FDA Unveils New Office of Dietary Supplement Programs

Regulatory NewsRegulatory News
| 21 December 2015 | By Zachary Brennan 

As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP).

The new office, which previously worked as a division under the Office of Nutrition Labeling and Dietary Supplements, comes as the supplement industry has more than quadrupled in the 20 years since the establishment of that first division – from about $6 billion to more than $35 billion in annual sales. The creation of the new office was welcomed by five dietary supplement industry associations.

“Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry,” FDA says.

The agency is also tightening up its enforcement of dietary supplement makers that are breaking the law, with the issuance of at least seven warning letters and six recalls over the last two months, including five letters for companies marketing products containing an undeclared pharmaceutical ingredient known as picamilon, which Sen. Claire McCaskill (D-MO) took issue with last month as well.

FDA also previously discussed the prospects of updating its “Red Book” to include more dietary supplement information.

ODSP and Leadership

FDA says the new ODSP will continue to work with FDA’s Center for Drug Evaluation and Research to help remove from the market products falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents, enforce the dietary supplement good manufacturing practices (GMP) regulation and take action against products that pose risks for consumers or are part of fraudulent economic schemes.

The agency also said it’s in the process of identifying permanent leadership for ODSP, but in the meantime, Bob Durkin will continue to serve as Acting Office Director.

ODSP’s former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, who joined FDA last week. As the head of the Office of Nutrition and Food Labeling, Balentine will oversee the development of policy and regulations for nutrition labeling and food standards, infant formula and medical foods.

FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership

FDA Enforcement: Protecting Consumers and Enhancing Public Confidence


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