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New Rules for Dietary Supplements?

by David S. Casey, Jr. and Martin W. Edelman



Do you know everything you should know about dietary supplements? Too often, the answer is no.



That is why a federal advisory panel recently required that manufactures and distributors of dietary supplements to tell the government if they have evidence of serious health issues related to their products.



A report issued by the Institute of Medicine and the National Research Council found that current regulations need to be strengthened.



Unlike drugs, dietary supplements do not require approval from the Food and Drug Administration (FDA) before they go on the market. The FDA can pull supplements off the shelves, but it is the agency that bears the burden of demonstrating that they pose a "significant or unreasonable risk."



Among the report's recommendations were that animal models be used to assess the potentially negative effects of these dietary supplements and that there be mandatory reporting of any negative side effects.



The report also recommended that supplement makers should be required to file safety information with the FDA when they change the formulation of a product, not just when they introduce an ingredient or product that is new to the market. A need for more safety research was also among the report's findings.



Legislation has been introduced in the U.S. Senate to require reporting of adverse events, and significantly, the supplements industry seems to be on-board with the idea. The American Herbal Products Association filed a citizen's petition last year asking for mandatory reporting.



The fate of the bill, however, is uncertain because of differences over the reporting methods that would be required, as well as disagreements over other aspects of a 1994 law that would require change.



The 1994 Dietary Supplement Health Education Act largely took away the FDA's power to regulate botanical dietary supplements. But in the wake of the recent federal ban on the dietary supplement, ephedra, those regulations are receiving new attention.



It took a number of years before the health risks of ephedra became known, and critics still feel that it took far too long to get ephedra removed from the market.



But with this new report in hand, consumer groups are optimistic that action will be taken to help assure the safety of dietary supplements.



"If the FDA and Congress see the wisdom of adopting the Institute of Medicine's guidelines, it will bring legitimacy and science into what is now a totally chaotic marketplace. In the long run, lives will be saved," said Marvin Lipman, the chief medical adviser to the Consumer's Union.



With the ball in Congress' and the FDA's courts, the best consumers can do right now is to be as careful as possible when using dietary supplements.



David S. Casey, Jr., president of the Association of Trial Lawyers of America, is a partner in the San Diego, CA law firm of Casey, Gerry, Reed, and Schenk.



Martin W. Edelman, president of the New York State Trial Lawyers Association, is a partner in the New York law firm of Edelman & Edelman, P.C.