Dietary Supplements For Weight Loss: Limited Federal Oversight Has Focused More on Marketing than on Safety
Published: 2002-07-31T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: Since the enactment of the Dietary Enactment Supplement Health and Education Act in 1994, U.S. sales of weight loss supplements have increased steadily. The sales of weight loss supplements--reported to be the fastest growing segment of the dietary supplement industry--increased 10 to 20 percent annually from 1997 to 2001, and industry officials expect that rate of increase to continue. Little is known about the effectiveness of weight loss supplements, but some supplements have been associated with the potential physical harm. Health consequences may result from the use of the supplement itself or from the interaction of the supplement with medications or foods. Federal and state activities related to weight loss supplements have been limited and have focused on oversight of marketing rather than on oversight of safety. In addition, several states have statutes or regulations in effect or pending to restrict the sale of some weight loss supplements. Some state attorneys general and local district attorneys have sued the manufacturers of supplements marketed with weight loss claims, and individuals have sued over injuries.

section_title: Letter
paragraphs: I am pleased to have the opportunity to testify as the Subcommittee  considers concerns about dietary supplements that are used for weight  loss. Since the enactment of the Dietary Supplement Health and  Education Act (DSHEA) in 1994, U.S. sales of weight loss supplements  have increased steadily. The sales revenue of weight loss supplements— reported to be the fastest growing segment of the dietary supplement  industry—increased 10 to 20 percent annually from 1997 to 2001, and  industry officials expect that rate of increase to continue. The prevalence  of obesity has increased in the United States, and many Americans are  looking for ways to help them lose weight. It is estimated that Americans  spent almost $2 billion on weight loss supplements in 2001. As sales of  weight loss supplements have increased, so have concerns associated with  their marketing and use. Regulators, medical experts, and the dietary  supplement industry recognize that some weight loss supplements may be  marketed with overstated claims, such as “lose weight while you sleep.” In  addition, some weight loss supplements have been reported to be  associated with serious side effects for some people.
Various government agencies have a responsibility for oversight, research,  and education efforts related to weight loss supplements. The Federal  Trade Commission (FTC) and the Department of Health and Human  Services’ (HHS) Food and Drug Administration (FDA) have oversight  responsibility for products marketed as weight loss supplements.  Marketing includes both advertising activities and product labeling. FDA  oversees the manufacture and labeling of weight loss supplements, but is  not required by DSHEA to approve dietary supplements for safety or  efficacy. FTC is responsible for ensuring that the advertising for these  products is not unfair or deceptive. HHS’s National Institutes of Health  (NIH) funds research to determine the safety and efficacy of weight loss  supplements. All three agencies carry out some consumer education  activities. State agencies also enforce individual states’ laws that govern  the sales and marketing of particular supplements.
Because of the concerns surrounding the marketing and use of weight loss  supplements, you asked us to examine these issues and how they are  being addressed by federal and state agencies and the dietary supplement  industry, as well as in the courts. My remarks today will focus on (1) safety  and efficacy concerns associated with weight loss supplements; (2) federal  oversight, research, and public education efforts; and (3) state and local  regulatory efforts aimed at consumer protection, including litigation  concerning weight loss supplements.
In our examination of these issues, we reviewed scientific literature about  weight loss supplements, as well as federal and state regulatory activities  involving weight loss supplements. In addition, we interviewed and  obtained documents from officials at FDA, FTC, and NIH. We also  interviewed representatives of trade associations and interest groups  pertinent to dietary supplements and weight loss. We identified dietary  supplements commonly used or marketed for weight loss and possible  side effects or contraindications for those supplements (see the appendix  for a list of these supplements). However, our work does not represent an  exhaustive review of the efficacy or safety of particular weight loss  supplements, nor did we look at meal replacements, over-the-counter  drugs, or prescription medications. We provided a draft of this testimony  to FTC, FDA, and NIH for their review. In oral comments, the Director of  FDA’s Center for Food Safety and Applied Nutrition agreed with our  statement. FTC and NIH declined to provide official comments. FTC, FDA,  and NIH provided technical comments which we have incorporated where  appropriate. We conducted our work from May through July 2002 in  accordance with generally accepted government auditing standards.
