decided April 2, 2025
The Family Smoking Prevention and Tobacco Control Act of 2009, codified at 21 U.S.C. §§ 387 through 387v, effectively require producers and sellers of electronic cigarettes (i.e.,“e-vape cigarettes”) to apply for permission from the federal Food and Drug Administration (the “FDA”) before marketing e-vape cigarettes in “interstate commerce.” 21 U.S.C. §387j(a)(2) and (c)(1). The Act requires the FDA to deny permission unless the producer has affirmatively shown that marketing its particular e-vape cigarette “would be appropriate for the protection of the public health.” 21 U.S.C. §387j(c)(2)(A).
In this case, the FDA denied several thousand applications after reviewing scientific evidence of e-vape cigarette safety that differed from the kinds of scientific evidence the FDA had asked the applicants to provide with their applications. Sensing a bait-and-switch operation, the unsuccessful applicants sued the FDA for acting arbitrarily and capriciously. Ultimately, the United States Supreme Court ruled that the FDA had not acted arbitrarily or capriciously, for the most part, and therefore dismissed the larger part of the applicants’ lawsuit. The Court explained that under the “change-of-position” doctrine it had developed over time in the field of administrative law, administrative agencies may change their position regarding a law they are enforcing, without being “arbitrary” or “capricious,” if they openly admit making the change, and give a reasonable explanation for making it, while addressing any “serious reliance interests” that may have been affected. In this case, the Court unanimously agreed that whatever alterations the FDA made in its evidentiary expectations for successful applications, the changes did not violate the “change-of-position” doctrine in federal administrative law.
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