In a survey conducted
last year by PREVENTION Magazine ("Survey of Consumer Use
of Dietary Supplements," Rodale Press, 733 Third Ave., New
York, New York 10017-2000) over 158 million consumers use
dietary supplements. Further, the survey found that consumers
use dietary supplements to help them achieve their self-care
goals and as a means of ensuring good health. They also
use them for "medicinal" purposes such as treating and preventing
various illnesses, colds, flu, increasing mental sharpness,
and alleviating depression. The consumer's desire for self-care
and the widespread use of dietary supplements raises a number
of issues, including the possibility of:
interactions between dietary supplements and prescription
or over-the-counter (OTC) pharmaceutical products;
unproven treatments for proven medical treatments;
products that have no health benefit;
focus of this hearing - health fraud.
When Congress passed DSHEA, it created a
unique regulatory framework for dietary supplements. Its
purpose was to strike the right balance between providing
consumers access to dietary supplements and truthful information
about them, while preserving regulatory authority for FDA
to take action against supplements that present safety problems
or that are labeled or promoted in a false or misleading
As you know, the regulation of dietary supplements
is, for the most part, a post-marketing program, and they
are regulated by FDA's Center for Food Safety and Applied
Nutrition (CFSAN). Since Congress considered dietary ingredients
marketed prior to the passage of DSHEA to be safe, dietary
supplements containing these ingredients are permitted to
be freely marketed, just like regular foods (e.g., fresh
fruits and vegetables, processed foods and beverages, and
seafood). Should safety problems arise after marketing,
the adulteration provisions of the statute come into play.
Under DSHEA, a dietary supplement is adulterated if, among
other reasons, it or one of its ingredients presents "a
significant or unreasonable risk of illness or injury" when
used as directed on the label or under normal conditions
of use (if there are no directions). The burden of proof
is on FDA to show that a product or ingredient presents
such a risk.
The mission of FDA's Center for Drug Evaluation
and Research (CDER) is to assure that safe and effective
drugs are available to the American public. They work to
accomplish this mission through a commitment that lasts
for the lifetime of the product - from the early stages
of drug review and approval to monitoring the products once
they reach the marketplace.
Consumers usually think of drugs as the
medicines they take to treat illnesses, but most Americans
use CDER-regulated drug products every day to maintain health.
Drugs include more than just medicines. For example, fluoride
toothpastes, antiperspirants, dandruff shampoos, and sunscreens
are all considered "drugs," within the meaning of the Federal
Food, Drug, and Cosmetic (FD&C) Act.
Most drugs CDER regulates are manufactured
by a chemical process. They can include:
drugs: medicines that must be administered under a doctor's
supervision or require a doctor's authorization for purchase;
drugs: medicines that are available to consumers without
a doctor's prescription. Consumers can successfully diagnose
many common ailments and treat them with readily available
OTC products; and,
drugs: medicines that are chemical clones of a drug sold
under a brand name. There are generic versions of prescription
drugs and OTC drugs.
Ailing Americans and their health care providers
have at their disposal more than 10,000 FDA-approved drugs
that have met the world's most rigorous reviews for safety
and effectiveness. Drug companies seeking to sell a "new
drug" in the U.S. must first test it, and prove that it
is safe and effective for its intended use before it can
be approved for marketing. CDER adheres strictly to its
high requirements for drug approval, which are recognized
as the world's gold standard.
Among its other activities, CDER is taking
steps to make drugs safer for older adults, who consume
a proportionately larger share of the nation's medicines.
Adults over 65 buy 30 percent of all prescription drugs
and 40 percent of all OTC drugs. Almost every drug that
comes through FDA for approval has been examined for effects
in the elderly.
In 1997, FDA finalized a rule that requires
drug companies to include a separate "Geriatric Use" section
in their drugs' labeling. Drug companies do not have to
perform additional studies, but must include available information
in a specific format and location on the label.
Of all the problems older adults face in
taking medications, drug interactions are probably the most
dangerous. When two or more drugs are mixed in the body,
they may interact with each other and produce uncomfortable
or even dangerous side-effects. This is especially a problem
for older adults because they are much more likely to take
more than one drug. Two-thirds of adults over the age of
65 use one or more drugs each day, and one-quarter of them
take three drugs each day.
There also is evidence that older adults
tend to be more sensitive to drugs than younger adults,
because of their generally slower metabolism and organ functions.
