have consumed the
    supplements was very real since erectile dysfunction is often a
    common problem in people who have diabetes, hypertension, high
    cholesterol, and heart disease.

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-   On September 18, 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,
    which caused them to be unapproved drugs. FDA had warned Jean's
    Greens in November 2001, to change its labeling for the products,
    but it did not comply. The seized goods, which included 385 bottles
    and 78 mix packages, were worth more than \$4,000.

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-   On June 18, 2003, the U.S. District Court for the Southern District
    of Florida entered a Consent Decree of Condemnation and Destruction
    for 450 bottles and 57,000 bulk capsules of dietary supplement
    products seized by U.S. Marshals at Global Source Management and
    Consulting, Inc. (Global Source), located in Sunrise, Florida, on
    February 13, 2003. The seizure occurred after FDA determined that
    these products claimed to treat a variety of medical conditions,
    causing them to be drugs. The seizure included almost 20 different
    products worth nearly \$19,000 that were sold under the names
    Vitamin Hut and RX for Health through retail outlets and by mail
    order. Under the terms of the Consent Decree, the Claimant, Global
    Source, had to destroy all of the products. In addition, Global
    Source agreed to cease manufacturing, processing, packing, labeling,
    holding, or distributing "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.

-   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 had been
    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.

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-   In the summer of 2002, FDA filed two seizure actions against dietary
    supplements making unsubstantiated claims about their effect on the
    structure or function of the body.

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-   [United States v. Undetermined Quantities of Cases of an Article of
    Food and Drug Labeled in Part: Brain Nutrient Capsule]{.underline},
    involved a 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.

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-   [United States v. 172/100 Capsule Bottles, More or Less, of an
    Article of Food Labeled in Part: Kirkman Taurine 325 mg Dietary
    Supplement Capsules]{.underline}, concerned a product offered as a
    supplementary treatment for autism. Materials promoting the product
    stated, "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida, who
    treats autistic patients reports good success using Taurine." The
    materials further asserted that "\[t\]aurine may be beneficial in
    developmental disorders." FDA alleged that there is no scientific
    support for these claims.

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-   In March, 2002, FDA seized products marketed as dietary supplements
    that contained synthetic ephedrine. For example, [United States v.
    1009 cases *et al.*]{.underline}, involved the seizure of nearly \$3
    million worth of Amp II Pro Drops from a company doing business as
    E\'OLA International. Although labeled as a supplement, the product
    contained synthetic ephedrine. FDA alleged that the product violated
    the law because synthetic ephedrine is not a dietary ingredient.
    Accordingly, a product containing synthetic ephedrine is not a
    dietary supplement. The Agency also alleged that the product, which
    was marketed to treat obesity, made illegal disease claims. The
    consent decree required the product's destruction and prohibited
    E'OLA from manufacturing or distributing products that violate the
    FD&C Act.

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-   In 2001, FDA brought a seizure 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.]{.underline} 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 "ecline\[d\] to carve
> out a statutory loophole for drug manufacturers attempting to profit
> from the illegal drug epidemic by masquerading potentially dangerous
> substances as dietary supplements."

-   In 2001, FDA's injunction actions also extended to supplement
    marketers who violated DSHEA's proscription of disease claims.
    Samples include:

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-   [U.S. v. Lane Labs USA, Inc. and Andrew Lane]{.underline}
    constituted an injunction action that involved several of Lane
    Labs'products, including its shark cartilage product. Lane Labs
    marketed this product as a dietary supplement, but made
    unsubstantiated cancer treatment claims about it. FDA contended that
    the disease claim caused the product to be an unapproved, and
    therefore illegal, new drug.

-   [U.S. v. Syntrax Innovations, Inc., et al]{.underline}, involved a
    drug called Triax Metabolic Accelerator, marketed by Syntrax as a
    dietary supplement for the treatment of obesity and to promote
    weight loss. FDA scientists determined that the product contained
    tiratricol, a hazardous compound that 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.

