No. 20-295

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

Lower Court: Eleventh Circuit
Docketed: 2020-09-08
Status: Denied
Type: Paid
Response Waived
Tags: botanical-ingredients constituent-definition dietary-supplements dmaa DSHEA FDA-approval federal-food-drug-and-cosmetic-act geranium-plants prior-history-of-use trace-quantities
Key Terms:
AdministrativeLaw DueProcess JusticiabilityDoctri
Latest Conference: 2020-10-16
Question Presented (from Petition)

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?

Question Presented (AI Summary)

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

Docket Entries

2020-10-19
Petition DENIED.
2020-09-30
DISTRIBUTED for Conference of 10/16/2020.
2020-09-25
Waiver of right of respondents Food and Drug Administration, et al. to respond filed.
2020-09-01
Petition for a writ of certiorari filed. (Response due October 8, 2020)

Attorneys

Food and Drug Administration, et al.
Jeffrey B. WallActing Solicitor General, Respondent
Hi-Tech Pharmaceuticals, Inc., et al.
John Cowles Neiman Jr.Maynard Cooper & Gale, P.C., Petitioner