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While dietary supplement regulatory oversight currently falls within a division of FDA, some industry leaders suggest the organization should hold “office" status.
August 28, 2015
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]."
VP, Partnerships & Sustainability, Informa Markets, Food EMEA division
Heather Granato is a 30-year veteran of the natural products industry, currently serving as vice president, partnerships & sustainability, in the Food EMEA division of Informa Markets. She is based in London, and leads efforts related to industry partnerships and broader sustainability initiatives for the Vitafoods and Food ingredients brands. She has been a presenter at events including SupplySide, Vitafoods, Food ingredients, Natural Products Expo, the Natural Gourmet Show and the Folio: Show. Her publishing experience includes Natural Products Insider, Food Product Design, Vitafoods Insights, Country Living's Healthy Living, Natural Foods Merchandiser, Delicious Magazine and WomenOf.com. Granato serves as the founding president of Women In Nutraceuticals, a global non-profit founded in 2022 focused on empowering women in the nutraceutical industry; she is also on the board of directors for the Organic & Natural Health Association. From 2016 to 2022, she was a vice president on the national governing board of Kappa Alpha Theta women’s fraternity. Granato was named to the FOLIO: 100 list of top media professionals in 2018, and was selected as a 2015 Top Woman in Media by FOLIO:. She received the 2014 Visionary Award and the 2018 Journalistic Excellence Award from the American Herbal Products Association (AHPA); and was honored with the CEO Merit Award for Content from Virgo in 2014. Granato graduated magna cum laude from the University of Richmond, Virginia, in 1992 with a bachelor’s degree in journalism.
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