Washington, D.C.—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced it has filed a Citizen Petition with the U.S. Food and Drug Administration (FDA) requesting clarity on the placement of the Dietary Supplement Health and Education Act (DSHEA) disclaimer on product labels and swift rulemaking action following the FDA’s December 2025 enforcement discretion announcement.
The petition, submitted by Venable LLP on CRN’s behalf, urges FDA to issue a Direct Final Rule confirming the Agency’s longstanding interpretation of 21 C.F.R. § 101.93(d). Specifically, CRN seeks clarification that dietary supplement labels comply with DSHEA when they include a single, prominently displayed boxed disclaimer on one panel, with structure/function claims on other panels linked to that disclaimer via an asterisk or similar symbol.
“For more than 25 years, FDA has consistently reviewed and accepted this approach to labeling without objection,” said Steve Mister, President & CEO of CRN. “Our petition simply asks the Agency to put into the regulation what has long been the practical and lawful standard in the marketplace.”
CRN’s petition highlights that FDA’s own enforcement record—spanning decades of inspections, warning letters, import reviews, and claim notifications—has never challenged the widely used cross-panel asterisk system for linking structure/function claims to a single DSHEA disclaimer. The organization argues that this approach aligns with both the plain language of the regulation and the statutory framework established under DSHEA.
“Consumers are already well accustomed to following asterisks on labels to find important qualifying information,” Mister added. “This format is clear, effective, and consistent with how people actually read product labels.”
The petition acknowledges that FDA issued an enforcement discretion announcement in December 2025 recognizing this interpretation, but notes that ongoing litigation, unimpeded by the earlier announcement, has created uncertainty for manufacturers. CRN is therefore asking FDA to formalize its position through rulemaking and confirm that the interpretation applies retroactively and preempts conflicting private legal actions.
“Without clear regulatory confirmation, companies face unnecessary litigation risk despite decades of compliance with the FDA’s expectations,” said Todd Harrison, a Partner in Venable’s Washington, D.C. office, who helped prepare the petition. “That uncertainty benefits no one—not consumers, not regulators, and not responsible manufacturers.”
According to CRN, requiring repetition of the full DSHEA disclaimer on every panel where a claim appears would impose significant costs without improving consumer understanding. Instead, the cross-referenced disclaimer approach provides clear, conspicuous, and effective communication consistent with consumer behavior and broader federal labeling practices.
“Requiring redundant disclaimers would add clutter, not clarity,” Mister said. “FDA has an opportunity here to reinforce a commonsense approach that supports both transparency and regulatory efficiency.”
The petition further aligns with recent federal policy priorities aimed at reducing unnecessary regulatory burdens while maintaining consumer protections. By pursuing a Direct Final Rule, CRN emphasizes that FDA can act efficiently to resolve ambiguity without disrupting longstanding, compliant industry practices.
“Regulatory certainty is essential to maintaining consumer trust and supporting innovation,” Mister added. “We’re confident FDA will recognize the importance of affirming this well-established framework.”
CRN’s petition underscores that uniform national standards for dietary supplement labeling are critical to avoiding a patchwork of conflicting requirements and ensuring that FDA retains primary authority over enforcement.
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The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing the dietary supplement and functional food industry. Bringing together manufacturers, ingredient suppliers, and service providers, CRN unites its member companies around a shared commitment to science, transparency, and responsible business practices—advancing a strong, credible marketplace that supports consumer health and industry growth.
In an increasingly complex regulatory and media environment, CRN serves as the industry’s front line—shaping science-based policy, defending market access, and countering misinformation. Through strategic advocacy, self-regulatory leadership, voluntary guidelines, and evidence-based communications, CRN ensures that responsible companies are recognized, protected, and positioned to innovate and compete. Learn more at crnusa.org and follow @CRN_Supplements on X and LinkedIn.