In summary, little is known about whether weight loss supplements are  effective, but some supplements have been associated with the potential  for physical harm. Health consequences, which can be serious, may result  from the use of the supplement itself or from the interaction of the  supplement with medications or foods. People with certain underlying  health conditions, such as heart disease, high blood pressure, and  diabetes, may be particularly at risk. In addition, supplements may be  contaminated with harmful ingredients or may not contain the amount of  an active ingredient that is stated on the label. Federal and state activities  related to weight loss supplements have been limited and have focused on  oversight of marketing more than on oversight of safety. FTC has  prosecuted manufacturers of weight loss supplements for making  misleading claims. FDA has issued warnings for some products and  ingredients. However, FDA faces difficulty in addressing safety concerns  due in part to weaknesses in its adverse event reporting system. The  agency must also meet different standards for addressing safety concerns  with supplements than it uses for drugs. Further, FDA has been slow to  issue good manufacturing practice (GMP) regulations. Federal agencies  have also been involved in research and education. NIH’s National Center  on Complementary and Alternative Medicine (NCCAM) has determined  that weight loss supplements are not as high a priority as its other areas of  research. Both FTC and FDA have developed publications and Internet  sites on weight loss that provide some educational materials to  consumers. In addition, several states have statutes or regulations in effect  or pending to restrict the sale of some weight loss supplements. Some  state attorneys general and local district attorneys have sued the  manufacturers of supplements marketed with weight loss claims, and  individuals have sued over injuries.
subsections: section_title: Background
paragraphs: More than half of U.S. adults are overweight or obese, and more than one- third of U.S. adults are trying to lose weight. Increasingly, they are turning  to weight loss supplements for help. The most widely used weight loss  supplement is ephedra, or ma huang. The active ingredients in ephedra— ephedrine alkaloids—are compounds with potentially powerful stimulant  effects on the nervous and cardiovascular systems. The dietary  supplement industry estimates that as many as 3 billion servings of  ephedra are sold each year in the United States and approximately 12  million individuals were using ephedra in 1999.
FDA regulates dietary supplements under DSHEA, which covers vitamins,  minerals, herbs or other botanicals, amino acids, certain dietary  substances, or derivatives of these items. A product that contains any  active ingredient not on the preceding list—such as synthetic ingredients  that are sold in over-the-counter drugs and prescription medications—may  not be marketed as a dietary supplement. DSHEA requires that dietary  supplement labels include complete lists of ingredients and the amount of  each ingredient in the product. Products may be labeled as “proprietary  blends” and must list all ingredients but do not need to list the amount of  each ingredient. In addition, dietary supplements cannot be promoted as a  treatment, prevention, or cure for a specific disease or condition. To the  extent that therapeutic claims are made, FDA may take action.
FDA generally oversees the safety of dietary supplements. It may issue a  regulation, for example, to prevent the further marketing of dietary  supplements that it has determined pose an unreasonable risk of illness  under the recommended conditions of use. A dietary supplement may also  be removed from the market if HHS finds that it poses an imminent hazard  to public health and safety. However, under DSHEA, it is the manufacturer  who is responsible for ensuring the safety of the weight loss supplements  it sells. Dietary supplements do not need approval from FDA before they  are marketed. DSHEA does not require manufacturers to register with  FDA, identify the products they manufacture, or provide reports of  adverse events—harmful effects or illnesses—to FDA. However, FDA is  authorized to issue regulations governing GMPs to standardize  manufacturing, packaging, and holding practices.
Since manufacturers of dietary supplements are not required to provide  reports of adverse events to FDA, the agency and others rely on voluntary  postmarketing reporting of adverse events to better understand the safety  of dietary supplements. In addition to these adverse event reports, FDA  uses data from poison control centers, reports and inquiries from  consumers and health care providers, and complaints from trade  competitors to track potentially dangerous supplements. These reporting  systems can then be used to signal safety concerns. There are numerous  problems with this passive system of adverse event reporting, and these  have been noted extensively in our earlier work. For example, only a  small proportion of adverse events are reported, and those reports often  are incomplete or contain inconsistent information.
In an effort to control unfair or deceptive acts or practices in the  marketplace, FTC oversees dietary supplement advertising to ensure that  product claims are truthful and substantiated. Manufacturers and  distributors of weight loss supplements make a wide variety of claims  about how their products work. They claim that the supplements reduce  appetite or cravings, increase metabolic rate, have a laxative effect, and  block digestion of fat, carbohydrates, sugars, or starches. Manufacturers  frequently combine multiple supplements into single products, promoting  several pathways to weight loss. FTC can demand that false, exaggerated,  or unsubstantiated claims be removed from advertising, and it also can  seek monetary relief for injurious conduct. The marketing of unsafe  products or potentially dangerous products without adequate safety  warnings could violate the Federal Trade Commission Act.
