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# FDA Signals Plan to Ease Supplement-Label Disclaimers
- URL: https://www.fdaweb.com/fda-signals-plan-to-ease-supplement-label-disclaimers/
- Published: 2025-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:28:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160375

FDA is weighing changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion as it evaluates industry requests to do so, the agency said in a 12/11 letter to industry.

At issue is a requirement in 21 CFR 101.93(d) that mandates the Dietary Supplement Health and Education Act of 1994 (DSHEA)-mandated 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.”—appears on each panel of a supplement label that includes a structure/function claim. Those statements, known as 403(r)(6) claims, are permitted under DSHEA when accompanied by the disclaimer.

Deputy Commissioner for Human Foods **Kyle Diamantas** wrote that FDA has received multiple petitions to revise the placement requirement, and the agency’s preliminary review suggests that eliminating the “each panel” mandate would be consistent with DSHEA while reducing label clutter and compliance costs. He also acknowledged that FDA has “rarely, if ever” enforced the rule as written.

If the agency identifies no significant concerns during its ongoing review, it expects to move forward with a proposed rule to amend the regulation.

Because rulemaking can be lengthy, FDA said it will exercise enforcement discretion in the meantime. Specifically, the agency does not intend to enforce the requirement that the DSHEA disclaimer appear on every panel containing a 403(r)(6) claim. However, firms must still include the disclaimer on the product label and must continue linking it — by adjacency or with an asterisk — to each structure/function claim, along with meeting all other requirements in 21 CFR 101.93.