Understanding the Dietary Supplement Industry
Barbara A. Brehm
Dietary supplement regulation in the U.S.
Begin with a better understanding of the supplement industry. In the United States, this industry is regulated by the Food and Drug Administration (FDA), a division of the Department of Health and Human Services. The Center for Food Safety and Applied Nutrition is the branch of the FDA that works with food and dietary supplements. You can find good information on supplements and their regulation at www.cfsan.fda.gov.
Whenever you read about supplement regulation, you will see references to DSHEA. Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. This act allows manufacturers to market products as "dietary supplements" rather than as drugs. To qualify as a "dietary supplement," the product must contain one or more of the following substances: "a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract" of the above. 2
The DSHEA advises that manufacturers of dietary supplements be sure their products are safe before they are sold. However, supplements do not need approval before being sold, nor do manufacturers need to submit any studies to the FDA before marketing a new product. The FDA does not need to look at a product unless it receives enough complaints about it. When a questionable product comes to the FDA's attention, it must show that the dietary supplement is unsafe before it can remove the product from the market. You may have read about the FDA ban on dietary supplements containing ephedrine. This action was recently overturned by a federal court ruling, which stated that the FDA did not have sufficient evidence to prohibit these products.
The DSHEA does not mandate that dietary supplements be effective. If a product is shown to be ineffective, the FDA need not require that the product be removed. However, if many complaints are received, action may be taken by the Federal Trade Commission (FTC), which may investigate fraudulent advertising.
Both foods and supplements are subject to the labeling requirements of the Nutrition Labeling Education Act of 1990 (NLEA). The NLEA prohibits labels from claiming that a product or its ingredients help to treat or prevent disease, except for certain health claims allowed by the FDA. Since sports performance is not a disease, statements claiming to improve sport performance are allowable without proof that the claim is true.
What's a fitness professional to do?
A few supplements that are marketed probably are beneficial for health or athletic performance. However, most agencies that certify personal trainers and other fitness professionals advise their members against recommending supplements to their clients for two reasons. First, recommending specific nutritional supplements is probably out of your scope of practice, unless you are a registered dietician. Second, because these products are so loosely regulated, the potential for harm outweighs their potential benefits in most cases. Stick to standard nutrition advice (eat plenty of fruits and vegetables) and exercise recommendations; these are the foundation of good health and athletic performance.
1. Bahrke, M.S., and C.E.Yesalis (eds.) Performance-Enhancing Substances in Sport and Exercise. Human Kinetics: Champaign, Ill., 2002.
2. Center for Food Safety and Applied Nutrition. "Overview of dietary supplements." www.cfsan. fda.gov/~dms/dsoview.html, Jan. 3, 2001.
3. Wolinsky, I., and J.A. Driskell. Nutritional Ergogenic Aids. CRC Press: Boca Raton, Fla., 2004.
You can report a product that you believe is being advertised falsely by contacting the FTC online at www.ftc.gov. Click on "File a Complaint Online."
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