PMTA Submission Deadline Delayed to September. 9th

Vaping companies will have an extra four months, until September 9, 2020, to submit their premarket tobacco applications (PMTAs). This postponement is due to the exceptional circumstances presented by the global coronavirus outbreak. The previous deadline was May 12, 2020.

The coronavirus pandemic has closed laboratories in the U.S. and deeply affected factories overseas which makes it difficult for companies to complete their applications. FDA staff members have also been pulled into the pandemic response. This delay gives vaping manufacturers the much needed time necessary to complete their applications.

Companies that submit a PMTA for their vapor product by the Sept. 9, 2020 deadline will be allowed to remain on the market for a year while the FDA decides if it meets its strict requirements.  

Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for any new tobacco product before it can be sold in the U.S. But e-cigarettes and vapor products weren’t always classified as tobacco products. 

However, on August 8, 2016, the FDA’s Deeming Rule defined e-cigarettes and vaping products as tobacco products and thus required them to receive FDA approval to remain on the market. 

Then, in July of 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for vaping companies to submit PMTAs to the FDA. Any company that did not submit a PMTA for their vapor product(s) by this deadline would no longer be legally allowed to sell them in the USA.

Submitting a premarket tobacco application (PMTA) is expensive, with costs in the low to mid hundreds of thousands of dollars. In order to get their PMTA approved, the manufacturer must demonstrate to the FDA that “permitting the marketing of the new tobacco product would be appropriate for the protection of public health”. This guideline is unclear and vague which leaves many companies wondering exactly what they would have to prove in order to submit a successful application.

For now, the vaping market is safe. But the Sept. 9, 2020 deadline is fast approaching and with it will come vast changes to the vaping market as we know it.