As people age, they lose muscle tissue and gain fat tissue,
and their digestive systems, liver, and kidney functions
diminish. All this affects how a drug will be absorbed into
the bloodstream, react in the organs, and how quickly it
will be eliminated. Not all combinations are bad. However,
unless supervised by a doctor, taking a mixture of products
can be dangerous.
FDA as a Law Enforcement Agency
As I mentioned, while we are a science-based
public health agency, FDA also is a law enforcement agency.
FDA is charged with protecting American consumers by enforcing
the FD&C Act, its implementing regulations, and several
related public health laws (e.g., the Public Health Service
FDA shares Federal oversight of dietary
supplements with the Federal Trade Commission (FTC). FDA
regulates safety, product manufacturing and product labeling.
FTC has primary responsibility for regulating the advertising
of these products.
When a problem arises with a product regulated
by FDA, the Agency can take a number of actions to protect
the public health. For dietary supplements, as with other
products, initially, the Agency works with the marketer
of the product to correct the problem voluntarily. If that
fails, the Agency also can ask the marketer to recall a
product voluntarily; seek, through the courts, seizure of
violative products and/or injunction against firms or individuals
who market violative products, and detain or refuse entry
of products presented for import at U.S. ports. When warranted,
criminal penalties - including prison sentences - are sought
through the courts, as well as against those who violate
As an agency that protects the health of
all Americans, FDA must keep in touch with consumers and
firms dealing with regulated products all over the U.S.
FDA's ORA is the lead office for all field activities for
the Agency, and represents about one-third of FDA's personnel.
Stationed in more than 150 District Offices, Resident Posts
and Laboratories from coast to coast and in Puerto Rico,
ORA's highly trained staff provides the eyes, ears, and
long arm of the Agency that assures the implementation of
FDA's public health standards.
Some of the major activities of ORA include:
Safety Officers and inspectors conduct about 16,000 domestic
and foreign inspections per year to assure that regulated
products destined for the U.S. market are in compliance
with the law and meet the Agency's standards;
in ORA's 13 laboratories analyze about 30,000 products each
year to determine their adherence to the law and the Agency's
affairs specialists reach out to consumer groups, health-care
professionals, and State health authorities to explain FDA
policies and encourage compliance with the law and FDA standards.
My office, the Office of Enforcement (OE),
is one of four offices in ORA. OE is the lead office for
setting regulatory and compliance policy for the Agency,
and coordinates and directs FDA's overall compliance efforts.
In addition, the Office of Criminal Investigations
(OCI), within ORA, is FDA's criminal investigative arm.
OCI is a traditional criminal investigative agency staffed
by experienced Special Agents drawn from a wide variety
of agencies throughout Federal law enforcement. Their job
is to identify and investigate suspected criminal violations
of the FD&C Act, PHS Act, and related Title 18, United
States Code violations.
ORA works in close cooperation and coordination
with all of FDA's Centers (the Centers) in enforcing the
law. With regard to health fraud specific to dietary supplements,
CFSAN has the lead and is responsible for the oversight
of dietary supplements. CDER also has a role to play, as
many of the most successful cases the Agency has brought
concerned products purporting to be dietary supplements
that were actually drugs within the meaning of the FD&C
Act and failed to meet the regulatory requirements that
drugs must meet prior to their introduction into interstate
How A Case Is Made
Health fraud, as with any other violation
of the FD&C Act or PHS Act, can be brought to the Agency's
attention in a variety of ways. For example, FDA's investigators
often identify the violations while conducting inspections.
FDA may also identify a violation or a suspected fraudulent
product through routine market-place surveys, searches on
the Internet; adverse event reports; complaints from consumers;
competitors or public interest groups; informants; or through
referrals from the FTC or other Federal, State, or local
As with all of FDA's activities, priorities
are established based on benefit/risk to public health.
The Agency's regulation of health fraud products is based
on a priority system that depends on whether a fraudulent
product poses a direct or indirect risk to public health.
The susceptibility of the population is an element that
is considered when determining risk. For example, terminal
cancer patients would be considered highly susceptible,
as many have exhausted conventional or standard of care
treatments, and are desperate to try anything that may promise
Products that present a direct health hazard
to the user are the Agency's highest priority. Such products
include those, which have a reasonable potential for causing
direct serious adverse effects, or there is documentation
of injury or death. Examples of such products include tiratricol,
dinitrophenol, and gammabutyrolactone (GBL). When such products
are encountered, the Agency will use all available civil
and administrative remedies to assure that the product is
quickly removed from the market. Publicity is used to warn
consumers and health professionals about such products.