Federal research regarding the safety and efficacy of weight loss  supplements marketed to the public is carried out under NIH sponsorship.  The agency’s NCCAM is primarily responsible for federal research on  complementary and alternative medicine, including dietary supplements,  although other NIH institutes may also fund such research. Generally,  NCCAM funds clinical trials to evaluate the safety and efficacy of popular  alternative medicine products and therapies of interest. NIH’s Office of  Dietary Supplements (ODS) supports research and disseminates research  results in the area of dietary supplements. Specifically, ODS plans,  organizes, and supports conferences, workshops, and symposia. Although  ODS can initiate such activities, it generally works in conjunction with  other NIH institutes and centers and other groups.
States and individuals can also take action against manufacturers of  weight loss supplements. States can enact and enforce laws and  regulations to protect consumers from dangerous weight loss supplements  and false or misleading advertising. Individuals can file lawsuits against  manufacturers alleging injury from using weight loss supplements.
section_title: Little Evidence of Efficacy Exists for Weight Loss Supplements, and Some May Have Serious Health Consequences for Certain Individuals
paragraphs: There is little evidence on whether weight loss supplements are  efficacious. However, we identified several ways that weight loss  supplements might cause health risks. Many weight loss supplements have  been associated with side effects, some of which can be serious. Some  weight loss supplements should be avoided by individuals with certain  medical conditions because particular effects of the supplements could  exacerbate the conditions. In addition, some weight loss supplements have  potentially dangerous interactions with prescription or over-the-counter  medications or foods. Further, a supplement may contain dangerous  contaminants or different amounts of an active ingredient than indicated  on the product label. Finally, we found multiple-ingredient products to be  of particular concern because of the increased difficulty involved in  evaluating and understanding their safety.
subsections: section_title: Little Evidence Exists on Efficacy of Weight Loss Supplements
paragraphs: For most weight loss supplements, little scientific evidence to date  supports their efficacy. Although there have been studies on specific  ingredients, many of these studies have been of short duration, involved  small numbers of individuals, or used study approaches that limited the  usefulness of their findings. There have been few comprehensive reviews  or long-term studies of efficacy. One comprehensive review of alternative  treatments for weight loss found no reliable scientific evidence for the  efficacy of any of the weight loss supplements that it reviewed. Another  review found similar results except for ephedra. Most of the research that  has been done to evaluate the efficacy of weight loss supplements has  involved ephedra. A recently published randomized study found that a  combination of ephedra and kola nut (a source of caffeine) promoted  weight reduction. Other smaller studies have shown similar results for  ephedra.
section_title: Adverse Effects, Contraindications, and Interactions Are Associated with Weight Loss Supplements
paragraphs: Available research on weight loss supplements, though limited, in general  suggests that some supplements are associated with both minor and  potentially serious adverse effects. Further, many supplements are  contraindicated for individuals with some underlying health problems.  That is, there are specific dangerous side effects for persons with certain  health conditions. In addition, a variety of weight loss supplements can  have dangerous interactions with prescription and over-the-counter drugs  that are being taken concurrently. However, just as with research on  efficacy, few systematic studies exist on the negative health consequences  of particular weight loss supplements. Adverse effects, contraindications,  and interactions that have been associated with some of the more  commonly used weight loss supplements are shown in the appendix.
The side effects associated with weight loss supplements are generally  mild and may include unpleasant digestive symptoms, insomnia, or rash.  However, for some supplements there may be more serious adverse  effects. For example, dehydroepiandrosterone (DHEA) may increase the  risk of some hormone-related cancers. Both aloe taken internally, such as  in a dieter’s tea, and chromium may also increase the risk of cancer. FDA  has identified illnesses and injuries reported to be associated with the use  of selected weight loss supplements, including yohimbe, which has been  associated with renal failure, seizures, and death, and ephedra, which has  been associated with seizures, heart attacks, psychosis, stroke, and death.
Use of some weight loss supplements has been found to be  contraindicated, or inadvisable, for persons with certain preexisting  medical conditions. For example, bitter orange (Citrus aurantium)  should be avoided by persons with certain heart conditions. DHEA may  worsen prostate hyperplasia. Neither herbal laxatives found in dieter’s  teas nor fiber should be used by persons with intestinal obstructions.  Fiber and gymnema may affect persons with diabetes. These risks are of  particular concern because serious health conditions, such as  hypertension and diabetes, often go undiagnosed. Consumers who have  undiagnosed medical conditions and inadvertently use contraindicated  dietary supplements may expose themselves to considerable risk.
