Rep. Duncan says proposed reorg ‘could lessen’ FDA focus on supplements

U.S. Rep. Jeff Duncan (R-S.C.) expressed concerns Monday in a letter to the head of the Food and Drug Administration that FDA’s proposed reorganization of its food programs could have a detrimental effect on its regulation of dietary supplement products.

In an update in late June on its proposal to create a unified Human Foods Program, FDA released an organization chart that proposed creating an Office of Food Chemical Safety, Dietary Supplements and Innovation.

Industry trade associations, and now Duncan, have raised concerns that FDA’s proposal could result in FDA devoting fewer resources to dietary supplements, compared to the current framework in which supplements are regulated under the Office of Dietary Supplement Programs (ODSP).

“I believe that this decision was shortsighted and could lessen the agency’s focus on the dietary supplement industry,” Duncan wrote in an Aug. 21 letter to FDA Commissioner Robert Califf, M.D.

At the time its dietary supplement program activities were elevated from a division to an office in late 2015, FDA stated in a constituent update, “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.”

Given FDA’s statements above, Duncan said it’s unclear how eliminating the Office of Dietary Supplement Programs benefits consumers or industry stakeholders.

“As you know, dietary supplements are a special category of foods under U.S. law, so this proposal’s genesis is even more troubling since the FDA excluded dietary supplements from its request to the Reagan-Udall Foundation to evaluate the human foods program,” Duncan wrote to Califf.

Industry trade groups have questioned the prudence of combining supplements and food additives in one office, considering the Dietary Supplement Health and Education Act of 1994 (DSHEA) exempted supplements from the food additive provisions in the Federal Food, Drug and Cosmetic Act.

When DSHEA was unanimously passed by Congress, “the primary objective of the legislation was to prohibit the FDA’s use of food additive provisions to remove dietary supplements from the market,” Duncan stated, adding, “This objective was laid out explicitly in the statute.”

Duncan’s letter quoted language in DSHEA that excludes supplements from the definition of a food additive.

“As a result, I believe eliminating ODSP erodes the prioritization of regulating dietary supplements and undermines the infrastructure that relies on funding specifically for dietary supplements,” he wrote to Califf. “I believe ODSP should remain free-standing, as was established, that is consistent with the statute.”

A little over a week ago, in a blog post, Califf said FDA’s dietary supplements program remains a crucial priority, notwithstanding its proposal to create an Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) as part of its broader plans to transform its myriad food programs into a unified Human Foods Program.

FDA has no plans to reduce the capabilities or resources of ODSP, Califf wrote in his blog post, “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.”

“The vision for the new OFCSDSI is to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements,” the FDA commissioner added. “ODSP will remain a distinct office executing the agency’s responsibilities under the Federal Food, Drug and Cosmetic Act for dietary supplement products.”

The Natural Products Association (NPA) remains concerned about the impact of FDA’s proposal on dietary supplements.

“We understand the reorganization and, more importantly, a culture change at CFSAN [FDA’s Center for Food Safety and Applied Nutrition] are formidable tasks. Still, how does the elevation to an office of dietary supplements less than a decade ago now deserve a demotion?” asked NPA Director of Government Affairs Kyle Turk.

“Supplement activities need a direct line through an independent office to the commissioner of foods so there is genuine accountability,” he added in an email to Natural Products Insider. “Filtering the dietary supplement programs through a different office will result in less effective regulatory implementation.”

An FDA spokesperson said the agency is reviewing Duncan's letter and will respond directly to him.

NMN

In his letter, Duncan also mentioned NMN, the healthy aging ingredient that FDA has determined is excluded from the definition of a dietary supplement.

FDA’s conclusions, made public in letters to several ingredient suppliers in the fall of 2022, constituted a reversal of its previous position that NMN was lawful in supplements.

“I believe that the sudden change of policy conflicts with historical precedent, including that the FDA permitted NMN to be included as an ingredient in dietary supplement products,” Duncan wrote in his Aug. 21 letter to Califf.

In April, in a separate letter to Califf, Duncan requested a hearing to clarify FDA’s position on NMN, which FDA essentially denied in a recent response to the congressman. FDA does “not believe that it is in the public interest to hold a public hearing on NMN,” based on the opportunity for the public to offer information and perspectives in response to a citizen petition filed in March by NPA and Alliance for Natural Health USA, explained FDA’s Kimberlee Trzeciak, associate commissioner for legislative affairs.

“We’re grateful to Congressman Duncan for his continued push on NMN, ensuring the agency is accountable and transparent with its actions and priorities,” Turk said. “The agency’s late and insufficient response to Congressman Duncan’s letter is a glaring example of why the natural products industry needs champions like him more than ever.

“NPA will keep working with Congress to ensure any reorganization addresses these critical matters,” Turk added. “Unfortunately, when supplements have been treated like food additives, it has led to more upheaval for the industry and uncertainty for the millions of Americans who safely use a supplement daily to maintain their health and wellness.”