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John M. Taylor


Statement of

John M. Taylor
Associate Commissioner for Regulatory Affairs
Food and Drug Administration

before

the Senate Committee on Commerce, Science, and Transportation

October 28, 2003

INTRODUCTION

Thank you Mr. Chairman, for this opportunity to testify at this hearing on dietary supplements and the current regulations to protect American consumers from the potential adverse health risks associated with the use of certain supplements. I am John M. Taylor, Associate Commissioner for Regulatory Affairs at the Food and Drug Administration (FDA or the Agency). In my statement today, I will address FDA actions to implement DSHEA, especially our regulations development, adverse event monitoring, and enforcement posture. I will also address FDA actions on two major types of dietary supplements that are of current concern, ephedra and steroid precursors. But first, let me provide you a short background on dietary supplements.

BACKGROUND ON REGULATION OF DIETARY SUPPLEMENTS

Nearly half of the population of the United States uses “dietary supplements.”1 The Dietary Supplement Health and Education Act of 1994 (DSHEA) establish a unique regulatory framework in an attempt to strike the right balance between providing consumers access to dietary supplements that they choose to use to help maintain and improve their health, and giving the FDA the necessary regulatory authority to take action against supplements or supplement ingredients that present safety problems, make false or misleading claims, or are otherwise adulterated or misbranded. Although dietary supplements are generally regulated as foods, there are special statutory provisions and implementing regulations for dietary supplements that differ in some respects from those covering conventional foods. Moreover, the regulatory requirements for dietary supplements also differ from those that apply to prescription and over-the-counter (OTC) drug products.

Congress defined the term dietary supplement as a product that, among other things, is ingested, 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 the diet, and that contains at least one 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. DSHEA placed dietary supplements in a special sub-category under the general umbrella of foods, but products that meet the drug definition are subject to regulation as drugs.

LABELING OF DIETARY SUPPLEMENTS

Under the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA’s implementing regulations, the label of a dietary supplement must include:

  • 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, packer, or distributor
  • the net quantity of contents

In addition, if the labeling includes a claim that the product affects 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 also 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. If a product that is marketed as a dietary supplement includes claims that the product is intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of a disease, it is considered a drug within the meaning of the Act.

DIETARY SUPPLEMENTS CONTAINING STEROID PRECURSORS

Because of the Committee’s interest in steroid precursors, let me discuss them now. FDA is aware of a wide variety of products that contain steroid precursors. Some consumers ingest steroid precursors because they believe these products boost testosterone levels and speed muscle growth.

Use of these products has grown dramatically in popularity in the United States. We have heard from athletic organizations, health care professionals and health organizations, and anti-drug abuse authorities about potential health risks that may be associated with their use. However, the scientific evidence about the benefits or adverse consequences of steroid precursors appears to be inconclusive at this time. These products are generally marketed as dietary supplements and targeted to athletes and body builders as performance enhancers. Some of these products are marketed for weight loss or as anti-aging products. While the majority of products containing steroid precursors are not promoted for disease treatment or prevention purposes, a minority of products may be promoted for therapeutic purposes and therefore are subject to regulation as drugs.

In addition, some steroid precursors are clearly outside the scope of the dietary supplement definition and are subject to regulation as drugs because they are intended to affect the structure or function of the body. For example, FDA considers tetrahydrogestrinone, or THG, the subject of what is rapidly becoming a major sports controversy, a new drug under FD&C. Our analysis demonstrates that this is a purely synthetic, non-naturally occurring, highly potent anabolic steroid. It is a designer steroid in the truest sense. It is directly derived, by simple chemical modification, from an anabolic drug that is explicitly banned by the U.S. Anti- Doping Agency. That drug, gestrinone, a synthetic product, is approved in Europe for the treatment of endometriosis, a painful condition of pre-menopausal women. Furthermore, THG is closely related, structurally, to trenbolone, a strong veterinary anabolic steroid approved in the U.S. to increase rate of weight gain and/or improved feed efficiency in beef cattle. Trenbolone is a controlled substance.

Steroid precursors marketed as dietary supplements present complex regulatory issues for FDA regarding the scope of the dietary supplement and drug definitions. FDA is still examining these issues and has not reached any formal conclusion about the status of steroid precursors as dietary supplements under the FD&C Act. Nevertheless, we understand that this is a public health issue that warrants our close attention. FDA is currently pursuing an evaluation of the legal and scientific uses that bear on the status of these kinds of substances and we hope to be able to address this matter more authoritatively in the future.

ADVERSE EVENT REPORTING

Now, let me turn to our discussion of dietary supplements. DSHEA’s regulatory framework is primarily a post-market program, like much of food regulation. There is no pre-market approval requirement for dietary supplements. Further, there is no requirement for manufacturers to provide evidence of product safety to FDA prior to marketing a dietary supplement, unless the supplement contains a “new dietary ingredient” (a dietary ingredient that was not marketed in the United States before October 15, 1994) that has not been “present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)). In contrast, drug regulation involves an extensive premarket evaluation of safety and effectiveness with explicit standards of evidence. This evidence provides a basis to guide not only approval decisions but also conditions of use to manage benefits and risks. In addition, there are post-market reporting requirements for drugs to support product safety monitoring. These requirements do not exist for dietary supplements.

