Ninth Circuit Provides Rare Clarity on Preemption in Dietary Supplement Structure/Function Claim Challenges
‘Ninth Circuit Provides Rare Clarity on Preemption in Dietary Supplement Structure/Function Claim Challenges,’ by Rend Al-Mondhiry and Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition, Washington Legal Foundation, February 28, 2019.
The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), permits dietary supplement manufacturers to make truthful statements about the benefits of a product or its ingredients on a structure or function of the body, known as “structure/function claims.”<note>21 U.S.C. § 343 (r)(6).</note> The law clearly distinguishes between these statements and “disease claims”—claims that a product can prevent, treat, or cure disease—which can only be made for drugs approved by the U.S. Food and Drug Administration (FDA). A recent U.S. Court of Appeals for the Ninth Circuit decision not only recognizes this distinction, but in a rare move by the court also affirms that the FDCA preempts state laws governing such claims.
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