Using weight loss supplements along with certain prescription  medications and certain foods poses an additional risk. For example, fiber  may alter the effects of some medications. Other supplements, such as  DHEA, may duplicate the effects of prescription medications. Similarly,  aloe and chromium affect blood sugar levels and may require altering the  dosage of medication for diabetes. And many supplements, such as fiber,  green tea, and guggul, may alter the effects of anticoagulant medications.  Yohimbe and St. John’s wort should not be used with certain foods (such  as red wine, liver, and cheese) because they may cause a toxic reaction,  and chitosan may affect the absorption of certain vitamins. The possibility  of such interactions is of particular concern because it has been reported  that more than 18 percent of those who use a prescription drug also use a  dietary supplement, and further, about 60 percent of people who use  dietary supplements do not discuss their supplement use with their  doctors.
section_title: Product Contamination and Content Variation May Pose Health Risks
paragraphs: Contaminated supplements and those with different amounts of active  ingredients than indicated on the labels, or different active ingredients  altogether, can pose significant health risks to consumers. Research has  found supplements contaminated with pesticides or heavy metals, some of  which are probable carcinogens and are toxic to the liver and kidneys. One  commercial laboratory found contamination in samples of the weight loss  supplements St. John’s wort and chromium. For dietary supplements in  general, the same laboratory found that 24 percent of the 62 herbal  products it tested, particularly those containing ginseng, and 4 percent of  the 68 nonvitamin, nonmineral supplement products it tested were  contaminated in some way.
Amounts of active ingredients can vary from what is indicated on a  product label. Too much of an active ingredient may increase the risk of  overdose for some consumers. Studies of DHEA, ephedra, and St. John’s  wort found that a number of products have substantially more active  ingredient than indicated on the label. One brand of DHEA was found to  contain 150 percent of the amount of active ingredient indicated. A study  of ephedra showed that one product contained as much as 154 percent of  the amount indicated. Too little of an ingredient can also pose a risk. For  example, one chromium product tested by a commercial laboratory had  less than 5 percent of its claimed amount of chromium. Because chromium  can affect insulin and blood sugar levels, diabetics taking products  containing chromium may attempt to adjust their medication dosage to  compensate. However, if the chromium product does not contain the  stated amount of active ingredient, the consumer may over- or  undercorrect his or her dosage.
Further, products may contain active ingredients not on the label. In 2002,  the International Olympic Committee (IOC) found that of 634 nutritional  products tested, 15 percent contained ingredients banned by the IOC but  not listed on product labels. Of the countries whose products were tested,  the United States had the most products—19 percent—that contained  ingredients that had been banned and were not listed on product labels.
section_title: Multiple-Ingredient Products Pose an Unknown Risk
paragraphs: Of particular concern to some federal officials is the widespread  prevalence of multiple-ingredient weight loss supplements. Rarely do  weight loss supplements contain just one active ingredient. In fact,  multiple-ingredient products account for 85 percent of the weight loss  supplement market. We found products containing as many as 22 active  ingredients, all of which are classified as dietary supplements. In  considering the scientific literature relevant to weight loss supplements,  we found that although the majority of products marketed for weight loss  contained more than one active ingredient, the majority of the research  and evidence of adverse events is reported for each individual ingredient,  not for multiple-ingredient products. FDA officials reported that there is  little systematic research on individual ingredients and virtually none on  multiple-ingredient products, with the possible exception of ephedra with  caffeine. With multiple-ingredient products, potentially dangerous  interactions may be more likely, as has been suggested with the  combination of ephedra and caffeine, both stimulants.
It is more difficult to study the safety and efficacy of multiple-ingredient  products because each product may have a different combination of  ingredients, meaning that each individual product would need to be  studied. Further, the amounts of ingredients in a product may be unknown  if the product contains a “proprietary blend” of various ingredients.  Proprietary blends must list ingredients but are not required to specify the  amount of any individual ingredient. Finally, it is harder to identify  patterns in the adverse events associated with multiple-ingredient  products and attribute the events to either an individual ingredient or a  combination of ingredients. A study found that in 95 percent of the adverse  events reported to FDA for products containing chromium, the products  also contained as many as 11 additional ingredients, any of which may  have been responsible for the adverse event. It is also possible that it is the  interaction of these ingredients that is responsible for the adverse events.
section_title: Limited Federal Efforts Have Focused More on Oversight of Advertising and Labeling than on Oversight of Safety
paragraphs: Federal oversight, research, and education efforts to protect and inform  consumers about the potential risks associated with the use of some  weight loss supplements have been limited. They have focused almost  entirely on marketing issues such as advertising and labeling, rather than  on safety issues associated with particular weight loss supplement  ingredients. These efforts include carrying out enforcement activities  against companies, funding research to evaluate weight loss supplements,  and providing educational materials on potentially dangerous ingredients  and fraudulent product claims. Since 1995, FTC, which generally oversees  the advertising of weight loss supplements, has taken 30 actions related to  supplements. FDA, which regulates the manufacturing and labeling of  weight loss supplements, has taken 16 actions against manufacturers in  the same period. FDA has faced difficulty in addressing safety concerns  and has been slow to issue GMPs for dietary supplements. Although  federal agencies have not given priority to research on weight loss  supplements, they do provide some educational material to consumers.
