While dietary supplement regulatory oversight currently falls within a division of FDA, established after the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the growth of the industry and concomitant regulatory challenges over the past 20 years have some in the industry suggesting the Division of Dietary Supplement Programs (DDSP) should be elevated to “office" status within the Center for Food Safety and Applied Nutrition (CFSAN). Currently, the DDSP is downstream from the Office of Nutrition, Labeling and Dietary Supplements (ONLDS), one of 10 offices within CFSAN; CFSAN is one of nine offices and centers under FDA.
In a letter to Stephen Ostroff, M.D., FDA’s acting commissioner, the heads of the Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and United Natural Products Alliance (UNPA), suggested the change would provide appropriate attention to an industry seeing strong consumer interest, advancing science and new regulatory challenges.
Loren Israelsen, UNPA president, commented: “Elevation of the Division of Dietary Supplement Programs to an office status would allow the current division to better operate within the FDA structure, by providing it with more funding, autonomy and more direct lines of reporting. Further, such a move would provide additional significance to dietary supplement issues and hopefully create a more robust environment for them within FDA."
The timing for a “more robust" environment is now, according to the association heads, as they noted in the letter they have consistently encouraged FDA to engage in stronger enforcement activities against companies and individuals marketing “dietary supplements" that contain drug compounds. The letter stated: “[E]levating DDSP’s status to an Office could help to increase FDA’s abilities to take more aggressive enforcement action; and better utilize CFSAN’s compliance and enforcement resources than it currently does as a ‘Division’ where it competes with other divisions for enforcement priorities within [ONLDS]."