Judge’s Ruling on PMTA’s Means Vaping Industry Could Be Very Different Less Than A Year From Now

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Thanks to a US district court ruling, vape companies now have less than a year to submit a PMTA for each product they sell, or face removal from shelves. 

The debate over how to properly regulate vaping has been one of the most hotly contested and important going on. It seems like no matter where you turn; there’s different opinions on how to properly reign in teenage vaping while preserving the value they provide adult smokers.

Unfortunately, one very unpopular regulation that has once again reared its ugly head is the FDA’s Pre-Market Tobacco Applications (PMTAs), which require any new tobacco product brought to market to pass a lengthy approval process. An Obama Administration ruling placed vaping products under the jurisdiction of PMTAs, with the original implementation date set for August of 2017.

This deadline was pushed back to 2022 by former FDA Commissioner Dr. Scott Gottlieb, giving vaping companies more time to prepare these robust applications.However, anti-vaping groups began suing the FDA over this deadline change almost as soon as it happened, and thanks to a recent US District court ruling they seem to have finally got their wish.

Both sides of the vaping debate had a lot to say about the ruling. The anti-vapers praised the judge for taking matters into his own hands, while vapers once again question the logic behind giving Big Tobacco a golden opportunity.

PMTA Ruling

The lawsuit which led to this unfortunate update was originally filed by the American Academy of Pediatrics along with some anti-vaping groups. It named the FDA and former Commissioner Gottlieb for exceeding their boundaries and delaying the PMTA much too long.

It was Judge Paul Grimm’s ruling, which ultimately altered the future of the vaping industry. He ruled last week that just ten months from now is the new deadline for vaping companies to submit a PMTA for every product they sell. Once submitted, companies can continue selling the product for a year, or until the application is approved or denied.

While this is a big problem for vaping companies and vapers themselves, it could have been a lot worse. The ten-month period is longer than the four months initially sought by the lawsuit. Experts believe the cost of each PMTA is somewhere in the ballpark of $300,000 since they require submission of research proving their value, among many other things.

As it stands now, the current deadline for vaping PMTAs is May 12th, 2020, with many vapers growing anxious about what the industry will look like a year from now. This is especially true for smaller brands, as they will especially feel the sting of the increased cost of doing business. Some vapers worry this will leave the door open for Big Tobacco companies who are desperately trying to take over vaping however they can.

The Evidence For Vaping

The biggest argument against vaping has consistently been regarding the impact they have on teens. However, if more people looked at the peer-reviewed evidence for themselves, this wouldn’t be such an issue.

A report of over 60,000 teens by Action on Smoking and Health concluded that less than 0.5% of non-smoking teens are ever vaping more than a few times. This means even fewer could possibly be ending up smokers because of the impact of vaping.

We also have evidence which suggests vaping is one of the single best smoking cessation tools we have at our disposal. A report out of the University of Louisville tested all the most common smoking cessation tools and methods before determining it was vaping which is more likely to succeed.

That’s not even to mention all the harm reduction evidence we have in favor of e-cigarettes. Studies as far back as 2015 strongly suggest that vaping is at least 95% safer than continued smoking. A report from just a few months back out of Roswell Park supports this stance, finding the toxicants in vapor are about 93% lower than in cigarette smoke.

However, nothing really proves the harm reduction value of vaping quite like the report from the Journal of Aerosol Sciences which concluded the excess lifetime cancer risk of a vaper is around 57,000 times lower than a demographically similar smoker!

Implications

PMTAs have been one of the most controversial topics surrounding the vaping industry ever, and it seems like they’re once again right on our doorstep. The harder it is for independent vaping companies to do business, the better the opportunity it is for Big Tobacco to sneak in.

The harder it is for vapers to have access to their preferred products, the more people who will revert to smoking. It’s crucial we don’t forget that smoking still kills more people every year than any other preventable cause.

The best thing we can do is continue to fight back against the PMTA and other misguided vaping regulations, which will ultimately make things much worse. If we all work together, we can protect our vaping rights and ensure that everyone who needs them has access.

What do you think about the PMTA? Do you believe the PMTAs give an advantage to massive Big Tobacco companies? How should we move forward with vaping in spite of the PMTA deadline change? Let us know what you think in the comments, and don’t forget to check back here or join our Facebook and Twitter communities for more news and articles.

 

Jimmy, lover, blogger, vaper and ex-smoker. I’ve been blogging about and supporting Vaping since 2009. They changed my life and I think history will show them as one of the most significant public health invention of the 21st century.

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