As a result, voluntary adverse event reports (AERs) are the primary means FDA has for identifying potential safety problems with dietary supplements. Under DSHEA, FDA must rely on AERs as a major component of its post-market regulatory surveillance efforts. Also, unlike drug regulation, FDA cannot compel reporting of adverse events by dietary supplement manufacturers.

In June 2003, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) put in place the CFSAN Adverse Event Reporting System (CAERS) to monitor adverse event reports for foods, cosmetics, and dietary supplements. This state-of-the-art system compiles and analyzes any reports of consumer complaints and adverse events related to CFSAN-regulated products presented to FDA. Health care professionals and consumers voluntarily send submissions to CAERS. While voluntary reporting systems are estimated to capture only one percent of adverse events, they provide valuable signals of potential problems.

ENFORCEMENT

Protecting the public health has always been the Agency’s first responsibility. Consumers need to have confidence in the safety and effectiveness of the products they use. Therefore, unsafe, ineffective, or fraudulent products are a threat to the public health.

FDA is serious about its responsibility of ensuring that there is access to effective, safe, scientifically-based health products for our nation’s citizens. U. S. citizens must have access to truthfully labeled, safe, effective, and non-misleading health products.

At the core of FDA’s enforcement efforts is our commitment to enhance the legitimate manufacture, sale, and use of dietary supplements while protecting consumers against unsafe products, fraudulent labeling claims, and other illegal practices. Achieving these goals utilizes a number of strategies, including cooperation and coordination with other state, Federal, and international law enforcement agencies in protecting consumers against unapproved and potentially harmful products offered by Internet outlets, some of which are based abroad.

On December 18, 2002, FDA announced its “Better Health Information for Better Nutrition” initiative. The purpose of the initiative is to improve the health of consumers by providing them with scientifically accurate, FDA-approved information about the health effects of foods and dietary supplements. In undertaking this initiative, FDA recognized that false claims that mislead Americans both endanger the public health and undermine the goals of the FDA. Because FDA recognizes that efficient, effective enforcement is an essential component to ensure that such false and misleading claims do not take root in commercial distribution channels, FDA is prepared to take aggressive enforcement action to ensure that consumers have access to truthful and non-misleading information about products related to their health.

FDA’s commitment to continue its efforts to ensure that there is access to safe, scientifically sound medical products is demonstrated by the Agency’s enforcement actions to combat fraudulent, misbranded, and misleading dietary supplements. For example, over the last 15 months, FDA has witnessed the voluntary destruction of approximately $7.7 million of dietary supplements that were determined to be non-compliant with the FD&C Act and has monitored two voluntary recalls of dietary supplement products.

FDA also sent numerous Warning Letters to marketers of products represented as dietary supplements but whose products did not qualify as such because claims on them caused them to be misbranded and/or unapproved drugs. At least two of these Warning Letters were sent to firms whose products were marketed in lieu of approved drugs that were available to the public. For example, one made claims that its products were alternatives to vaccinations/immunizations against anthrax, measles, smallpox, and encephalitis; the other promoted its product as a natural alternative to Ritalin for ADHD. This calendar year, FDA also issued Warning Letters to 18 firms marketing coral calcium products as effective treatments or cures for a variety of disease conditions. In addition, FDA and the FTC warned website operators, manufacturers, and distributors who were making misleading or deceptive claims on the Internet regarding their products ability to prevent, treat, or cure SARS that they must cease making these impermissible claims. FDA also issued Warning Letters to 8 firms marketing “dietary supplements” as street drug alternatives and warned 26 firms to stop making unproven claims that ephedrine-containing dietary supplements could enhance athletic performance.

Lastly, over the course of the course of the last 15 months FDA utilized its judicial and administrative enforcement tools to take one injunction action and 8 seizure actions against marketers of, and/or fraudulent dietary supplements. Six of the seizure actions occurred in FY 2003 alone, including 3 that were undertaken in cooperation with FTC.

Health Fraud

Traditionally, FDA has taken action against violative dietary supplements as part of its health fraud efforts. Generally, FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of articles that are represented as being effective to diagnose, prevent, cure, treat, or mitigate an illness or condition, or provide a beneficial effect on health where the product has not been scientifically proven safe and effective for such purposes.

The Internet is one avenue by which fraudulent products have been 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 obtaining meaningful medical information that helps them understand health issues and treatment options. As beneficial as this technology can be, it also creates a new marketplace for activity that is illegal, such as the sale of unapproved new drugs, prescription drugs dispensed without a prescription, and products marketed with fraudulent claims about health benefits. Also, because the Internet is a worldwide communications system, U.S. citizens are now more directly susceptible to fraud from sources both foreign and domestic.

