Juul Labs Inc. said the Food and Drug Administration omitted a key part of Juul’s application when it ordered the e-cigarette maker’s products off the U.S. market, according to documents filed by Juul. court.
In a court filing on Tuesday, Juul said the agency ignored more than 6,000 pages of data the company submitted to the FDA about aerosols that users inhaled. Juul also said the agency has not reviewed Juul’s evidence in its entirety, which the company believes the public health benefits of Juul products significantly outweigh the potential risks.
https://www.wsj.com/articles/juul-says-fda-mishandled-its-e-cigarette-application-11656423670?mod=pls_whats_news_us_business_f Juul says FDA mishandled their e-cigarette application