Ebook Dietary Supplements For Weight Loss: Limited Federal Oversight Has Focused More On Marketing Than On Safety
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.
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