Consumers respond to these promotions by spending billions of dollars a year on fraudulent health products. They hope to find a cure for their illness or improve their well-being or appearance. Yet, 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.

FDA Web Site Triage Process

In June 1999, FDA established a case assessment or “triage” team with representatives from the Offices of Criminal Investigation within the Office of Regulatory Affairs, the Center for Drug Evaluation and Research, the Office of Chief Counsel, and the Office of Policy. The scope of this group has been expanded to cover all FDA Centers and regulated products including the CFSAN’s Office of Nutritional Products, Labeling and Dietary Supplements.

Under the triage process, FDA identifies web sites that potentially violate the FD&C Act from the Agency’s Internet monitoring activity, other Federal or foreign law enforcement agencies including our joint partnership with the Federal Trade Commission (FTC), and from states and the public. The triage team evaluates each case to determine whether or not it should be pursued through a civil or criminal investigation. Using this information, we give priority to cases involving unapproved new drugs, health fraud, prescription drugs sold without a valid prescription, and products with the potential for causing serious or life-threatening reactions.

This triage process results in improved coordination of criminal and civil enforcement actions within the Agency, reduces overlapping efforts, and helps the Agency appropriately achieve a maximum deterrent effect when taking action to remove harmful products from the market.

Oversight of Dietary Supplements

FDA shares Federal oversight of dietary supplements with the Federal Trade Commission (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, the FDA and the FTC have worked well together to ensure that there is a seamless assertion of our jurisdiction over these products.

As with all of FDA's activities, priorities are established based on benefit/risk to public health. The Agency's enforcement of fraudulent health products is based on a priority
system that is often driven by whether a fraudulent product poses a direct or indirect risk to public health. The susceptibility of the population is also an element that we consider when determining risk. For example, cancer patients are considered a highly susceptible population, as many have exhausted conventional or standard care treatments, and may be desperate to try anything that offers hope of a cure.

Products that present a direct health hazard to consumers are the Agency’s highest priority. These are products that have a reasonable potential for causing direct serious adverse effects, or for which there is documentation of injury or death. 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.

Products that are not themselves hazardous can still present an indirect health hazard in that the consumer may delay or forego proven medical treatments or drug therapies, or rely on these products for benefits that simply are never going to materialize. 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, we also give priority to products that undermine the integrity of the new drug application (NDA) and Over-the-Counter (OTC) drug review processes. The NDA and OTC drug review procedures provide consumers with assurance that prescription 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. Such actions help ensure that manufacturers comply with the requirement to submit an NDA to the Agency for their product and that the playing field is fair and equitable for those who do.

Initiation of Enforcement Activity

When a problem arises with a product, or the Agency receives information that a product may violate the FD&C Act or regulations, FDA can take a number of enforcement actions to protect the public. For example, FDA may initially work with a product’s manufacturer or marketer to correct the problem voluntarily. If that fails, the Agency may bring a lawsuit to seize the product and/or enjoin the firm marketing or distributing the product. When warranted, FDA may also seek criminal penalties, including prison sentences, against parties who break the law.

In the appendix attached to my testimony, I describe some of FDA’s recent dietary supplement enforcement activities. As you will see, our enforcement actions are wide-ranging and diverse and take full advantage of the entire breadth of enforcement tools that are available to FDA. You will also see that the type of cases that we have brought have evolved over time. We hope that they also illustrate to the public and the industry that we will take action when warranted, and that FDA also remains committed to consumer and industry education about the proper labeling and use of dietary supplements.

Outreach and Education

FDA recognizes that traditional enforcement actions and coordinated efforts with other agencies are necessary, but these steps are not the only components of a thoughtful enforcement strategy. We fully appreciate that the dietary supplement industry has a vested interest in curbing fraudulent operators and practices and that most of FDA’s regulated industries are interested in complying with the Act – and do so. For this reason, FDA will continue in its efforts to complement these measures with industry and consumer education and will continue to assist the industry by issuing regulations and guidance documents addressing the manufacture, labeling, and sale of dietary supplements.

Examples of prominent FDA outreach activities in this area include:

  • continuing to develop mechanisms, including expanded use of our Web site, to communicate critical information and useful strategies about dietary supplements to industry and consumers. Coordination with groups like the Better Business Bureau, and with professional groups like the American Medical Association, will help FDA to reach the broadest possible audience;
  • continuing to encourage consumers to involve their health care practitioners in their health care decisions. Ultimately, however, consumers must be able to evaluate the accuracy of labeling claims, and with the assistance of health professionals when appropriate, determine which dietary supplements are right for them. Accordingly, through written materials and Web-based resources, FDA has provided consumers with the means to make informed choices about dietary supplements. Examples include FDA Talk Papers, articles in the FDA Consumer magazine, and information on FDA’s web site to educate consumers about safely purchasing FDA regulated products. Other examples of these materials include CFSAN’s “Overview of Dietary Supplements” and “Tips for the Savvy Supplement User.” CFSAN has also published consumer advisories concerning dangerous products, such as the advisory that the Agency issued about dietary supplements containing kava, a botanical ingredient;
  • continuing to communicate with industry regarding those practices that are permissible under DSHEA. We will continue our practice of providing this information through guidance documents and information posted on the Agency’s web site. For example, FDA’s “Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide” discusses compliance with the Agency’s regulations implementing DSHEA’s labeling provisions; and
  • leveraging resources by continuing to coordinate mutually effective relationships with other Federal and state entities involved in combating health fraud. For example, in 1992, FDA began sponsoring a National Health Fraud Working Group. This working group is comprised of representatives from the Association of Food and Drug Officials, State Attorneys General, FTC, Health Canada, and FDA representatives from headquarters and field offices. The group meets on a regular basis to facilitate the coordination of regulatory activities, information exchange, and leveraging the efforts of each member agency.
Partnership with Federal Trade Commission (FTC)

