Juul Labs sues U.S. FDA over vaccine ban

Juul Labs sues U.S. FDA over vaccine ban

Juul Labs is suing the U.S. Food and Drug Administration over its refusal to reveal documents supporting its order banning the company, which has been blamed for sparking a teenage vaping crisis, from selling e-cigarettes on the U.S. market.

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 had 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 said that 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.

A spokeswoman for the FDA didn't say anything about the agency's 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.

The agency said it filed an administrative appeal, but the FDA didn't have a Sept. 13 deadline to resolve it.

The FDA then decided on July 5 to let Juul keep selling 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.

In 2018, Marlboro cigarette maker Altria Group Inc paid $12.8 billion for a 35% stake in Juul. As of June 30, Altria valued the stake at $450 million.

The case is Juul Labs Inc v Food and Drug Administration, U.S. District Court, District of Columbia, No.