Washington, D.C.—The U.S. Food and Drug Administration (FDA) issued a constituent update to the dietary supplement industry that signals the agency’s intent to amend the labeling regulation that currently calls for 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.

FDA’s letter follows advocacy efforts from the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and others. AHPA President & CEO Graham Rigby spread the word on LinkedIn, sharing: “This win was also made possible through strong, collaborative advocacy across the supplement sector. I’m deeply grateful to NPA and its President & CEO, Daniel Fabricant, Ph.D., for standing shoulder-to-shoulder with AHPA as we engaged FDA together and pressed for both enforcement discretion and regulatory revision.We also worked closely with our colleagues at DSTA, and specifically CHPA, CRN, and UNPA, coordinating outreach and messaging with FDA and ODSP leadership. Thank you to Duffy MacKay [CHPA], Steven Mister [CRN], and Loren Israelsen [UNPA] for your partnership, focus, and shared commitment to regulatory clarity and fairness.”

As APHA noted, “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).” AHPA added that the contemplated revision would accord with FDA’s historical enforcement approach, since, FDA has “rarely, if ever, enforced this requirement.”

CRN explained that, for nearly 30 years, FDA practice has allowed the use of an asterisk to direct consumers to the full DSHEA disclaimer elsewhere on the label, consistent with section 403(r)(6)(C) of the Food, Drug & Cosmetic Act and 21 C.F.R. § 101.93(d). Complicating matters: A recent increase in class-action lawsuits that have argued that the full disclaimer must be placed on every panel where a structure/function claim is used on a product label. CRN noted, “These legal challenges have created confusion, prompted unnecessary litigation, and imposed costly and disproportionate burdens on responsible manufacturers—without improving consumer understanding.”

Industry welcomes “major win”

“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.”

Council for Responsible Nutrition (CRN) President & CEO Steve Mister said of the news: “CRN has long advocated for FDA to reaffirm the original intent of DSHEA and provide clear regulatory direction on this issue. We welcome FDA’s attention to this matter and appreciate the opportunity to support the agency in recognizing the practical, commonsense approach that consumers and companies have relied on for nearly three decades. Consistency in labeling standards strengthens consumer confidence and supports a stable regulatory environment.”

Megan Olsen, Senior Vice President and General Counsel, CRN, added, “This clarification is in alignment with the statute and eliminates ambiguity that has fueled opportunistic litigation. For years, FDA’s implementation has allowed companies to use an asterisk to direct consumers to the disclaimer, and that approach is fully consistent with DSHEA. Clear guidance helps ensure that companies can meet their obligations without unnecessary litigation risk, while still providing consumers with accurate, meaningful information. We appreciate FDA’s willingness to revisit this issue and apply a clear, legally sound interpretation moving forward.”

Not the finish line: Next steps

In the letter, FDA said, “Given that the rulemaking process can take some time, we intend to exercise enforcement discretion regarding the requirement for the DSHEA disclaimer to appear on each panel of a product label where a 403(r)(6) claim appears. We do not intend to exercise enforcement discretion with respect to the requirement to include the DSHEA disclaimer on the product label and link the disclaimer to each 403(r)(6) claim, along with other requirements of 21 CFR 101.93.”

“This is important step forward, but it’s not the finish line,” Graham noted.

As NPA explained, the current labeling requirements remain in effect until an amendment is finalized, so the DSHEA disclaimer requirement still stands, though enforcement may be more flexible regarding panel placement.

Related: FDA Provides Update on NMN; Industry Reacts

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