United States v. California Stem Cell Treatment Center, Inc., 117 F.4th 1213

Defendants are California physicians who operate clinics providing stromal vascular fraction (SVF) treatments, which involve extracting and processing fat tissue to isolate a mixture of stem cells and other cells for reinjection into the patient.
The clinics advertise SVF treatments for a wide variety of conditions, charge significant out-of-pocket fees, and have treated thousands of patients.
The FDA, after inspections in 2017, determined that defendants were manufacturing unapproved drug products and violating federal requirements.
The FDA sued, alleging violations of the Food, Drug, and Cosmetic Act (FDCA), specifically claims of manufacturing and distributing unlawful “drugs.”
The district court found for defendants, ruling that SVF is not a "drug" under the FDCA and that the procedures qualified for the “same surgical procedure” exception, exempting them from FDA regulation.
The FDA appealed, arguing both that SVF is a drug and that the same-day procedures do not fall within the exemption.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Is SVF a “drug” under the FDCA?	SVF is a product intended to treat disease and alter body structure/function, so it is a “drug.”	SVF is part of physicians’ medical practice, not a manufactured pharmaceutical; FDCA should not apply.	SVF is a “drug” within the meaning of the FDCA.
Does the major questions doctrine apply?	FDA’s regulation is consistent with longstanding authority; no extraordinary expansion here.	FDA’s broad application would intrude on areas not contemplated by Congress.	Doctrine does not bar FDA action; regulation is appropriate.
Does the “same surgical procedure” (SSP) exception exempt same-day SVF?	Exception only applies if removed and implanted HCT/Ps are the same item, not when significantly processed (fat ≠ SVF).	The relevant comparator is the targeted cells, not the tissue as a whole; cells are not altered.	SSP exception does not apply; exception requires no significant processing.
Should the FDA’s interpretation get deference?	FDA’s interpretation best fits the purpose and risk-based framework of the regulations.	Exception is ambiguous; both views are reasonable; FDA should not get deference.	Majority: FDA interpretation stands (text/purpose); Concurrence: defer to FDA’s reasonable view.

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (scope of FDA authority under the FDCA for products like tobacco)
Wyeth v. Levine, 555 U.S. 555 (broad protective purpose of FDCA)
United States v. Article of Drug, Bacto-Unidisk, 394 U.S. 784 (FDCA’s definition of “drug” interpreted broadly)
United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014) (stem cell mixture is a drug under the FDCA)
United States v. Kaplan, 836 F.3d 1199 (application of FDCA to physicians’ practices)
United States v. Sullivan, 332 U.S. 689 (rejecting narrowing of FDCA's application through hypotheticals)
Kisor v. Wilkie, 588 U.S. 558 (framework for Auer deference to agency interpretation)
Auer v. Robbins, 519 U.S. 452 (deference to agency interpretation of ambiguous regulation)