The decision to open a criminal investigation is based primarily
on the public health threat level, indications of criminal
intent, and the scope of the violation, as well as the potential
impact of an effective prosecution.
Products that are not themselves hazardous
can still present an indirect health hazard in that the
consumer may delay or forego proven medical treatment and
the use of proven
drug therapies. 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, priorities are also established with respect
to risks posed by such products in undermining the integrity
of the new drug application (NDA) and OTC Drug Review processes.
The NDA and OTC Drug Review procedures provide consumers
with assurance that Rx 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. Coupled with a credible threat of enforcement,
the Agency's actions assure that manufacturers are properly
motivated to bear the costs of developing "new drugs" in
conformance with the NDA provisions and that the playing
field is fair and equitable for those who do.
Examples of FDA Enforcement Actions
Despite the complexities involved in building
and bringing an enforcement action, the Agency, working
with the Department of Justice's (DOJ) Office of Consumer
Litigation, has been successful in bringing cases against
fraudulent products in all categories of FDA-related products.
Let me discuss a few examples.
Last November, Christian Brothers Contracting
Corporation and its President, Jason Vale, signed a consent
decree of permanent injunction in which they agreed to stop
manufacturing, processing, and distributing the firm's amygdalin
products, also referred to as Laetrile, Vitamin B-17 or
apricot kernels. This case was developed in conjunction
with the FTC and DOJ. Despite repeated warnings by FDA,
the products continued to be promoted through numerous websites
for the cure, treatment, and prevention of cancer.
Amygdalin is a glucoside found in the kernel
or seeds of many fruits and is frequently referred to as
"Laetrile" or "Vitamin B-17." While some of the proponents
have recommended it for the treatment and control of cancer,
FDA has never approved these claims. There are no published
clinical studies that demonstrate that laetrile is safe
and effective and cancer patients who take it sometimes
forgo conventional therapies to their detriment.
World Without Cancer Inc., The Health
World International, Health Genesis Corporation, and David
E. Arjona, an officer of the three corporations
Last summer, 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 injectable and tablet form, and
apricot seeds, were promoted as cancer treatments through
their Internet websites. Despite FDA warnings to these companies
in 1998, they continued to promote their products as remedies
for cancer. In January 2001, District Court Judge Shelby
Highsmith entered a Consent Decree of Permanent Injunction
in this case with regard to defendants World Without Cancer,
Health Genesis Corporation, and David E. Arjona. The preliminary
injunction and Consent Decree of Permanent Injunction required
the defendants to cease using the websites to promote the
sale or offer for sale their laetrile products.
United States v. Syntrax Innovations,
Inc., et al.
This case 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 Triax posed a serious health
hazard to those who consumed the product. The product contained
tiratricol, a potent thyroid hormone, that FDA medical review
identified as a hazardous compound that could 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 the definition set
forth in DSHEA.
This case began as a seizure by DOJ, but
the government amended the complaint to request injunctive
relief. Syntrax originally contested the case, but later
conceded that Triax is a drug. On February 14, 2001, a District
Court Judge entered an order of injunction to prevent the
distribution of Triax by Syntrax Innovations.
This case demonstrates the extremes to which
promoters of fraudulent products will go to create a market
for their products. These products were marketed towards
a younger consumer base. Hit Products, Inc., and Organic
Diversions, Inc., were marketing 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 charged that they were misbranded
and unapproved new drugs in violation of the FD&C Act.
Therefore, the government seized the violative products.
The court found FDA's position on street
drug alternatives "highly persuasive" and criticized the
defendant's characterization of the products as dietary
supplements as a "veiled attempt to circumvent" the FD&C
Act. The court "decline[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." This case was the Agency's first
suit following issuance of a guidance document in
April 2000 informing the public that any
product promoted as an alternative to illegal street drugs
would be regarded by FDA as a misbranded and unapproved
Nature's Nutrition Formula One
FDA determined that this pre-DSHEA product,
which was marketed between 1992 and 1994 as an all natural
"nutritional supplement" that contained 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, ranging from serious and life-threatening
conditions, such as irregular heartbeat, heart attack, stroke,
seizures, hepatitis and psychosis, to relatively minor and
temporary conditions such as dizziness, headache and gastrointestinal
distress. At least one death was associated with the use
of this product.
