FDA Strengthens Dietary Supplement Regulation

As part of an effort to better regulate the growing supplement industry, the FDA today announced today the creation of its Office of Dietary Supplement Programs (ODSP).

The program was initially a division under the agency’s Office of Nutrition Labeling and Dietary Supplements, which has been renamed the Office of Nutrition and Food Labeling.

The new office’s responsibilities will include:

• Taking action to remove dangerous supplement products from the market.
• Working with the FDA’s Center for Drug Evaluation and Research to help remove products falsely labeled as dietary supplements from the market.
• Enforcing the dietary supplement good manufacturing practices (GMP) regulation, with priority given to cases in which GMP violations potentially compromise product safety, fail to ensure product identity, or result in consumer deception.
• Taking action against claims in cases involving serious risk of consumer harm or widespread economic fraud.

The elevation of the ODSP will raise the profile of dietary supplements within the FDA and enable a greater number of government resources to be allocated to the effective regulation of these products, according to an FDA press release. In the 20 years since the establishment of the dietary supplement program, the industry has grown from about $6 billion to more than $35 billion in annual sales.

The FDA is also in the process of identifying permanent leadership for ODSP. In the meantime, Bob Durkin will serve as the Acting Office Director of the ODSP until the agency appoints a permanent leader, while Doug Balentine, PhD, has been tasked with leading the Office of Nutrition and Food Labeling.