Changes

{{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.}}

{{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).

''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1308 (11th Cir. 2021).

== Analogous therapies ==

== Analogous therapies ==