Juul Labs Inc. said the Food and Drug Administration overlooked a critical part of Juul’s application when the agency e-cigarette manufacturer’s products ordered Off the US market, according to court documents.
In Tuesday’s court filing, Juul said the agency overlooked more than 6,000 pages of data the company submitted to the FDA on aerosols that users inhale. Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said significantly outweighs the potential risks to the public-health benefits of Juul products.