The legal challenges facing the vaping industry in the EU/UK and the US: An overview and a look ahead
To date, the vaping industry in the EU and the UK has largely avoided government investigations and enforcement actions, as well as personal injury litigation. This is in contrast to the US vaping industry, which has faced increasing regulatory scrutiny, enforcement actions and a growing number of private and public lawsuits over the last few years.
There are several factors that might account for this difference, including:
Youth use: One reason for the divergent treatment of the industry is likely the differences in youth use of vape products. In the UK, the rate of minors using vape products has consistently been below 2 percent. A 2019 study found that 4.2 percent of German adolescents (approximate ages 14-19) reported using a vape product in the last 30 days. By comparison, one 2019 study found that 10.5 percent of US middle-school-aged students (approximate ages 11-14) and 27.5 percent of high-school-aged students (approximate ages 15-18) reported vape product use. The US Surgeon General, the chief public health official in the US, has declared that this level of e-cigarette use “has become an epidemic among our nation’s young people.” Surgeon General’s Advisory on E-Cigarette Use Among Youth, at p. 2 (Dec. 18, 2018).
A different attitude towards vaping: The regulatory and enforcement approaches to the vaping industry adopted thus far by UK and EU officials reflect a different attitude concerning vape products than that held by US officials. In the UK, vape products are viewed as a useful tool for harm reduction because users of traditional combustible cigarettes could switch to vaping. This harm reduction view is exemplified in a statement made by Martin Dockrell, Head of Tobacco issues at Public Health England, an agency of the UK Department of Health, in September 2019: “If you’re a smoker and you have not stopped smoking, try vaping.” Public Health England has also repeatedly stated that vaping is 95 percent less harmful than cigarettes. French officials have also stated that vape products were a “complementary tool for risk reduction” that “allows a significant proportion of users [to] significantly reduce the deleterious effects of combusted tobacco.” Vape shops in Italy were also exempt from the closing of commercial businesses during the coronavirus disease (COVID-19) outbreak after a prominent scientist petitioned the government to keep the shops open because of the public health risk of vapers returning to smoking.
By contrast, US regulators have primarily focused on the potential harm caused by the use of vape products without regard to the possible health benefits users of combustible products might experience by switching to vaping. As part of the US government’s scrutiny of the industry, vape industry executives have been called to testify in front of Congress and have been pressured by Congressional Representatives to cease advertising their products. At the state level, lawsuits have been filed by attorneys general in five US states, including New York and California, seeking, among other things, civil penalties, restitution, and disgorgement, based primarily on allegations that vape products were inappropriately marketed to youth, contained more nicotine than advertised, and were misrepresented as a safer alternative to smoking. Attorneys general for a number of other US states are in the process of investigating the marketing and sales practices of some US vape manufacturers. Local US municipalities have also filed lawsuits against vaping manufacturers, seeking to recover for the time, money, and human resources that they claim they have expended to combat the harm purportedly caused by the use of vaping products.
Regulatory regime: In addition to the above, another possible reason for the lack of enforcement actions in the UK and the EU may be the vape product regulatory regime that has been in place in the EU since 2016. Article 20 of the Tobacco Products Directive (TPD) sets forth proactive regulatory rules governing the sale, marketing, and distribution of e-cigarettes and other vape products in the EU and UK. Among other things, the TPD prohibits the advertisement of e-cigarettes in the EU; whereas US e-cigarette advertisements caused increased scrutiny from US officials. The TPD also limits the maximum amount of nicotine to 20 milligrams per milliliter of e-liquid, whereas some e-cigarettes available in the US deliver 59 milligrams of nicotine per milliliter.
Under the TPD, European vape manufacturers are also required to list the ingredients contained in the e-liquid on product packaging, as well as to provide insert information with the product, including warnings to specific risk groups, a list of possible adverse effects, and the risk of addiction and toxicity. No similar uniform labeling rule exists in the US (although many commercial e-cigarette manufacturers provide such information with their product). The TPD further requires that all e-cigarettes manufacturers “submit a notification to the competent authorities of the member states of any such products which they intend to place on the market” six months before the product can be sold (or if the product was already in the market six months after the enactment of the TPD).
In the US, like in Europe, vape products went largely unregulated until 2016. Effective August 8, 2016, the US Food and Drug Administration (FDA) extended its regulation over tobacco products to e-cigarettes and vape products. The FDA has not issued a similar regulatory framework to the TPD. However, the FDA is requiring US e-cigarette manufacturers to file an application to sell their products by September 2020. The FDA must approve these applications for the products to remain on the market. US vape manufacturers are not prohibited from selling their products prior to approval of the application.
