FDA’s 2025 legislative wish list calls for mandatory supplement product listing

By Stephen Daniells

- Last updated on GMT

© LightFieldStudios / Getty Images
© LightFieldStudios / Getty Images

Related tags mandatory product listing Dietary supplements Fda

The U.S. Food and Drug Administration has outlined its budget and legislative proposals for 2025, with the only dedicated section concerning dietary supplements renewing calls for mandatory product listing and seeking clarifications on the Agency's authorities.

Mandatory product listing (MPL) has been a priority for FDA for several years. MPL would require dietary supplement manufacturers to notify the FDA before bringing a product to market and to upload label information to a central database.

The issues dominated headlines—and divided the industry—in 2022 as legislative attempts led by Senator Dick Durbin, D-IL, to include this requirement ultimately failed to pass through Congress.

However, a MPL has remained a high priority for the Agency.

In its 2025 budget and legislative proposals​, it notes that the Dietary Supplement Health and Education Act (DSHEA) was enacted three decades ago and that the market has boomed over that time, growing from about 4,000 products in 1994 to well over 100,000 today.

"FDA is seeking to modernize DSHEA to provide for a more transparent marketplace, help facilitate a risk-based regulation of dietary supplements and clarify FDA’s authorities relating to products marketed as 'dietary supplements'," the Agency stated in its new proposals.

Specifically, the Agency is requesting amendments to its authorities to:

(1) require all dietary supplements to be listed with FDA, including by providing the product label and other basic information; and

(2) 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," FDA stated.

NPA: A non-starter

Commenting on the proposals, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told us: "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.

“While the FDA continues to receive more funding, the previous price tag for mandatory product listing was $34 million and does not include the millions spent for the NIH Dietary Supplement Label Database.”

"In 2022, House and Senate leaders successfully prevented mandatory product listing from being included in the FDA User Fee Reauthorization. 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."

UNPA: No agreement on what is ‘basic’

Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA), said the FDA's continued desire to amend DSHEA to require all dietary supplements to be listed with FDA is noted, specifically by providing the product label and other basic information.

"As we have seen from prior draft MPL legislation, there is no agreement on what is ‘basic’," he said. "This remains our concern. And, as we have noted in the past, FDA has access to a number of data resources to identify what dietary supplements are in the market, and we would maintain our current view that mandatory product listing remains problematic, as the scope of this request has had a tendency to expand well beyond basic information.

“As to point #2 where FDA would like to clarify its authority over products marketed as dietary supplements, it is unclear from this language whether this is a different objective than point #1 (MPL). Consequently, we have no comment at the moment, as we are unsure about what FDA is requesting."

CRN: "We continue to believe that mandatory listing will provide much needed transparency"

Steve Mister, President and CEO of the Council for Responsible Nutrition, a longtime supporter of a mandatory product listing, welcomed the FDA's proposals. “CRN is encouraged that the President’s budget expressly calls out the need to modernize DSHEA, the transformative law for this industry," he said. "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.

“We are likewise heartened by the express reference to creating a registry of dietary supplements and their labels. 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. 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.”

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