As discussed earlier, FTC and FDA have a long-standing history of working together to combat health fraud. This partnership was formed out a recognition that although protection of the public health may be FDA’s primary goal, other can contribute to achieving this goal. To further their mutual interest in consumer protection, FDA and FTC formed a Dietary Supplement Enforcement Group to closely coordinate their enforcement efforts against health care fraud. A major activity includes Operation
Cure-All, which is aimed at halting the Internet promotion of products, including dietary supplements, that make false or misleading disease claims In addition, FDA and FTC chair an Interagency Health Fraud Steering Committee that meets regularly to coordinate activity on these issues. The workgroup includes Federal agencies in the U.S. and Canada, and Mexico also has been invited to join the group. As part of its effort to curb Internet health fraud, 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 the U.S. and abroad. These efforts have led to many successful actions that have protected the public health. Together, we have succeeded in accomplishing goals that neither one of our agencies could accomplish individually.

DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS

A number of plant genera, including ephedra, are known to contain ephedrine alkaloids. Ma huang is a common name given to Chinese Ephedra, which is used in traditional Chinese medicine. Ephedra has been shown to contain various chemical stimulants, including the alkaloids ephedrine, pseudoephedrine, phenylpropanolamine and norpseudoephedrine, as well as various tannins and related chemicals. The concentrations of these alkaloids depend upon many factors, such as the species, parts of the plant used, time of harvest, growing location, and production methods. Ephedrine and pseudoephedrine are used in some OTC and prescription drugs, where they have been demonstrated to be safe and effective for the labeled use.

Dietary supplements containing ephedrine alkaloids have known, and potentially serious, side effects. While ephedra has been used in herbal medicine preparations for thousands of years, in recent years ephedra has been sold primarily in dietary supplement products for weight control, as well as in products promoted to boost energy levels or to enhance athletic performance. Some ephedra-containing products have been marketed as herbal alternatives to illicit street drugs. Ephedra-containing products often contain other stimulants, such as caffeine, that may have synergistic effects and increase the potential for adverse effects.

A number of adverse effects associated with ephedrine alkaloid-containing dietary supplements have been reported to FDA. These include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis, and memory loss. More serious effects have also been reported, including heart attack, stroke, seizure, and death.

As the tragic deaths of the Baltimore Orioles’ pitching prospect Steve Bechler and of Sean Riggins, the sixteen year-old from Illinois have reminded us that use of ephedra, particularly in sports, raises serious concerns about safety and has long posed difficult issues for health care professionals, regulators, and consumers. These concerns stem from both the mechanism of action of ephedrine alkaloids on the sympathetic nervous system, and accumulating evidence of potentially serious adverse events after use of ephedra-containing products.

While there has been considerable debate about the safety and effectiveness of dietary supplements like ephedra, as well as the most effective approach to regulating them, one thing is clear: although dietary supplements are regulated as foods and not drugs, the consumer should not assume they are always safe to use. “Natural” does not necessarily mean safe. In particular, botanical and herbal products may have active ingredients with pharmacologic properties similar to, or in the case of ephedra identical to, drug products. They have the potential to cause adverse effects, as well as interactions with prescription and OTC drugs and with ingredients in other dietary supplements.

USE OF EPHEDRA BY ATHLETES

Although FDA is reviewing ephedrine alkaloids under DSHEA to assess the safety concerns, FDA has particular concerns about the use of ephedra by persons engaged in strenuous exercise. A recent study by RAND, discussed in more detail below, concluded that ephedra has minimal if any proven benefit for enhancing sports performance. Yet ephedra acts like an adrenaline boost, stressing the heart, raising blood pressure, and increasing metabolism. Moreover, the stimulating effects of ephedra may mask the signs of fatigue, causing even the most well conditioned athletes to push beyond their physical limits.2 Thus, ephedra’s risks are potentially much more serious for competitive athletes than for the general population. As FDA has said before, ephedra should not be used by people who engage in strenuous activity.

Because of the special risks of ephedra use in athletes, sports leagues that have acted to restrict ephedra use are making a prudent decision. Even as the Agency evaluates the safety of ephedra use in the population more generally, including its use for weight loss, we see that ephedra poses special risks in the context of sports performance with little or no identified benefit for athletes.