subsections: section_title: FTC Has Focused Its Oversight and Enforcement Efforts on Advertising
paragraphs: FTC staff told us that the agency has taken legal action in 30 cases  involving the advertising of weight loss supplements since 1995, after  DSHEA went into effect. These actions resulted in more than $21.5 million  in monetary relief and consumer redress. In addition, as of June 2002, FTC  staff reported that they had a significant number of investigations pending  against different manufacturers of weight loss supplements. In 2000,  Enforma Natural Products agreed to a settlement with FTC regarding  deceptive claims for two products and agreed to pay $10 million in  consumer redress. The products, a chitosan-based product called “Fat  Trapper” and a pyruvate product named “Exercise In A Bottle” made  claims such as  “you can eat what you want and never, ever, ever have to diet again,”  “you can enjoy all these delicious foods like fried chicken, pizza,  cheeseburgers, even butter and sour cream, and stop worrying about the  weight,” and  “foods you can eat when you crave them without guilt, without worry, and  it’s all because of a few little capsules.”
However, in 2002, the company was still marketing the products in  question. Since the filing of the final judgment in that case, FTC attorneys  have filed two contempt actions against Enforma to enforce the provisions  of the court’s order. In 1999, FTC action was upheld in a case against  SlimAmerica for its “Super-Formula,” consisting of three different pills,  containing chromium picolinate, hydroxycitrate (HCA), chitin, and konjac  glucomannan (a soluble fiber). The company was ordered to pay more  than $8.3 million in consumer redress. In addition, the president and vice  president of the company were ordered to post a $5 million and a   $1 million performance bond, respectively, prior to engaging in any  business related to weight loss products or services.
To help manufacturers better understand the advertising restrictions and  requirements for dietary supplements, FTC issued a guide for advertising  dietary supplements in November 1998. In addition, FTC conducts  outreach to the industry regarding responsible advertising.
section_title: FDA Has Focused Its Oversight and Enforcement Efforts on Labeling
paragraphs: FDA is involved in varied activities to protect consumers of weight loss  supplements, including enforcement actions against manufacturers for  improper labeling and publication of a proposed rule regarding ephedra  dosing. FDA has taken 16 enforcement actions since 1995 against the  manufacturers of dietary supplements marketed with weight loss claims,  and the majority of these have been for products that are improperly  labeled as dietary supplements. For example, FDA determined in 1999 that  Triax Metabolic Accelerator, labeled as a dietary supplement, was an  unapproved new drug that contained a potent thyroid hormone that could  cause heart attacks and strokes. The manufacturer agreed to stop  distributing products containing the specified ingredient. In 2001, FDA  took action resulting in the seizure of $2.8 million worth of AMP II Pro  Drops, an unapproved drug product that contained ephedrine from a  nonherbal source but was labeled as a dietary supplement. The  manufacturer agreed in 2002 that it would not manufacture and distribute  such products in violation of the law. In June 2002, FDA sent six more  warning letters to companies that were also marketing nonherbal  ephedrine products as dietary supplements.
In fiscal year 2002, FDA has allocated $1.4 million to support enforcement  initiatives against manufacturers of dietary supplements making  unsubstantiated labeling claims. From February 1997 through January  2002, FDA issued seven warning letters to manufacturers of weight loss  products, focusing mainly on the labeling of these products. Five of these  warnings were for products labeled as alternatives to the prescription  drugs fenfluramine and/or phentermine, also known as Fen-Phen. These  actions were taken because labels for dietary supplements cannot contain  references to prescription drugs.
The only enforcement action FDA has taken on the basis of safety  concerns specific to weight loss supplement ingredients came in 2001,  when the agency warned consumers not to use LipoKinetix because of  multiple reports of liver injury or failure while using the product. This  product contained, among other things, caffeine and yohimbe. In addition,  the agency issued a letter to health care professionals and the distributors  of the product alerting them to the product’s risks and asking distributors  to voluntarily remove the product from the market.
To date, the most concerted attempt taken by FDA to protect consumers  of weight loss supplements has been its effort to regulate dietary  supplements containing ephedra. In 1997, FDA published a proposed rule  regarding the dosing and labeling of products containing ephedra. After  public comment and following our report on the subject that was critical  of the science FDA used to develop some of its proposed rule, the agency  withdrew the parts of the proposed rule on dosing; the remaining elements  focus on warnings and combinations with other ingredients. In June 2002,  the Secretary of Health and Human Services announced that HHS was  funding a comprehensive review of the existing science on ephedrine  alkaloids as input to the proposed rule. This study is supported through  the Agency for Healthcare Research and Quality.
section_title: FDA Has Faced Difficulty in Addressing Safety Concerns
paragraphs: FDA has been hindered in its ability to address safety concerns with  weight loss supplements by weaknesses in its adverse event reporting  system. Further, its authority to address potential safety concerns for  weight loss supplements is different from that for drugs.
