Controversies Surrounding the Use of Dietary Supplements

Opponents of DSHEA claim that the issue of public safety is their primary concern. Steven H. Zeisel, of the University of North Carolina School of

Public Health and School of Medicine, writes that "DSHEA modifies the regulatory environment so that it becomes possible, even likely, that products will be marketed that inadvertently harm people" (Zeisel, p. 1855). Zeisel believes that the DSHEA legislation makes it easy for small enterprises to market products without investing the time and money needed to prove their product's safety and efficacy. He contrasts the development of a new dietary supplement to that of a new drug or food additive, for which there is a formal process to evaluate safety.

A manufacturer developing a new drug or food additive must conduct safety studies following FDA procedures. Results must be submitted to the FDA for review and approval before the ingredient or drug can be sold to the public. This is not the case for dietary supplements, however, because under DSHEA they are legally in a class by themselves. The FDA must simply be notified of the new product, and the notification must provide information that supports the manufacturer's claim that its product is safe. Once the product is marketed, the FDA is responsible for proving that a dietary supplement is unsafe before it can take action to restrict that product's use or remove it from the marketplace.

Another issue critics of DSHEA cite is the scant quality control of dietary supplements. Quality control is important to assure consumers that a product contains the ingredients stated on the label in the stated amounts. Neither the FDA nor any other federal or state agency routinely tests dietary supplements for quality prior to sale. But some manufacturers of dietary supplements do adhere to Good Manufacturing Practices (GMPs) and make every effort to produce a quality product. Also, the FDA has assisted the industry by proposing GMPs that focus on ensuring the identity, purity, quality, strength, and composition of dietary supplements.

DSHEA supporters fear that increased regulation of dietary supplements will decrease access to beneficial products. National opinion surveys show that many supplement users feel so strongly about the potential health benefits of supplements that they would continue to use them even if the supplements were shown to be ineffective in clinical studies. Consumers value freedom of choice, and many view regulation as an attempt by the government and medical establishment to monopolize treatment options. Clearly, a balance needs to be reached between preserving freedom of choice and ensuring that dietary supplements are safe and effective. see also Alternative Medicines and Therapies; Food Labels; Health Claims; Quackery; Vitamins, Fat-Soluble; Vitamins, Water-Soluble.

Jackie Shank

Bibliography

Blendon, R. J.; DesRoches, C. M.; Benson, J. M.; Brodie, M.; and Altman, D. E. (2001). "American's Views on the Use and Regulation of Dietary Supplements." Archives of Internal Medicine 161(6):805-10.

Dwyer, Johanna T.; Garceau, Anne O.; Evans, Marguerite; Li, Donglin; Lytle, Leslie; Hoelscher, Deanna; Nicklas, Theresa A.; and Zive, Michelle (2001). "Do Adolescent Vitamin-Mineral Supplement Users Have Better Nutrient Intakes than Nonusers? Observations from the CATCH Tracking Study." Journal of the American Dietetic Association 101(11):1340-1346.

Fleming, Thomas, ed. (1998). PDR for Herbal Medicines. Montvale, NJ: Medical Economics.

Sarubin, Allison (2000). The Health Professional's Guide to Popular Dietary Supplements. Chicago: American Dietetic Association.

Skidmore-Roth, Linda (2001). Mosby's Handbook of Herbs & Natural Supplements. St. Louis, MO: Mosby.

Somer, Elizabeth (1996). The Essential Guide to Vitamins and Minerals, 2nd edition. New York: HarperPerennial.

Zeisel, Steven H. (1999). "Regulation of Nutraceuticals." Science 285:1853-55. Internet Resources

National Institutes of Health, Office of Dietary Supplements. <http://ods.od.nih.gov>

U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (2001). "Overview of Dietary Supplements." Available from <http://www.cfsan.fda. gov/~dms>

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