FDA Delays PMTA Deadline For Vaping Products


There are no parts of our life in the countries most effected by the coronavirus pandemic that are not suffering in some way. Many non-essential stores, restaurants and cafes have all had to close due to strict social distancing and lockdown rules. One industry that has really taken a beaten as a result though is the vaping sector.

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Thanks to the restrictions in place it has been harder for companies to meet the increased demand for vaping products. Another potential issue manufacturers and retailers of vaping products like vape pens face is the PMTA submission deadline, which was set to May 12th as of June last year by the US District Court Judge Paul Grimm. That was until a request to extend the deadline was issued. Why does the original deadline cause problems for vaping retailers, manufacturers and importers and what was the result of the request?

What Is A PMTA?

A PMTA is a pre-market tobacco product application and is an important legislative document that all relevant parties should have in order to market and sell their products. Whereas many tobacco and similar products that were available before August 2016 onwards do not require this, the vast majority of vaping products do.

The move was made in line with the increase in younger people using vaping products and e-cigarettes (anything related is included, such as atomizers etc.). It exists to ensure that all products on the market for purchase are safe and have been rigorously tested to prove that fact. If they do not have a PMTA completed and successfully approved, vaping retailers, manufacturers and even importers would not be able to produce, distribute or sell those products. Which is something that will be of concern to anyone who uses a vape pen or other associated and similar items.

Why Is This A Problem Under Current Circumstances?

For many companies who have already submitted their PMTA this is perhaps not an issue. However, for others who are still in the process, it poses a huge threat to their business. As the application requires product samples for the FDA to test themselves and test results that the companies themselves have conducted, there are many companies that may not be able to submit theirs in time. Most labs and other facilities are closed as a result of the lockdown and social distancing measures that have been put in place to battle the spread of Covid-19.

That is why following a letter submitted by the National Association of Tobacco Outlets (or NATO for short) to the FDA, that a request was issued by the FDA to ask for a 120-day delay on the PMTA deadline to Judge Grimm. It was also felt, further to the point about testing centers and labs not being opened, that the approaching deadline would place even more burden on the vaping manufacturers and retailers who were serving the public by providing essential items during the current emergency.

Although it is not certain if this would be of benefit to all companies and afford them enough time to get suitably tested and submit their PMTA, it will help a large majority.

Good News

The really good news is though, that District Court Judge Grimm agreed to the extension, which now sees the deadline for PMTAs to be submitted being September 9th, 2020. While various restrictions remain in place, time will only tell really if this has been enough to help the majority of businesses get through the epidemic unscathed. It must be seen as a move in the right direction at the very least, though, and one that has been welcomed by many vaping product retailers, manufacturers and importers alike.


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