On December 11, 2025, the Food and Drug Administration issued a letter to the dietary supplement industry announcing its intent to amend the labeling regulation governing placement of what is commonly referred to as the “DSHEA disclaimer.” This development occurred following receipt of several industry requests to do so.
Currently, the DSHEA disclaimer must appear on each panel of a dietary supplement label where a structure/function claim appears. See 21 CFR § 101.93(d). The disclaimer—mandated by section 403(r)(6)(C) of the Federal Food, Drug, and Cosmetic Act—states: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” While the statute requires this disclaimer to be prominently displayed in boldface type, FDA’s regulation goes further by requiring it to appear on every panel containing such claims.
The agency acknowledges that the every-panel requirement has “rarely, if ever” been enforced. FDA now indicates that removing this requirement would be consistent with the statutory mandate while reducing label clutter and unnecessary costs for manufacturers.
Barring significant concerns raised during its continuing review, FDA expects to amend this requirement. Given that the rulemaking process typically takes considerable time, FDA plans to exercise enforcement discretion regarding the every-panel requirement. However, manufacturers should continue to include the DSHEA disclaimer on the product label and link it to each structure/function clam, and otherwise comply with all other requirements of 21 CFR § 101.93.
For dietary supplement manufacturers and distributors, this represents a welcome modernization of labeling requirements. The change would provide flexibility in label design while maintaining the core requirement that consumers receive the required disclaimer information.
We will continue to monitor FDA’s rulemaking process on this issue and are available to answer any questions about how these developments may affect your business.