• On December 11, 2025, the U.S. Food and Drug Administration (FDA) issued a letter to the dietary supplement industry which clarifies the placement of the Dietary Supplement Health and Education Act (DSHEA) disclaimer on dietary supplement product labels.  The letter comes in response to several regulatory requests from industry members.
  • Section 403(r)(6)(C) of DSHEA allows certain statements for a dietary supplement to be made, so long as the statement is accompanied with the following disclaimer: “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.”  This is referred to as the DSHEA disclaimer.  Pursuant to 21 CFR § 101.93(d), the DSHEA disclaimer “shall appear on each panel” of a product label where there is a Section 403(r)(6)(C) statement (e.g., a structure or function claim).
  • In the letter, FDA states that it intends to revise 21 CFR § 101.93(d) to remove the requirement for the DSHEA disclaimer to appear on every packaging panel in order to reduce label clutter and unnecessary costs.  The agency also acknowledged that it has rarely, if ever, enforced this requirement, and that it would exercise enforcement discretion during the rulemaking process.
  • Industry members, such as the Council for Responsible Nutrition (CRN), applauded FDA’s decision, stating in its earlier request to FDA that the revision “would maintain adequate levels of consumer protection while reducing unnecessary, redundant regulatory burdens on companies.”
  • Keller and Heckman will continue to relay any developments in the rulemaking process.