Loyola University Chicago School of Law, JD 2020
The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.
A brief history of FDA e-cigarette regulation
In 2016, the FDA finalized a rule extending its regulatory authority to include e-cigarettes. The announcement acknowledged the potential benefit of e-cigarettes’ reduced toxicity compared to traditional cigarettes, but also mentioned the risk of increasing e-cigarette use among youths. While the rule’s initial timeline allowed e-cigarette manufacturers to continue selling their products without FDA review and approval through late 2018, just one year later in 2017 the FDA pushed back this premarket review compliance deadline to 2022. All noncombustible tobacco products already on the market on August 8, 2016 that came under FDA purview following the 2016 rule could continue to be manufactured and sold without FDA premarket review until 2022.
Juul: a victim of its own success?
Juul, an e-cigarette produced by Juul Labs, epitomizes the “epidemic” of underage use. Sales of this small, flash drive-shaped device that heats flavored nicotine liquids increased nearly 800% over the past year. Juul has rapidly established itself as the dominant player in this space, with 71% market share and a $15 billion valuation from venture capital funds. Its popularity among high school and junior high school students is alarming, as anti-smoking campaigns had succeeded in drastically reducing teen cigarette use over the past two decades. Parents, school administrators, and now regulators see Juul and other e-cigarettes as the major threat to keeping teen nicotine dependency on the decline. Retailers selling to underage customers, social media popularity of “Juuling”, and a failure to properly educate young people on the risks associated with e-cigarettes are among the most prominent issues.
While Juul believes it offers a safer alternative to combustible cigarettes for adults, its detractors say its e-cigarette product is a dangerous and addictive new product that is far too appealing to young people. Juul’s flavored pods contain 5% nicotine, as much as a pack of cigarettes. Prior to the most recent FDA announcement, Juul had already pledged $30 million over the next three years on education, research, and community engagement. It is also working with Iowa Attorney General Tom Miller to develop a more effective teen anti-smoking approach after earlier educational efforts from the company were widely criticized. Even as the company was making these efforts, at the end of September the FDA seized documents relating to Juul’s sales and marketing practices during a surprise inspection of the company’s San Francisco office. Juul CEO Kevin Burns called dialogue with the FDA “constructive,” but the FDA’s recent actions against e-cigarette manufacturers signal that manufacturers have to step up initiatives to rein in teen and underage use of e-cigarettes.
FDA to revisit regulation of e-cigarettes
While anti-smoking efforts have succeeded in bringing the rate of high school smokers down from 36.4% in 1997 to 8.8% last year, e-cigarette use rose from 1.5% to 16% between 2011 and 2015. This tenfold increase over a five year period and perceptions about the relative harmlessness of e-cigarettes are also concerning to the FDA. Only 22% of 18-29 year-olds consider vaping to be harmful to health, versus 83% saying smoking is very harmful to health.
The FDA recently expanded its “The Real Cost” education campaign to focus more on e-cigarettes, and in March of 2018 it issued an advance notice of proposed rulemaking (ANPRM) soliciting public comment on the role flavored tobacco products play in appealing to youth. According to the ANPRM, adolescents and young adults are particularly vulnerable to nicotine dependence, and flavors in tobacco products enhance and promote youth use. Use of flavored products also coincides with higher likelihood of continued use. The perception that e-cigarettes are not harmful to health, particularly among younger age groups, is another powerful factor that spurs young people to experiment. Information received through the ANPRM will help the FDA with future regulatory actions including possible restrictions on sales and distribution of tobacco products with flavors. If e-cigarette manufacturers wish to continue to operate under relaxed FDA regulation, they must find a way to educate youth on the health risks of e-cigarette use. They will also need to demonstrate that flavored products are not being marketed to a youth audience and that they are taking steps to keep kids from experimenting with flavored e-cigarettes.
Next steps in the fight against the e-cigarette “epidemic”
In its hope to help adult smokers shift away from combustible cigarettes toward less toxic e-cigarettes, the FDA’s decision to ease into regulating e-cigarette manufacturers has had significant ripple effects. The FDA’s success in keeping youth away from traditional cigarettes is commendable, but this progress is at least partially in jeopardy from the rise of popular e-cigarette products like Juul. While the FDA believes e-cigarettes offer a healthier future for adults who either cannot or do not want to quit smoking, it must be vigilant and not foster a new generation of nicotine dependency.