03.01.02
Congress, FDA Continue Dialogue Over DSHEA
In the ongoing battle between Congress and FDA over the definitions and limitations of the Dietary Supplement Health & Education Act (DSHEA), recent correspondence between Dan Burton (R-Indiana) and FDA’s Department of Health and Human Services (HHS), Rockville, MD, covered the controversy over the establishment of Good Manufacturing Practices (GMPs), red yeast rice products and supplement/OTC combination products.
GMP’s: Rep. Burton questioned the timing of FDA-established GMPs; FDA responded that one of its top priorities is to publish a proposed rule for dietary supplement GMPs. If FDA publishes the proposed rule near the middle of 2002, as planned, it will review comments and prepare the final rule for publication by mid 2003.
Red yeast rice: Rep. Burton raised questions about FDA’s decision on Pharmanex’s Cholestin® red yeast rice product and on red yeast rice in general. FDA said red yeast products containing lovastatin are unapproved new drugs in violation of the FD&C Act and may not be marketed as dietary supplements. However, according to the agency, the decision in the Pharmanex case does not prohibit the marketing of all red yeast rice-containing products as dietary supplements, only limiting the marketing of those that contain lovastatin or other substances that are excluded from the dietary supplement definition. Further, said FDA, the Congressional intent of the exclusion clause that is the basis of the agency’s decision on Cholestin was to protect the research development incentives for new drugs to treat serious diseases.
Additionally, the FDA response addressed whether certain types of cholesterol maintenance claims are appropriate structure/function claims. The letter stated that claims that describe the maintenance of cholesterol levels that are already within normal limits are appropriate structure/function claims, while claims that a product will reduce an elevated blood cholesterol are disease claims because reducing elevated blood cholesterol is inextricably linked with preventing heart disease. FDA is currently reviewing a petition to reconsider its position.
Supplement/OTC combination products: Rep. Burton questioned FDA’s enforcement position with respect to products that combine a dietary supplement with an over-the-counter (OTC) drug. So far, FDA has sent warning letters to two firms that combine OTC drugs and dietary supplements into a single formulation. The letter reflects the agency’s conclusion that such combination drug-dietary supplement products are drugs that must comply with FD&C Act’s applicable drug provisions. FDA has not issued, nor is it developing, any guidance on this subject at this time because the law on this is relatively clear, said the agency. The letter also detailed the legalities of adding a dietary supplement ingredient to an OTC product. Currently, FDA is formulating its approach to carefully consider the complex issues associated with co-packaging (of OTC drugs and dietary supplements), including multiple claims, dual labeling, conditions of use, the risks of overdose and the agency’s historical regulation of combination drug products.
In the ongoing battle between Congress and FDA over the definitions and limitations of the Dietary Supplement Health & Education Act (DSHEA), recent correspondence between Dan Burton (R-Indiana) and FDA’s Department of Health and Human Services (HHS), Rockville, MD, covered the controversy over the establishment of Good Manufacturing Practices (GMPs), red yeast rice products and supplement/OTC combination products.
GMP’s: Rep. Burton questioned the timing of FDA-established GMPs; FDA responded that one of its top priorities is to publish a proposed rule for dietary supplement GMPs. If FDA publishes the proposed rule near the middle of 2002, as planned, it will review comments and prepare the final rule for publication by mid 2003.
Red yeast rice: Rep. Burton raised questions about FDA’s decision on Pharmanex’s Cholestin® red yeast rice product and on red yeast rice in general. FDA said red yeast products containing lovastatin are unapproved new drugs in violation of the FD&C Act and may not be marketed as dietary supplements. However, according to the agency, the decision in the Pharmanex case does not prohibit the marketing of all red yeast rice-containing products as dietary supplements, only limiting the marketing of those that contain lovastatin or other substances that are excluded from the dietary supplement definition. Further, said FDA, the Congressional intent of the exclusion clause that is the basis of the agency’s decision on Cholestin was to protect the research development incentives for new drugs to treat serious diseases.
Additionally, the FDA response addressed whether certain types of cholesterol maintenance claims are appropriate structure/function claims. The letter stated that claims that describe the maintenance of cholesterol levels that are already within normal limits are appropriate structure/function claims, while claims that a product will reduce an elevated blood cholesterol are disease claims because reducing elevated blood cholesterol is inextricably linked with preventing heart disease. FDA is currently reviewing a petition to reconsider its position.
Supplement/OTC combination products: Rep. Burton questioned FDA’s enforcement position with respect to products that combine a dietary supplement with an over-the-counter (OTC) drug. So far, FDA has sent warning letters to two firms that combine OTC drugs and dietary supplements into a single formulation. The letter reflects the agency’s conclusion that such combination drug-dietary supplement products are drugs that must comply with FD&C Act’s applicable drug provisions. FDA has not issued, nor is it developing, any guidance on this subject at this time because the law on this is relatively clear, said the agency. The letter also detailed the legalities of adding a dietary supplement ingredient to an OTC product. Currently, FDA is formulating its approach to carefully consider the complex issues associated with co-packaging (of OTC drugs and dietary supplements), including multiple claims, dual labeling, conditions of use, the risks of overdose and the agency’s historical regulation of combination drug products.