U.S. Representative Jeff Duncan (R-S.C.) has expressed concerns over the Food and Drug Administration’s (FDA) proposed reorganization of its food programs, particularly regarding the potential impact on the regulation of dietary supplements. In a letter sent to FDA Commissioner Robert Califf on August 21, Duncan warned that the changes could reduce the agency’s focus on dietary supplements, potentially hindering their proper regulation.
The FDA’s plan, introduced in June, proposes the creation of a unified Human Foods Program, which includes an Office of Food Chemical Safety, Dietary Supplements, and Innovation. Duncan, alongside industry groups, fears that this restructuring could diminish the resources currently allocated to dietary supplements, which have been regulated under the Office of Dietary Supplement Programs (ODSP) since 2015.
Concerns Over the Loss of ODSP’s Autonomy
In his letter, Duncan pointed out that when the FDA elevated the dietary supplement program to an office in 2015, it was to ensure that supplements received the attention and resources they required. The move was intended to raise the profile of supplements within the agency and improve their regulation, as the industry was growing rapidly. The proposal to eliminate ODSP, Duncan argued, could reverse these gains and undermine the specialized infrastructure designed to oversee supplements.
Duncan further emphasized that dietary supplements are a unique category of food under U.S. law, and combining them with food additives could blur the lines established by the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSHEA explicitly exempted supplements from being treated as food additives, and Duncan questioned whether this reorganization was consistent with the legislative intent of the Act.
FDA’s Response to the Reorganization Concerns
While the reorganization proposal has raised alarms, FDA Commissioner Califf assured that the dietary supplement program would remain a key focus for the agency. In a blog post, Califf explained that the new Office of Food Chemical Safety, Dietary Supplements, and Innovation would modernize the way the FDA assesses food chemicals and ingredients, including those in supplements. He stressed that ODSP would continue to operate independently and maintain responsibility for overseeing dietary supplement products.
However, industry groups like the Natural Products Association (NPA) remain skeptical of the changes. NPA’s Director of Government Affairs, Kyle Turk, questioned why dietary supplements, which had recently been elevated to an office within the FDA, should now be subjected to a reorganization that could diminish their standing. He stressed that the industry needed a direct line to the FDA Commissioner to ensure effective regulation and accountability.
The NMN Issue and Further Concerns
In his letter, Duncan also addressed the FDA’s recent stance on NMN (nicotinamide mononucleotide), a popular ingredient in healthy aging supplements. The FDA has recently reversed its previous position and determined that NMN is no longer considered a lawful ingredient for dietary supplements. Duncan expressed concern that this shift in policy conflicted with historical precedent and has left the industry uncertain about the agency’s future actions.
Duncan had previously requested a public hearing to clarify the FDA’s position on NMN, but the agency declined, stating that a public hearing was unnecessary given the ongoing opportunities for public feedback. Industry leaders, including those at NPA, have been vocal in their support for Duncan’s efforts to hold the FDA accountable and transparent, especially regarding the shifting policies on ingredients like NMN.
Looking Ahead: Advocacy and Industry Impact
As the FDA moves forward with its proposed reorganization, the natural products industry is closely watching how these changes will affect the regulation of supplements. Advocates like Rep. Duncan continue to push for clarity and transparency, ensuring that dietary supplements remain adequately prioritized within the FDA.
With the ongoing uncertainty surrounding the regulation of supplements, including the treatment of ingredients like NMN, industry groups are committed to working with Congress to ensure that the reorganization does not hinder the industry’s ability to serve consumers effectively.
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