A relative formality? Trades request elevation of DDSP to ‘Office’ within FDA

By Stephen DANIELLS

- Last updated on GMT

Image © iStockPhoto / amedved
Image © iStockPhoto / amedved
The five main trade associations have signed a letter to members of Congress requesting that the FDA’s Division of Dietary Supplement Programs be elevated to an ‘Office’.

The letter, which can be read below, follows an earlier letter to Stephen Ostroff, MD​, acting commissioner of the FDA that expressed their “interest in and support for”​ the elevation to an ‘Office’ within the Center for Food Safety and Applied Nutrition (CFSAN).

A matter of time?

Speaking with NutraIngredients-USA at SupplySide West​, Dr Cara Welch, Acting Deputy Director of the Division of Dietary Supplement Programs at the FDA, said: “We do believe that it would be good for the dietary supplement program to be elevated to an office. But there are certain processes that have to happen: it has to be signed off on by HSS, and then it has to go to Congress.”

Since that interview, the Secretary of Health and Human Services "signed off" on a letter to Congress asking approval for the administrative restructuring, Ted Elkin, director of the FDA’s Office of Analytics and Research, told attendees at the Council for Responsible Nutrition’s Annual Symposium in Palm Springs, CA. Elkin said he didn’t foresee any obstacles and that he didn’t think there was anything political holding it up.

“Important”

Mike Greene, VP of government relations at the Council for Responsible Nutrition, told us that all five trade associations believe the elevation is important and this letter is a reflection of the importance.

“All five trade associations have worked closely on this, and we’ve been talking with members of Congress during our meetings with them,”​ he said. “We want them to understand that this is not a reaction to recent events but that industry has been supportive of this from very early on.

“The new step from the industry would be to encourage Congress to provide appropriate appropriations.”

Below is the full letter from AHPA, CHPA, CRN, NPA, and UNPA:

“Dear Senator/Representative:

On behalf of the trade associations representing the dietary supplement industry […] we write to express collectively our support for the elevation of the Division of Dietary Supplement Programs (DDSP) to an “Office” status within the FDA’s CFSAN. The Secretary of Health & Human Services has recently notified Congress of its desire to implement this reorganization within FDA, and we endorse this change on behalf of our members as well.

“Since DDSP was established within FDA, 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 to more than $35 billion in sales in 2014. 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. 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. In addition, we believe such a reorganization 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.

“Moreover, 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. Our 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 increase FDA’s abilities to take more aggressive enforcement action; raise the visibility and attention for dietary supplement safety and compliance measures at FDA; and better utilize CFSAN’s enforcement resources. Currently, as a “Division,” DDSP must compete with other divisions for enforcement priorities within the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS); as an Office, it would share equal stature with the Office of Cosmetics, the Office of Food Additives, the Office of Food Safety, etc. While mere restructuring of FDA alone does not assure the appropriate attention to implementation of the Dietary Supplement Health and Education Act, we believe this change represents constructive progress toward more robust enforcement of the law. 

“Our associations and our members do not always agree with DDSP on all issues related to FDA’s regulation of dietary supplements and we are likely to continue to have occasional differences  with the Agency should this Division become an Office. In expressing our support for this change, we therefore hope, regardless of its administrative structure for dietary supplement oversight, that FDA will engage actively and communicate openly with industry on issues of mutual concern and will seek opportunities to discuss appropriate dietary supplement regulation.”

Related topics: Regulation, GMPs, QA & QC

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