Congressional Testimony; 6/8/2004

Congressional Testimony


Statement of Robert Brackett, Ph.D. Director, Center for Food Safety
and Applied Nutrition U.S. Food and Drug Administration Committee on Senate
Governmental Affairs Subcommittee on Oversight of Government Management
June 8, 2004
Thank you, Mr. Chairman for this opportunity to testify before
your Subcommittee at this hearing entitled, ``Dietary Supplement Safety
SUPPLEMENTS Many Americans take some type of dietary supplement, and in
many cases, there is either strong or suggestive evidence that many of
these vitamins and minerals and other naturally occurring products have
important health benefits. The Dietary Supplement Health and Education
Act of 1994 (DSHEA) (P.L. 103-417) amended the Federal Food, Drug, and
Cosmetic (FD&C) Act to set up a distinct regulatory framework for these
products in an attempt to strike the right balance between providing consumers
access to dietary supplements that they may choose to help maintain and
improve their health, and giving the Food and Drug Administration (FDA
or the Agency) regulatory authorities to take action against supplements
or supplement ingredients that present safety problems, have false or misleading
claims, or are otherwise adulterated or misbranded. Although dietary supplements
are regulated as foods in that pre-market approval is not mandatory, DSHEA
and FDA`s implementing regulations establish special requirements for dietary
supplements that differ in some respects from those covering ``conventional``
foods, and that also differ from those that apply to drug products (prescription
and over-the- counter). Congress defined the term ``dietary supplement``
as a product that, among other things, is intended for ingestion, is intended
to supplement the diet, is labeled as a dietary supplement, is not represented
as a conventional food or as a sole item of a meal or diet, and contains
a ``dietary ingredient.`` ``Dietary ingredients`` are defined as vitamins,
minerals, amino acids, herbs or other botanicals, dietary substances (such
as enzymes), and concentrates, metabolites, constituents, extracts, or
combinations of the preceding types of ingredients. Dietary supplements
may be found in many forms, such as tablets, capsules, liquids, or bars.
LABELING OF DIETARY SUPPLEMENTS Under the FD&C Act and FDA`s implementing
regulations, the label of a dietary supplement must bear a statement of
identity (product name) that identifies the product as a dietary supplement;
nutrition information in the form of a Supplement Facts panel; a list of
any ingredients not listed in the Supplement Facts panel; the name and
address of the manufacturer, packager, or distributor; and the net quantity
of contents. In addition, if the labeling includes a claim to affect the
structure or function of the body, a claim of general well-being, or a
claim of a benefit related to a classical nutrient deficiency disease,
the product must bear a disclaimer stating that FDA has not evaluated the
claim and that the product is not intended to diagnose, treat, cure, or
prevent any disease. Furthermore, a manufacturer of a dietary supplement
making such a claim must have substantiation that the claim is truthful
and not misleading and must notify FDA that its product bears such a claim
within 30 days of marketing the product with the claim. Dietary Supplement
Safety Statutory Framework As with most foods, there is no requirement
for manufacturers of most dietary supplements to provide evidence of product
safety to FDA prior to marketing. Accordingly, FDA regulates the safety
of dietary supplements primarily through a post-market evaluation of whether
the product is adulterated under one of the provisions of the FD&C Act.
