FDA issues letter to industry explaining DHSEA disclaimer use for labels

In response to multiple deregulatory requests it received, on December 11, 2025, US Food and Drug Administration (FDA) issued a letter to the dietary supplement industry further explaining the Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer.¹

Contents of the FDA’s letter

The letter was addressed to dietary supplement manufacturers, distributors, and retailers, and was sent by Kyle Diamantas, FDA Deputy Commissioner for Human Foods.

The letter explains that under current regulations, certain claims for a dietary supplement may be made if the statement contains the text, in bold: “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."² Additionally, the disclaimer must appear adjacent to the structure/function claims on each panel of a product label with a claim. The FDA is considering removing the placement requirement to reduce “label clutter and unnecessary costs” and still remain consistent with section 403(r)(6)(C) of the Federal Food, Drug, and Cosmetic Act, and is likely to propose a rule for the amendment.

FDA also noted that it had rarely enforced the requirement, and also stated it intends 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,” but does 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)."

Industry response on the FDA letter

The Council for Responsible Nutrition (CRN) published a press release on December 11, commending the FDA’s attention to the topic.³ The press release highlights the increase in confusion and litigation based on the interpretation that the full disclaimer appear on each panel of the product label where a claim is stated.

Earlier this year, CRN had submitted comments to the to the Department of Health and Human Services’ (HHS) in response to comments on deregulation information, asking the FDA to clarify the use of the DSHEA disclaimer, and also stating that a disclaimer linked by an asterisk or symbol to the claims would provide consumers enough information while remaining consistent with the requirement.⁴

“This clarification is in alignment with the statute and eliminates ambiguity that has fueled opportunistic litigation,” states Megan Olsen, senior vice president and general counsel, CRN, in the press release. “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.”

The association added that the FDA’s action is anticipated to benefit consumers and the marketplace. “CRN has long advocated for FDA to reaffirm the original intent of DSHEA and provide clear regulatory direction on this issue,” explains Steve Mister, CRN President and CEO. “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.”

Additionally, in a statement emailed to Nutritional Outlook, the Natural Products Association (NPA) explained it had previously met in person with FDA and also submitted a regulatory filing and letters, including one co-authored with the American Herbal Products Association, to the FDA, requesting changes to the DSHEA disclaimer placement.

“NPA appreciates that FDA carefully considered the concerns of industry over the requirement for the DSHEA disclaimer to appear on each panel of a dietary supplement product label where an applicable claim is made,” stated NPA President and CEO Daniel Fabricant, Ph.D. “Our association will continue to advocate for dietary supplement rules that ease undue burdens on our members, reduce frivolous litigation and protect the integrity of DSHEA."

References

1. US Food and Drug Administration. FDA Issues Letter to Industry on the DSHEA Disclaimer. December 11, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-issues-letter-industry-dshea-disclaimer. (Accessed 2025-12-15).
2. US Food and Drug Administration. Letter to the Dietary Supplement Industry on the DSHEA Disclaimer. December 11, 2025. https://www.fda.gov/food/information-industry-dietary-supplements/letter-dietary-supplement-industry-dshea-disclaimer. (Accessed 2025-12-15).
3. The Council for Responsible Nutrition. CRN Applauds FDA Clarification on DSHEA Disclaimer After Years of Industry Advocacy. December 11, 2025. https://crnusa.org/newsroom/crn-applauds-fda-clarification-dshea-disclaimer-after-years-industry-advocacy (Accessed 2025-12-15).
4. The Council for Responsible Nutrition. Request for Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation To Make America Healthy Again. Docket ID. AHRQ-2025-0001. 90 FR 20478 (May 14, 2025). https://crnusa.org/sites/default/files/weekly/25-07-17/CRN%20Comment_HHS_RFI_Deregulation_Final.pdf (Accessed 2025-12-15).