Juul says FDA overlooked key data in e-cigarette application before banning sales
E-cigarette giant Juul argued in court documents filed on Tuesday that the Food and Drug Administration (FDA) had overlooked a mountain of data that it had included in its application that demonstrated its products’ benefit to public health and said the decision to ban them was based on “deeply flawed reasons.”
In the court documents, the electronic cigarette company said it had included more than 110 scientific studies and over 125,000 pages of data and analysis that showed its products offered “substantial public-health benefits.”
They company claimed that its e-cigarettes were helpful in switching people over from traditional cigarettes to the electronic kind, which it said lessened their exposure to “deadly toxicants.” It also claimed that e-cigarettes had “little appeal to non-smokers.”
Last week, the FDA announced it was banning Juul from marketing and selling it products. Products from the company that are already out on the market would have to be removed, per the agency’s decision. According to the FDA, Juul had failed to prove that keeping its products on the market was “appropriate for the protection of the public health.”
One day after the FDA’s ban was announced, a federal appeals court temporarily blocked the decision pending further arguments.
“Instead of praising a significant public-health victory, FDA denied JLI’s applications for arbitrary reasons and demanded that retailers remove all JUUL products from their shelves or face immediate action,” Juul wrote in its argument, further claiming that the FDA’s decision could not be “squared” with science.
The company countered the FDA’s claim that Juul had not provided data such as aerosol data on the impact of four chemicals. Juul claimed that it had in fact provided over 6,000 pages worth of data on this point.
Juul appeared to insinuate that the FDA had bowed to political pressure from lawmakers and claimed that there had been an “unprecedented” level of congressional interference in the approval process.
The company said it would suffer “significant irreparable harm” if the ban was allowed to stand and said it served the public interest to allow its products continued availability.