FDA v. Wages and White Lion Investments, LLC (No. 23-1038)
Summary
The Supreme Court case FDA v. Wages and White Lion Investments, LLC (2025) addresses the FDA's authority to regulate e-cigarettes, specifically flavored e-liquids. The Court vacated the Fifth Circuit's ruling that the FDA acted arbitrarily and capriciously in denying premarket approval to certain flavored e-cigarette products. The Court found that the FDA's denial orders were sufficiently consistent with its predecisional guidance, except regarding the consideration of marketing plans, for which it remanded for further consideration under the correct harmless-error standard.
Expected Effects
The ruling reinforces the FDA's regulatory authority over e-cigarettes and its ability to deny marketing authorization based on public health concerns. This may lead to fewer flavored e-cigarette products on the market, particularly those appealing to youth. The remand regarding marketing plans means the Fifth Circuit will need to re-evaluate whether the FDA's failure to consider those plans was a harmless error.
Potential Benefits
- Potentially reduced youth vaping rates due to stricter regulation of flavored products.
- Possible decrease in nicotine addiction among young people.
- Reinforced FDA authority to protect public health.
- Greater clarity on the standards for premarket tobacco product applications.
- Upholding the administrative procedures act.
Potential Disadvantages
- Potential for reduced availability of e-cigarettes for adults seeking alternatives to traditional cigarettes.
- Possible negative impact on businesses that manufacture and sell flavored e-liquids.
- Increased burden on manufacturers to provide extensive scientific evidence for product approval.
- Continued uncertainty regarding the FDA's expectations for marketing plans.
- Potential shift to black market for flavored e-liquids.
Most Disadvantaged Areas:
Constitutional Alignment
The case primarily concerns the interpretation and application of the Family Smoking Prevention and Tobacco Control Act of 2009, which grants the FDA regulatory authority over tobacco products. The Court's decision affirms the FDA's authority under this Act, aligning with Congress's power to regulate interstate commerce (Article I, Section 8). The APA ensures due process in administrative actions, and the court's analysis centers on whether the FDA followed proper procedures.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).