| U.S. Food and Drug Administration |
FDA Special Report, Sep 10, 2001
STATEMENT OF John M. Taylor
Director, Office of Enforcement, Office of Regulatory Affairs
Food and Drug Administration Before the Special Committee on Aging
John B. Breaux, Chairman, United States Senate
Introduction
Good morning, Mr. Chairman, Members
of the Committee. I am John M. Taylor, Director, Office of Enforcement, Office
of Regulatory Affairs (ORA), Food and Drug Administration (FDA or the Agency). I
am pleased to be here this morning to participate in this discussion of "health
fraud," specifically as it relates to dietary supplements. I will describe FDA's
role, some successes, and challenges in combating this threat to public health -
particularly as it is targeted to our senior citizens and other vulnerable
populations.
Health Fraud
What is health fraud? Health fraud
is the deceptive promotion, advertising, distribution, or sale of articles
represented as being effective to diagnose, prevent, cure, treat, or mitigate an
illness or condition, or provide a beneficial effect on health but has not been
scientifically proven safe and effective for such purposes. You do not have to
look far to find a health product that is potentially fraudulent, or a consumer
who is totally unsuspecting. Promotions for fraudulent products appear daily in
newspaper and magazine ads and television "infomercials." They accompany
products sold in stores and through mail-order catalogs. They also are passed
along by word of mouth.
The Internet is another method by
which fraudulent products can be 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 obtain a plethora of medical information
that often helps them to understand health issues and treatment options. As
beneficial as this technology can be, it also creates a new marketplace for
activity that is already illegal, such as the sale of unapproved new drugs,
prescription drugs (Rx) dispensed without a prescription, and products marketed
with fraudulent claims about health benefits. Furthermore, because the Internet
is a worldwide communications system, U.S. citizens are now susceptible to fraud
from sources outside the U.S. as well as domestically.
Consumers respond to these
promotions, spending billions of dollars a year on fraudulent health products,
according to Stephen Barrett, M.D., head of Quackwatch Inc., a non-profit
corporation that combats health fraud. Hoping to find a cure for their illness,
improve their well-being, or even their appearance, 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.
In general, these promotions are
not specifically targeted to one population - such as senior citizens - as the
goal is to quickly establish a broad customer base and maximize sales before
being "found out." Given the types of claims that these products make, however,
one could certainly extrapolate that some of these products are intended
primarily for senior citizens. While FDA's law enforcement efforts cannot be
defined by population and demographics, our education and outreach efforts do
certainly strive to reach specific populations, which I will describe later.
FDA's mission is to protect and
promote the public health. While we are first and foremost a science-based
public health agency, we also are a law enforcement agency. It is in both of
these capacities that we strive to meet our mission of protecting consumers
against health fraud. Strong law enforcement tools - including a cadre of
seasoned law enforcement agents and sufficient statutory authority - coupled
with a strong base of medical and scientific expertise to evaluate marketed
health products are vital to the Agency's ability to meet its mission of
protecting the public health.
Let me first provide a brief
background on dietary supplements and drugs and the statutory framework under
which they are regulated.
Background
Dietary Supplements
Congress defined the term "dietary
supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
A dietary supplement is a product that is ingested, is intended to supplement
the diet and, among other requirements, contains a "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. Information on
their label must not represent the product as a conventional food or a sole item
of a meal or diet. Instead, DSHEA placed dietary supplements in a special
category under the general umbrella of "foods" and requires that every
supplement be labeled as a dietary supplement.
The dietary supplement industry has
grown exponentially since the enactment of DSHEA. Today's multi-billion dollar
dietary supplement industry is now one of the world's fastest growing
industries. In the past, dietary supplements were mainly sold to adults in
health food stores. These products can now be purchased in supermarkets, retail
stores, and even through the Internet, making them available to a much wider
range of consumers of all ages.
The Washington Post reported last
month on just herbal supplements. The Post stated that "Americans alone bought
$4.5 billion worth of such popular preparations as St. John's wort, echinacea
and many others. . . ." Further, according to a graph in the article, the $4.5
billion spent by Americans last year is up from around $3 billion in 1996. The
full range of dietary supplement product sales is reported to have reached $17.1
billion in 2000.1 Between 1994 and 2000, consumer spending on dietary
supplements nearly doubled, and sales continue to grow at better than ten
percent a year.2
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:
- harmful interactions between
dietary supplements and prescription or over-the-counter (OTC) pharmaceutical
products;
- substituting unproven treatments
for proven medical treatments;
- taking products that have no
health benefit;
- adverse effects; and,
- the 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 fashion.
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.
Drugs
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:
- Prescription drugs: medicines
that must be administered under a doctor's supervision or require a doctor's
authorization for purchase;
- OTC 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,
- Generic 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 [PHS] Act).
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 the law.
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:
- Consumer 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;
- Scientists in ORA's 13
laboratories analyze about 30,000 products each year to determine their
adherence to the law and the Agency's standards; and,
- Public 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 commerce.
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 government authorities.
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 a cure.
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.
Christian Brothers
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.
Hit Products
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 new drug.
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 these substances.
Other Activities To Combat
Health Fraud
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
health departments.
"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."
Internet Activities
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
online.
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 products.
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.
Conclusion
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.
1 "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.
2 Nutrition business
Journal, San Diego, 1998.
The text in this article was prepared by the FDA Office of Public Affairs.