With e-cigarette use among youth rising to epidemic levels, Juul and other e-cigarette companies are facing greater scrutiny, more attention from regulatory agencies, and private litigation. On December 20, 2019, President Trump signed into law an amendment to the Federal Food, Drug, and Cosmetic Act, raising the federal minimum age for the sale of tobacco products from 18 to 21 years, effective immediately.
The amendment follows a statement by the Trump Administration in September 2019, advancing the Administration’s plan to ban all non-tobacco e-cigarette flavors following the nationwide outbreak of severe lung illnesses linked to vaping. Congress, too, is concerned with the growing epidemic—congressional subcommittees have launched investigations into the marketing practices of leading e-cigarette companies. Amid the epidemic levels of youth usage combined with the popularity of certain products among minors, the U.S. Food and Drug Administration (“FDA”) has recently issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. Many products are flavored like fruit and mint flavors. According to an FDA news release, “under this policy, companies that do not cease manufacture, distribution, and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.“
Is Juul Labs Inc. the Culprit?
Much of the government’s ongoing scrutiny surrounding the underage vaping epidemic focuses on a single e-cigarette manufacturer—Juul Labs Inc. Juul commands approximately 75 percent of the e-cigarette market, making it the most commonly used brand of e-cigarettes, especially among young users. Juul manufactures a cartridge-based electronic nicotine delivery system (“ENDS”) that operates in conjunction with small enclosed cartridges or “pods” that contain nicotine e-liquids that are aerosolized through product use. Until recently, Juul Labs manufactured Juul-compatible e-liquid pods in a variety of flavors, including mango, fruit, mint, crème, and cucumber.
Not only has Juul Labs Inc. been a concern for the FDA, but democrats in Congress have also cautioned the company. Amidst a House panel’s investigation into whether or not Juul intentionally targeted minors with its marketing, Congress threatened to subpoena Juul if it does not produce documents revealing its advertising practices. In the summer of 2019, the House Subcommittee on Economic and Consumer Policy launched an investigation into the role Juul played in the spread of e-cigarette use among youths. Following this congressional hearing, the FDA issued warning letters to Juul for allegedly marketing its products as safer than regular cigarettes without the agency’s approval, as well as marketing the devices to underage students.
Of particular concern to the FDA are the design features that appear to make cartridge-based ENDS so popular among youth. Because cartridge-based ENDS are typically relatively small in size, these products allow for easy concealability and discrete use. To someone unfamiliar with ENDS devices, the device could easily go undetected, as many would find its design indistinguishable from a flash drive. Furthermore, cartridge-based ENDS typically include convenient features that facilitate ease of use, including prefilled pods and USB rechargeability. These ease-of-use attributes indicate that cartridge-based ENDS may have lower barriers to the initiation, the FDA suggests.
In 2016, all ENDS products became subject to the FDA’s tobacco regulatory authorities. This includes the pre-market review process in which the FDA evaluates products based on a public health standard, weighing the risks and benefits of the product to the population as a whole, including tobacco users and non-tobacco users. However, the FDA has the authority to exercise enforcement discretion for these policies. To date, the agency has deferred enforcement of the pre-market authorization requirements; thus, the FDA has not authorized any ENDS products. In effect, this means that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.
In deciding to defer the pre-market authorization for ENDS products, the FDA noted that the overall public health impact of ENDS products would depend crucially upon “who uses the products and how they are used. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net public health impact at the population level to be positive.” Unfortunately, data suggest that the net public health impact has not been positive.
FDA Enforcement Guidance
The FDA’s January 2020 enforcement guidance sets forth the agency’s intentions to prioritize enforcement resources concerning the marketing of certain ENDS products that do not have pre-market authorization, focusing on flavored, cartridge-based ENDS products. The agency will prioritize enforcement against:
- any flavored, cartridge-based ENDS product (other than tobacco- or menthol-flavored);
- all other ENDS products for which the manufacturer has failed to take adequate measures to prevent minors’ access; and
- any ENDS product that targets minors or whose marketing is likely to promote the use of ENDS by minors.
According to the FDA, this approach “strikes an appropriate balance between restricting youth access to such products while maintaining the availability of potentially less harmful options for current and former adult smokers who have transitioned away from combusted tobacco products.” E-cigarette manufacturers will have until May 12, 2020, to submit marketing applications showing that their products meet the public health and marketing standards set forth by Congress.
Youth Vaping Epidemic
The FDA’s Enforcement Priorities for ENDS products on the Market Without Premarket Authorization comes as the 2019 National Youth Tobacco Survey results on e-cigarette use show that more than 5 million U.S. middle and high school students are current e-cigarette users–with a majority reporting cartridge-based products as their usual brand. The FDA’s concerns lie primarily with the increased popularity of ENDS among the nation’s youth and the safety issues concerned with ENDS that are not fully understood. U.S. Department of Health and Human Services (HHS) secretary, Alex Azar, emphasized the severity of the problem, stating that “the United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes.”
Overall, data shows that ENDS product use has more than doubled among middle and high school students from 2017 to 2019, with an overwhelming preference for cartridge-based ENDS products. The New England Journal of Medicine suggests that this increase means “an increasing number of youth are at greater risk of nicotine addiction at a time when the developing brain is particularly susceptible to permanent changes from nicotine use and when almost all nicotine addiction is established.” Research has also shown that flavors increase the youth’s appeal to tobacco products. The FDA’s enforcement guidance seeks to address the popularity of flavored, cartridge-based ENDS among youth by banning all unauthorized flavored ENDS products, including mint. The inclusion of mint in the “flavored” category finds support in a National Survey study that characterized Juul flavors most often used by middle and high school students in 2019. Among the seven flavors of pods Juul offered, the use of mango and mint ranked highest, followed by fruit. Reported use of menthol and tobacco flavors was among the lowest-ranked options.
The FDA also remains concerned about the health and safety issues related to ENDS products, particularly cases of lung injuries associated with the use of vaping products. While the U.S. Centers for Disease Control and Prevention (“CDC”) has confirmed that most patients suffering from the injury used THC products, rather than nicotine products, the investigation is still ongoing. These current public health issues affirm the importance of the FDA’s pre-market review process, as companies marketed the majority of these injury-causing devices without pre-market evaluation. The FDA’s new guidance prioritizes enforcement against these types of products lacking the requisite authorization.
Implications of the FDA Guidance
The FDA’s enforcement priorities attempt to strike a balance between the public health concerns related to youth use of ENDS products and considerations regarding addicted adult cigarette smokers using ENDS as a transition away from combustible tobacco products. However, the FDA cannot be certain that banning flavored products will stop the youth vaping epidemic. FDA’s enforcement priorities fail to consider the possibility that menthol and tobacco products may ultimately become more popular for youth when other flavors become unavailable. While younger users may prefer the taste of mint to menthol, the FDA ignores the possibility that these individuals are not using ENDS products for the taste— they are hooked on nicotine, regardless of the flavor. The continuous efforts of the FDA and federal government are crucial to ensure that these products are not marketed, sold to, or used by children.