Dietary Supplements: Caveat Athlete

By Melanie R. Margolis

On September 8, 1998, Mark McGwire hit his 62nd home run in 1998, breaking professional baseball's record for the most home runs in a single season. Media coverage during his pursuit of this record often mentioned his use of certain dietary supplements, including androstenedione (Andro) and creatine. Players using dietary supplements believe the substances will enhance their performance. Andro is used to increase strength and is said to increase the amount of testosterone produced by the user's body. Creatine, an amino acid, is also used to increase strength and is said to rebuild energy used by the muscles during explosive bursts. Apparently, dietary supplements are widely used among players of professional baseball and other sports. The use of dietary supplements, legal in Major League Baseball, has been banned in varying degrees by the governing bodies of other sports, including the National Football League, the National Collegiate Athletic Association and the International Olympic Committee.

The United States Food and Drug Administration (FDA) maintains a database, known as the Special Nutritionals Adverse Event Monitoring System Web Report, which is available on the FDA's website. Adverse event reports associated with the use of dietary supplements may be searched on this database. A search of "creatine" revealed twenty reports of adverse events, including vomiting and diarrhea, seizures, and even death. A search of " androstenedione" and "andro" turned up no reports. The FDA points out that reporting of adverse events to the FDA is voluntary, and the information in the database is as reported by the consumer. Thus, the absence of a reported adverse event associated with a certain product does not mean that no adverse event has occurred, and the existence of adverse event reports is not conclusive proof that a product caused the adverse event.

Even though the safety and effectiveness of dietary supplements are often called into question, dietary supplements are an enormous industry in the United States with estimates of sales topping $6.5 billion annually. Dietary supplements include vitamins, minerals, herbs, botanicals, other plant-derived substances, amino acids, and concentrates, metabolites, constituents and extracts of these substances.

Many consumers may not be aware that the dietary supplement industry is not closely regulated. Drugs, which are tightly regulated, are tested for safety, effectiveness, dosage amounts, and possible interactions with other substances and must be approved by the FDA prior to being marketed. Unlike drugs, however, dietary supplements are not subject to review for safety and effectiveness by the FDA prior to their availability for sale to consumers. The FDA and the Federal Trade Commission (FTC) share jurisdiction over the regulation of dietary supplements. The FDA oversees labeling requirements, while the FTC regulates advertising.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA has the burden of showing that a dietary supplement is unsafe before it can restrict the use of the supplement. Federal law requires that manufacturers of dietary supplements ensure the safety of the dietary supplements they manufacture, but no information substantiating safety is required to be submitted to the FDA.

Also, the FDA regulates the claims manufacturers make on the labels of supplements touting the health benefits of the substances. The FDA categorizes these claims as follows: nutrient-content claims; disease claims; and nutrition support claims, which include structure-function claims. Structure-function claims relate the effect of the supplement to the body's structure or function and must be accompanied by the phrase "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Within thirty days of marketing a supplement using such a claim, the manufacturer must inform the FDA. The FDA proposed regulations in April of 1998 that would clarify requirements relating certain types of claims on dietary supplement labels.

The FTC regulates the claims made in the advertising of dietary supplements. Under Section 5 of the Federal Trade Commission Act (FTC Act), deceptive and unfair acts or practices in or affecting commerce, including deceptive advertising, are prohibited. Also, Sections 12 and 15 of the FTC Act prohibit advertisements of foods, drugs, devices, services and cosmetics that are misleading in a material respect. The FTC requires that advertising be truthful and not misleading and that advertisers substantiate claims before the claims are disseminated.

When children who aspire to be like McGwire see him using these substances, they often want to use them. The desire to use what the pros use, like having the shoes endorsed by a basketball star, is strong…and, in the case of dietary supplements, potentially very dangerous given the lack of premarket safety, effectiveness, dosage, and interaction testing of dietary supplements. The dangers hold true for anyone using dietary supplements from pro athletes to amateur athletes to individuals who simply wish to look or feel better.

09/10/98