In this case, the court considered this issue: Was the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products arbitrary and capricious, in violation of the Administrative Procedure Act?
The case was decided on April 2, 2025
The Court unanimously held that the FDA's decisions were neither arbitrary nor capricious. Specifically, the Court agreed with the FDA's assessment that the manufacturers failed to demonstrate that the benefits of their flavored products to adult smokers outweighed the risks to youth. This ruling reversed a prior decision by the Fifth Circuit Court of Appeals, which had found the FDA's denials unwarranted. The Supreme Court's decision underscores the FDA's authority to regulate tobacco products, particularly those appealing to younger audiences, in line with public health objectives.
The opinion is presented here in its entirety, but with citations omitted. If you appreciate this episode, please subscribe. Thank you.
