Juul Sues FDA, Accuses It Deliberately Withheld Scientific Materials Related To Sales Ban

Juul Sues FDA, Accuses It Deliberately Withheld Scientific Materials Related To Sales Ban
  • E-cigarette maker Juul Labs Inc, backed by Altria Group Inc MO, filed a complaint accusing the FDA's refusal to disclose documents supporting its banning order on the company's products.
  • In June, the agency ordered Juul to stop selling and distributing all its products marketed in the U.S., saying the company's products played a disproportionate role in the rise in youth vaping.
  • In a Reuters report, the complaint noted that the FDA invoked the "widely abused" deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the sales ban.
  • In the report, Juul said the materials would show whether the FDA conducted a legally required risk/benefit analysis of its products, including claims they help smokers quit cigarettes, and whether the agency's reasoning was scientifically sound.
  • "The public deserves a complete picture of the scientific facts behind one of the agency's most controversial and closely scrutinized decisions in recent years," Juul said.
  • In July, FDA administratively stayed the marketing denial order," the agency's tobacco division wrote in a tweet. "The agency has determined that scientific issues unique to the Juul application warrant additional review." 
  • Juul Labs agreed to pay $438.5 million to 34 states and territories in September to sort out a two-year bipartisan investigation into its marketing and sales practices.
  • Price Action: MO shares closed at $43.00 on Tuesday.
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