Under pressure from a federal court, the FDA has finally released vaping industry guidance for filing premarket tobacco applications (PMTAs). And depending on what happens in the federal lawsuit in Maryland, vape manufacturers could be forced to submit multi-million dollar applications in as little as four months or be forced out of business.
No vape company has ever submitted a PMTA, and the FDA Center for Tobacco Products has only approved one PMTA for an inhalable nicotine product during its 10 years in existence. That product, Philip Morris International’s heat-not-burn tobacco device IQOS, is not an e-liquid vaping device. The IQOS PMTA was approved this April, after a review process that lasted more than two years.
Since only a handful of companies would dare to risk millions of dollars on applications that would probably be denied, we could be facing the end of the legal independent vaping industry in the very near future. That would mean tens of thousands of employees losing their jobs, and perhaps millions of vapers either turning to the black market for e-liquid and supplies, or migrating back to cigarettes.
At this point, the vaping industry is depending on its perpetual enemy the FDA to fight this legal battle, or the industry will be forced to immediately submit mountains of paperwork most companies aren’t capable of doing properly only to be rejected by regulators unprepared to review it. No one wants this to happen except the anti-vaping groups that brought the lawsuit against the FDA.
But let’s start at the beginning.
On July 28, 2017 then-FDA Commissioner Scott Gottlieb announced a bold “comprehensive strategy” for addressing tobacco and nicotine. Among other initiatives (like reducing the nicotine in cigarettes), he announced a four-year delay of the 2018 PMTA deadline for manufacturers of “deemed tobacco products” — time that would offer breathing room to businesses as they prepared. And Gottlieb promised the vape industry would soon have “a firm foundation of rules and standards for newly-deemed products.”
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