Hey guys, Dawn again, your ever-ready blogger. You may have noticed the letters PMTA being thrown around a lot in regards to e-cigarettes, vapes and FDA regulation. You may even have seen it mentioned in some headlines claiming that all vape and e-cig shops will be shutting down in the next 10 months. Regardless of where you have heard it mentioned the big questions are the same. What is it? and What does it mean for your e-cigarette brand?
****Small disclaimer *****
This is NOT intended to be legal advice or to cover all of the aspects of the PMTA. This is a VERY brief overview of the process. It is intended for informational uses only. If you have legal questions regarding any aspect of the PMTA, please talk to a licensed lawyer or an appropriate law professional.
PMTA = Premarket Tobacco Application
Okay, first things first we need to look at what the PMTA is and how it came about.
The year is 1997.
President Bill Clinton and the United States Congress have committed to stepping up the fight against deadly burning tobacco. Multiple anti-smoking educational campaigns are in full swing. Under the Clinton administration, the FDA enforces a number of new and existing regulations brought on by the Federal Food, Drug, and Cosmetic Act in an attempt to get the sheer number of tobacco-related deaths under control.
Fast forward to March 2000
“The Supreme Court in FDA v. Brown & Williamson Tobacco Corp., in a 5-4 decision, held that the Federal Food, Drug, and Cosmetic Act, particularly when considering “Congress’ subsequent tobacco-specific legislation,” that Congress had not given the FDA the authority to regulate tobacco products as customarily marketed” (1)
The ruling basically stripped the FDA of its ability to regulate tobacco products on the interstate market.
Then 2009 happens. (We can’t help that the government is slow and it took 9 years for things to happen.)
Enter the Family Smoking Prevention and Tobacco Control Act. Which is signed in by the Obama administration and created with the help and support of many of the biggest tobacco companies. While the act is marketed as legitimately created as a means to prevent the use and abuse of deadly burning tobacco, it also helped keep new competition off of the market. Win-win? (Maybe for big tobacco.)
This document placed a February 2007 deadline on all tobacco products. If a product was not on the open market here in the US before that date it would need to immediately go through a long and expensive process known as the PMTA.
2008/2009 ENDS (Electronic Nicotine Delivery Systems) units blast on to the open market.
A bright new option for long term addicted smokers breaks on to the market. Reports of smokers switching away and in some cases quitting smoking become a public norm. Flavors start popping up everywhere and there is a new player in the market daily.
Unfortunately, due to the unknowns with these new devices misinformation and propaganda run rampant. This leaves some folks thinking e-cigarettes are completely without any harm risk and others believing they are deadlier than burning tobacco. The truth, however, is somewhere in between.
Nothing you inhale into your lungs is good for you. Period. Add to that fact that e-cigarettes and vapors containing the highly addictive chemical nicotine and you have a product that is definitely NOT harmless and risk-free. On the other hand, there are 600 more ingredients in the average cigarette. Plus since ENDS are not lit on fire. There is no tar going into your lungs.
The next few years are considered the E-Cigarette and Vapor BOOM. Business was good.
Enter 2016 and the FDA’s “Deeming” Rule.
The lack of regulation on this new industry has some people worried. So, in May of 2016, the FDA issued a guidance document that effectively “deemed” electronic cigarettes and vapor products as “other” tobacco products. This deeming immediately placed all vapes or e-cigs that contained or could ever contain a tobacco product. As such these products now had to abide by tobacco industry rules and regulations.
Some of the regulations were welcomed by the industry. Things like label warnings, age restriction, and basic advertising restrictions were not met with much if any, resistance. With those common-sense regulations, however, came the PMTA requirement. Since no e-cigarettes were on the market by February 2007, all ENDS products would need to complete the process.
The PMTA in a nutshell.
The problem with the original PMTA draft and it’s regulations is that they were made with traditional burning tobacco in mind. As you can imagine the types of testing and standards that are needed for tobacco products made from the plant won’t work for an electronic product made of metal. That issue had people in the industry asking how they could adhere to standards that had no bearing on their products? The FDA responded with a series of updated drafts.
