FDA signals intent to amend DSHEA disclaimer requirements in AHPA-advocated win for industry

• By: AHPA
• On: 12/11/2025 15:46:49
• In: Regulation / Legislation

December 11, 2025

The American Herbal Products Association (AHPA) applauds a major step toward sensible regulatory reform outlined in a letter released today from the U.S. Food and Drug Administration (FDA) to the dietary supplement industry. The letter signals the agency's intent to amend the labeling regulation that currently requires the Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer to appear on every panel of a dietary supplement product label where structure/function claims appear.

This significant action comes directly in response to sustained advocacy from AHPA dating back to and continuing since 2021. AHPA and others have argued that the existing “every panel” requirement (found in 21 C.F.R. § 101.93(d)) is overly prescriptive and exceeds the demands of DSHEA. AHPA has long advocated for FDA to update the regulation to reflect historical industry practice: prominently displaying the disclaimer once on the product label or labeling, not necessarily on every panel, and connecting each claim to the disclaimer via symbols (e.g., asterisks). The contemplated revision would also accord the technical requirements of the regulation with FDA's historical enforcement approach; as conceded in the letter, and consistent with AHPA's analysis of agency documents, FDA has “rarely, if ever, enforced this requirement.”

"This news is a major win for the dietary supplement industry," said AHPA President & CEO Graham Rigby. "AHPA has long led the charge for this sensible regulatory reform, and we thank FDA for taking action on an unenforced provision that has fueled opportunistic litigation. This is a strong, positive signal of the agency's commitment to modernizing regulations, and AHPA looks forward to continued engagement in shaping a rational and modern regulatory environment for this vital category of products.”

Recognizing that formally amending the regulation through the rulemaking process will take time, FDA also stated that the agency will exercise enforcement discretion regarding the “every panel” DSHEA disclaimer requirement, providing immediate relief to industry from this unnecessary burden.