## Criminal Enforcement 

-   As a result of concurrent federal search warrants executed by OCI in
    Georgia and New Jersey, FDA warned consumers on June 20, 2003, not
    to purchase or consume Sigra, Stamina Rx, and Stamina Rx for Women,
    Y-Y, Spontane ES, and Uroprin. These products, which were marketed
    as dietary supplements, contained a prescription drug ingredient,
    tadalafil, which posed health risks when taken with certain
    prescription drugs containing nitrates. Tadalafil is the active
    ingredient in Cialis, an Eli Lilly product approved in Europe to
    treat male erectile dysfunction. The products were being sold
    over-the-counter and claimed to increase stamina, confidence, and
    performance. (A civil, permanent injunction was also filed -- see
    description under Seizures/Injunctions.)

    1.  [In U.S. v. Cap-Tab Nutritional Formulating and Manufacturing
        Inc.]{.underline}, an officer of a corporation known as Cap-Tab,
        along with the corporation itself, was convicted in June 2002 of
        one count of introducing misbranded food into interstate
        commerce. This case stemmed from an allegation that three
        individuals who were all officers of Cap-Tab conspired and
        knowingly substituted low-price ingredients for the ingredients
        listed on the label of their dietary supplement product
        (encapsulated vegetable powders). Three of the defendants in the
        case received sentences of one year's probation and were ordered
        to pay fines of \$500, \$250, and \$5000, respectively. A fourth
        defendant received a sentence of 180 days' incarceration
        followed by five years' incarceration on a related state
        criminal conviction.

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-   [In U.S. v. Diane Eckert-Kunick]{.underline}, an individual was
    convicted in April 2002 of introducing unapproved new drugs into
    interstate commerce and subsequently received a sentence of four
    months' incarceration in a community correctional center. The
    defendant, along with her parents, had formed a company known as New
    Gaia Products (NGP) in 1996. The company manufactured, distributed,
    and sold dietary supplements including colloidal gold, colloidal
    silver, and colloidal titanium. The defendant also distributed
    promotional literature claiming that NGP products cured cancer,
    rheumatoid arthritis, and heart disease.

    1.  [In U.S. v. Theodore Sosangelis and Thomas Knox]{.underline},
        two individuals pled guilty in October 2001 and February 2002,
        respectively, to trafficking counterfeit dietary supplements in
        interstate commerce. From January through July 2000, via their
        company, East Coast Ingredients, the defendants produced
        inexpensive versions of legal supplements manufactured by
        Muscletech. After placing fake Muscletech labels on their
        products, the defendants sold them to customers who believed
        that they were purchasing legitimate Muscletech dietary
        supplements. One of the defendants in the case received a
        sentence of three years' probation and was ordered to pay
        restitution of almost \$77,000.

    2.  FDA determined that the pre-DSHEA product known as Nature's
        Nutrition Formula One, which was marketed between 1992 and 1994
        as an all natural "nutritional supplement" containing plant
        ingredients, was actually made with two pharmaceutical-grade
        chemicals, ephedrine hydrochloride and caffeine anhydrous. FDA
        received more than 100 reports of injuries and adverse reactions
        related to the product and at least one death was associated
        with the use of this product. This case was developed by alerts
        provided from adverse event reports, ORA's field staff, and the
        work of OCI together with DOJ. Through these sources, FDA
        learned that the Chemins Company, Inc., which manufactured the
        product, went to great lengths to hide its actions from the
        Agency and concealed the actual ingredients of Formula One. As a
        result, the government initiated a criminal prosecution against
        the company and its president. On July 7, 2000, a Federal judge
        sentenced the president to 21 months in jail and fined him and
        this corporation \$4.7 million. In his plea agreement, the
        president admitted that he and his company labeled Formula One
        as "all natural" but secretly spiked the product with synthetic
        ephedrine hydrochloride and caffeine anhydrous. He also admitted
        that the product's labeling failed to disclose the use of the
        chemicals on the list of ingredients, and that he and his
        employees had misled FDA investigators and hindered inspections
        of Chemins. The sentence marked the culmination of a three-year
        investigation.