Personal injury litigation: In general, personal injury litigation is less common in the EU and the UK than it is in the US. This is true in the vaping context as well. To date, there do not appear to have been any claims brought against vape manufacturers involving allegations that use of vape products caused nicotine addiction or acute or chronic disease. The few cases that have been brought relate to trademark violations and an exploding vape device, rather than health conditions allegedly caused by use of the products.
It should be noted that most of the earliest cases brought in the US were also intellectual property disputes and “exploding device” cases. In the US, however, those cases were followed by a wave of cases, numbering in the hundreds, asserting claims that vaping caused nicotine addiction. US vaping manufacturers are also beginning to face claims that their products caused the plaintiff to develop various diseases, including hemorrhagic stroke, seizures, and acute lung injury (resulting in either serious injury or death). Taking a page from traditional cigarette litigation, US plaintiffs have also brought a putative class action lawsuit alleging that use of certain vape products may have exposed class members to secondhand “toxins” from e-cigarette vapor that may result in future injury and alleging that the class should be compensated for the possibility that this exposure occurred.
A further issue facing the US vaping industry concerns the confusion and misinformation surrounding the outbreak of acute lung injury among certain vape product users. Since March 2019, according to the US Centers for Disease Control and Prevention (CDC), 2,807 people have been hospitalized for vape product use-associated lung injury (EVALI), with 68 confirmed deaths. Notably, substances other than nicotine can be vaped, including THC, the psychoactive ingredient in cannabis. The CDC has identified vitamin E acetate, which is frequently used as an additive in black-market e-liquids containing THC, as the primary cause of EVALI. However, despite the fact that no e-cigarette manufacturer has had its products identified as a cause of EVALI, and the fact that many major commercial e-cigarette products are constructed to discourage the use of third-party vaping liquids, commercial e-cigarette manufacturers have been caught up in concerns about EVALI. This problem was exacerbated by the initial lack of distinction, by both the CDC and the media, between various commercial e-cigarettes and vitamin E-tainted black-market THC products.
What might be ahead?
As the industry matures, EU and UK officials will likely continue to enact additional regulations as new information is acquired about vaping products. Vape manufacturers doing business in the EU and the UK should closely monitor regulatory developments. It is expected that laws governing the industry will evolve differently between the EU and the UK following Brexit. Indeed, as part of Brexit, UK officials have agreed to “assess recent legislation such as the Tobacco Products Directive, including as it applies to e-cigarettes, and consider where the UK’s exit provides opportunity to alter the legislative provisions to provide for improved health outcomes within the UK context.” Further, at the moment, the Tobacco Products Directive does not provide comprehensive regulatory rules on e-cigarettes, leaving many important decisions concerning regulation of the products to EU member states. For instance, each member state is responsible for its own rules on e-liquid flavorings. Failure to adhere to these complex and multi-jurisdictional regulations could expose a company to the risk of fines, investigations and litigation. To limit this exposure, companies should keep up to date on the ever-changing landscape of laws affecting this evolving business.
Along with the increased popularity of vape products, research into the health effects of vaping has increased. The European Respiratory Society, a nonprofit medical organization, recently assembled a task force to review research on the health implications of vaping, comprised of twelve experts from Germany, Italy, the Netherlands, Spain, Greece, Sweden, the UK and the US. The task force issued a report in late 2018 concluding that the long-term effects of e-cigarette use remain unknown, but that negative health effects cannot yet be ruled out and further research is needed.
Research associating the use of e-cigarettes and vape products with disease may result in EU and UK officials taking a more aggressive approach to the regulation and enforcement of the vaping industry. It may also encourage private lawsuits in the UK and EU. To that end, in the UK, the Medicines and Healthcare Products Regulatory Agency recently issued an update to healthcare professionals, reporting that as of January 8, 2020, the Agency was aware of 244 suspected adverse reaction reports associated with e-cigarettes or vaping, including 20 reports that included severe respiratory events. Similarly, a study was just released reporting three cases of pulmonary illness in Germany that the researchers concluded were caused by using e-cigarettes. There has also been a recent report of a vape product associated death in Brussels.
In addition to staying current on the laws governing the industry, manufacturers should keep up to date on the relevant scientific literature concerning the use of vaping products and disease. It may be advisable for a company in the vaping industry to consult with independent external scientific and medical experts, who can assist in evaluating what, if any, risks are posed by product use. Keeping abreast of scientific literature and taking the advice of outside experts will assist a manufacturer in fulfilling its duty of care in connection with its products and protecting itself from any claims that might be made by governmental entities or private litigants.
An earlier version of this alert appeared in PHi, 2020 issue 3, in German.