In Wages & White Lions Investments LLC v. FDA, the Fifth Circuit found many problems with the FDA’s denial of a company’s application to market flavored e-cigarettes. Among them, the Court identified two issues with the FDA’s review of the company’s marketing plan to avoid improper product use by young people; the Court’s reasoning is of broad general interest for Daubert practice as well as administrative law:
- The FDA’s contention “that no marketing plan would be sufficient, so it stopped working”: “That’s like an Article III judge saying that she stopped reading briefs because she previously found them unhelpful.”
- Reliance on expertise and experience. “An agency’s ‘experience and expertise’ presumably enable the agency to provide the required explanation, but they do not substitute for the explanation, any more than an expert witness’s credentials substitute for the substantive requirements applicable to the expert’s testimony under [Rule] 702.”
No. 21-60766 (Oct. 26, 2021).