NicQuid v. FDA: Substantive Rulemaking and Comparative Efficacy Standards

This episode details a Fifth Circuit Court of Appeals decision regarding the FDA's denial of marketing applications for electronic nicotine delivery systems (ENDS). The court concludes that the agency's comparative efficacy standard, which requires manufacturers to prove flavored products benefit adults more than tobacco-flavored ones, is a substantive rule rather than a simple adjudicatory tool. Because this standard was applied broadly to millions of products without public input, the court finds the FDA bypassed the Administrative Procedure Act’s notice-and-comment requirements. Consequently, the court vacates the marketing denial orders for the petitioning companies and remands the cases for further proceedings. The ruling emphasizes that agencies cannot use informal adjudication to establish rigid, prospective policies that significantly impact the rights of an entire industry.