USA Vape Lab, maker of the Naked100 line of bottled e-liquids, filed suit against the Food and Drug Administration, alleging it unlawfully delayed action on its premarket tobacco applications for more than five years. The suit was filed November 21 in the U.S. District Court for the District of Columbia.
In the complaint, the Huntington Beach, Calif.–based company says it submitted extensive PMTAs for its flavored and tobacco e-liquid products ahead of the September 9, 2020 deadline. Despite a Tobacco Control Act provision requiring FDA to issue decisions within 180 days, the agency has yet to act, the suit states. USA Vape Lab is asking the court to order FDA to issue final determinations.
The company also argues FDA must consider what it describes as robust population-level evidence included in its submissions. According to the filing, a randomized controlled trial showed nearly one-third of participants achieved six-month cigarette abstinence when using Naked100 e-liquids—quit rates the company claims are two to three times higher than those reported for FDA-approved nicotine replacement therapies. USA Vape Lab further alleges that flavors such as Really Berry and Strawberry Pom demonstrate net public-health benefits that outweigh potential youth risks and exceed those of comparable tobacco flavors.
“We felt that we had no choice but to initiate this lawsuit,” founder Huy Nguyen said in a statement, criticizing the agency for years-long delays while threatening enforcement actions against products lacking marketing orders.
USA Vape Lab manufactures a range of popular e-liquids, including American Patriots, Crisp Menthol, and Lava Flow.
