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Supreme Court Affirms FDA’s Authority in E-Cigarette Regulation

PENNSYLVANIA RECORD

Wednesday, April 16, 2025

Supreme Court Affirms FDA’s Authority in E-Cigarette Regulation

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A scholar of constitutional law and health law, Ruger unpacks the significance of FDA v. Wages and White Lion Investments—a case that tested the limits of agency discretion in a shifting judicial landscape. His commentary explores how this decision signals a nuanced willingness to preserve agency expertise in matters of urgent public health.

Ruger writes:

The case, FDA v. Wages and White Lion Investments, called into question the FDA’s interpretation and implementation of the Tobacco Control Act of 2009, which gives FDA pre-market approval authority over a range of new tobacco related products. The FDA has struggled to keep pace with the technological and marketing advances of the e-cigarette, or vaping, industry, and over the past seven years FDA issued guidelines to the industry that were allegedly unclear about what standards of research were required to prove the new products did not harm public health. With respect to flavored vapes, given evidence of high usage by teens who were not otherwise smoking traditional cigarettes, the FDA found the products detrimental to public health and banned a large number of such flavored products. The manufacturers sued, and won a major victory last year in the Fifth Circuit Court of Appeals, which applied and extended the Supreme Court’s own newly distrustful attitude towards agency decision-making to hold that the FDA was “arbitrary and capricious” in the standard it had applied to ban flavored vapes.In unanimously overturning the lower court, and upholding the FDA’s authority, the Supreme Court signaled that its distrust of agency discretion is not without limit: writing for the full Court, Justice Alito held that there was nothing inherently unlawful in the agency’s changing its mind, and its policies, on an evolving public health issue, and noted that Congress had vested substantial interpretive authority in the FDA to protect public health by framing and revising safety standards for new nicotine containing products. The ruling is momentous within the e-cigarette industry, and will result in many flavored products being removed from the marketplace at least until they can prove through better scientific studies that they are not harmful. More broadly, the Court’s endorsement of agency discretion in this case may signal that despite hemming in broad agency authority on issues like climate change, and despite overturning the deferential Chevron standard for reviewing agency interpretations, there remains a substantial role for consumer protection agencies in deciding on and developing standards for protection of the public health.

Original source can be found here.

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