Hi-Tech Pharmaceuticals, Inc., et al. v. Food and Drug Administration, et al.

To increase the dietary supplements available to the public, the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), 21 U.S.C. §321(ff), amended the Federal Food, Drug, and Cosmetic Act. DSHEA’s amendments allow manufacturers to sell supplements, without first obtaining FDA approval, if their ingredients are, among other things, “constituent[s]” of “herb[s] or other botanical[s].” 21 U.S.C. §321(ff)(1)(C) & (F). The dietary supplements at issue in this case contain an ingredient known as DMAA, which studies have shown occurs in geranium plants. The courts below held that, even if these studies are accurate, DMAA is not, as a matter of law, a “constituent” of a “botanical”—and thus is not presumptively marketable as an ingredient in dietary supplements under DSHEA—because these studies show that DMAA appears in geraniums only in trace quantities, and DMAA has no prior history of being directly extracted from the plant for medicinal, cosmetic, or dietary use. The question presented is as follows: Did the Eleventh Circuit err in holding that a substance that naturally occurs in a plant is not a “constituent” of an “herb or other botanical”— and therefore cannot be included in presumptively marketable dietary supplements under the Dietary Supplement Health and Education Act—if the substance naturally occurs in the plant only in trace quantities and has no prior history of being extracted from the plant for medicinal, cosmetic, or dietary use?