FDA’s ACTIONS ON EPHEDRINE ALKALOIDS

The Agency’s professional, scientific and legal staffs are currently working hard to address the extraordinary challenges presented by these products. Earlier this year, the Agency published a Federal Register notice reopening the comment period on its 1997 proposed rule on dietary supplements containing ephedrine alkaloids to seek comment on new scientific evidence about the risks of these products and on a proposed warning statement for the labels of these products. Our Federal Register announcement also sought comments on whether, in light of current information, FDA should determine that dietary supplements containing ephedrine alkaloids present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or under ordinary conditions of use if the labeling is silent.

We are currently in the process of analyzing the over 30,000 public comments we received earlier this summer as well as adverse event information and the best available scientific evidence of ephedra's pharmacology and mechanism of action. We are in the final stages of our deliberative review, so I cannot discuss the specifics of that process or the anticipated outcome. However, I want to emphasize that we are committed to moving forward expeditiously to make a determination that is well grounded in all available scientific evidence and that is protective of the public health in accordance with DSHEA.

While we are undertaking these reviews, the Agency has dramatically increased its enforcement actions against ephedrine alkaloids and other dietary supplement products making false or misleading claims. These actions, many of which have been undertaken in collaboration with the FTC, are having an impact on the marketing of dietary supplements in general and ephedra in particular.

Sports Uses of Ephedra

On February 28, 2003, based on the conclusions of the RAND study, FDA warned 26 firms to cease making unproven claims that ephedrine-containing dietary supplements enhance athletic performance.3 The actions were primarily a result of the Agency’s surveillance of the firms’ web sites. Fourteen of the firms responded to the warning letters by discontinuing the product or the claim. The remaining twelve firms were inspected by FDA. Of those twelve inspected firms, all but one either discontinued the product or the objectionable claims. Investigation for consideration of regulatory action against the remaining firm is ongoing. Since performance enhancement was one of the two principal ways in which ephedra has been marketed, the impact of these warning letters has been substantial. FDA continues to monitor the compliance of products on the Internet.

DIETARY SUPPLEMENT CURRENT GOOD MANUFACTURING PRACTICES

Another important aspect of FDA’s regulatory and surveillance programs is to help ensure that dietary supplements are manufactured in a manner that will not result in adulteration. DSHEA gave FDA the authority to promulgate regulations for dietary supplement current good manufacturing practices (CGMPs).

On March 13, 2003, FDA published a proposed rule to establish CGMPs for dietary supplements. FDA's proposed rule, if finalized as proposed, will give consumers greater confidence that the dietary supplements they choose to use will have the identity, strength, purity, quality or composition claimed on the label. The CGMPs will help prevent product quality problems such as superpotency, subpotency, contamination, improper packaging, and mislabeling.

The proposed rule would:

  • include requirements on the design and construction of physical plants, to facilitate maintenance, cleaning, and proper manufacturing operations;
  • include requirements for production and process controls with the use of a quality control unit in the manufacturing, packaging and label operations;
  • include requirements for product testing and handling of consumer complaints; and
  • apply to all firms that manufacture, package, or hold dietary ingredients or dietary supplements, including those involved with testing, quality control, packaging, labeling, and distribution. The proposed regulations also would apply to both domestic and foreign firms that manufacture, package, or hold dietary ingredients and dietary supplements for distribution into the U.S.

The public comment period on this proposed rule closed on August 11, 2003. The Agency is carefully reviewing all of the comments.

Mr. Chairman, thank you for this opportunity to testify. I am happy to answer your questions.


FOOTNOTES:

1 Bennett, J. and CM Brown. 2000. “Use of Herbal Remedies by Patients in a Health Maintenance Organization.” Journal of the American Pharmaceutical Association. Volume 40, Number 3: 353-358.

2Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. File Inventory, Evidence Report/Technology Assessment Number 76. AHRQ Publication No. 03-E022, March 2003. Agency for Healthcare Research and Quality, Rockville, Maryland.

3Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. File Inventory, Evidence Report/Technology Assessment Number 76. AHRQ Publication No. 03-E022, March 2003. Agency for Healthcare Research and Quality, Rockville, Maryland.

 

ENFORCEMENT STATEGIES USED TO ENFORCE DSHEA

 

