Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is a collection of seemingly contradictory signals, keeping us guessing as to whether we will see an increase or decrease in HCT/P regulation – either by written regulation or enforcement. To date, aside from some recent enforcement,[2] not a whole lot has changed.
On Tuesday, though, news from the courts made a splash and upended the picture. In a decisive move, the Supreme Court declined to take on California Stem Cell Treatment Center v. U.S.,[3] a Ninth Circuit holding that stem cell treatments which chemically isolate stromal vascular fraction, or “SVF,” from extracted tissue and insert the resulting SVF back into the patient fail to meet the “same surgical procedure” exemption[4] and are, therefore, subject to full regulation as biologics under the Food, Drug, and Cosmetics Act (“FDCA”). By declining to take on the case, the Supreme Court appears to passively condone the Food & Drug Administration’s (“FDA’s”) narrow construction of the “same surgical procedure” exemption for HCT/Ps. Until further action is taken, this narrow construction will remain the law of the land, at least in the Ninth and Eleventh Circuits, where it has been applied by the courts[5]
This action – or lack thereof – from the Supreme Court, combined with the aforementioned FDA enforcement against HCT/P developers, suggests that we may see tighter regulation of HCT/Ps under the new administration, despite posturing to the contrary earlier in the year. Or not, if FDA declines to enforce. We will nevertheless be watching closely to see whether a trend of closer scrutiny for HCT/Ps continues to develop… or not.
FOOTNOTES
[1] See What To Expect For Stem Cell Regulation Under Trump Admin, Law360 (Mar. 25, 2025); What’s Going on with Human Cell and Tissue Products?, Sheppard Mullin FDA Law Blog (June 30, 2025).
[2] See, e.g., Warning Letter to New Life Medical Services, LLC; Warning Letter to Cellebration LLC; Warning Letter to NuVida Medical LLC.
[3] See Petition Denied, U.S. v. Cal. Stem Cell Treatment Ctr. Inc., No. 22-56014 (9th Cir. 2024).
[4] See 21 CFR 1271.15(b).
[5] See U.S. v. Cal. Stem Cell Treatment Ctr. Inc., No. 22-56014 (9th Cir. 2024); United States v U.S. Stem Cell Clinic LLC, 998 F.3d 1302 (11th Cir. 2021).