Recently foreign media reported that U.S. e-cigarette company Juul Labs has sued the U.S. Food and Drug Administration to obtain documents related to an order banning the company’s e-cigarette products from the market.
According to the complaint, the FDA withheld the requested documents on the basis of the deliberative process privilege, which allows the federal government to refuse to release materials that could compromise internal agency deliberations.
Juul argues that because the FDA issued its marketing denial order, the materials incorporated or relied upon in the final agency action are, by definition, no longer pre-decisional materials protected by the privilege.
The agency initially banned Juul’s product on June 23, citing a lack of evidence to protect its safety and pointing to a disproportionate role in the rise of e-cigarette smoking among young people. The next day, Juul won an emergency court order that temporarily blocked the FDA’s decision.
The FDA then suspended the injunction pending further review, effectively allowing Juul to continue selling its product for now.
Juul said the materials will show whether the FDA has struck the legally required balance of public health benefits and risks of its products, including claims that they can help smokers quit, and whether the agency’s reasoning is scientifically sound.
Juul said the public deserves a full understanding of the scientific facts behind one of the agency’s most controversial and closely watched decisions in recent years.
An FDA spokesman declined to comment, saying he would not discuss pending litigation.
Juul accuses the FDA of violating the federal Freedom of Information Act by rejecting much of the scientific disciplinary review behind the marketing ban.
It says it filed an administrative appeal through the agency, but the FDA missed a Sept. 13 deadline to resolve it.
A federal appeals court temporarily suspended the marketing ban on June 24.
The FDA decided on July 5 to temporarily let Juul continue selling its product, saying scientific issues specific to the company needed further review.
On Sept. 6, Juul agreed to pay $438.5 million to settle claims in 34 U.S. states and territories over its marketing and sales practices, including improperly attracting teenage buyers.