However, there is a 75-day pre-market notification requirement for manufacturers
or distributors of dietary supplements that contain ``new dietary ingredients,``
those dietary ingredients that were not marketed in the U.S. before October
15, 1994, unless the supplement contains only ingredients that have been
present without chemical alteration in the food supply as an article used
for food. In its notification to FDA, the manufacturer or distributor of
the supplement must submit information, including citation to published
articles, that forms the basis for the firm`s conclusion that the dietary
supplement containing the new dietary ingredient will reasonably be expected
to be safe. Unless there is a history of use or other evidence of safety
establishing in the labeling that the new dietary ingredient will reasonably
be expected to be safe when used as recommended, the supplement is deemed
adulterated. Scientific Research In order to be informed about the safety
of dietary supplements, in addition to assessing known reported adverse
events, FDA evaluates published literature, evidence-based reports, and
the known pharmacology of a compound in order to assist in the evaluation
of dietary supplement products. Collaboration with academic centers such
as the National Center for Natural Products Research (NCNPR), Federal partners
such as the National Institutes of Health and the National Center for Toxicological
Research, and our consumer and industry stakeholders is important in developing
a comprehensive safety evaluation of dietary supplement products. For example,
the partnership that FDA has with NCNPR at the University of Mississippi
is valuable for finding practical solutions to scientific problems. For
dietary supplements containing botanical ingredients, development of such
a science base can be especially difficult because of the complexity of
the chemicals that make up these products and the variability between one
product and another. CFSAN Adverse Event Reporting System (CAERS) Adverse
event reports (AERs) are an important tool for developing a ``signal``
which can help FDA to identify potential safety problems with dietary supplements.
Last year, FDA`s Center for Food Safety Applied Nutrition (CFSAN) put in
place the CFSAN Adverse Event Reporting System (CAERS) to monitor adverse
event reports for CFSAN-regulated products, i.e. food (including dietary
supplements) and cosmetics. Adverse event reporting for dietary supplements
is not mandatory. CAERS is a computerized system that records reports submitted
voluntarily by industry, health care providers, and consumers. This system
started collecting reports after June 15, 2003, and unifies CFSAN`s adverse
event reporting through one common portal. Future planned capabilities
include transitioning data from older systems into the CAERS portal, developing
a botanical thesaurus to enable more sophisticated search strategies, and
electronic links to other databases such as MedWatch and poison control
Under DSHEA, another important arm of FDA`s regulatory and surveillance
activities used to help ensure the safety of dietary supplement products
is the Agency`s authority to promulgate regulations for dietary supplement
current good manufacturing practices (cGMPs). Such regulations will help
ensure product quality and consistency. FDA published a proposed rule for
dietary supplement cGMP on March 13, 2003. Examples of product quality
problems the dietary supplement cGMP proposal would help prevent are: superpotent
and subpotent products, wrong ingredients, presence of contaminants (e.g.,
bacteria, pesticide, glass, and lead), under-filled containers, foreign
material in a dietary supplement container, improper packaging, and mislabeling.
The publication of the final rule on dietary supplement cGMP remains a
high priority for FDA. A 90-day public comment period on the proposed rule
was extended 60-days and closed on August 11, 2003. During the comment
period, FDA staff participated in two outreach meetings and an FDA-sponsored
satellite downlink, as well as three outreach meetings organized by industry
groups to ensure that dietary supplement manufacturers (especially small
manufacturers) and other interested parties were familiar with the proposal.
Due to the volume of comments and requests by commenters, FDA extended
the time period in order to receive additional public comments. We are
currently reviewing over 1600 pages of comments, which include more than
400 substantive comments that are being carefully analyzed. We plan to
publish a final rule once this evaluation is completed. We recognize the
importance of having dietary supplement cGMP in place and we are moving
forward to complete this regulatory priority under DSHEA. This proposed
rule, if finalized as proposed, will give consumers greater confidence
that the dietary supplements that they choose to use will have the identity,
strength, purity and composition that they are represented to have. Consumer
Health Information for Better Nutrition Initiative As part of FDA`s efforts
on dietary supplements, the Agency has been working to inform consumers
about these products and their uses. On December 18, 2002, the FDA Commissioner
announced the Consumer Health Information for Better Nutrition Initiative.
