United States v. Hi-Tech Pharmaceuticals, Inc., No. 17-13376 (11th Cir. 2019)Annotate this Case
This case arose from the FDA's seizure from Hi-Tech a substantial quantity of products containing 1,3-dimethylamylamine or DMAA, which is used in fitness products aimed at bodybuilders and other athletes. The district court granted the FDA's motion for summary judgment, holding that the seizure of DMAA was both substantively and procedurally proper.
The Eleventh Circuit affirmed and held that DMAA is not an "herb or other botanical" and is not a "constituent" of an herb or other botanical under the Dietary Supplement Health and Education Act of 1994. Furthermore, the court held that DMAA is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The court also held that the district court did not abuse its discretion when it declined to reopen discovery, and Hi-Tech was afforded the full range of procedural due process available in federal court.