Elevation of former division hailed by industry trade groups

WASHINGTON — The Food and Drug Administration has established the Office of Dietary Supplement Programs (ODSP), raising the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements.

The FDA said Monday that it’s also in the process of identifying permanent leadership for ODSP. Meanwhile, Bob Durkin will continue to serve as acting office director.

In the 20 years since the FDA created its dietary supplement program, the industry has grown to more than $35 billion from about $6 billion in annual sales. The FDA noted that elevating the program will boost the profile of dietary supplements within the agency and enhance the effectiveness of supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this swiftly expanding industry.

ODSP will use its current authorities and resources to monitor the safety of dietary supplement products, the FDA said, by continuing to take action to remove from the market supplement products that are dangerous to consumers; 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; and take action against claims in cases involving serious risk of harm to the consumer or widespread economic fraud.

In addition, the FDA said, ODSP will continue to enforce the dietary supplement good manufacturing practices (GMP) regulation, focusing especially on cases in which GMP violations potentially compromise product safety; fail to ensure product identity, potentially jeopardizing consumer safety; and result in consumer deception, such as if manufacturers do not verify the identity of their raw materials.

The FDA’s elevation of the Division of Dietary Supplement Programs (DDSP) to office status within its Center for Food Safety and Applied Nutrition (CFSAN) was hailed on Monday by the five trade associations representing the dietary supplement industry: the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA).

The groups also commended the Department of Health and Human Services, FDA and Congress for supporting the reorganization, which they said will enhance the effectiveness of dietary supplement regulation.

In a letter of support to Congress sent earlier this month, the associations stated that the elevation of DDSP to an office could help “increase FDA’s abilities to take more aggressive enforcement action.” The groups added that the elevation also could “raise the visibility and attention for dietary supplement safety and compliance measures at FDA” as well as “better utilize CFSAN’s enforcement resources.”

The FDA added that with the creation of ODSP, its former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, who joined the agency on Dec. 14. 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.