The focus of this effort is to make available more scientifically accurate
information about foods and dietary supplements so Americans know the health
consequences of what they consume. This Better Health initiative is designed
to foster two complementary goals concerning the labeling of food and dietary
supplements: * encouraging makers of conventional foods and dietary supplements
to make accurate, science-based claims about the health benefits of their
products, and * bringing enforcement actions against those dietary supplement
marketers who make false or misleading claims. In a July 10, 2003, status
report on the Better Health Initiative, FDA issued interim guidance on
a process to review qualified health claims, pending rulemaking to provide
for qualified health claims. In addition, the Agency announced enhanced
enforcement activity against dietary supplement manufacturers and others
who make misleading claims about health benefits that are not based on
science. These enforcement activities are described below. ENFORCEMENT
ACTIONS At the core of FDA`s DSHEA enforcement efforts is our commitment
to work with industry in order to encourage the legitimate manufacture,
sale, and use of dietary supplements while enforcing the law aggressively
against fraudulent product claims and other illegal practices. Dietary
supplement enforcement efforts include inspections that have resulted in
voluntary compliance, voluntary recalls, warning letters, seizures and
injunctions, criminal enforcement, and joint enforcement actions with the
Federal Trade Commission (FTC) and the Department of Justice. FDA shares
Federal oversight of dietary supplements with 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, FDA and FTC have worked well together to ensure that there
is a seamless assertion of our jurisdiction over these products. With the
mutual goal of consumer protection, FDA and FTC chair an interagency health
fraud steering committee that includes Federal agencies in the U.S., Canada,
and Mexico. Also, as part of FDA`s effort to curb Internet health fraud,
the Agency has conducted several ``surfs`` to identify fraudulent marketing
of health care products over the Internet. These actions were carried out
in partnership with FTC and other law enforcement and public health authorities
in the U.S. and abroad. From October 2002 through April 2004, FDA has conducted
224 domestic inspections of dietary supplement manufacturers, issued more
than 170 warning letters and ``cyber letters`` to marketers of dietary
supplement products, seized products worth more than $9 million, supervised
the voluntary destruction of more than $3 million worth of products marketed
as dietary supplements that were promoted with unsubstantiated claims or
that were unapproved drugs, and obtained permanent injunctions against
5 firms distributing misbranded or unapproved drugs as dietary supplements.
FDA enforcement has extended to our nation`s borders, where we have refused
importation for more than 1,500 foreign shipments of potentially unsafe
or misbranded dietary supplements offered for entry in the U.S. The Agency`s
enforcement actions send a clear message that FDA will not tolerate fraudulent
practices that victimize or endanger consumers. As with all of FDA`s activities,
priorities are established based upon the direct impact upon public health.
Products that present a direct health hazard to consumers are the Agency`s
highest priority, although FDA also proceeds against products that present
indirect health threats. When the Agency encounters such products, FDA
will use all available civil and administrative remedies to assure that
the product is quickly removed from the market. We also aggressively publicize
our actions to warn consumers and health professionals about such products.
In some cases, the Agency may initiate a criminal prosecution against manufacturers
or distributors of violative products. HIGHLIGHTS OF RECENT ENFORCEMENT
ACTIONS April 2004 Dietary Supplements Promoted Online for Weight Loss
In April 2004, FDA sent warning letters to 16 dietary supplement distributors
making false or misleading claims for weight loss products promoted over
the Internet. Many of these products claim to block starch, carbohydrates,
and fat calories, while maintaining that consumers would lose weight without
any changes in lifestyle. For example, some of the product labels have
claimed: * ``Eat All You Want! Block the Starch and Lose Weight!`` * ``Neutralize
up to 66 percent of the starch consumed in a meal.`` * ``This advanced
dietary-fat inhibitor helps block the absorption of fat calories.`` * ``Take
3 capsules before bedtime. Watch the fat disappear!`` * ``Guaranteed to
block the breakdown of carbohydrates and simple sugars from being converted
into fat.`` Consumer Warning on ``Street Drug Alternatives`` On April 9,
2004, FDA issued a Press Release warning consumers not to purchase or consume
products that claim to provide ``safe legal highs`` or that are marketed
as ``street drug alternatives`` by Cytotec Solutions, Inc., of Tampa, Florida.
The April 9th warning expanded on the February 2004 warning concerning
a product called Green Hornet, also marketed by Cytotec Solutions, Inc.
The products included in this warning were Trip2Night, Invigorate II, Snuffadelic,
Liquid Speed, Solar Water, Orange Butterfly, Schoomz and Green Hornet Liquid.
