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Dietary Supplement Enforcement Report
July 2003

Executive Summary

Effective enforcement is an essential part of FDA's ongoing "Consumer Health Information for Better Nutrition" initiative, which is designed to improve the health of consumers by providing them with scientifically accurate, FDA-approved information about the health effects of foods and dietary supplements.

False health claims that mislead Americans endanger their health and undermine the goals of the FDA health information initiative while enriching irresponsible manufacturers. As FDA expands and enhances its efforts to help consumers get better product information, it will continue its aggressive law enforcement against false and misleading health claims on all regulated products.

On December 18, 2002, FDA announced a significant enforcement initiative targeted at misleading claims about dietary supplement-associated health benefits. Dietary supplements are used by an estimated 158 million Americans, and so misleading claims about their health benefits may have significant consequences - not only for wasting consumers' money but also for luring consumers interested in improving their health in wrong directions. While FDA's enforcement goals related to truthful and nonmisleading statements about health benefits apply to all of the products the agency regulates, this initiative was especially focused on products that in recent years have been the subject of important misrepresentation.

As part of this December announcement, FDA released the "Dietary Supplement Enforcement Report" which pledged to closely scrutinize and bring enforcement actions against products identified as "clearly problematic." This included dietary supplements that falsely claim effectiveness as treatments for life-threatening diseases; overweight; autism; behavioral disorders; mental retardation and Down's syndrome; as well as colloidal minerals; supplements for smokers and drinkers; and colloidal silver products.

Over the last six months, the FDA has accomplished the following:

Collaborated with the Federal Trade Commission and other consumer protection and law enforcement agencies to increase FDA's effectiveness: In one joint action by FDA and the Federal Trade Commission (FTC), a Federal District Court ordered marketers of a dietary supplement to cease making unsubstantiated disease treatment claims and froze the company's assets, while FDA seized $7 million worth of these products at two warehouse sites.
Increased actions in priority areas identified in the December report: Since December, FDA has issued 40 Warning Letters and Cyber Letters to firms for making misleading claims about their products for treatment of life-threatening diseases such as cancer, lupus and heart disease. FDA also seized approximately $9 million worth of dietary supplement products which were promoted to treat a variety of serious medical conditions.
Increased actions against dietary supplements containing the following unapproved drugs: lovastatin, a prescription drug to reduce cholesterol; sildenafil and tadalafil, drugs for the treatment of male erectile dysfunction; and a product containing multiple prescription drugs that claimed to treat high blood pressure.
Rapidly acted against manufacturers of products claiming to offer health benefits for SARS: FDA and FTC warned all firms to remove deceptive claims that their products would treat or prevent SARS, and FDA sent warning letters to 8 firms promoting SARS products on the Internet.

Altogether, FDA issued 73 warning letters and Cyber letters to marketers of dietary supplement products, seized products worth almost $9 million, refused import of 368 shipments of dietary supplement products offered for entry, and supervised the voluntary destruction of $515,000 worth of dietary supplements promoted with unsubstantiated structure/function claims. By comparison, in 2001 FDA issued 21 warning letters and seized unlawful dietary supplement products worth $2 million.

Introduction

This report is an update of the significant efforts in the enforcement program highlighted in the December 18, 2002, announcement of FDA's "Consumer Health Information for Better Nutrition" initiative. At the core of FDA's efforts is its commitment to enhance the legitimate manufacture, sale, and use of dietary supplements while maintaining a zero-tolerance for fraudulent product claims and other illegal practices. Achieving these goals relies on a number of strategies, including cooperation and coordination with other federal, state, and international law enforcement agencies in protecting consumers against unapproved and potentially harmful products offered by Internet outlets, some of which are based abroad.

With a mutual goal of consumer protection, FDA and FTC formed a Dietary Supplement Enforcement Group to closely coordinate their enforcement efforts against health care fraud. In addition, FDA and FTC chair an interagency health fraud steering committee that meets regularly to coordinate activity on these issues. The workgroup currently includes federal agencies in the U.S. and Canada. Mexico has been invited to join the group.

As part of its effort to curb Internet health fraud, the 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 United States and abroad.

Dietary Supplement Enforcement Strategy

FDA has developed a strategy for enforcement of the laws and regulations that apply to the dietary supplement industry. The strategy, which includes cooperation with FTC and other federal, state and international organizations, sets out a number of areas where FDA will focus its effort to protect consumers against dietary supplements with unsubstantiated claims. The strategy targets substances such as ephedra, and claims for treatment of serious diseases such as cancer or diabetes.

