WASHINGTON--The Food and Drug Administration (FDA) responded in early February to Rep. Dan Burton's (R-Ind.) Jan. 22 letter asking about the agency's positions on several issues related to dietary supplements. Burton, the chairman of the House Committee on Government Reform, asked FDA for its position on issues including Good Manufacturing Practices (GMPs), red yeast rice products and combination dietary supplements.
Melinda Plaisier, FDA's associate commissioner for legislation, responded to the general topics outlined by Burton. On the subject of GMPs, Plaisier wrote that FDA intends to publish a proposed rule for dietary supplement GMPs in fiscal 2002 and is one of FDA's top priorities. The final rule, she said, will be published by mid-2003.
The second issue concerned the status of red yeast rice products as dietary supplements. Plaisier reiterated FDA's position that red yeast rice products containing lovastatin are unapproved new drugs and may not be marketed as dietary supplements. If a red yeast rice product did not contain lovastatin "or other substances that are approved drugs," it could be marketed as a dietary supplement.
Plaisier next addressed Burton's question on how products combining dietary supplements and over-the-counter (OTC) pharmaceuticals could be marketed in a single dosage form. Plaisier said the law is relatively clear: "When an ingredient is added to an OTC drug product, the combination created also is a drug product if it is labeled (even only in part) as an OTC drug and is marketed for its original OTC drug use." However, she added that the agency is looking at creating a policy to consider the issues associated with co-packaging dietary supplements and OTC drugs, such as multiple claims, dual labeling, conditions of use, etc. "We may ultimately determine that it is appropriate to issue guidance or regulations on co-packaging," Plaisier wrote.
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