FDA Releases PMTA Guidance

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.

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