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Will the September PMTA destroy the Vaping Industry?

Will the September PMTA destroy the Vaping Industry?

The Premarket Tobacco Product Application (PMTA) intends to regulate the production of e-cigarettes, cigars, and other tobacco products under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act.  But this action will destroy the vaping industry if we don’t take action against it.

The very first step in our opinion is to get informed about the implications and the consequences, how would the vaping industry change after September, and what problems will appear for consumers to access safely harm reduction products.

Well, to keep it short, this regulation means that every manufacturer of new or modified tobacco products needs to submit a premarket application to FDA. This application must provide sufficient information about their product(S) to allow the agency to access and decide whether to approve the product(S) as safe for public health or not.

FDA initially gave a deadline for August 2017 for vape companies to submit PTMA. But the time was entirely unfeasible for the vape companies and FDA, and every once in a while, the deadline pushed forward multiple times.

Even if e-liquid manufacturers, such as Freeman, have worked closely and adjusted accordingly to each requirement, the FDA has come up within the last years; it seems to us that the fight against the vaping industry it's never really over.

It's our duty to make sure that our products have the highest quality on the market, making them safe for our clients and being extremely transparent with our ingredients list. And in the same amount of importance, we take our responsibility to keep our products away from underage kids, ensuring that our website has all the right age verification requirements, and Paul Freeman (CEO) himself goes through customer support to ensure our core values are met always.

Despite the constant collaborative attitude vape companies have displayed, the PMTA is still in discussion and now closer than ever.

The coalition of health-related entities led by the American Academy of Pediatrics (AAP) sued the FDA, claiming that it was shirking its duties and giving the industry more time to comply. Judge Paul W. Grimm sided this in the District Court of Maryland, and he set the deadline for PMTA’s to be May 11, 2020.

However, due to the COVID-19 pandemic, the FDA filed a request for a 120-day extension on the deadline. And on April 3, Judge Paul Grimm agreed to the application and moved the period to September 9, 2020.

So here we are, just a month away to the expected date required for all vape companies to prepare and submit their product application to the FDA. Any company that fails to provide a PMTA by the September deadline will have their products pulled from the market.  

More so, FDA is fully aware of the recent surge in youth use of e-cigarettes and the need for these and other deemed new tobacco products to undergo the premarket test. But is the safety of our kids the true underlying intention that drives these extreme measures?

Will the September PMTA destroy the vaping industry? Continue reading.

Effect on Small Manufacturers

The FDA estimated the cost of PMTA for manufacturers to be between $117,000 and $400,000 per product.  And different nicotine strength of vape juice is counted as a new product. Now imagine the amount you would need to apply for all products.

As an example, Freeman Vape Juice currently selling 24 flavors (without the nic salts); if you do the math, it adds up to ridiculous numbers. Between $2,808,00 and $9,600,000 just for us to be able to keep our products on the market! 

There is no way for independent mom and pops liquid manufactures to survive these fees!

With that said, on the average, the PMTA application costs $2,000,000 in legal and other fees.  And experts still believe these estimates are low and in fact, it will cost way more.

If we take a more in-depth look at small manufacturers and the size of their business, the cost is alarming, and the regulation would surely eliminate all small businesses selling vaping products.

More so, the FDA is leaving small businesses to handle the bill of PMTA, even when they have tested and endorsed most of these products and ingredients to be safe.

So the regulation is only intended to save the big tobacco companies, which have the resources to survive the market even for a few years, waiting out for all the competition to be destroyed. Not to mention that they can afford multiple tests without breaking a bank. That’s a massive loss to small businesses that will be destroyed, without even having a fair chance to get their products tested.

Juul and Big Tobacco

With many small businesses having a large number of people working for them throughout each state, the regulation will only put them out of jobs just to strengthen the big tobacco manufacturers. And it will add up to America's Employment Crisis, on top of the harm COVID-19 has already created.

The PMTA is supposed to regulate tobacco or vapor use, but the one-size approach is automatically placing a ban on small businesses and putting their employees out of jobs. The bad part is that Big Tobacco will not replace those jobs lost, nor do they have any intention to have our economy's best interest at hearts. As you know by now Big Tabacco only cares about profit and what goes into their pocket, at the cost of hundreds of lives per year. The MSA only reinforces this statement.

This issue is beyond the dollars, no doubt; it is a matter of OUR HEALTH, but the interest at play don't seem to see the situation with the same eyes. Besides, it is a fact that because of vaping products thousands, if not millions, of people have found a new lifestyle where vaping products helped them as a smoking-cessation aid. Improving their overall health. 

There has been a significant decrease in cigarette use across nearly every American demographic. But banning vapor products would only drive adults back to smoking cigarettes. Putting their health, and their families' health, at risk!

Advocacy and its importance

Trump’s administration has recently recognized the need to save small businesses across America. Little wonder the president issued an executive order for all federal agencies to identify burdensome regulations that are impeding economic recovery and implement waivers or modifications “for the purpose of promoting economic growth and job creation.”

So one regulation that must be on the list to alter is the PMTA by the Food and Drug Administration (FDA) that is most likely going to destroy hundreds of small vapor businesses by September 9, 2020.

It is economically unfair to lump small businesses in with big tobacco. The regulation only favors tobacco production, and small vapor businesses view themselves are safer alternatives to big tobacco products.

We need to stand to get Americans all across our country off tobacco and stop our youths from having access to these deadly products. And the only way is to advocate for a change in this regulation policy, reinforce better policy around marketing and brand messaging. Creating high sanctions for those vapor companies that market to the youth, such as Jull, and actually putting them in practice to educate the vaping market to stay away from selling to kids. Which mostly its to begin with an issue created by Jull, which is owned by you guess who. Big tobacco! 

