News & Events
Dietary Supplement Safety Act: How is FDA Doing 10 Years Later
Robert E. Brackett, Ph.D
Center for Food Safety and Applied Nutrition
Food and Drug Administration
the Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia
Senate Committee on Governmental Affairs
June 8, 2004
Thank you, Mr. Chairman for this opportunity to testify before your Subcommittee at this hearing entitled, “Dietary Supplement Safety Act: How is FDA Doing 10 Years Later.”
BACKGROUND ON REGULATION OF DIETARY 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
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.
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 centers.
DIETARY SUPPLEMENT CURRENT GOOD MANUFACTURING PRACTICES (cGMPs)
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.
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
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 9 th 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.”
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.
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.
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 Musclemaster.com in Northboro, Massachusetts. The complaint alleged that Musclemaster.com was making unsubstantiated claims on its websites for the ephedra-containing products. Specifically, it is alleged that Musclemaster.com claimed that its products enhanced the athletic and muscle performance of consumers without adequate scientific basis to support such claims.
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.
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.”
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.
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.
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.
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. Global Source agreed to destroy the products and to cease manufacture and marketing of “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.
Severe Acute Respiratory Syndrome (SARS)
In May 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 SARS. An Internet “surf”" conducted by FTC, FDA and the Ontario Consumer and Business Services, found numerous sites promoting a variety of SARS treatment 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 8 Internet firms promoting dietary supplement products to treat or prevent SARS. FTC also notified violative firms that they were subject to possible civil or criminal actions under the FTC Act.
Gero-Vita International, Inc.
In May 2003, the FTC filed a complaint against Glenn Braswell and four of his corporations for making false and unsubstantiated claims that several 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 were: Lung Support Formula, which claimed to cure or ameliorate asthma, emphysema, smoking damage and other respiratory problems; Antibetic Pancreas Tonic, which claimed to treat or cure diabetes and to lower blood sugar levels; and GH3 and GH3 Romanian Youth Formula, which 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, which claimed to treat erectile dysfunction.
In April 2003, FDA announced that Nature’s Youth, LLC, of Centerville, Massachusetts, voluntarily destroyed approximately 5700 boxes of its product, “Nature’s Youth hGH,” worth $515,000. The action followed FDA’s advisory that the products appeared to be misbranded by labeling that included unsubstantiated “structure/function” claims that the product would, among other things, “improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions.”
In February 2003, FDA investigators found that Ancom Anti-Hypertensive Compound tablets, which were marketed on the Internet and in retail stores as dietary supplements, contained several prescription drug ingredients, including reserpine, diazepam (Valium), promethazine, and hydrochlorothiazide. Best Life International, the manufacturer, ceased distribution and recalled the product. Subsequently in May 2003, Best Life International 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.
Yellow Jackets and Black Beauties
In January 2003, FDA and the U.S. Marshal’s Service served an inspection warrant that would allow FDA to witness the voluntary destruction of $4 - 5 million worth of products known as “Yellow Jackets” and “Black Beauties.” The warrant was served at NVE Pharmaceuticals, Inc., the manufacturer of the products, located in New Jersey. A distributor in the Netherlands promoted the products on the Internet as alternatives to street drugs. Yellow Jackets and Black Beauties are street terms for controlled substances and were sold as herbal street drug alternatives. In September 2002, FDA became aware of the tragic death of a 16-year old high school football player who had taken Yellow Jackets. FDA placed the products on Import Alert on October 7, 2002.
On December 16, 2002, U.S. Marshals seized approximately 3,000 bottles of EverCLR, a dietary supplement, valued at more than $100,000. EverCLR was marketed by Halo Supply Company of San Diego, California, as a “natural” treatment for viruses such as the herpes virus and “cold and flu protection.” None of these claims was substantiated. FDA charged that EverCLR was an unapproved and therefore, illegal, new drug because it was promoted to treat and prevent specific diseases. Because EverCLR’s labeling lacked adequate directions for use, FDA also charged that the product was misbranded.
In August 2002, FDA issued a warning letter to Better Way Kids. This firm distributed “Calm Focus,” a product promoted to treat Attention Deficit and Hyperactivity Disorder. Based on claims made for the treatment of disease, FDA charged that the product was an unapproved new drug. The firm corrected its product claims.
U.S. v. Syntrax Innovations, Inc., et. al
U.S. v. Syntrax Innovations, Inc., involved a substance called Triax, marketed by Syntrax as a dietary supplement for the treatment of obesity. FDA scientists determined that the product contained a potent thyroid hormone called tiratricol that, if taken in sufficient quantity, can cause heart attacks and strokes. FDA alleged that Triax could not be a dietary supplement because it was promoted to treat a disease (obesity) and because it did not contain any of the dietary ingredients identified in DSHEA. In February 2001, the court entered an injunction barring the distribution of Triax.
U.S. v. Lane Labs USA, Inc. and Andrew Lane
FDA brought an injunction action against Lane Labs USA, Inc., Andrew Lane, and three of Lane Labs’ products, including its shark cartilage product, BeneFin. Lane Labs claimed that two of these products were dietary supplements, but the company promoted those products for the treatment of cancer and HIV ( human immunodeficiency virus) . The third product is a skin cream promoted for the treatment of skin cancer. FDA contended that the disease claims caused all three of these products to be unapproved, and therefore illegal, new drugs and misbranded drugs. The case is pending before the court for decision.
Mr. Chairman, thank you for this opportunity to testify. I am happy to answer your questions.