Politics

Supreme Court to Hear Case Involving FDA Denial of Flavored Vapor Products

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The Supreme Court said Tuesday it will hear a case involving the Food and Drug Administration’s (FDA) marketing denial of two companies that sell flavored tobacco vaping products.

The court granted the FDA’s appeal after the U.S. Court of Appeals for the 5th 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 marketing permission for flavors such as sour grape, pink lemonade and creme brulee, and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

The FDA denied the authorizations, concluding that the companies failed to provide reliable and robust evidence to overcome the risks of youth addiction and show benefits for adult smokers.

The FDA authorized the sale of just 27 e-cigarette products, and all but one were tobacco-flavored, which is not widely used by young people. Denied millions of others. Companies seeking approval from the agency must clear a high legal hurdle, as such products pose a “known and substantial risk to young people,” the FDA said.

The companies sued and the 5th Circuit, considered the most conservative panel in the country, heard the case. In January, a full panel of 5th Circuit judges ruled 10-6 that the FDA violated the Administrative Procedure Act by denying the applications without considering the companies’ plans to prevent minors’ access and use.

The court said the FDA asked the companies for detailed plans on how they would market their products to prevent youth abuse, but then denied their requests without reviewing them.

In court documents, the FDA countered that the companies only “requested that their products be sold only in age-limited vape and specialty tobacco stores and through age-limited online sales,” which the agency previously said was does not work. The marketing plans were no different than the plans the agency rejected from other companies.

The FDA said other federal appeals courts ruled in its favor, creating a split and advancing the agency’s appeal to the Supreme Court.

The agency argued that if the lower court’s ruling were upheld, it would “seriously undermine the 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.



This story originally appeared on thehill.com read the full story

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