Weaknesses in the adverse event reporting system include difficulty in  detecting patterns of events, as well as in obtaining voluntary adverse  event reports. Adverse event reports are often incomplete and contain  inconsistent information. Officials reported that it is easier to identify  patterns with over-the-counter drugs and pharmaceuticals than with  dietary supplements because there is a better understanding of the  biological mechanisms of action from preclinical testing of these drug  products and because manufacturers of such products that have approved  applications are required to report adverse events to FDA. In contrast, it  can be difficult to detect patterns for serious adverse events for dietary  supplements in part because of the absence of preclinical testing.  Nevertheless, HHS has reported that a pattern of potentially related events  has been identified from adverse event reports for products containing  ephedra, although questions remain on the strength of the products’  association to the adverse events reported to FDA. The voluntary, or  passive, nature of the adverse event reporting process for dietary  supplements contributes to the difficulty in establishing causal  connections. One manufacturer received more than 1,200 complaints of  adverse events for a weight loss supplement containing ephedra, but,  because there is no reporting requirement for dietary supplements, it did  not forward any of these reports to FDA. The HHS Inspector General  reviewed the adverse event reporting system in April 2001. In response to  that review, FDA is developing a new reporting system with an emphasis  on dietary supplements, which should be available in mid-2003. Agency  officials stated that the new system will enhance FDA’s ability to capture  data and follow up on event reports, but reporting will remain voluntary.
Although agency officials stated that the criteria they use to review  adverse events reported for dietary supplements and for over-the-counter  or prescription drugs are the same, the authority to regulate dietary  supplements, and to take action on safety concerns, is different from that  for drugs. When FDA has health concerns about an over-the-counter  ingredient, or combination of ingredients, the agency may determine that  it is not generally recognized as safe and effective, and may issue a  regulation or take other action to prohibit further marketing. FDA is not  required to find that an over-the-counter drug is unsafe or dangerous to  remove it from the market. In the case of dietary supplements, more  significant safety concerns would have to be identified. For example, FDA  is authorized to take regulatory action against a dietary supplement if its  use would present a significant or unreasonable risk of illness under  recommended conditions of use. If FDA were to take such action,  however, it must be prepared to prove its allegations either in an  administrative hearing or court. Unlike its regulation of over-the-counter  drugs, FDA has the burden of proving that a dietary supplement presents a  significant or unreasonable risk before it can be taken off the market.
These differences in regulatory standards are reflected in differences in  actions taken for similar or identical ingredients. Specifically, FDA has  concluded that two categories of products are not generally recognized as  safe and effective and cannot be marketed for over-the-counter use. These  categories of products, however, may be used in dietary supplements.  First, in September 2001, FDA ruled that over-the-counter drugs containing  ephedrine and related alkaloids in combination with an analgesic or  stimulant would be removed from the list of ingredients generally  recognized as safe and effective, and thus could no longer be marketed as  drugs. There is no similar rule prohibiting the manufacture and marketing  of dietary supplements containing herbal ephedra in combination with  herbal analgesics or stimulants. Second, in May 2002, the agency issued a  rule that the stimulant laxative ingredients aloe and cascara sagrada in  over-the-counter drugs are not generally recognized as safe and effective  and cannot be marketed. However, these ingredients may be marketed in  dietary supplements and are commonly found in dieter’s teas.
section_title: FDA Has Been Slow to Finalize Good Manufacturing Practice Regulations
paragraphs: FDA has drafted GMP regulations for dietary supplements but has been  slow to finalize these regulations. GMPs would standardize manufacturing,  packaging, and holding practices for dietary supplements. The agency  published an advance notice of proposed rule making for GMPs in  February 1997. A draft proposed rule was developed during the summer of  2000. The new administration was given the opportunity to review the  proposed rule, and HHS as well as the Office of Management and Budget  had significant comments. Currently, the rule is in administrative  clearance with HHS. As we have previously stated, publication of final  GMP regulations will improve FDA’s enforcement capabilities, since  DSHEA provides that dietary supplements not manufactured under  conditions that meet GMPs would be considered adulterated. FDA would  be able to take enforcement action against the manufacturers of  adulterated products if they were subject to GMP regulations.
