Stronger Supplement Regulation: Is it Needed?

Many analysts hope that as competition in the herbal remedy market increases, so too will the motivation for marketers of the supplements to research and regulate their products. The more than 80 member companies of the Council for Responsible Nutrition already voluntarily adhere to guidelines developed by the group. "The science behind these products is going to be one way that [supplement manufacturers] are going to distinguish themselves from other companies on the market," says Stuart Pape, a former FDA official who represents Pharmanex, the maker of Cholestin. "Consistency, standardization and reliability is where one would think the regulators would want to encourage the industry to go."

Yet some observers remain wary about what supplement manufacturers will do to regulate themselves without the guidance of the FDA. Varro Tyler, a professor of pharmacology at Purdue University in Indiana and author of The Honest Herbal (1993), contends that although some manufacturers are assuming responsibility to research their products, "the bulk of them are just happy that they can sell anything and make wild claims for it and get away with it."

In November 1997, a presidentially appointed commission on dietary supplement labels urged the FDA to review herbal products and to establish a system for approving some supplements as over-the-counter drugs if they are safe and effective. The FDA responded with a new set of guidelines about herbal supplement labeling, and those changes are pending while the FDA receives comments on them from the public.

In the meantime, experts caution that consumers should pay close attention to the supplements they choose. In order to protect themselves, they say, consumers should learn as much as they can before taking a supplement. Tyler advises consumers to be wary about the information they receive about herbal supplements. "You just really have to be very cautious about your sources and try to look at the reliable ones, of which there are not very many," he says.

Medical experts suggest that those who use herbal supplements inform their doctors about what they are taking in order to avoid adverse reactions or interactions with other medications. They say that to be safe, consumers should read supplement labels carefully and examine research on the active ingredients. Well educated consumers may be the greatest motivation for supplement companies to test and standardize their products.

Sources

Ruppel Shell, Ellen. "The Hippocratic Wars." New York Times Magazine (June 28, 1998): 34.

Sharpe, Rochelle. "FDA Aims to Clarify the Distinction Between Drugs, Dietary Supplements." Wall Street Journal (April 27, 1998): B6.

Stabiner, Karen. "With Alternative Medicine, Profits are Big, Rules are Few." New York Times (June 21, 1998): Sect. 15, p. 25.

Stolberg, Sheryl Gay. "Drug Regulators Make Push to Rein in Herbal Remedies." New York Times (June 10, 1998): A1.