September 20, 2022

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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.

The Big Tobacco / FDA legal timeline so far this year:

  • April 26, 2002 - FDA approves Njoy Ace pod and tobacco flavor (rejects flavored pod products)
  • May 12, 2022 - FDA approves the Vuse Vibe and Vuse Ciro (devices and tobacco flavored pods)
  • June 23 2022 - FDA rejects PMTA for JUUL
  • June 24, 2022 - Federal Court of appeals allows JUUL pods to remain on the market pending an appeals process (stay issued)
  • July 5, 2022 - FDA allows JUUL to remain on the market stating "scientific issues unique to the Juul application that warrant additional review"
  • September 6, 2022 - JUUL reaches a $438.5 million settlement with 34 states to end a 2 year long investigation into the companies marketing practices -- other lawsuits from states which will continue

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.