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.
Jim McDonald – Vaping360 – June 17, 2019.