Federal Preemption of ‘Structure/Function’ Claims on Dietary Supplements
Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) with the Nutrition Labeling and Education Act (NLEA) in 1990 and, in 1994, with the Dietary Supplement Health and Education Act (DSHEA), which provided the Food and Drug Administration (FDA) with regulatory authority over dietary supplements and specifically established “standards with respect to dietary supplements.” Together, the NLEA and DSHEA established “a new category of food products—specifically, dietary supplements—that have unique safety, labeling, manufacturing, and other related standards.” Kroessler v. CVS Health Corp., 977 F.3d 803, 808 (9th Cir. 2020). With Congress finding consumers “should be empowered to make choices” about potential benefits of dietary supplements, DSHEA implemented major shifts in dietary supplement regulation, including exempting “dietary supplements” from FDA drug approval and FDA food additive approval, 21 U.S.C. §321(g)(1), and expressly permitting dietary supplement labels to make “structure/function claims.” 21 U.S.C. §343(r)(6)(A).
By definition, a structure/function claim “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans [or] characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” Id. at §343(r)(6). Federal law allows such label claims, provided: (1) the manufacturer “has substantiation that such statement is truthful and not misleading”; (2) the label contains a prominent disclaimer that the statement was not evaluated by FDA and the product is not intended to treat or prevent any disease; and (3) the statement does not claim that the supplement is intended to “diagnose, mitigate, treat, cure, or prevent” disease. Id. at §343(r)(6)(B)(C).
The full article, published in this week’s New Jersey Law Journal, can be found here.