On September 12, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a press release declaring a 60-day ultimatum on all e-cigarette companies, including the ever-popular JUUL Labs, a Bay Area manufacturer controlling 73 percent of the e-cigarette market.
Gottlieb warned that the FDA will now require “robust plans on how [JUUL will] convincingly address the widespread use of their products by minors,” an area of concern since the devices became popular culture mainstays after their release in June 2015. Failure to meet standards could result in a market ban.
The FDA has released statements widely airing disapproval for the ad campaigns of JUUL and its competitors, companies who have frequently employed young people in their endorsements in an effort to play up the “novel” and “hip” aspect of the e-cigarette phenomenon. The allure of flavored nicotine delivery has put e-cigarette companies under fire, most recently prompting an FDA-issued ANPRM (advanced notice of proposed rule-making) requesting public data on underage tobacco use.
The FDA has also developed its 2014 anti-tobacco campaign, “The Real Cost,” to include e-cigarettes. The multimillion-dollar effort uses social media, online video advertisements, and posters to inform teens of the health consequences of vaping.
In response to public grievances, JUUL stopped selling its most obviously youth-aimed flavors (i.e. bubblegum), in addition to nixing enticing adjectives in names like “Cool Cucumber” from product descriptions. San Francisco has taken the more dramatic measure of banning the sale of flavored tobacco altogether, passing ‘Prop E’ with 68 percent voter support in early June 2018.
JUUL Labs was a prototypical Silicon Valley startup, bred out of the back of a Stanford classroom by James Monsees and Adam Bowen, a pair of former smokers. They created “Juul Salts,” an alternative delivery system to freebase nicotine in cigarettes. The JUUL device vaporizes an “e-liquid” comprised of a proprietary blend of nicotine salts, which quickly transfer nicotine into the bloodstream when inhaled.
However, JUUL’s upbeat designation as a healthy stepping stone away from cigarette addiction quickly went awry when hordes of non-smoking teens began to pick up the product. 2018 has effectively been the “year of the vape,” with a 75 percent increase in teen usage from 2017, according to an FDA survey. And the majority of these teens vape for “reasons other than to quit smoking,” citing the taste of flavored vapor and the fun, social appeal of the device. Recent studies also show e-cigarettes to be a gateway to marijuana use, as the devices can be easily modified to deliver THC, the active chemical in marijuana.
The number of nicotine-addicted teens is relatively unsurprising considering the combination of targeted advertising and a developing brain’s susceptibility to substance dependence. More concerning than the raw data, however, are its implications; the chemicals used in JUUL and similar products can cause arterial stiffening and other long-term cardiovascular damage. The toxicity of tobacco inhibit the body’s production of nitric oxide, a compound that represses clotting and inflammation. In addition to an elevated stroke risk, a recent UCSF study found a nearly doubled risk of heart attacks in e-cigarette users.
Although e-cigarettes are still technically healthier, having eliminated the highly toxic carcinogens, heavy metals, and carbon monoxide released into the body when smoking a traditional cigarette, they are by no means as innocent as many of their users have come to believe. E-cigarettes ditch the smoke by rapidly heating nicotine salts to form an aerosol, fast enough to bypass the combustion reaction that is so damaging to the lungs. But, contrary to popular belief, the user doesn’t emerge unscathed. Chemicals contained in the vapor release tiny particles into the bloodstream, known to damage tissue and DNA. Although these harmful chemical fragments flew under the health radar due to their size, the newly published cardiovascular health consequences are undeniable.
Also cause for concern are the elevated nicotine levels in JUUL’s disposable cartridges containing the e-liquid (“JUUL Pods”), the firm’s solution to the body’s limited absorption of vaporized nicotine. Research published in Tobacco Control, a peer-reviewed journal covering worldwide tobacco use, found urinary Nicotine levels in young JUUL users to be higher than those of combustible cigarettes. Dr. Tomas Aragon, director of the San Francisco Population Health Division, is adamant about JUUL’s malintent, saying that, “This is an example of the tobacco industry doing everything it can, anything it can get away with, to get people to be addicted to their product and create lifelong customers.” To their credit, JUUL released a lower-nicotine option in late August 2018 to promote gradual weaning off the psychoactive chemical. There is not yet data available about whether teens are actually buying this alternative product.
JUUL is, however, in the early-stages of prototyping a solution for the teen usage epidemic. In response to the FDA-mandated plan of action, JUUL and similar companies have looked at the possibility of synching e-cigarettes to a phone via serial number, so the device could only be used by its owner. “So if some 21-year-old college kid goes to a convenience store and buys 100 JUULs, ” says Ben Bologna, managing Director at Maverick Capital, an investment firm specializing in healthcare, “they won’t be sable to resell them to kids because all those JUULs will be linked to his/her phone and the devices won’t work unless the phone is in the vicinity.” Although certainly not the complete solution to the teenage epidemic, it could be a step to control the proliferation of e-cigarettes.
On October 2, 2018, the FDA conducted a surprise investigation of JUUL’s San Francisco headquarters. The inspection was motivated by the alarming results of a recent study concerning teen e-cigarette use, although the actual data has not yet been released to the public. Thousands of documents containing the company’s retail blueprints were taken during the search. According to the the FDA statement released shortly thereafter, they uncovered “further documentation related to Juul’s sales and marketing practices.” The tension between JUUL and law enforcement continues to escalate, and the FDA has heightened its multimillion dollar advertising campaign opposing teenage e-cigarette use. The era of freely marketed e-cigarettes seems to be drawing to a close.
There is no precedent for a full market ban of e-cigarettes. However, if JUUL (or any of its competitors) fail to provide sufficient strategies to minimize underage usage to the FDA in the allotted 60 days, individual products could be banned. Currently, all companies with e-cigarette products that appeared on the market after February 2009 must submit an application to the FDA by 2021 to prove the products don’t pose a serious threat to public health. If the 60-day ultimatum isn’t satisfied, the FDA may pull forward the application due date from 2021 to sometime in the near future. After failing to produce action-steps in time for the 60 day cut off, a company likely wouldn’t be able to prove a reduction in teen-usage in the expedited application, giving the FDA grounds to ban the product as a threat to public health.
While the fate of JUUL is still uncertain, one thing is clear: the FDA is now taking a far stricter stance on e-cigarettes, and JUUL is going to have to adjust if they want to stay afloat.
