The Supreme Court announced Tuesday that it will hear a case involving the Food and Drug Administration's (FDA) refusal to allow two companies to market flavored tobacco vapor products.
The court heard the FDA's appeal after the U.S. Court of Appeals for the Fifth Circuit ruled earlier this year that the agency's actions in rejecting the companies' applications were arbitrary and capricious.
The companies Triton and Vapetasia LLC sell flavored e-liquids and in 2020 applied for a license to market flavors such as sour grape, pink lemonade and crème brûlée, and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
The FDA denied the approvals because it said the companies failed to provide reliable and robust evidence that they addressed the risks of youth addiction and demonstrated a benefit to adult smokers.
The FDA has approved the sale of just 27 e-cigarette products, and all but one are tobacco-flavored, which is not widely used by young people. Millions more have been denied. Companies seeking the agency’s approval must overcome a high legal threshold, since such products pose a “known and substantial risk to young people,” the FDA said.
The companies sued, and the Fifth Circuit, considered the most conservative panel in the country, heard the case. In January, a full panel of judges on the 5th Circuit ruled 10-6 that the FDA violated the Administrative Procedure Act by rejecting the applications without considering the companies’ plans to prevent access and use by minors.
The court found that the FDA had asked the companies for detailed plans about how they would market their products to prevent youth abuse, but then rejected their applications without reviewing them.
In court documents, the FDA countered that the companies merely “requested that their products be sold only in age-restricted vape and tobacco specialty stores and through age-restricted online sales,” which the agency has previously said do not work. The marketing plans were no different than those the agency has rejected from other companies.
According to the FDA, other federal appeals courts ruled in its favor, creating a divide that allowed the agency to appeal to the Supreme Court.
The agency argued that if the lower court's decision were allowed to stand, it would “seriously hamper FDA's efforts to protect young people from the harmful effects of e-cigarettes.”
The case will be heard when the Supreme Court begins its next term in October.
