The Vapor Technology Association (VTA) and Vapor Stockroom have filed a lawsuit in federal court against the FDA for their unreasonable and arbitrary Pre-Market Tobacco Application (PMTA) process. The full text of their press release is available here.
The plaintiffs in this case are represented by Thompson Hine LLP, and the case has been filed under the name Vapor Technology Association, et al. vs. Food & Drug Administration, et al., in the US District Court for Eastern District of Kentucky. The filing can be found here.
Unreasonable, Unfair, Unlawful
To summarize their complaint, the FDA has repeatedly altered the PMTA timeline, while failing to provide basic guidelines that would allow a vape companies to navigate the process and obtain approval for their products. Moreover, the timeline has been moved up to May 2020. A deadline which is nearly impossible to meet, no matter how much money a vape company is willing to dump into the PMTA process.
“It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses. (The) FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette. Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits.”
Tony Abboud, Executive Director of the Vapor Technology Association
Abboud also argues the “FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that 'could adversely affect the public health."
Tony Florence, president of Vapor Stockroom, also blasted the capricious nature of the ever moving PMTA goal posts.
“Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards. We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business. It’s a devastating one-two punch to small businesses all over the country.”Tony Florence, Vapor Stockroom President
What is a PMTA?
The FDA only finalized the pre-market tobacco authorization process in June. As outlined in their press release, vape manufacturers and importers must demonstrate that their products are appropriate for the protection of public health. The FDA will consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
The elephant in the room is the uptick in underage vaping, which is commonly referred to as the teen vaping epidemic.
“The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products. This is especially important for youth.”FDA Press Release, 6/19/2019
The FDA’s evaluation includes reviewing a vape products ingredients, additives, health risks, manufacturing, packaging and labeling. The vaping industry already meets the first wave of requirements with nicotine warnings, child proof bottles, battery information, and electronic functionality being visible on every product.
Where is gets tricky is the vague “risks benefits” analysis and the fact that constituent and chemical testing will be required for every flavor and nic strength from vape juice company.
A fairly tall order for any company, and a set of requirements likely to drive much of the vaping industry out of business. It is also unclear if the FDA is even capable of handling this flood of applications.
For a full overview, check out the FDA PMTA portal.
Defending the Vaping Industry
This is first real effort to defend the embattled vaping industry from a seemingly endless string of regulatory and legislative assaults. Just this summer, a San Francisco e-cig ban punished marginalized residents by enacting a total vape ban that left cigarettes untouched. Any vaper lacking the mobility, time or financial wherewithal to shop outside of city limits has been funneled back onto combustible cigarettes.
This law is a complete betrayal of the city’s tradition for harm reduction, and the most heavily impacted group will be the city’s thriving LGBTQ+ community, which vapes and smokes at a higher rate than any other demographic group.
Flavor bans, which completely ignore the fact that the vilified sweet and fruit flavors are preferred by adult vapers while the most popular flavor with minors is mentholated mint flavor by Juul, are also in the works across the country.
Vaping Under Siege
The teen vaping epidemic continues to pose an existential threat to the vaping industry. Unfortunately, flavor bans and other proposals are unlikely to have any impact because they completely ignore what minors are actually vaping.
Tilting with Skittles and Cinnamon Toast Crunch High-VG boogiemen has no impact on menthol vape pod sales. Retro ejuice flavors target adults. Or put another way, teens are not the target market of flavor profiles meant to elicit nostalgia by mimicking Reagan-era breakfast cereals and Clinton-era candies.
Millennial does not equal minor. The major gains made in reducing the smoking rate does not include millenials (aged 24-39). The failure to understand this basic math and marketing are two reasons why the much ballyhooed Stanford University hit piece on vaping and Juul is nothing but a curated slideshow and shining example of motivated reasoning.
Reducing Teen Vaping Rate
Education and strict age verification are the only proven methods of reducing teen use. At Vapor4Life, we have no interest in selling to either minors or non-smokers. We now offer nicotine free Juul compatible pods, so pod users have the same flexibility and option to reduce nicotine levels.
Our goal has always been to switch smokers to vaping, and to help e-cig users eventually cease vaping by offering multiple nicotine options. The road to zero nicotine is well-traveled by mod, ecig and refillable vape pod users. We have decided to offer the same option to nic salt vapers. For the science behind nic salts, check out our deep dive "What is Salt Nic?"
The Rational Approach to Vaping in UK and New Zealand
Unlike the US, where what has been framed as a teen vaping epidemic is being used to deny e-cig access to adults, the UK’s National Health Service is famous for actively promotes vaping as an alternative to cigarettes.
Vaping remains in the good graces of UK bean counters, and they attribute their superior rates of smoking cessation to this policy. It is also worth noting that despite promoting vaping, the UK has lower rates of teen vaping than the US.
New Zealand is another country that promotes vaping and has decided not to punish marginalized groups with strict e-cig laws. Vaping “could disrupt the significant inequities that are present” in the demographic makeup of the smoking population, according to the New Zealand Ministry of Health mission statement on vaping.
They are referring to the elephant in the room, poor and marginalized groups are much more likely to vape and smoke. As the wealthy have largely abandoned smoking, they are much more willing to suppress any use of nicotine and view vaping as an alien and disreputable activity.
Compare how vaping is treated to the way alcohol is portrayed in the media and by politicians. Wealthy and educated Americans drink more than any other group, and this explains why there is no massive outcry about the scourge of alcohol. A total of 88,000 US adults die prematurely due to alcohol annually.
The CDC reports that each year 4,300 US teens are killed and 100,000 plus are sent to the ER due to the scourge of underage drinking. I am not advocating prohibition. My question is this: If teen vaping is considered an epidemic, then what should alcohol be classified as?