Meanwhile, four private efforts are under way to review the manufacturing  practices of supplement makers and evaluate the ingredients in dietary  supplement products. Specifically, the U.S. Pharmacopeia, Good  Housekeeping Institute, consumerlab.com, and NSF International each  have voluntary programs in which manufacturers submit products and pay  a fee to get their products reviewed. These programs do not look at  product safety, but rather focus on label accuracy. In addition, the  National Nutritional Foods Association, a trade association representing  manufacturers of dietary supplements, has two programs to help ensure  product quality.
section_title: Weight Loss Supplements Have Not Been a Federal Research Priority
paragraphs: NIH officials reported that research on weight loss supplements is not a  priority and the agency has not made any formal program announcements  or requests for proposals to study weight loss supplements. However, the  agency has sponsored limited research on weight loss supplements  through two of its research institutes and centers. In fiscal year 2001,  NCCAM spent $627,000 of its annual budget of $89.1 million on research of  weight loss supplements. The National Institute of Diabetes and Digestive  and Kidney Diseases (NIDDK) currently supports investigator-initiated  research on conjugated linoleic acid (CLA) and chromium picolinate. In  addition, NIH has supported other research on ingredients found in weight  loss supplements, though not in studies specifically related to weight loss.  Data from this research may help address the safety of some of these  supplements. Further, the National Institute of Environmental Health  Sciences and the HHS National Toxicology Program are conducting  toxicological research on weight loss supplements in animals to further  understand their potential adverse effects in humans.
ODS officials reported that the office had been asked by the Congress to  work with other federal agencies to study the safety and efficacy of dietary  supplements in general and develop a research agenda on the safety and  efficacy of ephedra, specifically. It is starting with a systematic evidence- based review of ephedra. This review is funded by ODS and NCCAM  through the Agency for Healthcare Research and Quality’s Evidence-based  Practice Program, and the findings are scheduled for release in the fall of  2002. ODS is also working with other agencies and trade associations to  develop analytic tools and standards for testing supplements. In addition,  the National Heart, Lung, and Blood Institute is working with ODS to offer  a workshop on weight loss supplements to review scientific evidence and  identify research gaps.
FDA has funded the Institute of Medicine’s Food and Nutrition Board to  develop a “Framework for Evaluating the Safety of Dietary Supplements”  that will allow the agency to prioritize further research on dietary  supplements, including weight loss supplements, by identifying which  ingredients are of the greatest concern. The framework will also establish  a methodology for doing rigorous safety evaluations. A preliminary  framework is currently undergoing review, and the final report is expected  to be available by the end of 2002.
section_title: Federal Agencies Provide Some Educational Materials to the Public
paragraphs: FTC and FDA have programs designed to provide the public with  information about healthy weight loss practices, including weight loss  supplements. FTC has Operation Waistline, which, among other activities,  highlights fraudulent claims made by the manufacturers and distributors  of weight loss products. FTC also has a number of links on its Web site  encouraging consumers to beware of certain advertising claims that may  be associated with some weight loss products. In addition, in an effort to  demonstrate to consumers how Web sites selling such products may be  misleading, FTC has developed a Web site designed to look as if it is  selling a real weight loss supplement. However, once a customer tries to  make a purchase, the Web site informs the customer that he or she would  have been scammed had this been a “real” Web site. According to agency  officials, this Web site has been visited more than 9,000 times since 1998.  In general, FDA makes information about supplements available to the  public through its Web site and media announcements. Two publications,  “Tips for the Savvy Supplement User” and “An FDA Guide to Dietary  Supplements,” together provide a general overview of the dietary  supplement industry. FDA provides updated information with periodic  news and warnings about specific products.
section_title: State Consumer Protection Efforts Include Legislation and Litigation
paragraphs: Some states have adopted a variety of statutes and regulations to protect  consumers from potentially dangerous supplement ingredients and  fraudulent supplement marketing practices. In addition, there have been  state and local lawsuits aimed at the manufacturers of some weight loss  supplements over product claims and private lawsuits over injuries.
subsections: section_title: State Statutes and Regulations
paragraphs: States have adopted statutes and regulations specific to the sale of certain  weight loss supplements. Most of these states’ actions control the sale of  ephedra; the exception is California, which requires a warning label for  products containing herbal ingredients with a laxative effect, such as  senna, aloe, buckthorn, cascara, grangula, and rhubarb root. The majority  regulate ephedra in connection with the regulation of controlled  substances. Generally, ephedra is regulated to deter its use in the illegal  manufacture of the controlled substance methamphetamine, rather than  its use as a dietary supplement. Some states have prohibited ephedra sales  to minors, some have declared it an illegal drug, and others have adopted  regulations on how and to whom it can be sold (see table 1).
