On Tuesday, June 14, the Senate HELP Committee advanced S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a “must-pass” bill that reauthorizes drug and medical device user fee programs.

The legislation, which passed out of Committee by a vote of 14 to 9, contained language establishing mandatory product listing (MPL) requirements for dietary supplements. The measure also grants FDA with a new authority to enforce against products “marketed as” dietary supplements that do not meet the law’s definition of “dietary supplement.”

AHPA opposes S. 4348 as passed out of the Senate HELP Committee. AHPA views the MPL provisions contained within S. 4348 as creating unnecessary, significant, and redundant burdens on industry. Moreover, to date, neither the U.S. Food and Drug Administration (FDA) nor other advocates for MPL have clearly articulated the need for this premarket product listing requirement.

An amendment offered by Sen. Mitt Romney (R-UT) during the HELP Committee markup of S. 4348 would have required FDA to provide a written justification in making a request of a manufacturer to provide the quantities of dietary ingredients in a product’s proprietary blend (rather than requiring inclusion of this information in each product listing) and dietary ingredient supplier information (rather than permitting FDA requests for this information without justification). The Romney amendment was rejected on a 11-to-11, party-line vote.

The MPL language contained in the Committee passed version of S. 4348 is similar, but not identical to, the provisions in Sens. Durbin and Braun’s S. 4090, the Dietary Supplement Listing Act of 2022, which was introduced on April 22. On April 27, AHPA issued a statement in opposition to S. 4090.

The House of Representatives passed its FDA user fee reauthorization measure, H.R. 7667, the Food and Drug Amendments of 2022, on June 6. H.R. 7667 contained neither MPL language nor any other dietary supplement related provision.

In the coming weeks, AHPA will advocate before the U.S. Congress that MPL language be removed from the final version of the user fee reauthorization measure. As a Congressional hearing has yet to be held on MPL issues, AHPA will urge Senators and House Members to take a step back and thoroughly examine MPL and other important dietary supplement issues through the normal Congressional review process—and not hurriedly shoehorn MPL language into legislation designed to reauthorize FDA’s unrelated user fee programs.