On September 10, 2026, Congresswoman Diana Harshbarger (R-TN) introduced H.R. 10336—the Dietary Supplement Innovation Act—which would modernize the U.S. Food and Drug Administration’s (FDA) drug preclusion provision to encourage pharmaceutical innovation while increasing and protecting consumer access to dietary supplements. Harshbarger asserts in a Fact Sheet that the drug preclusion provisions of the federal Food, Drug, and Cosmetic Act (the “FD&C Act”) “have created regulatory uncertainty for dietary supplement and drug manufacturers alike.”
Late last month, the FDA finalized a new guidance document, explaining the agency's current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
The ...
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