The following are the highlights of FDA's enforcement actions since December 18, 2002:

FEBRUARY

· Global Source and Consulting: Product seizure
On February 13, 2003, U.S. Marshals seized 450 bottles and 57,000 bulk capsules of dietary supplement products from Global Source Management and Consulting, Inc. ("Global Source"), Sunrise, Florida. The seizure occurred after FDA determined that these products claimed to treat a variety of medical conditions. 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.

On June 18, 2003, the U.S. District Court for the Southern District of Florida entered a Consent Decree of Condemnation and Destruction for the seized drugs. Under the terms of the Consent Decree, the Claimant, Global Source, must destroy the all of the drugs. 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.

· Ancom: Product recall
On February 11, 2003 Best Life International recalled Ancom Anti-Hypertensive Compound tablets, which represented as dietary supplements but were found by FDA investigators to contain several prescription drug ingredients, including reserpine, diazepam, promethazine, and hydrochlorothiazide. The product was sold on the Internet and at retail stores.

APRIL

· Nature's Youth hGH: Product destruction
On April 30, 2003, FDA announced that Nature's Youth, LLC, of Centerville, Mass., 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 action followed FDA's advisory that the products appeared to be misbranded by labeling that included unsubstantiated "structure and function" claims that the product would, among other things, "improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions." The product was also claimed to be "your body's best defense against aging."

MAY

· Gero-Vita International, Inc.: FDA and FTC concurrent actions
On May 27, 2003, the FTC filed a complaint against Glenn Braswell and four of his corporations for making false and unsubstantiated claims that five products marketed as dietary supplements are "scientific breakthroughs" to treat or cure numerous serious medical conditions. FDA provided technical assistance and scientific support to FTC for this action.

Products identified in the complaint include: 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.

· Viga: Product recall
Responding to an FDA contact, Best Life International, Mayaguez, P.R., on May 23, 2003 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.

· SARS: FDA and FTC concurrent action
On May 9, 2003, FDA and FTC warned Website operators, manufacturers and distributors to remove misleading or deceptive Internet claims 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 include 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 to treat or prevent SARS on the Internet. FTC also notified violative firms that they were subject to possible civil or criminal actions under the Federal Trade Commission Act. FDA is following up to determine if the firms have taken appropriate corrective action.

JUNE

· SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin: Warning to consumers
On June 20, 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, Inc., in Newton, N.J. and distributed by Hi-Tech in Norcross, Ga. These products, which are marketed as dietary supplements, contain a prescription drug ingredient, tadalafil, that poses 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 are being sold over-the-counter and are claimed to increase stamina, confidence and performance.

FDA's Office of Criminal Investigations, with assistance from FDA's New Jersey and Atlanta Districts, executed concurrent federal search warrants in Georgia and New Jersey after finding these dietary supplements.

· Seasilver: FDA and FTC took concurrent actions
On June 17, 2003, United States Marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million from Seasilver USA's San Diego headquarters in an action initiated by FDA. The complaint for seizure alleged that, although Seasilver USA markets Seasilver as a dietary supplement, it promotes 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, the US Marshals seized an additional 1.7 million dollars worth of Seasilver from a distribution center in Parma, OH.

In response to an FTC request, the federal district court in the Southern District of California issued on June 13, 2003 a temporary restraining order 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.

· Coral Calcium: FDA and FTC concurrent actions
On June 9 and 10, 2003, FDA issued warning letters to 18 firms which operate 24 Web sites marketing multiple coral calcium products as effective treatments or cures for a variety of diseases and conditions. Many of these coral calcium products also make unsubstantiated structure/function claims. Coral Calcium Supreme is 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 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.

ADDITIONAL ACTIONS

· Cyber letters
As of June 30, 2003, FDA has issued 16 cyber letters in Fiscal Year 2003 to individuals and firms that promote products over the Internet claiming to treat, prevent, or cure a range of serious diseases, including cancer, diabetes, and osteoarthritis.

· Imports
From October 1, 2002 to May 31, 2003 FDA issued 368 refusals of dietary supplement products offered for entry.

· Inspections
From October 1, 2003, to May 31, 2003 FDA carried out approximately 72 inspections of manufacturers and distributors of dietary supplements.