936 F.3d 1341
11th Cir.2019Background
- Hi-Tech Pharmaceuticals marketed fitness supplements containing 1,3‑dimethylamylamine (DMAA); the FDA seized a large quantity and initiated forfeiture, and Hi‑Tech intervened and separately sued the FDA.
- DSHEA (21 U.S.C. § 321(ff)) treats products as dietary supplements (with more favorable treatment) if they contain “an herb or other botanical” or a “concentrate, metabolite, constituent, extract, or combination” of a botanical; dietary supplements can be condemned only on a heightened risk showing.
- FDA contended DMAA is not a dietary supplement but an unapproved food additive and not generally recognized as safe (GRAS); Hi‑Tech argued DMAA is a dietary supplement because it is a constituent of geraniums (found in trace amounts) and alternatively that DMAA is GRAS.
- Scientific evidence in the record showed (a) DMAA was synthesized in 1944 and produced industrially, (b) some studies reported trace DMAA in pelargonium (geranium) materials while others questioned that finding or pointed to contamination sources, and (c) literature and government reports associated DMAA with adverse events, including deaths and cardiovascular/liver harms.
- The district court granted summary judgment to the FDA; Hi‑Tech moved to reopen discovery and for reconsideration; the Eleventh Circuit affirmed the district court’s determinations as to statutory meaning, GRAS, discovery, and rulemaking.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether DMAA qualifies as an “herb or other botanical” | DMAA is a botanical/part of plant life because trace DMAA was found in geraniums | DMAA was invented and manufactured artificially; statutory “botanical” refers to substances derived from plants, not lab‑made coincidental traces | DMAA is not an “herb or other botanical” |
| Whether DMAA is a “constituent” of a botanical | “Constituent” means anything naturally contained in a plant; trace presence suffices | “Constituent” connotes an essential/derivable part or one that has been used/extracted; incidental trace does not qualify | DMAA is not a qualifying “constituent” of a botanical |
| Whether DMAA is generally recognized as safe (GRAS) | Hi‑Tech: studies and experts support safety at recommended doses | FDA: peer‑reviewed studies, adverse‑event reports, and DoD review show lack of general recognition of safety | DMAA is not GRAS; FDA entitled to summary judgment on this ground |
| Whether FDA was required to use rulemaking instead of a forfeiture action | Hi‑Tech: FDA should have used rulemaking process | FDA: agencies may choose adjudication or rulemaking; forfeiture proceedings are permitted | FDA was not required to rulemake; forfeiture/remedy via adjudication was lawful |
| Whether the district court abused discretion by denying reopening of discovery | Hi‑Tech: needed more discovery to show DMAA was actually derived from geraniums | FDA: parties had full agreed discovery period and opportunity; Hi‑Tech had incentive to develop facts earlier | Denial to reopen discovery was not an abuse of discretion |
Key Cases Cited
- Price v. Comm’r, Dep’t of Corr., 920 F.3d 1317 (11th Cir.) (summary judgment reviewed de novo)
- Corwin v. Walt Disney Co., 475 F.3d 1239 (11th Cir.) (reconsideration standard)
- Artistic Entm’t, Inc. v. City of Warner Robins, 331 F.3d 1196 (11th Cir.) (reopening discovery standard)
- RTC Transp. Inc. v. ICC, 731 F.2d 1502 (11th Cir.) (agencies may choose rulemaking or adjudication)
- United States v. Articles of Food & Drug Consisting of Coli‑Trol, 518 F.2d 743 (5th Cir.) (forfeiture upheld against food additive)
- United States v. Article of Food, 752 F.2d 11 (1st Cir.) (GRAS and forfeiture principles affirmed)
- Bonner v. City of Prichard, 661 F.2d 1206 (11th Cir. en banc) (Fifth Circuit precedents binding on this circuit)