The VTA Doesn’t Need Juul Labs

Source from:  Vaping Post 08/29/2019

Juul Labs, the e-cigarette giant partly owned by Altria Group, announced that it was ditching its membership with the Vapor Technology Association (VTA). The VTA is one of the leading industry trade groups working to fight encroaching regulation from the Trump Administration and to offer one of the more sobering organizational perspectives on vaping as a regulated industry and consumer phenomenon.

For the sake of transparency, I consider myself colleagues with many on the VTA board and share many of their positions on regulation and tobacco harm reduction. The news of Juul’s split from the VTA came as the trade group and a coalition of other industry organizations filed a lawsuit against the Food and Drug Administration over apparently unworkable premarket approval application timelines (PMTA).

As a result of other litigation that mandated the expedited regulation of products in the vaping category, the FDA announced new guidance mandating that e-cigarette manufacturers submit premarket approval applications a lot sooner than previously issued guidance.

Why Juul, why?
Juul, ironically, filed an amicus brief in federal court as it relates to that case. Of course, this is the American Academy of Pediatrics et al v. FDA case that handed public health and tobacco control advocacy groups a win mandating that the public health regulator advance the PMTA process.

In this amicus brief, Juul’s Joanna Engelke, the chief regulatory officer, wrote that the FDA’s issuance of final PMTA guidance as a result of the case “leaves important questions unanswered.” Essentially, the brief was in opposition to the findings of the federal magistrate, Paul Grimm, ordering FDA to regulate on an expedited schedule.

However, the recent dissent from Juul leaves me questioning why the company was even involved with the VTA in the first place.

The VTA, in a press release, notes that Juul’s representative to the organization’s board offered no opposition in advancing the new lawsuit against the FDA. An association spokesperson similarly noted the amicus brief Juul filed in opposition to the American Academy of Pediatrics summary judgments.

The latest case, Vapor Technology Association et al vs. Food & Drug Administration, et al, was filed in a federal court in Kentucky. Given the history of Kentucky being a pro-tobacco jurisdiction, the case filing makes sense. Keep in mind; e-cigarettes are only considered tobacco products under deeming rules issued by the FDA under the Tobacco Control Act of 2009. As I have previously noted in my reporting on litigation, these rules are antiques of an old regulatory era and treat semiconductors, microchips, and lithium-ion batteries as “tobacco.”  Enditem