Vape and the FDA: Look Upon My Works and Despair

Vape and the FDA: Look Upon My Works and Despair

A certain hysteria has broken out over recent years. Dubbed the “teen vaping epidemic”, countless articles, reports and videos have been drafted on the subject. Contrary to how some might view the title of this article, this isn’t meant to disparage these people. There is a teen vaping epidemic. Studies from the Federal Drug Administration (FDA), the National Institute on Drug Abuse (NIDA) and every teacher in America can confirm that this a real problem facing the modern world. The hysteria isn’t in the proclamation that there is an epidemic, but rather in our response to this epidemic. The reaction of the FDA’s overzealous regulation and the response of local and state government to this issue has been nothing short of hysterical.

From Here to There

Vaping’s rise to prominence in Aughts andearly 2010s has seen it go from obscure hobby, to a legitimate force of changein the tobacco industry. Where once combustible tobacco was the only option forpeople addicted to nicotine, a challenger arose that threatened the dominanceof global juggernauts. The vape industry became a space for intense and rapidinnovation. With simple mechanical devices from the Aughts becoming compact,powerful devices that could fit in your pocket by the mid 2010s. With thatinnovation came the advent of the pod system device. These devices allowed aperson to ditch their bulkier vape devices for a convenient USB-sized batterysystem that accepted disposable pods. Easy to carry, quick to charge, thesedevices would go on to quickly become a domineering force in the robust vapormarket. This was not always the case. Initially, pod devices in the vaporindustry were considered an inferior product. To some, they were regarded aslittle more than a novelty, a passing fad that would fade into obscurity. Toothers, they were considered a cheap cash grab by Chinese manufacturers,desperate to gain a leg up on more successful vape device manufacturers whilethe market was hot. Fewer saw the reality as how it would unfold.

When JUUL launched in 2015, vape devices were starting to be taken more seriously by Chinese manufacturers. They were starting to see a trend both domestically and abroad for consumers intimidated by more complex vape devices looking for a simple solution to switch away from tobacco. They wanted a device even more simple than cartomizers and cig-a-likes, something more reliable. JUUL’s launch came at the precise right time in the market. Their expansion was rapid and domineering. While most of the vape industry was preoccupied with looming vape regulations coming down through the FDA, JUUL was fast at work, developing sleek branding and engaging their products with markets vape had traditionally failed to penetrate in any meaningful way: the convenience store. This dominance allowed JUUL to grow. With a business model more Silicon Valley start-up than vape company, they secured funding and grew astronomically, attracting a majority investment from Tobacco giant Altria in late 2018. It was during this time that a critical problem was unfolding: the teen vaping epidemic.

While teens vaping was a always a concern in the vaping industry, it was never regarded as a serious emerging problem. Most vape shop and vape juice brand owners eagerly established best practices for selling vape early, banning sales under 18 years before the FDA issued guidance requiring such a ban. The vast majority of vape companies made this the modus operandi for their businesses the day they opened. With most fielding brick-and-mortar stores from which they launched their brands, they were able to efficiently prevent underage buyers from obtaining their vape juices and the more complicated and bulky nature of vaping using Sub-ohm tanks, vape mods and 18650 batteries made hiding the hobby from parents and teachers virtually impossible. The introduction of vape pod systems completely shattered this previous model. As traditional vape juice companies saw profits stagnate, JUUL and other pod system manufacturers saw explosive growth. Indeed this growth in the pod system market was fueled, in part, by underage vapers obtaining the devices from the more lax environment of the convenience store (referred to as C-Stores, by vendors.)

An Inconvenient Truth

Since their inception, the penny-pinching and margin obsessed convenience store has been a reliable way for underage Americans to get access to substances they aren’t supposed have access to. Cigarettes and beer have long proved relatively low barriers of access for the enterprising teenager looking to acquire both at their local convenience store. Whether it was apathetic employees, desperate independent operators or third-party acquisition, teens have managed to acquire beer and cigarettes for decades. Large customer bases, quick interactions and new technology have proven to be a perfect storm for delivering an easily concealed vaping device into the hands of teenagers.

Compounding this problem is the type ofnicotine used in a plurality of pod systems. While most vape juices usefreebase nicotine in their products, vape pod systems use nic salts – a type ofnicotine that occurs naturally in tobacco leaves that is treated with benzoicacid to lower its pH level and make it convert to vapor at much lowertemperatures than would be needed in its virgin state. This process produces atype of nicotine that is much more concentrated into a form that is much moresimilar to traditional tobacco nicotine than freebase nicotine. This is aproduct designed primarily to appeal to smokers searching for something thatcan approach parity with the experience they are used to. However, aninconvenient truth emerges at the juxtaposition between the rise of teen vapingand the use of nic salts. That truth being that a device that has much higherlevels of nicotine is going to – barring genetics of the user – foster adependency on nicotine in a way that much more closely resembles cigarette use.As the country learned of the emergence of the so-called “teenage vapeepidemic” and “Juuling”, it has fueled a panic based on an inconvenient truth.

Coming to grips with this reality has never been a problem with the rest of the vape market. The vast majority of vape companies have moved to double-down on protection of America’s youth by implementing more robust barriers to youth sales months and even years before FDA regulation and guidance. But no amount of compliance and preparation was enough to stop a market upon which they had no control. The rest of the vape industry faced an inconvenient truth of their own: vape companies were going to be labeled as part of the problem, whether or not they were JUUL. This isn’t to say the entire vape industry is blameless. Bad actors in the industry flaunted FDA regulations and guidance by creating labeling and packaging that was deemed to appeal to kids. It is nearly impossible to perceive the impact these companies had on teen vaping. However, stagnating vape sales and the explosive growth of pod systems coinciding with the rise of the team vaping epidemic (along with the verb “juuling” becoming the go-to moniker for vaping among teens) points to a – to put it mildly – disproportionate responsibility for the cause of the problem.

Hammers and Flies

The response to the teenage vaping epidemic has been one that constantly threatens tens of thousands of small businesses across America. In the crusade to put an end to “juuling”, the FDA has had enormous pressure thrust upon it to address the epidemic. This has prompted rash action by the FDA, threatening to move up registration deadlines that would result in what would amount to a virtual overnight closure of the vape industry for businesses that can’t afford the enormously costly regulatory process the FDA requires for approval that can reach into the millions of dollars for a single product or product line. While this impetus for rushing to swat the fly of teen vaping is understandable, it comes at the cost of using a hammer to swat flies. While the hammer punches massive holes and damages the integrity of the traditional vape industry, the fly continues buzzing around as the actual problem is failed to be addressed.

A company worth billions like JUUL, withthe backing of investment from the traditional Tobacco Industry is naturallygoing to be able to weather whatever regulatory storm befalls the vaporindustry. In the quest to regulate the problem away, the FDA may very welleliminate all competition that stood in JUUL’s way outside of other pod devicesmade by Big Tobacco. The grand irony is that this process may very well end upreturning the entire vaping industry back into the hands of Big Tobacco andaway from independent business owners that have spent years trying to conductbusiness in an ethical manner. If such a future comes to pass, it won’t be longbefore millions are left with left competition, steeper prices and we’ll watchas countless adults switch back to combustible cigarettes, while teens continuevaping their JUULs.

The Future of Vaping

It is hard to truly forecast where vaping will go from here. Legal challenges from bigger players in the vape industry could keep FDA regulations from completely crippling the industry for years to come. Big Tobacco’s foray into vaping could end up crushing all the innovation years earlier than it should have. But in the meantime, the future is unclear and unnerving for countless vapers that have found the value of a radical new technology, now on the precipice of total destruction.