The labeling for these products lists a variety of herbal and other ingredients
but is incomplete or inaccurate because it does not provide either the
name of the manufacturer or the presence of these active drug ingredients.
By way of background on this product type, in 2001, FDA brought a seizure
and injunction action against purported supplement firms, Hit Products,
Inc., and Organic Diversions, Inc. that marketed products as alternatives
to illegal street drugs. The case, U.S. v. Undetermined Quantities of Articles
of Drug, Street Drug Alternatives, concerned the firms` marketing of products
made from a mixture of herbs that promised users effects comparable to
illegal street drugs. FDA seized these street drug alternatives as misbranded
and unapproved new drugs in violation of the FD&C Act. FDA also sought
the destruction of the seized goods and an injunction barring defendants
from future FD &C Act violations. In granting this relief, the court found
FDA`s position on street drug alternatives ``highly persuasive`` and criticized
the defendants` characterization of the products as dietary supplements
as a ``veiled attempt to circumvent`` the FD&C Act. The court ``declined
to carve out a statutory loophole for drug manufacturers attempting to
profit from the illegal drug epidemic by masquerading potentially dangerous
substances as legitimate dietary supplements.`` March 2004 Androstenedione
Warnings On March 11, 2004, the Department of Health and Human Services
(HHS) Secretary Tommy G. Thompson announced a crackdown on companies that
manufacture, market, and distribute products containing androstenedione,
or, ``andro.`` These products act like a steroid once metabolized by the
body. As a result they can pose health risks similar to those of steroids.
Andro products are generally advertised as dietary supplements that enhance
athletic performance based on their claimed anabolic and androgenic properties
to stimulate muscle growth and increase production of testosterone. As
part of the crackdown, FDA issued warning letters to 23 companies asking
them to cease distributing products sold as dietary supplements that contain
androstenedione. The warning letters notified the firms that they could
face enforcement actions if they did not take appropriate actions. The
warning letters stated that FDA assumed that each firm had a basis to conclude
that androstenedione was a dietary ingredient. If androstenedione is a
dietary ingredient, FDA believes that it is also a new dietary ingredient
for which a pre-market safety notification is required. Because no such
notification has been submitted by any manufacturer or distributor who
received a warning letter, these products are adulterated and their marketing
is prohibited under the FD&C Act. Conviction Hadi Ghadour On March 9, 2004,
Hadi M. Ghandour pled guilty to conspiracy to introduce misbranded and
unapproved new drugs into interstate commerce, counterfeiting human growth
hormone, and conspiracy to distribute a controlled substance. Ghandour
owned and operated Genapharm, Inc., a distributor of supplements specifically
marketed to athletes to enhance performance. During investigations, Ghandour
and his co-conspirators were found to be selling tiratricol, a potent thyroid
hormone and Class I health hazard, as a weight-loss drug. Ghandour and
his co- conspirators also sold products to people seeking alternatives
to street drugs and a veterinary drug used to de-worm animals as an imitation
of MDMA (``ecstasy``), a schedule I controlled substance. Ghandour also
counterfeited the labels for Nutropin AQ, a human growth hormone manufactured
by Genentech, Inc., and placed them on vials containing an insulin mixture.
Ghandour was previously convicted of counterfeiting steroids (misdemeanor)
in November of 1998. Two of Ghandour's co- conspirators pled guilty in
2003 and received sentences ranging from probation to three years incarceration.
Ghandour faces up to 14 years in prison and a $1,000,000 fine. Consent
Decree of Permanent Injunction: Seasilver USA, Inc., and Americaloe, Inc.
