FDA Premarket Requirements for Vape Makers Upheld on Appeal

A federal appeals court upheld a Food and Drug Administration rule imposing premarket application requirements on makers of vaping products.

The FDA adequately assessed the impact of the requirements on small-business makers of vaping products, and considered less burdensome regulatory alternatives in promulgating a 2021 final rule, the US Court of Appeals for the Fifth Circuit said.

The Fifth Circuit affirmed a lower court’s ruling upholding the Premarket Tobacco Product Applications and Recordkeeping Requirements rule against a challenge by seven makers of e-liquids and a trade association.

The FDA issued a final rule in 2016 deeming electronic nicotine-delivery systems ...