WASHINGTON--The Food and Drug Administration (FDA) responded to Rep. Dan Burton's (R-Ind.) recent 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. (For details on the letter, see www.naturalproductsinsider.com/hotnews/21h28143839.html.)
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 within fiscal 2002. "Publication of this regulation is one of our top priorities," she noted. If FDA publishes the proposed rule near the middle of the fiscal year, "we will review comments and prepare the final rule for publication by mid-2003."
The second issue was concerning 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. She added that because statins are powerful substances with benefits that outweigh the possible risks, they are best taken with caution and under the guidance of a health care professional.
Plaisier next addressed Burton's question on how products combining dietary supplements and over-the-counter 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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