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The FDA: Underfunded or Just Inept?

''Incredibly stressed' at the FDA'' (Science & Technology, Oct. 11) raises legitimate issues of whether the Food & Drug Administration's budget is adequate, given the growing list of important tasks it must perform. There is no question that the FDA's program for regulating is not doing an adequate job of keeping up with the rapidly growing industry of dietary supplements. The industry has tried to fill the vacuum by developing good manufacturing practices, guidelines for marketing particular supplement products such as ephedra, and other needed rules while the FDA's Office of Food Safety & Applied Nutrition reorganizes under its new director, Joseph A. Levitt. But it's not true that the supplement industry is unregulated and that the agency needs more money to do the job right.

The dietary-supplement law that Congress passed in 1994 did not tie the FDA's hands. The FDA's new commissioner, Jane Henney, has acknowledged that, with this law, Congress struck ''the right balance'' between permitting greater access to supplements and permitting the FDA ''to take action when necessary.'' But the FDA has repeatedly failed to exercise the authority it has to remove dangerous drug products that masquerade as dietary supplements, even though these products are being marketed to children as substitutes for illicit drugs and, according to the FDA's records, the products have caused serious injuries. Some of these products contain ephedra as well as other ingredients. Removing these products would be applauded by consumers and industry alike.

It is the FDA's own ineptitude that has caused the ephedra process to take four years, not any lack of funding or a a new legal standard, and certainly not any lack of cooperation from industry.

A. Wes Siegner Jr.
Hyman, Phelps & McNamara PC
Washington

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