Juul Says FDA Mishandled Its E-Cigarette Application
Juul Labs Inc. said the Food and Drug Administration overlooked a key part of Juul’s application when the agency ordered the e-cigarette maker’s products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
Juul Labs Inc. said the Food and Drug Administration overlooked a key part of Juul’s application when the agency ordered the e-cigarette maker’s products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
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