The government regulatory agency, FDA that puts the small vape businesses in with big tobacco think vaping is a safer alternative to adults but still wants to regulate vaping like tobacco. 

“Products like e-cigarettes and other nicotine-delivery systems are a less-harmful alternative for addicted adult smokers”- FDA.

Other organizations advocating for vaping products over tobacco products include the National Academy of Science, American Cancer Society, Royal College of Physicians, American Association of Public Health Physicians, British Lung Foundation, and more.

But the truth is that the new PMTA guidelines will be too difficult for small vape juice and e-cigarette companies, even if the FDA is going to grant ten months more. And this will potentially wipe out most e-cigarette companies off the market, leaving consumers with only one alternative. To buy vaping products from companies that also sell cigarettes. 

Many have pointed out that the FDA rules could have been influenced by Big Tobacco as a way to wipe out the competition. So, in the end, the boutique e-liquid manufacturers and vape shops will be wiped out, and Big Tobacco would dominate the industry.

This tactic allows large businesses to send signals that they support government regulations when, in the real sense, what they are doing is using the government to prohibit smaller players from entering the market. This way, they earn a government-enforced monopoly.

More so, the regulation would leave gas stations and corner shops to sell only tobacco and menthol flavors, and there will be a strict ban on advertising or any form of marketing.

So, now is the best time to advocate for your access to flavors and alternative nicotine products. The end may genuinely be on the horizon, but with the right support against this FDA’s regulation, we can save our society and preserve our smoking-cessation tool (vaping products).

Remember, this is an election year, so make sure you raise your voice!

Support your favorite small vendor’ vape shops

You are probably asking how to support your favorite small vendor’s vape shops to continue to get your favorite brand and flavor of vaping products. Well, step one is to share this article far and wide and consider bulking up for your family and friends

Stand with harm reduction products and say NO to the monopoly of the Big Tobacco. Let your voice be heard today, so we can stop the injustice brought upon small e-liquid manufacturers and vape shops!

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Comments

Shirley Colwell - August 11, 2020

I support the vaping industry. If it wasn’t for them I’d still be smoking real cigarettes. Please don’t put them out of business. It will cause many of us to start smoking again. To me this is so counterproductive it makes the FDA & the circuit court judges seem stupid.

David Maresca - August 21, 2020

Is it true that products prior to2016 are exempt from the pmta? If so how many did you have?

Gary Patty - August 21, 2020

I have been able for 5 years to be free of nasty cigarettes, my health has improved substantially. If I have to go back to cigarettes, I may as well plan for my death.

Parbriz auto FORD ESCORT IV GAF AWF ABFT 1986 - October 16, 2020

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Marilyn Boyer - August 11, 2020

I used to smoke but I am severely handicapped and holding a cigaret and falling asleep or jerking caused e to drop lit ciggarets, plus the health hazzards of smoking are far greater than vaping and I am not holding something that could potentionally burn the house down with us in it. @ bottle of vape juice lasts me a month each, cigaretts are $50 a carton a month, 120 ml bottles I get from Freemans I buy on sale 3 for $33. free ship so big tabacco doesn’t want the vape industry,because they want to sell unhealthy hazzardess products to us and kids and it is dangerous and affecting the lives of millions of people and families who pay extraordinary prices for a carton that causes lung cancer and other health risks. We people have a right to protect our lives and buy from whomever we wish without huge expectations of The FDA estimated the cost of PMTA for manufacturers to be between $117,000 and $400,000 per product. This is rediculous and against our rights as Americans and small business’. Tabacco companies have no right to bring such action against vape co’s and risk American lives nation wide. Do not allow this to happen, unfair and big co easily afford fighting vape, vape co’s do not have that power, but power is not what is important but the health of people everywhere to stop smoking dangerous products, it is our right as much as stop smoking kits and gum and patches to stop smoking, I’ve used them too. Vape is satisfying without the risks posed buy tobacco industry. I implore you to reason the fault lies with tabacco co’s not vape co’s, and like most powerful cos they have made a huge fortune and caused millions of deaths, my own Father died a horrible death with huge cancer tumors on his chest and back, he was eaten alive, the cancer went into his mouth he could not drink orange juice he loved, it went into his brain and all major organs but he died an agonizing death from lung caner, the things they did to him were inhumane knowing he would die anyway, yet they cut his lung in half and filled it with mustard gas which nearly killed him then. Had vaping been available back then as it is today he would have lived to a happy old age, my Mother lived to age 87, she quit smoking when Dad got lung cancer. So you see what the tabacco industry fails to point out, yes they put risk factors on packaging but smokers are addicted and will smoke anyway. Carcinagens in their products cause lung cancer, smoking was advertized as chic and strong, the Marlboro man billboards, he also died of lung cancer, everyone smoked back then unfiltered camels, pallmalls and others, filters did not stop the problem, just another gimmick to peddle their killing products. You people need to look at healthy rather than money, it is unfair and un American to knowingly sell to people the very products that kill them. When I smoked my lungs hurt and, my nose burned and my throat, but I was addicted, vaping got me out of that madness and saved my life. Now you people need to save lives by allowing us to choose what we want rather than what is shoved down our throats, literally, smoke full of carcinegens. Stop the killing companies and help the ones helping us financially and health wise, the vaping industry.

david - August 11, 2020

Thank you for taking time to write this excellent article. I have expressed the same sentiment to my customers. I can’t bear to think what will actually take place on Sept 9th. My lease is not up until May 2021. Should I have to close up I will be out of a job and still responsible for the remainder of my lease.

My hope is Trump will use his executive powers to authorize another delay until after the election. By then, maybe, and that is a big maybe, the republican party will take over the house and create lasting change that will permanently protect small vape business for good.

Thank you for being a voice for the industry. I appreciate what you do.

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