Summer of discontent

Call it the summer of our discontent. FDA’s plans to reorganize its food-oversight programs, including for dietary supplements, continue to alarm leaders in the dietary supplement industry. A recent blog post by FDA Commissioner Robert M. Califf, MD, stating that FDA’s dietary supplement program remains an agency priority did not assuage fears that under this new reorganization, the supplements industry risks losing attention and resources needed to regulate the nearly $60 billion U.S. supplements market.

To recap: In January 2023, FDA announced its plans to revamp its Human Foods Program (HFP). The changes would, in part, see the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and some functions of the Office of Regulatory Affairs (ORA) “unified in a newly envisioned organization called the Human Foods Program.” For the dietary supplement industry, this means that the current Office of Dietary Supplement Programs (ODSP), which today reports in to CFSAN, would instead report to a newly created entity called the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI).

For industry, the concern is that under this new umbrella, dietary supplements will lose the attention and funding that ODSP held previously. Under a new OFCSDSI, will dietary supplements become a lesser priority for FDA?

Commissioner Califf tried to address these concerns in his August 14 post for his blog “Catching Up with Califf.” In the blog post titled “FDA’s Dietary Supplements Program Remains a Critical Priority,” Califf wrote: “Under the new proposed HFP structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency.”

He added: “There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act.” In the blog, Califf assured that ODSP would remain a “distinct office.” Meanwhile, the benefits and purpose of creating the OFCSDSI, he stated, are “to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.”

FDA is already moving ahead with its reorg plans. In August, the agency appointed James “Jim” Jones as its first-ever Deputy Commissioner for Human Foods. Jones would oversee offices including the newly proposed OFCSDSI. In a statement, Steve Mister, president and CEO of the Council for Responsible Nutrition, wrote, “We are hopeful Mr. Jones shares our interests in robust agency attention to dietary supplements as well.”

Industry leaders, not to mention lawmakers like U.S. Senate Majority Whip Dick Durbin (D–IL) and U.S. Senator Richard Blumenthal (D–CT), have expressed concerns over how the proposed reorg could weaken oversight of the vast U.S. supplements industry. (In an August 24 letter to Commissioner Califf, the senators wrote, “ODSP is the lead office at FDA responsible for oversight of the $50 billion supplement market in the United States. With little more than $13 million in funding, it sets strategic priorities, and ensures that limited resources are used in the best manner possible to protect the health and well-being of consumers….We are concerned that these changes could divert resources, funding, and attention from the supplement market at a time when it is needed more than ever.”

Industry continues to look for more clarity, still to come, on how this reorg will shake out for the supplements industry. No doubt attendees of CRN’s upcoming “Now New Next” conference will be listening carefully for clues when Califf, who is scheduled to be a guest speaker on October 4, addresses the industry.

With many questions still unanswered, industry groups are trying to stay optimistic but remain concerned. As Michael McGuffin, president of the American Herbal Products Association (AHPA), tells Nutritional Outlook, “AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities under this reorganization. However, our main concern is transparency. AHPA and the responsible industry has made great efforts to increase ODSP’s budget and to be able to readily obtain details about ODSP’s budget size, number of full-time equivalent employees, etc. It is not apparent that this same budgetary information would be as accessible under the new structure, though we have received some assurances from FDA that the agency will exhibit great transparency.”

Hope, wait, and see is industry’s current stance even as FDA gives every indication it is moving forward with this plan. In his August 14 blog post, Califf wrote, “I look forward to sharing more information on how the FDA’s dietary supplement program is positioned within the HFP later this year, as more details are finalized.” In other words, more is certainly to come.