Inspections That Resulted in Voluntary Compliance
  • In October 2003, FDA witnessed the voluntary destruction of Royal Tongan Limu, a liquid dietary supplement distributed by NBTY, Inc., in Murphysboro, Illinois. This destruction concluded a series of Agency actions that started with the issuance of a Cyber Letter to Dynamic Essentials of Lake Mary, Florida for health claims associated with the product that were made on the firm’s website. Subsequent follow up revealed that Dynamic Essentials was a subsidiary of NBTY, and that the product was being distributed from NBTY’s Illinois location. Even after the issuance of the Cyber Letter, the product remained in distribution channels and, therefore, FDA recommended a seizure action. However, in lieu of seizure, the firm chose to voluntarily destroy its inventory of approximately 90,000 bottles of Royal Tongan Limu, along with the product’s related literature and materials. Approximately 188 tons of material was destroyed with an estimated value of $2.7 million.
  • On April 30, 2003, Nature’s Youth, LLC, of Centerville, Massachusetts, 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 firm’s action was the result of an FDA advisory that the products appeared to be misbranded by virtue of unsubstantiated “structure and function” statements that claimed that the product would, among other things, “improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions.” The product also claimed to be “your body's best defense against aging.”
  • 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 to 5 million worth of products known as “Yellow Jackets” and “Black Beauties.” The warrant was served at NVE Pharmaceuticals, 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. An attempt by FDA to inspect the manufacturer of the products on October 8, 2002, resulted in an inspection refusal, forcing FDA to obtain an inspection warrant. FDA obtained an additional inspection warrant in January 2003. After NVE stopped marketing Yellow Jackets and Black Beauties, it began marketing “Yellow Swarm” and “Midnight Stallion” as replacement products. Although these products appear to be almost identical in formulation and appearance to the previous products, they no longer bear street drug names or claims.
  • FDA conducted a May 2002 inspection of Fresh Vitamins, a manufacturer of Noni Fresh Juice. Fresh Vitamins marketed its product to treat conditions ranging from immune system disorders to arthritis, malaria, and alcohol addiction. Following the inspection, the firm’s president stated that he had removed impermissible claims from the firm’s website and that he was educating himself on FDA policy regarding dietary supplement claims.
  • Following a May 2002 inspection of Health Ventures, a manufacturer of Miracle Bust, a FDA investigator witnessed the destruction of the company’s inventory. The company signed an affidavit stating that it would voluntarily stop the sale and distribution of Miracle Bust, delete references to it on its website, and refrain from placing future orders from its contract manufacturer.
Voluntary Recalls
  • On May 23, 2003, Best Life International, Mayaguez, Puerto Rico, 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.
  • On February 11, 2003, Best Life International recalled Ancom Anti-Hypertensive Compound tablets. Although these products claimed to be dietary supplements, they were found to contain several prescription drug ingredients, including reserpine, diazepam, promethazine, and hydrochlorothiazide. The product was sold on the Internet and at retail stores.
Warning Letters
  • On September 30, 2003, FDA issued a Warning Letter to Dr. Gordon Joseph, Chelationcare Centers U.S.A., Scottsdale, Arizona. Dr. Joseph’s websites, http://www.anti-thrax.com and http://www.homeovax.com marketed an anthrax vaccine alternative and viral immune alternative immunizations and vaccinations. The anti-anthrax vaccine contained Bacillus anthracis and other ingredients that are recognized in the Homeopathic Pharmacopeia of the United States (HPUS). The “Viral Immune” product made claims that it was a defense against smallpox, measles, and encephalitis viruses. These statements, and the therapeutic claims establishing the intended use of the products, caused them to be misbranded drugs.
  • A Warning Letter was issued to Michael Peng, President of Greenvalley, LLC, located in Farmingdale, New York on September 26, 2003, for offering trans-dermal products intended for the treatment of diabetes and prostate disease-related symptoms via a website, http://gyconline.com. Moreover, although the products were represented as dietary supplements, they did not qualify as dietary supplements since they were not intended for ingestion as set forth in the Act. Additionally, FDA had no information to indicate that the products were generally recognized as safe and effective for their intended use; and the products were misbranded because the labeling failed to bear adequate directions for use.
  • On July 22, 2003, FDA issued a Warning Letter to Ayoula Dublin, New York, New York, for marketing and distributing “Lipostabil,” an injectable product that claimed to break down and dissolve fat “for the person who wants to lose those last 5-10 extra pounds.” Although the product claimed to be a dietary supplement, its route of administration disqualified it as a dietary supplement (since it was not intended for ingestion). Moreover, the product’s structure/function claims and lack of substantiation to show that the product was generally recognized as safe and effective for its intended use made it a new drug without an approved drug application.
  • On June 9 and 10, 2003, FDA issued Warning Letters to 18 firms that operated 24 websites marketing multiple coral calcium products as effective treatments or cures for a variety of diseases and conditions. Many of these coral calcium products also made unsubstantiated structure/function claims. Coral Calcium Supreme was 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 March 31, 2003, FDA sent Warning Letters to 8 firms after an investigation revealed that the firms sold “street drug alternative” products marketed for “recreational” purposes with claims that they would produce such effects as euphoria, a “high,” or hallucinations. These street drug alternatives cannot meet the legal definition of a dietary supplement because they are not intended to supplement the diet. The 8 letters were targeted primarily to manufacturers of products that contained ephedrine or norephedrine hydrochloride and whose products were labeled as dietary supplements for use in weight loss, suppression of appetite, and enhanced libido.
