FDA seeks dietary supplement listing requirement in FY25 budget proposal

For the sixth year in a row, the Food and Drug Administration has requested legislative authority to require manufacturers list their dietary supplement products with the agency.

FDA on March 11 released its $7.2 billion budget request for FY25 as part of President Joe Biden’s proposed budget. The request includes several legislative proposals that the agency said “better support” its “efforts to protect American consumers and patients.”

FDA requested amending its authorities to require a listing of dietary supplement products with the agency, “including by providing the product label and other basic information.” In addition, the agency wants Congress to “clarify FDA’s authorities over products marketed as dietary supplements.”

“These amendments would help FDA to know when new products are introduced and quickly identify dangerous or illegal products on the market to take appropriate action to protect consumers when necessary,” the agency added in its FY25 legislative proposals.

So-called mandatory product listing (MPL) was first proposed by FDA in FY20 under then-President Donald Trump. MPL gained momentum in the summer of 2022 when the Senate Committee on Health, Education, Labor and Pensions passed a bill (FDA Safety and Landmark Advancements Act) that included FDA’s proposal. However, MPL was not included later that year in a continuing resolution to fund the government.

Related:FDA makes the case for dietary supplement product listing requirement

FDA’s FY25 request for product listing nearly coincides with the 30th anniversary of the Dietary Supplement Health and Education Act (DSHEA), which then-President Bill Clinton signed on Oct. 25, 1994.

In its legislative proposal, FDA noted the supplement market has grown from about 4,000 products since 1994 to more than 100,000.

Council for Responsible Nutrition (CRN) President and CEO Steve Mister said his organization was “encouraged” that Biden’s “budget expressly calls out the need to modernize DSHEA, the transformative law for this industry.”

“Now thirty years old, the law can use some refinements and updates to better serve the 21st century industry and consumers, while maintaining the fundamental balance between broad consumer access and safety that was enshrined in 1994,” Mister said in an email to Natural Products Insider.

CRN remains a supporter of MPL and also manages a product registry called the Supplement OWL (Online Wellness Library).

“We continue to believe that mandatory listing will provide much needed transparency to the industry and provide FDA with better visibility to enforce the existing requirements,” Mister said. “Of course, this is just one piece of the needed modernization of DSHEA, and we look forward to continued discussions with FDA and congressional offices on how to accomplish these changes. Congress must also rebalance the drug preclusion provision, make FDA’s inspection authority more efficient and more effective, and provide clarity for how the agency enforces the law against illegal and unsafe ingredients. All these items need to be part of that discussion.”

Related:Trade associations debate mandatory product listing

The Natural Products Association (NPA) remains at odds with FDA and CRN over the legislative proposal for MPL.

“Year after year, the FDA’s budget proposal includes mandatory product listing. Congress has routinely shut down this proposal, another example of the FDA being distracted from doing the basics,” said Daniel Fabricant, Ph.D., president and CEO of NPA, in a statement.

He added the previous cost for MPL excluded the millions spent for a Dietary Supplement Label Database maintained by the National Institutes of Health (NIH). The 2022 bill passed by the Senate HELP Committee would have earmarked about $7.5 million in FY23 for FDA to conduct activities under the dietary supplement listing provisions, plus another $6.3 million for each of fiscal years 2024 through 2027.

“In 2022, House and Senate leaders successfully prevented mandatory product listing from being included in the FDA user fee reauthorization,” Fabricant said. “These influential members of Congress expressed significant concerns with mandatory product listing. Congress has spoken on this issue, and giving FDA an administrative excuse to reject ingredients from being marketed as dietary supplements — regardless of the science or history — is a non-starter.”

In a 2023 column published by Natural Products Insider, FDA Office of Dietary Supplement Programs (ODSP) Director Cara Welch, Ph.D., rejected the notion that her agency is trying to “prevent or slow the introduction of supplements to the market.”

“In fact, a simple listing requirement does not give FDA the authority to apply premarket approval or provide new authority for premarket review,” she wrote. “If needed, this limitation can be made clear through legislative text. But also, it’s how other registration and listing programs for FDA-regulated commodities are handled.”

FDA requested an increase of $495 million, or 7.4% over the FY23 funding level. Duffy MacKay, SVP of dietary supplements with the Consumer Healthcare Products Association (CHPA), said the request for an increase demonstrates FDA’s “recognition of the critical role self-care plays in public health, among other priorities, and aligns with CHPA’s goal to ensure Americans have continued access to safe, reliable and affordable consumer healthcare products.”

“We’re specifically pleased to see FDA’s accompanying legislative proposals prioritize the modernization of dietary supplement regulation, by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products,” MacKay added in an email. “This proposal underscores [FDA Commissioner Dr. Robert Califf’s] view that stronger oversight of dietary supplements is a key part of FDA’s mission to bring regulations into the 21st century to better protect consumers against bad actors attempting to use ingredients that don’t meet safety standards. CHPA looks forward to working with FDA and Congress on the shared goal of regulatory modernization as they map out the path forward for FY 2025.”