JUUL sues the FDA over the agency refusing to disclose documents justifying the denial of the PMTA to sell the popular
September 20, 2022
Big Tobacco owned JUUL, best known for their flagship vape pod, is continuing to fight for its life with the filing of a lawsuit against the FDA.
JUUL is currently filing suit to look for answers as to the reason behind the surprising PMTA denial issued by the FDA over the summer.
From Reuters:
In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul accused the FDA of invoking the "widely abused" deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the June 23 sales ban.Juul said the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims they help smokers quit cigarettes, and whether the agency's reasoning was scientifically sound....Juul accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the "scientific disciplinary reviews" underlying the sales ban.It said it filed an administrative appeal through the agency, but the FDA missed a Sept. 13 deadline to resolve it.
In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul accused the FDA of invoking the "widely abused" deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the June 23 sales ban.
Juul said the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims they help smokers quit cigarettes, and whether the agency's reasoning was scientifically sound.
...
Juul accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the "scientific disciplinary reviews" underlying the sales ban.
It said it filed an administrative appeal through the agency, but the FDA missed a Sept. 13 deadline to resolve it.
The Big Tobacco / FDA legal timeline so far this year:
The legal battle will surely continue on as billions of dollars are at stake.
Marlboro acquired a 35% stake of JUUL for $12.8 billion back in 2018 which is now worth just over $450 million according to Altria, the parent company. This means the once juggernaut has gone from a $30 billion dollar valuation to less than $2 billion.