  • On February 28, 2003, based upon the conclusions of the RAND study, FDA warned 26 firms to cease making unproven claims that ephedrine-containing dietary supplements enhance athletic performance. These warnings were issued primarily as a result of the Agency’s surveillance of the firms’ websites. Fourteen of the firms responded to the Warning Letters by discontinuing the violative products and/or fraudulent claims. FDA inspected the twelve remaining firms. Since performance enhancement is one of the two principal ways in which ephedra products have been marketed, the impact of these Warning Letters was substantial. FDA continues to monitor the firms/websites/products to ensure their compliance with applicable regulations.
  • In August 2002, FDA issued a Warning Letter to Better Way Kids. This firm distributed “Calm Focus," a product promoted to treat Attention Deficit Disorder and Hyperactivity Disorder. The firm characterized its product as a “natural alternative to Ritalin” and claimed that it was “formulated to energize neurotransmitters in the brain.” The Warning Letter made clear that dietary supplements may not make disease claims or unsubstantiated structure/function claims. The firm corrected its product claims.
    In mid-June, 2002, FDA sent seven Warning Letters to manufacturers of products containing synthetic ephedrine.
  • In 2002, the Agency issued 17 Dietary Supplement Warning Letters, with products containing synthetic ephedrine receiving particular attention. Marketers promoted these products for use in weight loss, energy enhancement, and to increase libido. However, the presence of synthetic ephedrine placed the products outside the definition of a dietary supplement.
Seizures and Injunctions
  • On September 22, 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. Despite FDA’s warnings, the defendant and his related businesses repeatedly sold dietary supplements that claimed to treat obesity and erectile dysfunction. Earlier in June 2003, FDA had issued a “Public Health Alert” warning consumers not to purchase or consume certain dietary supplements sold by Hi-Tech Pharmaceuticals, Inc., and related businesses because FDA test results had found that the supplements were adulterated with the prescription-strength drug ingredient taldalafil. An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and taldalafil could cause a drastic lowering of blood pressure. The possibility that patients who did, indeed, take nitrates could have consumed the supplements was very real since erectile dysfunction is often a common problem in people who have diabetes, hypertension, high cholesterol, and heart disease.
  • On September 18, 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, which caused them to be unapproved drugs. FDA had warned Jean’s Greens in November 2001, to change its labeling for the products, but it did not comply. The seized goods, which included 385 bottles and 78 mix packages, were worth more than $4,000.
  • On June 18, 2003, the U.S. District Court for the Southern District of Florida entered a Consent Decree of Condemnation and Destruction for 450 bottles and 57,000 bulk capsules of dietary supplement products seized by U.S. Marshals at Global Source Management and Consulting, Inc. (Global Source), located in Sunrise, Florida, on February 13, 2003. The seizure occurred after FDA determined that these products claimed to treat a variety of medical conditions, causing them to be drugs. 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. Under the terms of the Consent Decree, the Claimant, Global Source, had to destroy all of the products. 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.
  • 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, a “natural” treatment for viruses such as the herpes virus and “cold and flu protection.” None of these claims had been substantiated. FDA charged that EverCLR was an unapproved and therefore, illegal, new drug because it was promoted to treat and prevent specific diseases and conditions. Because EverCLR’s labeling lacked adequate directions for use, FDA also charged that it was misbranded.
  • In the summer of 2002, FDA filed two seizure actions against dietary supplements making unsubstantiated claims about their effect on the structure or function of the body.
    • United States v. Undetermined Quantities of Cases of an Article of Food and Drug Labeled in Part: Brain Nutrient Capsule, involved a product offered as a supplementary treatment for mental retardation, cerebral palsy, and epilepsy. The product’s distributor claimed that it “has the function of increasing the intelligence, elevat[ing] the intelligence quotient (IQ) and promoting growth..” FDA alleged that these claims were baseless.
    • United States v. 172/100 Capsule Bottles, More or Less, of an Article of Food Labeled in Part: Kirkman Taurine 325 mg Dietary Supplement Capsules, concerned a product offered as a supplementary treatment for autism. Materials promoting the product stated, “Dr. Jeff Bradstreet, a physician in Palm Bay, Florida, who treats autistic patients reports good success using Taurine.” The materials further asserted that “[t]aurine may be beneficial in developmental disorders.” FDA alleged that there is no scientific support for these claims.
  • In March, 2002, FDA seized products marketed as dietary supplements that contained synthetic ephedrine. For example, United States v. 1009 cases et al., involved the seizure of nearly $3 million worth of Amp II Pro Drops from a company doing business as E'OLA International. Although labeled as a supplement, the product contained synthetic ephedrine. FDA alleged that the product violated the law because synthetic ephedrine is not a dietary ingredient. Accordingly, a product containing synthetic ephedrine is not a dietary supplement. The Agency also alleged that the product, which was marketed to treat obesity, made illegal disease claims. The consent decree required the product's destruction and prohibited E'OLA from manufacturing or distributing products that violate the FD&C Act.
  • In 2001, FDA brought a seizure action against a purported supplement manufacturer that marketed its products as illegal street drugs. The case, U.S. v. Undetermined Quantities of Articles of Drug, Street Drug Alternatives . . . et al. showed that Hit Products, Inc., and Organic Diversions, Inc., marketed 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 seized them as misbranded and unapproved new drugs in violation of the FD&C Act. FDA 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 "ecline[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."
