Rockville, MD—The Dietary Supplement Programs has been elevated from a division to an office at the U.S. Food and Drug Administration (FDA) under the parent Office of Nutrition and Food Labeling. Bob Durkin will serve as the acting office director of the Office of Dietary Supplement Programs while FDA finds permanent leadership.
According to an FDA statement, "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."
Several industry trade associations—the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association (NPA) and the United Natural Products Alliance—previously voiced their support for this move, and now are congratulting the Department of Health and Human Services, FDA and Congress for supporting this reorganization.
The groups stated the change not only underscores the tremendous growth of the industry since the division was established in 1994, but it will also help the agency take more aggressive enforcement action when needed and will elevate the visibility of dietary supplement safety and FDA compliance.
“This is a long-overdue step toward elevating the dietary supplement division within FDA so that it can exercise all the authorities it has to regulate this important industry,” stated Daniel Fabricant, Ph.D., NPA's executive director and CEO. “We strongly support this decision and will continue to work with FDA and other regulatory officials to deliver quality products for the millions of people in the U.S. and around the world.”
Industry companies are also welcoming this change. For instance, Jarrow Rogovin, president and founder of Jarrow Formulas in Los Angeles, CA, is hop[ing the new office status will help "be the beginning of the end of the media's spin that the industry is 'unregulated.' The Office has created its own strong incentive to not just more rigorously enforce against outliers making illegal drug claims but the most serious offenders who are selling products with undisclosed drugs as ingredients. We expect the agency to seek more jail sentences for those offenders but, just as importantly, to publicize when its done."
Published in WholeFoods Magazine, February 2016, online 12/21/15 (updated 12/28/15)