Anti-Vaping Groups Sue the FDA to Reinstate the 2018 PMTA Deadline

Anti-vaping groups are suing the FDA to push the agency to enforce its original deadline for all vaping products to go through premarket review. The original deadline was Aug. 8, 2018.

Seven organizations and five individual pediatricians filed a lawsuit in the Maryland U.S. District Court, claiming that the FDA’s four-year postponement of the due date for filing premarket tobacco applications (PMTA’s) exceeded its authority under the Family Smoking Prevention and Tobacco Control Act.

The FDA announced last July that it was postponing the deadline until Aug. 8, 2022. The delay allows products that were already available for sale on Aug. 8, 2016 to remain on the market without seeking authorization until the new deadline in 2022.

The plaintiffs are:

All other parts of the FDA Deeming Rule that went into effect in 2016 remained in place; it was just the deadline for submission of PMTA’s that changed. But to hear the lawsuit’s plaintiffs tell it, the PMTA deadline postponement unleashed an onslaught of kid-attractive products designed to lure “our kids” (as Matthew Myers says) into addiction. And the number-one culprit, of course, is JUUL.

“The need for the FDA to review e-cigarettes now on the market has been underscored by the recent surge in popularity of JUUL, which has become the best-selling e-cigarette brand and is reported to be widely used by teens,” says the press release from the Campaign for Tobacco-Free Kids, on behalf of the plaintiffs.

“According to widespread news stories,” the press release adds, “reports from educators and documented social media posts, JUUL e-cigarettes have become very popular among high school and college students (see reports by The Boston Globe, Pittsburgh Post-Gazette, NPR and WJLA TV in Washington, DC). Despite these reports, the FDA has taken no action regarding JUUL.”

“The media reports of a teenage juuling ‘epidemic’ do not add up with population studies that show regular use of these products by never smokers to be very low,” University of Waterloo (Ontario) sociologist Amelia Howard said in Vaping360's recent article on juuling. “The juuling stories have the classic hallmarks of a moral panic: widespread fear based on exaggerated risk.”

With the Cole-Bishop rider left out of the final omnibus budget bill by the Senate, and the outcome unclear for multiple lawsuits against the FDA by vaping organizations, a return to the Aug. 8, 2018 deadline for filing PMTA’s would essentially wipe out the American independent vapor industry.

If the FDA contests the lawsuit, it will take months or years to be resolved — so there’s probably no chance of a reinstatement of the 2018 deadline. But the uncertainty about what might happen will cause damage by itself. Every day, vape shops and other small vaping businesses make decisions about signing leases, expanding, and hiring. The FDA has already signalled its intention to crack down on non-compliant products.

And the multi-prong FDA plan to remake the nicotine marketplace offers no reassurance. The proposal to reduce nicotine in cigarettes comes along with a suggestion to eliminate liquid nicotine products. The agency’s e-liquid flavors notice is even worse. It’s clearly slanted toward eliminating most vaping products.

FDA Commissioner Scott Gottlieb defended his agency’s actions on Twitter Tuesday, but this is a distraction he’d probably like to avoid. The tobacco control lobby is powerful and persistent.

Who won’t be affected if this lawsuit succeeds? The cigarette industry. Their cornerstone product is grandfathered onto the market and profitable beyond belief. They have the lawyers and money to keep any reduced-nicotine scheme at bay for years. Anyway, the FDA and the whole tobacco control structure needs cigarettes.

After all, who funds the FDA Center for Tobacco Products? That’s right — 100 percent of the center’s operations are paid for by tobacco company user fees. Philip Morris already has PMTA and modified risk applications in for its IQOS heat-not-burn device, and British American Tobacco/RJ Reynolds will follow soon with Glo.

The vape company probably most likely to have the money, knowledge, and ability to succeed through the PMTA route — JUUL Labs — is the subject of a massive attack campaign run by the same groups filing this lawsuit. Tobacco-Free Kids’ Matt Myers and his cronies don’t want open system vaping and bottled e-liquid to remain available, and a closed-system product like JUUL that is clearly aimed at providing adults a smoking alternative is also unacceptable. What else is there?

“You’re guaranteeing you’re going to kill off all the novel products and we’re going to once again be favoring the cigarette which is by far the most deadly of all tobacco products,” University of Michigan emeritus professor of public health Kenneth Warner told BuzzFeed News.

The message to the vape industry is clear: please die quickly and rot in hell.