The Cost and Time
As the dust started to settle and things became more clear the picture for the ENDS industry was grim. Estimates on the cost alone for the PMTA started to come in at over a million dollars per flavor and nicotine level. Small companies found themselves looking at cost upwards of 30 million dollars to stay open. To make matters worse, on top of the nearly impossible cost, the time table made the process impossible for any vape or e-cigarette company not backed by big tobacco’s deep pockets.
Even the FDA could see that the path forward for the ENDS market was all but closed. For their part, they responded by offering alternative ideas to long and costly clinical trials. They also issued a couple of industry-wide extensions. These extensions pushed the PMTA process out to 2024. That was long enough to offer hope to some of us in the industry.
The reasons that the FDA kept giving for the extensions and leniency is that so many smokers were using the products to get away from the deadly burning tobacco that the public health benefit of ENDS warranted the effort. Tens of thousands of past smokers reached out with their stories. Add that to the overwhelming amount of research data that was coming in daily. Most of which called e-cigarettes “magnitudes” less harmful than burning tobacco and even the FDA could see their possible public health benefits.
Enter The American Cancer Society, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five pediatricians.
Even though most research on e-cigarettes point to a possible reduction in smoking-related cancers if everyone switched on to them, cancer groups don’t see the value. In fact, in 2018 all of the Cancer/Health groups listed above and 5 pediatricians filed a lawsuit against the FDA. They claimed that the FDA had overstepped their authority by extending the PMTA deadline.
The court agreed.
The industry shuddered.
Worse off than before
The fall out of the court case is that now the extensions we were counting on and the timeline we were working with, is completely different. Where we thought we had until Aug of 2024 for the PMTA regulation. We now only have until May 2020. Unfortunately, we are actually a bit worse off than before the FDA tried to help. Since everything we have been doing to prepare was with the 2024 deadline in mind.
Don’t get me wrong, we are in for the fight and not even close to tapping out. At least now we know who our real enemies are. It’s not just big tobacco like we thought (although they are not our friend either) it’s big cancer. (At least in my opinion.)
What needs to be done?
Here is a VERY short list of the things each company must do for each flavor and each nicotine level they sell to comply with the PMTA. Some of these things A Clean Cigarette already has complete. Some of them like the GMP certificate we have had since BEFORE the deeming ever took place. Unfortunately, there are some things that just need time. They are in the works but getting them done by will be a stretch, to say the least.
- All research that’s ever been done on any product at all like ours.
- Bridging to any research that has ever been done regarding products like ours or components of those products
- Clinical and non-clinical short and long term studies regarding the APPH (Appropriate for the Protection of Public Health)
- Market studies and research as well as copies of all advertising ever used.
- Public impact studies/assessments.
- Public perception testing and observations.
- Environmental assessments.
- Stability and quality testing.
- GMP standards certification.
- Particulate testing.
- CAD designs all products and components.
- Toxicology and constituents HPHC testing.
- Leachable testing.
- And so much more.
As someone who has read the entire 400+ page first deeming regulation and every 50-75 page draft guidance after that, I can tell you that list is not even close to a full list. But it gives an idea as to what types of things are in there.
The PMTA is a huge burden and now that burden has a nearly impossible timeline. Only large big tobacco backed players are expected to find their way through the mess and come out with a business in 2020. The rest of the industry may well be out on their ear. Which is really unfortunate because we are talking about an industry that employs hundreds of thousands of people. Not to mention an industry that is offering the first glimmer of hope to millions of smokers who are dying to get their nicotine.
Thanks for stopping in and I hope this brief overview of the PMTA helps you understand what all the talk is about. If you have more questions or you would like to share a thought please reach out. You can do so in the comments below or by email at Dawn@acleancigaretteblog.com.
Our Customers: Do NOT worry we are going to be fine. We will need volunteers for a few market studies though so if you are interested in a way to help us out CLICK HERE.
If you are a current smoker looking to switch away from burning tobacco please visit www.ACleanCigarette.com for more information.
Thank you for stopping in!