FDA Signals Flexibility on Placement of the DSHEA Disclaimer

On December 11, 2025, the U.S. Food and Drug Administration (“FDA”) announced in a letter to the dietary supplement industry that it is actively considering requests to amend its dietary supplement labeling regulation at 21 C.F.R. § 101.93(d), which governs placement of the disclaimer required for structure/function claims under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).

The regulation currently requires the DSHEA disclaimer—which states that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent disease—to appear on each panel of a product label where a qualifying structure/function claim is made. Based on its initial review, FDA indicated that removing the “each panel” requirement would be consistent with the DSHEA, could reduce label clutter and unnecessary costs, and would align with the agency’s historical enforcement posture, noting that the requirement has rarely, if ever, been enforced. FDA further stated that, absent significant concerns, it is likely to propose formal rulemaking to amend the regulation.

In the interim, FDA announced it will exercise enforcement discretion with respect to the requirement that the DSHEA disclaimer appear on each label panel containing a structure/function claim. Importantly, this discretion is limited: FDA emphasized that it continues to expect dietary supplement manufacturers to include the DSHEA disclaimer on product labeling and to properly link the disclaimer to each structure/function claim, consistent with the remaining requirements of § 101.93. For industry stakeholders, the letter signals a potentially meaningful shift toward more practical labeling flexibility, while underscoring that core DSHEA disclaimer obligations remain firmly in place. Companies considering label revisions should proceed cautiously, ensure continued compliance with all other labeling requirements, and monitor FDA’s forthcoming rulemaking for formal changes to the regulation.