  • In 2001, FDA's injunction actions also extended to supplement marketers who violated DSHEA's proscription of disease claims. Samples include:
    • U.S. v. Lane Labs USA, Inc. and Andrew Lane constituted an injunction action that involved several of Lane Labs'products, including its shark cartilage product. Lane Labs marketed this product as a dietary supplement, but made unsubstantiated cancer treatment claims about it. FDA contended that the disease claim caused the product to be an unapproved, and therefore illegal, new drug.
    • U.S. v. Syntraz Innovations, Inc., et al, 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 the product contained tiratricol, a hazardous compound that 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
Criminal Enforcement
  • As a result of concurrent federal search warrants executed by OCI in Georgia and New Jersey, FDA warned consumers on June 20, 2003, not to purchase or consume Sigra, Stamina Rx, and Stamina Rx for Women, Y-Y, Spontane ES, and Uroprin. These products, which were marketed as dietary supplements, contained a prescription drug ingredient, tadalafil, which posed 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 were being sold over-the-counter and claimed to increase stamina, confidence, and performance. (A civil, permanent injunction was also filed – see description under Seizures/Injunctions.)
  • In U.S. v. Cap-Tab Nutritional Formulating and Manufacturing Inc., an officer of a corporation known as Cap-Tab, along with the corporation itself, was convicted in June 2002 of one count of introducing misbranded food into interstate commerce. This case stemmed from an allegation that three individuals who were all officers of Cap-Tab conspired and knowingly substituted low-price ingredients for the ingredients listed on the label of their dietary supplement product (encapsulated vegetable powders). Three of the defendants in the case received sentences of one year’s probation and were ordered to pay fines of $500, $250, and $5000, respectively. A fourth defendant received a sentence of 180 days’ incarceration followed by five years’ incarceration on a related state criminal conviction.
  • In U.S. v. Diane Eckert-Kunick, an individual was convicted in April 2002 of introducing unapproved new drugs into interstate commerce and subsequently received a sentence of four months’ incarceration in a community correctional center. The defendant, along with her parents, had formed a company known as New Gaia Products (NGP) in 1996. The company manufactured, distributed, and sold dietary supplements including colloidal gold, colloidal silver, and colloidal titanium. The defendant also distributed promotional literature claiming that NGP products cured cancer, rheumatoid arthritis, and heart disease.
  • In U.S. v. Theodore Sosangelis and Thomas Knox, two individuals pled guilty in October 2001 and February 2002, respectively, to trafficking counterfeit dietary supplements in interstate commerce. From January through July 2000, via their company, East Coast Ingredients, the defendants produced inexpensive versions of legal supplements manufactured by Muscletech. After placing fake Muscletech labels on their products, the defendants sold them to customers who believed that they were purchasing legitimate Muscletech dietary supplements. One of the defendants in the case received a sentence of three years’ probation and was ordered to pay restitution of almost $77,000.
  • FDA determined that the pre-DSHEA product known as Nature’s Nutrition Formula One, which was marketed between 1992 and 1994 as an all natural “nutritional supplement” containing 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 and at least one death was associated with the use of this product. This case was developed by alerts provided from adverse event reports, ORA’s field staff, and the work of OCI together with DOJ. Through these sources, 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. On July 7, 2000, a Federal judge sentenced the president to 21 months in jail and fined him and this corporation $4.7 million. In his plea agreement, the president 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.
Joint Enforcement Affairs
  • 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. Legal proceedings are ongoing.
  • On June 17, 2003, U.S. Marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million, from Seasilver USA's San Diego, California, headquarters in an action initiated by FDA. The complaint for seizure alleged that, although Seasilver USA marketed Seasilver as a dietary supplement, it promoted 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, U.S. Marshals seized an additional 1.7 million dollars worth of Seasilver from a distribution center in Parma, Ohio. In response to an FTC request, the Federal district court in the Southern District of California issued a temporary restraining order on June 13, 2003, 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. Legal proceedings are ongoing.
  • On May 27, 2003, the FTC filed a complaint against an individual and four of his corporations for making false and unsubstantiated claims. The individual claimed that that five of the products marketed by him and his corporations as dietary supplements were “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 included: 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).
  • On May 9, 2003, FDA and FTC warned website operators, manufacturers, and distributors to remove misleading or deceptive claims on the Internet 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 included 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 as treatment or preventative remedies for SARS over the Internet. FTC also notified violative firms that they were subject to possible civil or criminal actions under the Federal Trade Commission Act. FDA has conducted appropriate follow-up to ensure that the firms have taken appropriate corrective action.
  • In World Without Cancer Inc., 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 both injectable and tablet forms, and apricot seeds, were promoted as “dietary supplement” cancer treatments through the firm’s websites. The preliminary injunction and the subsequent Consent Decree of Permanent Injunction required the defendants to cease using the websites to promote the sale or offer for sale their laetrile products.