December 21, 2015
The U.S. Food and Drug Administration is announcing today the creation of the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The FDA is also in the process of identifying permanent leadership for ODSP. In the meantime, Bob Durkin continues to serve as Acting Office Director.
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. 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.
In the last several years, the FDA has taken numerous actions on dietary supplements to protect public health. The Office of Dietary Supplements Programs will continue to utilize its current authorities and available resources to monitor the safety of dietary supplement products 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;
- Enforce the dietary supplement good manufacturing practices (GMP) regulation, giving priority to cases in which GMP violations:
- Potentially compromise product safety;
- Fail to ensure product identity, potentially jeopardizing consumer safety; and
- Result in consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.
- Take action against claims in cases involving serious risk of harm to the consumer (such as egregious claims of benefit in treating serious diseases) or widespread economic fraud.
As a result of the transition announced today, ODSP’s former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, Ph.D., who joined FDA on December 14, 2015. Dr. Balentine has a Ph.D. in food science and nutrition from Rutgers University. As the head of the Office of Nutrition and Food Labeling, Dr. Balentine will oversee the development of policy and regulations for nutrition labeling and food standards, infant formula and medical foods. Dr. Balentine brings a wealth of knowledge and expertise to this position.
For more information:
- What's New in Dietary Supplements
- Questions and Answers on Dietary Supplements
- FDA 101: Dietary Supplements