United States: Supreme Court upholds FDA decision to ban flavored vaping products

On April 2, 2025, the U.S. Supreme Court largely upheld the Food and Drug Administration's (FDA) refusal to allow two e-cigarette companies to sell flavored products deemed harmful to youth. The Court overturned a lower court ruling that the FDA had exceeded the restrictions of the federal Administrative Procedure Act when it denied the applications of Triton Distribution and Vapetasia.[1].

Business Arguments and Legal Analysis

The FDA had appealed a ruling by the U.S. Court of Appeals for the Fifth Circuit in New Orleans that found the agency unfairly changed its approval criteria for e-cigarette liquids while deciding applications from two companies seeking to sell new products with names such as "Jimmy the Juice Man Peachy Strawberry," "Suicide Bunny Mother's Milk and Cookies," "Iced Lemonade," and "Killer Kustard Blueberry."

E-cigarette companies had argued that the FDA required more rigorous scientific evidence than it had initially announced, making it virtually impossible for the companies to obtain approval. In delivering the unanimous decision, conservative Justice Samuel A. Alito Jr. clarified that the FDA had not gone beyond its mandate to analyze scientific evidence and other established guidelines.

The latter concluded that the manufacturers had not provided sufficient evidence that these products would provide benefits to smokers that outweighed the substantial risks they posed to young people and that they had therefore not demonstrated that these products would be appropriate for the protection of public health, as required by law.

However, the Court left open the question of whether the FDA had disregarded the companies' proposed plans to limit minors' access, sending that question back to a lower court to reconsider under a different legal standard.

Regulatory context and reactions of anti-tobacco stakeholders

The 2016 FDA regulation classifies e-cigarettes as tobacco products, subject to the 2009 Tobacco Control Act, which requires manufacturers to obtain a license to sell vaping devices and nicotine-containing liquids. This regulation was enacted in response to the rise in youth vaping use. According to a nearly decade-old estimate, there were more than 7,700 different flavors available at the time, including fruit, candy, and dessert flavors, which enticed teens to start vaping.[2]Since then, the FDA has approved only 34 flavored e-cigarettes, mostly tobacco or mint. Despite this, flavored products remain widely available, although their sale is illegal without a license from the state agency.

According to the 2024 National Youth Tobacco Survey, which included vaping, more than 1.6 million American children in the 6^e in their final year of high school still use e-cigarettes, and nearly 90% of them use flavored products. Health authorities warn of the effects of vaping on young people's brain development, particularly on attention and memory. Added to these effects are the risks of respiratory illnesses.

Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, hailed the Supreme Court's decision as a victory for youth health.[3]She also called for tougher action against illegally traded e-cigarettes, saying in a statement: " Today's decision is a major victory for the health of America's children and for efforts to protect them from flavored e-cigarettes that have fueled a youth nicotine addiction crisis. ".

This marks a step forward in federal tobacco control, a move opposed by Donald Trump, one of whose campaign promises was to defend the vaping industry. Since Trump's election, Massive layoffs have taken place within the FDA, including the departure of Brian King, director of the Center for Tobacco Products (CTP). This new situation greatly compromises public health efforts, particularly those to enforce existing laws, at a time when other health agencies such as the Centers for Disease Control and Prevention and the National Institutes of Health are also facing staff reductions.

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[1]Kruzel John, US Supreme Court largely backs FDA's denial of flavored vape product applications, Reuters, published April 2, 2025, accessed April 3, 2025

[2]Justin Jouvenal, Supreme Court upholds FDA's rejection of fruit-flavored vape liquids, The Washington Post, published April 2, 2025, accessed April 3, 2025

[3]C. Richardson Yolanda, In Victory for Kids, US Supreme Court Rules FDA Properly Denied Marketing Applications for Flavored E-Cigarettes, Campaign for Tobacco-Free Kids, published April 2, 2025, accessed April 3, 2025

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