######## Joint Enforcement Actions

-   On June 19, 2003, in an action initiated by FDA, 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 such as cancer, multiple sclerosis, lupus, and
    heart disease. Stipulated preliminary injunctions have been entered
    against Trudeau, Barefoot, Shop America, LLC, and Deonna
    Enterprises, Inc. The preliminary injunctions prohibit the
    challenged claims and restrict defendants' ability to use or
    dissipate their assets. Legal proceedings are ongoing.

-   On June 17, 2003, U.S. Marshals seized 132,480 bottles of Seasilver,
    worth nearly \$5.3 million, from Seasilver USA\'s San Diego,
    California, headquarters in an action initiated by FDA. The
    complaint for seizure alleged that, although Seasilver USA marketed
    Seasilver as a dietary supplement, it promoted it on the Internet
    and in marketing materials sent with the product as a treatment for
    serious diseases including cancer, diabetes, hypoglycemia,
    psoriasis, hepatitis, and arthritis. On June 25, 2003, U.S. Marshals
    seized an additional 1.7 million dollars worth of Seasilver from a
    distribution center in Parma, Ohio. In response to an FTC request,
    the Federal district court in the Southern District of California
    issued a temporary restraining order on June 13, 2003, prohibiting
    Seasilver USA, Americaloe Inc., and principals in the companies from
    making the challenged claims, and froze their assets. FTC is seeking
    preliminary and permanent injunctive relief, including restitution
    to consumers who purchased the product. Legal proceedings are
    ongoing.

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-   On May 27, 2003, the FTC filed a complaint against an individual and
    four of his corporations for making false and unsubstantiated
    claims. The individual claimed that that five of the products
    marketed by him and his corporations as dietary supplements were
    "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
    included: Lung Support Formula (claimed to cure or ameliorate
    asthma, emphysema, smoking damage and other respiratory problems);
    Antibetic Pancreas Tonic (claimed to treat or cure diabetes and to
    lower blood sugar levels); GH3 and GH3 Romanian Youth Formula
    (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 (claimed to
    treat erectile dysfunction).

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-   On May 9, 2003, FDA and FTC warned website operators, manufacturers,
    and distributors to remove misleading or deceptive claims on the
    Internet that their products may prevent, treat or cure Severe Acute
    Respiratory Syndrome (SARS). A net "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 included dietary supplements containing ingredients
    such as colloidal silver, ascorbic acid, beta glucan, pycnogenol,
    and oregano oil.

> FDA sent Warning Letters to eight firms promoting dietary supplement
> products as treatment or preventative remedies for SARS over the
> Internet. FTC also notified violative firms that they were subject to
> possible civil or criminal actions under the Federal Trade Commission
> Act. FDA has conducted appropriate follow-up to ensure that the firms
> have taken appropriate corrective action.

-   In World Without Cancer Inc., FDA and DOJ, with the assistance of
    FTC, sought a temporary restraining order, preliminary injunction,
    and permanent injunction against the marketing of unapproved new
    drugs by three corporations and one individual. The products,
    laetrile, in both injectable and tablet forms, and apricot seeds,
    were promoted as "dietary supplement" cancer treatments through the
    firm's websites. The preliminary injunction and the subsequent
    Consent Decree of Permanent Injunction required the defendants to
    cease using the websites to promote the sale or offer for sale their
    laetrile products.

[^1]: Bennett, J. and CM Brown. 2000. "Use of Herbal Remedies by
    Patients in a Health Maintenance Organization." *Journal of the
    American Pharmaceutical Association*. Volume 40, Number 3: 353-358.

[^2]: *Ephedra and Ephedrine for Weight Loss and Athletic Performance
    Enhancement: Clinical Efficacy and Side Effects*. File Inventory,
    Evidence Report/Technology Assessment Number 76. AHRQ Publication
    No. 03-E022, March 2003. Agency for Healthcare Research and Quality,
    Rockville, Maryland.

[^3]: *Ephedra and Ephedrine for Weight Loss and Athletic Performance
    Enhancement: Clinical Efficacy and Side Effects*. File Inventory,
    Evidence Report/Technology Assessment Number 76. AHRQ Publication
    No. 03-E022, March 2003. Agency for Healthcare Research and Quality,
    Rockville, Maryland.