“We believe that the elevation of DDSP to an ‘Office’ would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities,” wrote the heads of the Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and United Natural Products Alliance (UNPA) in a letter to Stephen Ostroff, MD, acting commissioner of the FDA.
“In addition, we believe such a re-organization would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency, along with other products under CFSAN’s jurisdiction (e.g., cosmetics, medical foods). Such a move would aid in accomplishing FDA’s current and long-range goals related to dietary supplements,” they wrote.
This proposal to elevate the ‘division’ to an ‘office’ is an industry initiative, and there are reports that the proposal does have some internal support at the DDSP.
‘Significant advancements in the science of nutrition and wellness’
The DDSP was established shortly after the passage of the Dietary Supplement Health and Education Act of 1994. The dietary supplement industry has grown from around $6 billion in annual sales in 1994 to over $35 billion in 2014, noted the trades.
“This robust growth of the industry reflects not only increased interest among consumers in these products, but also significant advancements in the science of nutrition and wellness and new regulatory challenges to appropriately monitor this marketplace.”
‘Deep concern’
Scott Melville at CHPA, Steve Mister at CRN, Daniel Fabricant, PhD, at NPA, and Loren Israelsen at UNPA, also noted that, “the industry is deeply concerned about entities – both individuals and companies – who engage in blatant criminal activity by manufacturing and marketing products that masquerade as ‘dietary supplements’ but contain anabolic steroids, active pharmaceutical ingredients (APIs), or analogues of APIs.
“[O]ur associations have consistently urged FDA to engage in stronger enforcement activities to address bad actors that illegally manufacture and sell misbranded drug products falsely labeled as dietary supplements.
“We believe that elevating DDSP’s status to an Office could help to increase FDA’s abilities to take more aggressive enforcement action; 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 the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS).”
‘Providing additional significance to dietary supplement issues’
Loren Israelsen, UNPA president, told NutraIngredients-USA: “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 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.”