On March 8, 2004, the U.S. District Court for the Southern District of
California entered a Consent Decree of Permanent Injunction agreed to by
the U.S. government, SeaSilver USA, Inc., Americaloe, Inc., of Carlsbad,
California, and their principals, Bela Berkes and Jason Berkes. In the
Consent Decree, the firms and their representatives agreed to stop manufacturing
and distributing violative products, including ``Seasilver`` - a purported
cure-all liquid supplement, and to destroy the seized products at their
expense under the supervision of a HHS representative within 60 days of
posting bond. This consent decree followed a coordinated effort in June
2003 between FTC and FDA against Seasilver U.S.A., Inc., and Americaloe,
Inc., their owners, and two of the companies` principal distributors. On
June 16, 2003, at FDA`s request, U.S. Marshals seized 132,480 bottles of
Seasilver, worth nearly $5.3 million, from Seasilver USA`s San Diego headquarters.
Under a settlement with the FTC, entered on March 4, 2004, the Seasilver
defendants and the individual distributors agreed to pay $4.5 million in
consumer redress. February 2004 Regulation Prohibiting Sale of Dietary
Supplements Containing Ephedrine Alkaloids On February 11, 2004, FDA published
a regulation declaring dietary supplements containing ephedrine alkaloids
(ephedra) adulterated because such supplements present an unreasonable
risk of illness or injury. The regulation went into effect on April 12,
2004. This rule is being challenged in court but remains in effect during
the challenge. Guilty Plea - David Hinkson David Hinkson, the owner of
Water Oz, pled guilty to two FDA- related counts. The firm manufacturers
and distributes water- based products, labeled as dietary supplements,
and ozone generators and body suits which the firm claimed were effective
to treat a variety of conditions such as AIDS (Acquired Immuno Deficiency
Syndrome) and cancer. In his plea, Hinkson admitted not labeling his lithium
water as a drug, despite making drug claims for the product, not labeling
the ozone generators as medical devices, and that he did not have approval
to market the devices. Sentencing is set for July 29, 2004. Consumer Warning:
Green Hornet, Promoted as Herbal Version of ``Ecstasy`` On February 25,
2004, FDA warned consumers not to purchase or consume a liquid product
called Green Hornet. This product is promoted on the Internet, and sold
in stores, as a herbal version of the illegal street drug ``Ecstasy.``
FDA considers this product to be an unapproved new drug since it contains,
among other ingredients, the undeclared active ingredients diphenhydramine
and dextromethorphan, found in over-the-counter (OTC) drugs. FDA became
aware of reports of adverse events experienced by four teenagers after
consuming Green Hornet. The teenagers were rushed to a hospital emergency
room suffering from seizures, excessive heart rates, severe body rashes
and high blood pressure. The Green Hornet product involved in this case
was sold by Kekio, Inc., Colorado Springs, Colorado, doing business as
a store called Mind Excursions. The store, which also operates a website,
has stopped selling the product. Consent Decree letter issued: Vital Health
A letter was issued on February 19, 2004, to Vital Health of West Allis,
Wisconsin, advising the firm that it was found to be in violation of the
court judgment filed against it in 1992. FDA found that the firm was actively
promoting the sale of Herp-Eeze and TobacOff, products labeled as dietary
supplements but promoted with drug claims. Seizure: On
February 5, 2004, the U.S. Marshal, at the request of FDA, seized approximately
925 bottles of ephedra-containing dietary supplements Betatrim, Thermbuterol,
and Stacker 2, from in Northboro, Massachusetts. The complaint
alleged that was making unsubstantiated claims on its
websites for the ephedra-containing products. Specifically, it is alleged
that claimed that its products enhanced the athletic and
muscle performance of consumers without adequate scientific basis to support
such claims. January 2004 Consumer Advisory and Warning Letter: FDA Warns
Consumers Not to Feed Infants ``Better than Formula Ultra Infant Immune
Booster 117`` On January 23, 2004, the Agency issued a warning to consumers
that a product, Better Than Formula Ultra Infant Immune Booster 117, sold
over the Internet as a dietary supplement should not be fed to infants.
