,"On December 11, 2025, the U.S. Food and Drug Administration (FDA) issued an industry letter announcing that it is evaluating potential amendments to 21 CFR 101.93(d), the regulation that governs how the DSHEA disclaimer (“This statement has not been evaluated by the FDA…”) must appear on dietary supplement labels. The FDA received multiple requests urging the agency to revise this requirement, particularly the mandate that the disclaimer must be printed on every panel of a product label containing a structure/function claim, also known as a 403(r)(6) claim.
FDA noted that its preliminary review indicates that removing the “each panel” requirement would still remain consistent with section 403(r)(6)(C) of the Federal Food, Drug, and Cosmetic Act, while reducing label clutter and lowering unnecessary costs for supplement companies. The agency also acknowledged that it has rarely if ever enforced the multi-panel disclaimer mandate.
While FDA continues reviewing the available data before making a formal regulatory proposal, it announced immediate enforcement discretion:
the agency will not enforce the requirement for the DSHEA disclaimer to appear on every panel containing a 403(r)(6) claim. However, firms must still include the DSHEA disclaimer on the label and properly link it (e.g., with an asterisk) to each structure/function claim, and must comply with all other provisions of 21 CFR 101.93.
This communication provides welcomed regulatory clarity for dietary supplement manufacturers, distributors, and retailers, signaling FDA’s intent to modernize DSHEA-related labeling requirements while maintaining consumer transparency."