- Manufacturer of e-cigarettes Juul Labs Incsupported by Altria Group Inc MONfiled a complaint alleging the FDA’s refusal to disclose documents supporting its banning order on the company’s products.
- In June, the agency appointed Juul to stop selling and distributing all of its products marketed in the US, saying the company’s products played a disproportionate role in the rise of vaping among youth.
- In a Reuters reportthe complaint found that the FDA relied on the “widely abused” privilege of the advisory process to improperly withhold scientific materials “central” to understanding the basis of the sales ban.
- In the report, Juul said the materials show whether the FDA has conducted a legally required risk-benefit analysis of its products, including claims that they help smokers quit, and whether the agency’s reasoning is science-based.
- “The public deserves a full picture of the science behind one of the agency’s most controversial and scrutinized decisions in recent years,” Juul said.
- FDA in July remained administrative 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 require additional review.”
- Juul Labs agreed Pay $438.5 million in 34 states and territories in September to conduct a biennial bipartisan investigation of its marketing and sales practices.
- Price promotion: MO shares closed at $43.00 on Tuesday.
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