For The Protection Of Their Profits

Wednesday, October 20th, 2021

On October 12th, 2021, the U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. At first glance, many on the outside of the industry may see this as a victory for the vaping industry, but that is far from the truth. Sadly, this just further shows that those in charge could care less about public health, and more about the green in their pockets.

In the FDA’s announcement, they discuss why they approved three of the R.J. Reynolds (RJR) Vapor Company’s Vuse Solo ENDs products – the device itself and two of its Tobacco flavored replacement pods. They were approved because they ‘submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health.’ On September 9th, the FDA published an announcement saying that they made ‘significant progress in science-based public health application review, taking action on over 90% of more than 6.5 million ‘deemed’ new tobacco products submitted.’ They have been rather boastful of how much ‘positive’ work they have been completing, with their percent raising to 98% in just a month since their last announcement. The hard reality of this is that all they really did was just go through all the vapor companies (not including Big Tobacco) and sent out blanket statements to each of these companies; basically saying your products are not approved due to lack of scientific evidence showing that your flavors are beneficial to the overall public health. In an article on thefederalist.com, the writer says “Flavored vaping bans strip smokers of far less harmful tools of smoking cessation in the righteous name of combating teen vaping when adolescent use of e-cigarettes has nothing to do with the flavored cartridges.” There were several larger vapor companies that had paid thousands (potentially millions) of dollars to get the appropriate testing done and were still denied, yet this branch of a major tobacco company was approved? This just goes to show that there is something larger at play here than just showing that these products are ‘appropriate for the protection of public health’.

A video created by ‘The Truth About Vaping’ published in October 2019, starts out with a strong description of the Master Settlement Agreement between Big Tobacco companies and the 50 U.S. States. Since 1998, U.S. cigarette sales have declined by almost 50%. This has a lot of States in debt since they are not getting the MSA money they planned for and risk defaulting on their loans. ‘Since 2014, financial analysts have said that e-cigarettes pose a rising but under-appreciated risk to tobacco cigarette sales and the tobacco bonds tied to the MSA payments.’ This makes state and federal legislators easy targets to be convinced that vaping should be banned. Enter the public health advocacy or tobacco control groups that have been whispering in their ears’. To sum it up, ‘the government ends up endorsing and funding these tobacco control groups, and in turn, they work together to legally execute their shared political agendas’. The video then continues to show links between these tobacco control groups and government agencies. These non-profit groups (like the Campaign for Tobacco-Free Kids, The Truth Initiative, American Heart Association, American Lung Association, and American Cancer Society) team up to pressure and sue the FDA, to make regulations that favor their agendas and vilify the vaping industry publicly. Due to the amount of persuasion of these groups working together, the media outlets and legislators don’t bother questioning their reasons and just act. This results in unjust regulations put in place, and leaving the industry to be seen as just as bad or worse than Big Tobacco. When in reality, we are two completely separate entities that are constantly being confused. In a previous blog post, we discuss this confusion and describe why were are separate. The vaping industry has not only caused major profit loss to Big Tobacco, but to these tobacco control groups and government officials who are also profiting from them. Do you see the pattern yet?

