United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302

US Stem Cell Clinic removed ~2 ounces of a patient’s adipose tissue, processed it (rinsing, enzymatic digestion, centrifugation, filtration) to isolate the stromal‑vascular fraction (SVF, containing stem cells), then reinjected the SVF into the same patient.
Clinic marketed the SVF therapy to treat many chronic and degenerative diseases (e.g., Parkinson’s, ALS, diabetes, arthritis), claiming regenerative benefits.
FDA inspections found sterility, contamination testing, and labeling deficiencies; FDA sued in 2018 alleging the SVF was an adulterated and misbranded drug under the FDCA.
Clinic claimed two regulatory exemptions: the “same surgical procedure” exception (21 C.F.R. §1271.15(b)) and the lighter 361 HCT/P regulatory path based on “homologous use” (21 C.F.R. §1271.10).
District court granted summary judgment to FDA, holding (1) the SVF is not the same HCT/P as the removed adipose tissue because of substantial processing, and (2) Clinic intended non‑homologous uses based on its marketing; permanently enjoined Clinic absent FDA approval.
Eleventh Circuit affirmed: processing removed the materials from the same‑procedure exception, and marketing showed non‑homologous intended use for the 361 exception.

Issue	Plaintiff's Argument (FDA)	Defendant's Argument (Clinic)	Held
Whether the “same surgical procedure” exception covers the Clinic’s SVF process	The SVF results from substantial processing (enzymatic digestion, isolation) and is not the same HCT/P removed (adipose tissue); therefore not exempt	The SVF is removed and reinjected into the same patient, so it is the same HCT/P and falls within the exception	Held for FDA: substantial processing means reinjected material is not “such HCT/Ps,” so exception does not apply
Whether the SVF qualifies as a 361 HCT/P under the “homologous use” requirement	Clinic’s marketing seeks therapeutic effects beyond adipose tissue’s basic functions (cushioning/support); SVF intended to treat many diseases -> nonhomologous	SVF’s basic function is regenerative/repair in adipose tissue and Clinic intends the same regenerative function post‑procedure -> homologous	Held for FDA: objective intent (marketing) shows intended therapeutic, non‑homologous uses; 361 exception not met

Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (standards for deference to agency interpretations of their own rules and when a regulation is genuinely ambiguous)
Skidmore v. Swift & Co., 323 U.S. 134 (1944) (weight of an agency interpretation depends on its persuasiveness and reasoning)
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (Court’s discussion of agency core objectives and statutory interpretation in regulatory contexts)
Bostock v. Clayton County, 140 S. Ct. 1731 (2020) (interpret laws in accord with ordinary public meaning at time of enactment)
United States v. US Stem Cell Clinic, 403 F. Supp. 3d 1279 (S.D. Fla. 2019) (district court decision granting summary judgment to FDA on same record)
Kamen v. Kemper Fin. Servs., 500 U.S. 90 (1991) (courts may consider grounds not advanced by the parties when properly before the court)
Olson v. Superior Pontiac-GMC, Inc., 776 F.2d 265 (11th Cir. 1985) (permitting sua sponte consideration of issues in limited circumstances)