Even though NSP Research Nutrition labeled their product as a dietary supplement,
FDA is concerned that the product appears to be represented as an infant
formula in the product labeling. On January 30, 2004, FDA issued a warning
letter to the firm, advising the firm that it had not filed the necessary
documentation for a new infant formula. The letter also advised the firm
that the product was misbranded, in that it was labeled as a dietary supplement
but did not meet the statutory requirements to be one. December 2003 Judgment:
Wildflower Pharmacal, Uttam Sethi Wildflower Pharmacal (now Aulistic Vitamins
Corp.) and Uttam Sethi were convicted of three felony counts relating to
their manufacturing of dietary supplements that did not contain the labeled
amounts of numerous nutrients. Judgment was filed in EDNY on 12/17/03.
Mr. Sethi received 5 years probation, $ 3 million fine, and $1.5 million
forfeiture. Wildflower Pharmacal received a $2.4 million fine. Coral Calcium
Consent Decree of Condemnation and Permanent Injunction On December 17,
2003, the U.S. District Court for the Northern District of Illinois entered
a Consent Decree of Condemnation and Permanent Injunction against Shop
America. The decree prohibits ``Shop America and each of its directors,
officers, agents, representatives . . . and any and all persons in active
concert from directly or indirectly doing or causing any promoting, representing,
or suggesting that an article manufactured, marketed, or distributed by
Shop America, is safe or effective in the diagnosis or treatment of cancer,
multiple sclerosis, lupus, heart disease, high blood pressure, or any other
disease in man or other animals.`` October 2003 Royal Tongan Limu In October
2003, FDA witnessed the voluntary destruction of 90,000 bottles worth $2.7
million of Royal Tongan Limu, a liquid dietary supplement distributed by
Dynamic Essentials, a subsidiary of NBTY, Inc. The firm was initially warned
in a 2002 FDA ``cyber letter`` that website claims to treat various diseases
such as cancer, arthritis, and Attention Deficit Disorder caused their
products to be in violation of the law. Despite the warning, the product
remained in distribution channels and, therefore, FDA recommended a seizure
action. Dynamic Essentials ceased operation and no longer promotes or sells
the products on its website. Germanium Sesqioxide In October 2003, FDA
refused an entry of 20 kilograms of bulk germanium sesquioxide valued at
$16,500, destined for use in human dietary supplements. Germanium has caused
nephrotoxicity (kidney injury) and death when used chronically by humans,
even at recommended levels of use. September 2003 Jean`s Greens In September
2003, at FDA`s request, the U.S. Marshal seized herbal tea products known
as Forticel and Forticel Mix from Jean`s Greens in Norway, New York. The
products claimed to treat and cure various life-threatening and serious
illnesses such as cancer, thus causing the products to be unapproved drugs.
FDA warned Jean`s Greens in November 2001 to change its labeling for the
products. The firm failed to comply. The value of the seized goods was
more than $4000. June 2003 SIGRA In June 2003, FDA warned consumers not
to purchase or consume SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y,
Spontane ES and Uroprin, manufactured by NVE Pharmaceuticals, Inc., in
Newton, New Jersey, and distributed by Hi-Tech in Norcross, Georgia. These
products, which were marketed as dietary supplements for sexual enhancement,
were found to contain the prescription drug ingredient tadalafil, which
can cause a drastic lowering of blood pressure when combined with prescription
drugs containing nitrates. Tadalafil is the active ingredient in Cialis,
an Eli Lilly product approved in Europe to treat male erectile dysfunction.
Despite FDA`s warnings, the defendant and his related businesses repeatedly
sold dietary supplements that claimed to treat obesity and erectile dysfunction.
Hi-Tech recalled the products and in September 2003, a U.S. District Court
Judge entered a Consent Decree of Permanent Injunction enjoining Hi-Tech
Pharmaceuticals, National Urological Group, National Institute for Clinical
Weight Loss, American Weight Loss Clinic, United Metabolic Research Center,
and the President of these corporations, from distributing unapproved new
drugs and misbranded drugs. Global Source and Consulting, Inc. In June
2003, a U.S. District Court entered a Consent Decree of Condemnation and
Destruction for the seized products from Global Source and Consulting,
Inc., which included 450 bottles and 57,000 bulk capsules of 20 products
marketed as dietary supplement worth $19,000.