With all of that in mind, let’s just take a brief look into the FDA’s Deeming Regulation to help flush out this whole story. ‘Probably no single event has rocked the vaping world like the announcement of the FDA Deeming Rule on May 5, 2016. The Deeming Rule is the regulation that gives the FDA authority over vapor products.’ (Vaping360). On June 22nd, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (usually referred to as the Tobacco Control Act or TCA). This bill was passed by Congress but was also created with the cooperation of tobacco company Philip Morris (now known as Altria) and Campaign for Tobacco-Free Kids president Matthew Myers. This bill ‘grandfathered’ cigarettes and other tobacco products already on the market, but made it incredibly difficult for any new products to enter the market – protecting Big Tobacco from competition essentially. One senator saw it for what it was and called them out on it – referring to the bill as the ‘Marlboro Protection Act‘. ‘The act gave the FDA the power to “deem” any new product containing “nicotine made or derived from tobacco” to be a tobacco product. That meant that the FDA could grant itself the power to regulate any product it decided met the standards laid out in the TCA without further oversight from Congress.’ (Vaping360). It wouldn’t be until 2013, that the FDA would start their vaping regulations – mainly because of the pressure from those Democratic members of Congress, tobacco control groups, and Philip Morris. The first target of their assault would be flavored eliquids. This is the start of the Deeming Regulations – basically laying out the template for the future Pre-Market Tobacco Application (PMTA) process. On April 24th, 2014 the FDA released its proposed regulations. Within this, the FDA allowed 75 days for public comments (which they later extend) before creating a final rule. This is usually only a formality, but one particular comment offered the FDA what could only now be considered the ‘blueprint for the elimination of the messy independent vaping industry.’ This comment is from none other than R.J. Reynolds (RJR), who also just happens to be the first of those approved in the PMTA process. ‘RJ Reynolds, whose cigarettes were grandfathered onto the market by the Tobacco Control Act, patiently instructed the regulatory agency how to get rid of its new competitor with burdensome and costly regulations.’ (Vaping360). Shortly after the FDA released their ‘Guidance for the Industry’ that was supposed to be a guide to prepare for the PMTA’s, but did not include any technical information or explain what would be an acceptable product. Many were left with more questions than answers after reading through the document. The new deeming regulations were set to take effect later on August 8th, 2016. This did not directly ban flavors just yet, but there was an ominous cloud that loomed over, many fearing that it may come. Then in November of 2016, Scott Gottlieb, M.D. was appointed the commissioner of the FDA. Many were torn, but at first, he did give the industry small glimmers of hope. He said the FDA would postpone the 2018 PMTA submission deadline 4 years to August 8th, 2022, so that the FDA could create viable and thoughtful pathways for small and large companies alike. Then JUUL happened. That sparked a change in how the industry was going to be treated. The tobacco control groups, FDA, CDC, and the media outlets all started taking their turns jabbing at the industry. With headlines ranging all over the place from various groups and organizations.

It was one shit show after another, and with each hit – we saw more and more vape shops closing as many couldn’t keep customers, profits, or their physical and mental energy up enough to keep their doors open. With each blow, each regulation, ridiculous headline, or news interview, they were wiping us out – painfully and slowly. With the closing of more and more shops, many vapers couldn’t get the products they needed and sadly ended up going back to smoking out of convenience or necessity. Think about it, it is way easier to just drive down to your local gas station to grab a pack of cigarettes than drive out of their way to the closest vape shop. Some Americans in certain states saw a complete ban and were basically forced back to smoking because online retailers are not legally able to ship to certain states. By creating such hurdles, many who found it more of an inconvenience decided it wasn’t worth the hassle. Compounded with the mass misinformation spread by the EVALI outbreak, many Americans who were vaping were scared back to smoking.

What Is EVALI?

EVALI stands for e-cigarette or vaping use-associated lung injury. It was originally known as VAPI (vaping-associated pulmonary illness). The new name is in response to a growing number of severe lung illness cases related to using an e-cigarette and vaping products, the first being identified during 2019. We are still learning about this disease, so changes may continue to be made to the terminology.

What Causes EVALI?

Health officials point to vitamin E acetate (an additive in some THC-containing e-cigarettes) as the primary, but not the only, cause of EVALI.

The EVALI media coverage changed the public perception of vaping, with a resounding 75% of Americans believing that vaping was more harmful than smoking. Then September 9th, 2020 PMTA deadline came around and those in the industry still left submitted thousands upon thousands of documents to the FDA. By submitting their PMTA’s, vape manufacturers were able to keep their products on the market legally for up to a year while their submissions were under review. Many in the industry were trying their best to stay hopeful as the deadline for the FDA’s decision on the PMTA’s was approaching fast. Slowly the MDO’s started being distributed to thousands of shops across the country. Leaving many owners questioning what their next steps were. Then about a month after many were denied, the FDA announces their first approved PMTA products – from a Big Tobacco company.

The industry started strong and was making such a positive impact for the first time in decades on the smoking rates in America. It was amazing! But it also made a big impact on Big Tobacco (and all those working with them) that they saw a drastic dip in their profits. They got to work and patiently but effectively managed to manipulate the system in their favor. When you break it all down, our leaders, correction…the corporations that are funding our leaders, have one goal in mind, which is taking any actions that are appropriate for the protection of their profits. That is just a sad truth we all must face, but it doesn’t mean we should stop fighting by any means. We must work harder to expose this hypocrisy and manipulation of those utilizing their position of power to profit. It’s time that our government starts working for us again, and not their own personal greed!