This case was developed by the alerts provided
from the adverse event reports, ORA's field staff, and the
work of OCI together with DOJ, 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, James Cameron.
On July 7, 2000, a Federal judge sentenced
James Cameron to 21 months in jail and fined him and this
corporation $4.7 million. In his plea agreement, Mr. Cameron
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. Mr. Cameron,
whose company continues to make dietary supplements, began
serving his sentence in September 2000.
In addition, FDA and DOJ have pursued seizures
of a number of unapproved drugs that have been promoted
on the Internet as dietary supplements, including GBL and
1,4 butanediol. FDA also has sought product recalls and
achieved the voluntary destruction of 18 products containing
Other Activities To Combat Health
The Agency has a number of ongoing activities
directed at combating health fraud. Many of these activities
are the result of a strategy plan begun by FDA in 1992,
to improve their processes for targeting and coordinating
regulatory activities between ORA, field, headquarters units,
the Centers, Office of General Council and other Federal/State/local
regulatory and law enforcement agencies. This strategy also
focused on improving the Agency's efforts to educate the
public about the importance of making wise choices concerning
their health care.
Health Fraud Working Group
In 1992, FDA began sponsoring a National
Health Fraud Working Group. The Working Group is currently
comprised of representatives from the Association of Food
and Drug Officials, State Attorneys General, FTC, Health
Canada, and FDA representatives from the center and field
offices. This group meets on a regular basis to facilitate
the coordination of regulatory activities, information exchange,
and leveraging of each member agency.
The Working Group is currently considering
ways in which their activities and outcomes can be improved
upon. Preliminary discussions include the benefits that
may be achieved by expanding the membership to include representatives
from non-governmental organizations that combat health fraud.
AIDS Health Fraud Task Force Network
FDA sponsors a network of AIDS Health Fraud
Task Forces throughout the U.S. The Task Forces, which are
currently located in 19 States, maintain a proactive approach
to combat fraudulent products and treatments affecting people
with HIV/AIDS and their families. The network strives to
promote awareness and prevent fraud through education that
empowers individuals to make informed decisions about their
health care. The Task Forces have developed hotlines, workshops,
conferences, and advocacy sharing as an alert mechanism
to new fraudulent product promotion. The media has been
utilized to broaden awareness in the diverse communities
that are served by the Task Force. Members of the Task Force
Network include persons living with HIV/AIDS, community-based
organizations, treatment advocates, health care practitioners,
educators, Federal and State government officials, and local
" Operation Cure.All "
In 1997, FTC, FDA, Health Canada, and various
State Attorneys General organized and implemented an ongoing
and comprehensive law enforcement and consumer education
campaign against the fraudulent marketing of supplements
and other health products on the Internet. The agencies
have moved to stop Internet scams for supplements and other
products that purport to cure cancer, HIV/AIDS and countless
other life-threatening diseases.
FDA has made Internet surveillance an enforcement
priority; the Agency's partnership with FTC, and others,
in "Operation Cure.All," further demonstrates FDA's commitment
to monitoring violative conduct on the Internet. Collaboration
on all "Operation Cure.All" activities maximizes FDA's effectiveness
in communicating to the Internet community that the various
regulatory and law enforcement agencies are working together
to combat health fraud. All activities are coordinated in
order to ensure consistent results in areas where FTC, FDA,
the States and Health Canada have jurisdiction.
Since its inception, "Operation Cure.All"
has resulted in 48 cyber-letters directed at sites selling
colloidal silver products with egregious disease claims
as well as several enforcement activities directed against
the marketing of fraudulent products.
In addition, the Agency has engaged in several
consumer education efforts with FTC including a "Facts for
Consumers" brochure that is focused on fraudulent claims
and spotting quackery and health fraud. Today, we are announcing
with FTC the publication of a recently revised brochure,
"Miracle Health Claims: Add A Dose of Skepticism."
