United States

The U.S. Supreme Court ruled unanimously that the FDA followed the law in denying marketing applications for certain flavored e-cigarette products. In September 2020, Triton Distribution and Vapetasia filed applications with FDA to sell nicotine e-liquids with kid-friendly flavors like “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Iced Lemonade” and “Killer Kustard Blueberry.” Their applications included existing studies on e-cigarettes and marketing plans to restrict youth access. In August 2021, FDA announced a new trial and study requirement specific to flavored products. Shortly thereafter, FDA denied the manufacturers applications, citing a lack of evidence. The manufacturers challenged this decision in a federal appeals court, which held the FDA had improperly changed its requirements without notice and refused to consider the submitted marketing plans.

The Supreme Court explained that under federal law, courts reviewing an agency’s actions can only set them aside if they are arbitrary and capricious, meaning they lack a rational basis or are unreasonable. The case was sent back to the federal appeals court to revisit whether it made a difference that FDA changed its position and failed to consider marketing plans submitted as part of their applications. 

The Campaign for Tobacco-Free Kids and other public health groups filed an amicus brief urging the court to deny the marketing applications (see "Related Documents").