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| | The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. We therefore affirm the judgment of the district court.}} | | The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. We therefore affirm the judgment of the district court.}} |
| | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1304 (11th Cir. 2021). | | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1304 (11th Cir. 2021). |
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| | + | This decision is notable for its passage against finding ambiguity in a regulation, and then deferring to a federal agency: |
| | + | {{cquote|There was a time when a court faced with a regulation that seemed "impenetrable on first read" might simply "wave the ambiguity flag" and defer to the agency's interpretation. ''Kisor v. Wilkie'', 139 S. Ct. 2400, 2415, 204 L. Ed. 2d 841 (2019). No longer. The Supreme Court recently clarified that judicial deference is appropriate only if a regulation is "genuinely ambiguous." Id. Before declaring a regulation genuinely ambiguous, we must "exhaust all the traditional tools of construction," which entails "carefully consider[ing] the text, structure, history, and purpose of [the] regulation." Id. (internal quotation marks omitted). We will consider the parties' textual arguments, giving the agency's view no special weight "except to the extent it has the 'power to persuade.'" Id. at 2414 (quoting ''Skidmore v. Swift & Co.'', 323 U.S. 134, 140, 65 S. Ct. 161, 89 L. Ed. 124 (1944) ("The weight of [an agency's interpretation] will depend upon the thoroughness evident in its consideration, the validity of its reasoning, [and] its consistency with earlier and later pronouncements")). In this case, our tools of construction resolve the apparent ambiguity in the FDA's favor, so we need not decide whether to defer to the interpretation expressed in the Guidance Document.}} |
| | + | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1308 (11th Cir. 2021). |
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| | == Analogous therapies == | | == Analogous therapies == |
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