Hi-Tech Pharmaceuticals, Inc., et al. v. Food and Drug Administration, et al.
AdministrativeLaw DueProcess JusticiabilityDoctri
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?
Whether a substance that naturally occurs in a plant is a 'constituent' of an 'herb or other botanical' under the Dietary Supplement Health and Education Act, even if the substance 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