Texas has the most specific regulations for products containing ephedra  concerning product content and labeling. In addition to the requirements  stated in table 1, each batch of a product must be analyzed to ensure that it  contains the amount of total ephedrine alkaloids listed on the product  label. In addition, labels must include the amount of caffeine and other  stimulants, cautions about use with caffeine, and FDA’s toll-free telephone  number for reporting adverse events.
Other states are considering legislation to regulate ephedra. For example,  in May 2002, the California State Senate passed a bill that would ban the  sale of ephedra to minors, require prominent warning labels, and include a  toll-free telephone number to FDA so consumers can report adverse  events. California also has proposed that school districts be required to  provide students with information on the effects of and the dangers of  ephedra. Massachusetts has proposed ephedra legislation that would limit  dosing and require warning labels. Idaho’s Board of Pharmacy has also  proposed establishing labeling, content, and registration requirements for  ephedra, as well as banning the sale to minors. Both New York and New  Jersey have proposed legislation that would prohibit the sale of products  containing ephedra to persons under age 18.
section_title: State, Local, and Private Lawsuits
paragraphs: Some state attorneys general and local district attorneys have sued  marketers or manufacturers of weight loss supplements over marketing  claims. One California county district attorney told us that since the mid- 1990s, his office has prosecuted more than 30 consumer protection cases  involving weight loss products, all of which were settled, with penalties  ranging from $5,000 to $500,000. For example, this county sued Enforma  (as did FTC, see above) and received $500,000 in civil penalties and costs,  including a $100,000 penalty against its celebrity spokesperson. The  Pennsylvania Attorney General has also settled with two companies. In  one case, a product claimed numerous health benefits such as that  consumers could lose 17 pounds in 1 month and that the product “reduces  fat and calories automatically by carrying them out of your body before  they could be absorbed.” The distributor is prohibited from selling or  delivering the product in the state, and agreed to offer full refunds and pay  $2,000 in civil penalties and $1,500 in investigation costs. In the second  case, the company claimed the product would “flush calories right out of  your body” and that consumers could “eat all you want and still lose  weight.” The manufacturer agreed to stop making unsubstantiated claims,  add disclosures to its product labels, and pay $2,000 in civil penalties and  $3,000 in investigation costs.
Attorneys involved in private lawsuits reported that most private lawsuits  alleging injuries from weight loss supplements are settled out of court and  do not go to trial. However, in 2001, a jury awarded $13.3 million to a  woman who suffered a debilitating stroke after taking a dietary  supplement containing ephedra for weight loss. This particular product  also contained synthetic stimulants that are not considered dietary  supplements, and the manufacturer had received warnings about the  product from FDA.
section_title: Conclusions
paragraphs: To date, federal activity on weight loss supplements has focused on  oversight of marketing more than on oversight of safety. Federal activity  has focused less on safety in part because FDA is largely dependent on  voluntary reporting of adverse events for information on safety. It is also  more difficult for FDA to identify patterns of safety concerns for dietary  supplements than for drugs. FDA’s authority to regulate dietary  supplements is different from its authority to regulate drugs and it has a  greater burden of proof to take action against supplements that may be  unsafe. Because of these differences in regulatory authority, some weight  loss products with similar or identical active ingredients may be marketed  as dietary supplements, but not as drugs.
Further, research specific to weight loss supplements has not been a  priority for federal agencies. There have been few systematic studies of  weight loss supplements. Consequently, little is known about whether  weight loss supplements are effective, but many of them have been  reported to be associated with the potential for physical harm. However,  as the upward trend in sales and use is expected to continue, more  consumers may be at risk of adverse events related to use of the  supplements. Consumers need scientifically accurate information about  safety and efficacy to help guide their choices about weight loss  supplements.
Mr. Chairman, this completes my prepared statement. I would be happy to  respond to any questions you or other Members of the Subcommittee may  have at this time.
section_title: Contact and Acknowledgments
paragraphs: For more information regarding this testimony, please call Janet Heinrich  at (202) 512-7119. Key contributors include Marcia Crosse, Carolyn Feis  Korman, Jennifer Cohen, Charles Davenport, Julian Klazkin, and Roseanne  Price.
section_title: Appendix: Identified Adverse Effects, Contraindications, and Interactions Associated with Weight Loss Supplements
paragraphs: We focused our review on dietary supplements that are commonly used  for weight loss. For each supplement, we have listed in table 2 the adverse  effects that have been reported to be associated with the supplement,  conditions for which the supplement might be contraindicated, and  prescription medicines and foods with which the supplement might have  dangerous interactions. The sources we used to generate this table  gathered information from laboratory, animal, and human studies. The  evidence from human studies includes case reports, observational studies,  and clinical trials. We have not independently validated these associations.