Over the past several years, FDA has sharpened
its focus on the issue of Internet promotion and sale of
drugs as online activity has expanded. In 1996 and again
in 1999 FDA held public meetings to discuss and examine
the issue of promoting, prescribing and dispensing drugs
In July 1999, FDA adopted, and has since
been implementing, an Internet Drug Sales Action Plan to
expand and improve its activities in addressing the unlawful
sale of drugs over the Internet. The illegally marketed
drugs targeted by the plan include a variety of fraudulent
products, including counterfeit drugs, drugs marketed with
fraudulent health-related claims, and unapproved new drugs
masquerading as dietary supplements. The plan is based on
internal deliberations, meetings with Federal and State
regulatory and law enforcement bodies, as well as organizations
representing consumers, health care practitioners, and the
pharmaceutical and pharmacy industries. The elements of
the plan include, among others:
• Public Outreach: FDA Talk Papers ,
articles in the FDA Consumer magazine, and information
on FDA's website to help educate consumers about safely
purchasing drugs online.
• Professional Outreach and Partnering:
Periodic meetings with State and Federal regulatory and
law enforcement bodies, consumers, health care practitioners
and industry to share information and strategize about how
to address the challenges the Internet presents.
•Coordinating Activities with other State
and Federal Agencies: Established cooperative working
relationships with DOJ, the Drug Enforcement Administration,
the Federal Bureau of Investigation, FTC, U.S. Postal
Service, U.S. Customs Service, and other appropriate Federal
and State law enforcement agencies.
•International Cooperation: Because FDA and
other Federal agencies possess limited investigatory jurisdiction
over sellers in foreign countries, we must work with foreign
governments to bring action against such individuals.
Take Time To Care Campaign (TTTC)
One of the Agency's most successful campaigns
has been FDA's Office of Women's Health (OWH), "Take Time
To Care" Campaign. While the campaign is not specifically
targeted to preventing or educating against health fraud,
the success of the program in educating women about using
medicines wisely certainly should lessen the chances that
the women educated will fall prey to the marketers of fraudulent
Started in 1997 as a pilot, expanded in
1998, and rolled out nation-wide in 1999, the intent of
the campaign was to educate women and their families about
safe medicine use. The key element of the campaign is the
"My Medicines" brochure. Colorful and compact, it includes
tips for taking medicines correctly as well as a personal
record card for tracking medicine use. Like the entire TTTC
campaign, the brochure is designed
primarily for women, who use more medication
than any other group and often manage medications for their
whole family. The purse-sized brochure promotes four key
messages: Read the Label, Avoid Problems, Ask Questions,
and Keep a Record.
In order to maximize FDA's OWH impact, the
OWH initiated partnerships with local health and social
service organizations, pharmacies, senior centers, religious
congregations, universities, women's groups, and workplaces.
In 1999, the National Association of Chain Drug Stores (NACDS)
joined OWH as an official co-sponsor. As a result of their
work and innovative collaboration, the campaign in partnership
with 80 national organizations and NACDS distributed over
6 million "My Medicines" brochures in a single month. This
now successful national campaign was the subject of a presidential
proclamation and received a public endorsement from the
American Medical Association.
While FDA tries to be vigilant against health
fraud, many fraudulent products escape regulatory scrutiny,
maintaining their hold in the marketplace for some time
to lure increasing numbers into their web of deceit. For
every such marketer that we put out of business, another
or more appear. As long as there are vulnerable populations
to prey upon, there will continue to be those unsavory and
unscrupulous characters who do so.
Mr. Chairman, combating health fraud is
a challenge, especially in light of the advent of the Internet,
and one to which the Agency is committed to addressing.
Our partnerships with our law enforcement, public health,
State, local and international colleagues expand FDA's reach
and impact. Good enforcement strategies and enforcement
actions, vigilant oversight of the marketplace, and sufficient
legal authority to remove these products from the market
is not enough. Successfully combating health fraud must
include educating our citizens to recognize fraud when they
see it, and warning them of the potential dangers that some
of these products pose. Only through these steps can we
help the public make fully informed decisions about their
health care purchases, and thereby reduce the number of
people who may fall prey to these fraudulent products.
We have a strong education program, and
we applaud hearings such as this, which bring this issue
to national prominence. Thank you for the opportunity to
participate in this hearing. We look forward to working
with you as we grapple with health fraud as a nation. I
would be happy to answer any questions you might have.
"U.S. Dietary Supplements Market Size Expressed
as Dollar Sales by Top Six Product Categories for 1994 to
1998 and Forecast for 1999 and 2000," National Business
Journal, 2000, Dialog file No. 93,
San Francisco: The Dialog Corporation, 2000.
Nutrition Business Journal, San Diego, 1998.
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Last revised: September 14, 2001