The United States Senate Committee on Health, Education, Labor and Pensions (HELP) has released a “discussion draft” of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a piece of must-pass legislation that reauthorizes drug and medical device user fee programs.
This document includes a number of provisions amending the Federal Food, Drug, and Cosmetic Act as applicable to other product categories within the jurisdiction of the U.S. Food and Drug Administration (FDA) or otherwise impacting FDA’s regulation of such other categories. These include provisions establishing mandatory product listing (MPL) requirements for dietary supplements and providing FDA new tools to enforce against products “marketed as” dietary supplements that do not meet the law’s definition of “dietary supplement.”
AHPA has long expressed support for FDA to act aggressively to remove from the market illegal drug-spiked products that masquerade as dietary supplements. On the other hand, AHPA has taken a position of opposition to the Dietary Supplement Listing Act, a standalone bill which would create similar MPL requirements with no promise or expectation that this new system would meaningfully deter criminal marketers of mislabeled, illegal drugs.
The FDASLA discussion draft also includes provisions that would significantly expand FDA’s regulation of cosmetics, including through good manufacturing practice requirements, facility registration and product listing requirements, serious adverse event reporting requirements, mandatory recall authority, and safety substantiation requirements, among other provisions.
AHPA staff are now reviewing the details of both the dietary supplements and cosmetics provisions of the discussion draft of this bill. Please email Robert Marriott, AHPA’s Director of Regulatory Affairs, at rmarriott@ahpa.org with your questions or comments. The Senate HELP Committee has stated that it will accept feedback on the document from stakeholders until May 22.
The text of the discussion draft of the bill is available here. Cosmetics provisions begin on page 83. Dietary supplement provisions, including the MPL provisions, begin on page 116.