Health Claims Allowed for Botanical Products
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Readers might conclude from “Commission Asks FDA to Regulate Diet Supplement” (June 25) that the Presidential Commission on Dietary Supplement Labels recommended that botanicals be regulated as drugs instead of as supplements. As a member of the commission, I can assure your readers that this was not at all the case.
The commission affirmed that botanical products, like other dietary supplements, are eligible for certain types of label claims--health claims and statements of nutritional support.
If manufacturers wish to make stronger claims--drug claims--for such products, then they must have FDA approval. There is a procedure in place called the OTC Drug Review, by which the FDA reviews the evidence supporting various classes of drug products. The commission simply recommended that the FDA use the existing OTC review process to evaluate botanical products that may be eligible for drug claims.
ANNETTE DICKINSON
Director of Scientific and
Regulatory Affairs, Council
for Responsible Nutrition,
and member, Commission on
Dietary Supplement Labels
Washington