• A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercial speech protections when the Agency blocked certain label claims connecting nutrients or ingredients to health outcomes.
  • According to the complaint, in September 2025, the plaintiffs filed a “Notification of Health Claims Based on Authoritative Statements” pursuant to 21 U.S.C. § 343(r)(3)(C). This provision permits “health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information.”
  • In December 2025, FDA notified the plaintiffs via letter that 4 of the 118 submitted claims were not health claims; however, according to the plaintiffs, FDA denied authorization of use for the remaining 114 claims, which were based on statements published by the National Institutes of Health, the National Institutes of Health Office of Dietary Supplements, the NIH National Center for Complementary and Integrative Medicine, and the Centers for Disease Control and Prevention. The complaint states that FDA asserted that a number of the claims misrepresented the scientific literature.
  • According to the plaintiffs, FDA does not have authority to prevent these claims from being used on products that contain “the same ingredients and same dose amounts identified in the government research” because the statute was only intended to create a notification process, not an approval review. Further, the plaintiffs said that the U.S. Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which stripped away Chevron deference, made it clear that FDA “is not entitled to deference for its narrow construction” of the statute and that the court must adopt a plain meaning construction of the statute, which would permit the health claims to be used.
  • Keller and Heckman will continue to monitor litigation related to claims made on labels and in labeling of food and dietary supplements.