Claudia Lewis and Alexander Rubel provided commentary to Nutritional Outlook on a federal lawsuit challenging the FDA’s refusal to permit certain dietary supplement disease-risk claims. Their insights appeared in the June 17 article, “Federal Lawsuit Challenges FDA's Refusal to Allow Dietary Supplement Disease-Risk Claims.” The following is an excerpt:
A lawsuit filed in the US District Court for the District of Columbia is challenging the FDA’s denial of a petition seeking authorization for more than 100 nutrient-disease risk-reduction health claims for dietary supplements. The case, Alliance for Natural Health USA et al. v. United States Department of Health and Human Services et al., was filed in January 2026 after the agency rejected the petition the previous December.
According to Claudia Lewis, co-chair of Venable LLP’s FDA Group, and Alexander Rubel, an associate with the firm, the case carries substantial commercial stakes: if the plaintiffs prevail, the range of claims available to both dietary supplements and conventional foods would expand significantly.
The petition, compiled by the Alliance for Natural Health USA along with several dietary supplement companies, proposed claims including "Riboflavin may reduce the risk of migraine headaches" and "Chromium may reduce the risk of type 2 diabetes," all drawn, according to the plaintiffs, directly from statements published on the websites of the National Institutes of Health and the Centers for Disease Control and Prevention (CDC).
What Legal Pathway Is at the Center of This Dietary Supplement Health Claims Case?
Health claims for foods and dietary supplements generally require premarket authorization from the FDA. The traditional route requires petitioners to demonstrate "significant scientific agreement" among qualified experts that a claim is accurate, a standard that requires the agency to engage in formal rulemaking before authorizing the claim. This is a process that as Lewis and Rubel note, has historically proven difficult to satisfy and slow to complete.
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