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Juul Labs, the vaping company blamed for much of the crisis gripping the nation’s teens, has sued the U.S. Food and Drug Administration over the agency’s refusal to disclose documents supporting its order banning the company.
In a complaint filed on Tuesday, 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.
The materials would let the company see the findings of whether 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.
An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.
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.
A federal appeals court temporarily stayed the sales ban on June 24.
The FDA then decided on July 5 to let Juul keep selling its products for the time being, saying ‘scientific issues’ unique to the company warranted further review.
On Sept. 6, Juul agreed to pay $438.5 million to settle claims by 34 U.S. states and territories over its marketing and sales practices, including that it improperly courted teenage buyers.
While the company admitted no wrongdoing during the settlement, it did say they were trying to ‘resolve issues from the past’
‘We think that this will go a long way in stemming the flow of youth vaping,’ said William Tong, Connecticut’s Attorney General, but added he ‘cannot claim that it will stop youth vaping.’
Connecticut and Virginia were awarded over $16 million in the suit, while Texas was awarded $43 million.
The investigation found that Juul attempts to market the vaping products to children using social media, hiring young models and even giving out free samples.
They also called the company’s age verification system ‘porous,’ and found that 45 percent of the company’s Twitter followers were teenagers.
Juul will now be barred from marketing their products using anyone under the age of 35 in the advertising images.
The company are still mired in legal trouble and find themselves facing lawsuits from the states of New York and California, along with 3,500 individual cases from people and schools that have now been consolidated into one case.
Marlboro cigarette maker Altria Group Inc paid $12.8 billion in 2018 for a 35% stake in Juul.
Altria valued that stake at $450 million as of June 30.