On Dec. 11, the U.S. Food and Drug Administration (FDA) published a letter to the dietary supplement industry regarding the agency’s labeling regulations that govern the placement of the disclaimer on dietary supplements labels under the Federal Food, Drug, and Cosmetic Act (FD&C) and Dietary Supplement Health and Education Act of 1994 (DSHEA).
The agency is considering a regulatory amendment on the requirement for the DSHEA 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”) to appear on each panel of a dietary supplement product label where an applicable claim is made.
According to the letter, FDA received multiple requests to amend 21 CFR 101.93(d). This regulation states the DSHEA disclaimer “shall be placed adjacent to the statement with no intervening material or linked to the statement with a symbol (e.g. an asterisk) at the end of each statement described in section 403(r)(6) of the FD&C Act such as a structure/function claim.”
The regulations state “the disclaimer shall appear on each panel” of a product where there is a 403(r)(6) claim. In its initial review, FDA said revising this regulation to remove the requirement for the DSHEA disclaimer to appear on each panel would be consistent with the FD&C Act while “reducing label clutter and unnecessary costs.”
“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,” wrote Kyle Diamantas, deputy commissioner for human foods at FDA. “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.”
The Natural Products Association (NPA), American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN) applauded the letter.
“For several months, prior to publication of FDA’s Dec. 11 constituent update, requested practical changes to placement of the DSHEA disclaimer, including the exercise of enforcement discretion while FDA considers adopting changes to its regulation (21 CFR 101.93(d)). NPA submitted a regulatory filing and letters to FDA, including a co-authored letter with the American Herbal Products Association, and we met in person with FDA as well regarding this matter,” said Daniel Fabricant, PhD, president and CEO of NPA.
“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. 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,” said Fabricant added.
AHPA said the existing “every panel” requirement 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 labeling, not necessarily on every panel and connecting each claim via symbols.
“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.”
According to CRN, a recent uptick in class-action lawsuits and legal challenges has created “confusion, prompted unnecessary litigation, and imposed costly and disproportionate burdens on responsible manufacturers without improving consumer understanding.”
“CRN has long advocated for FDA to reaffirm the original intent of DSHEA and provide clear regulatory direction on this issue,” said CRN President and CEO Steve Mister. “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.”
“This clarification is in alignment with the statute and eliminates ambiguity that has fueled opportunistic litigation,” added Megan Olsen, senior vice president and general counsel, CRN. “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.
For more information, visit www.fda.gov.
