After Two Embarrassing Years, FDA Rescinds Juul Denial Order

Nearly two years after ordering all Juul products removed from the market for supposed toxicological concerns, the FDA has rescinded its marketing denial order (MDO), and placed Juul Labs’ marketing application back into scientific review.

On June 23, 2022, the FDA Center for Tobacco Products announced that Juul’s premarket tobacco application (PMTA) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

Today, the agency said in a press release that it has “gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers.” 

For these reasons, apparently, the original PMTA review was deemed insufficient, and Juul will get another bite at the authorization apple—which could take another two years, or even longer. 

“Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” the agency said today. “Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA.”

FDA embarrassment: forced to stay its own order

The 2022 MDO covered the JUUL device, and Virginia Tobacco and Menthol pods in both 3 and 5 percent strengths—all of Juul’s active products—and advised retailers and distributors to remove them from store shelves. “Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action,” the FDA warned in its 2022 press release.

Just a day later, the order was stayed by a federal court after Juul claimed that the FDA had simply ignored thousands of pages of evidence that addressed the very issues the agency had used as a pretext to deny Juul’s application.

Two weeks later, the FDA embarrassingly reversed course and issued an administrative stay that put its own denial order on hold. The agency said it had “determined that there are scientific issues unique to the JUUL application that warrant additional review.” 

Then the agency spent two years deciding that it would be best to just wipe the slate clean and begin its scientific review from scratch. 

The FDA has a big political problem

In Juul Labs’ court filings, the company accused the FDA of letting politics overrule its scientific judgment. The agency issued the hurried denial order after “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping,” the company told the court.

The day before the FDA issued the MDO, Senator Dick Durbin (D-IL) said in a press release that FDA Commissioner Robert Califf should quit if he couldn’t remove unauthorized vaping products like Juul’s from the market. “It’s time for Commissioner Califf to do his job to protect our children or step aside,” said Durbin.

In fact, tobacco control groups and Democratic politicians openly celebrated the FDA denial as a political win, bragging that they had influenced the decision. 

Illinois House member Raja Krishnamoorthi, a longtime opponent of vaping and harm reduction for smokers, attended a celebratory webinar held by Parents Against Vaping (PAVe) and told the prohibitionist group he was “heartened” by the FDA decision, and “so glad” to have “an ally” in FDA Commissioner Robert Califf.