By Spencer Shockness.
Who can take a sunrise? Sprinkle it with dew? Add a taste of chocolate and make an e-cigarette or two? Not the Candy Man, nowadays, but the large vape brands can. The modern state of the tobacco industry encourages us to ask the question: are flavored e-cigarettes a dangerous threat to the American youth? As of 2021, the FDA has denied marketing applications for over 946,000 flavored e-cigarette products citing the dangers presented by youth usage of these products. The Agency has issued marketing denials left and right for products featuring flavors such as Apple Crumble, Cinnamon Toast Cereal, and more. However, the Agency has yet to rule on the marketing applications from some of the major e-cigarette manufacturers. One e-cigarette company whose flavored products are popular amongst young users is JUUL. In September, the FDA postponed its decision on whether to remove flavored JUUL products and others from the marketplace. Anti-vaping groups, like the Campaign for Tobacco-Free Kids, are disappointed with the FDA’s delay.
So, are e-cigarette flavors a problem?
The Vaping Epidemic
Many e-cigarette brands state that their product is meant to provide a cigarette alternative for adult smokers. Yet in 2021, 2.06 million middle school and high school students in the U.S. used e-cigarettes. Some experts blame such widespread use on the flavors featured in many e-cigarettes.
It is true that young e-cigarette users generally prefer flavored products; 84.7% of youth e-cigarette users consume flavored e-liquid. Some evidence shows that teens who consume sweetly flavored e-liquid are more likely to continue vaping and inhale more during each vaping session. However, not all experts agree on blaming flavored e-liquid for the youth vaping epidemic.
A recent CDC survey showed that a majority of youth e-cigarette users tried e-cigarettes because they were curious about them, not because they feature candy-like flavors. Additionally, a recent study from the Yale School of Public Health found that a ban on flavored e-liquid would double the chance that high-school aged e-cigarette users switch to smoking combustible cigarettes. Furthermore, some writers argue against a ban on flavored e-liquid by citing the benefits those flavors present to adult smokers attempting to quit using combustible cigarettes. A British Medical Journal study concluded that a ban on flavored e-liquid would result in an 11.1% decrease in vaping, but also an 8.3% increase in smoking amongst adults.
With such conflicting evidence, who is to say which side is correct?
The Large Players in the E-Cigarette Market
In September, the FDA postponed its review of the marketing applications belonging to JUUL, NJOY, and VUSE. JUUL accounts for more than 41% of national e-cigarette sales. Back in 2015, JUUL first introduced its e-cigarette to the marketplace featuring flavors such as mango, fruit medley, cucumber, mint, and crème brulee. As time went on, JUUL and other e-cigarette brands faced criticism for selling flavored products. And with the potential for FDA regulation looming, JUUL has discontinued the sale of many of its flavored pods, leaving only Virginia Tobacco and Menthol for sale today. NJOY and VUSE also currently only sell tobacco and menthol flavor variations.
Perhaps these companies have their own opinions about the potential danger in selling sweetly flavored e-cigarettes. Still, the question remains whether the FDA will determine that tobacco and menthol flavors are just as dangerous as the candy-like flavors that other brands sell.
Strict Products Liability as an Alternative to FDA Regulation?
Activists disappointed with the FDA’s delay have claimed they may seek judicial relief if the FDA does not promptly rule on JUUL and others’ marketing applications. But what kind of judicial relief could they seek?
It is possible that consumers injured by e-cigarettes–potentially teens who consumed flavored e-cigarettes and became addicted to nicotine–could bring a claim under strict products liability law. Strict products liability law recognizes that manufacturers of products may incur liability for any design defects that make their products unreasonably dangerous to use. In Arizona, courts use two tests for determining whether a manufacturer defectively designed its product: the consumer expectations test and the risk-utility test.
The consumer expectations test considers whether a product performs as safely as an ordinary consumer would expect when used in a reasonable manner. Step one is determining whose expectations are relevant. Arizona courts state that a defective product is unreasonably dangerous when its inherent danger exceeds the expectation of the ordinary or ultimate consumer. Step two is determining whether the ordinary or ultimate consumer has any expectations about the inherent danger of the product; in this case, e-cigarette flavors. Arizona courts primarily use the consumer expectations test, but in cases where a consumer would not know how safe a manufacturer could make a product, courts use the risk-utility test. In other words, Arizona courts likely would evaluate whether an e-cigarette consumer has knowledge of the properties of e-liquid and how manufacturers could design e-cigarettes to minimize the risk of injury. If the consumer does have adequate knowledge about e-liquid, then courts will determine whether the inherent dangers of the e-cigarette in question exceeded the consumer’s expectations. If so, a court will find it unreasonably dangerous. If the plaintiff does not have adequate knowledge, this test cannot provide an adequate legal standard, and the risk-utility test will be used. In close cases, courts may instruct a jury on both the consumer expectations test and the risk-utility test to let the jury decide which is most applicable.
The risk-utility test considers whether the benefits of the product’s design outweigh the risks inherent in the design. Arizona courts use seven factors to evaluate whether a defect is unreasonably dangerous under the risk-utility test: (1) the usefulness and desirability of the product; (2) the availability of other or safer products that would meet the same need; (3) the likelihood of injury alongside the seriousness of that injury; (4) the obviousness of the danger; (5) normal public expectation of danger; (6) the ability to avoid injury by employing care when using the product; and (7) the ability to eliminate the danger without seriously impairing the usefulness of the product or making it unduly expensive. For example, in an e-cigarette case, courts may balance the likelihood that the flavored e-cigarette in question would injure the ordinary or ultimate consumer, alongside any potential usefulness of flavored e-liquid and whether eliminating those flavors would seriously impair the usefulness of e-cigarettes. If, after balancing the remaining factors as well, a court finds that the risks of the product’s design outweigh its benefits, it will find the design defective.
What is Next for Flavored E-Cigarettes?
The FDA has yet to predict when it will finish its review of JUUL and others’ marketing applications, but it expects to take action soon. However, in the absence of the FDA’s action, strict products liability lawsuits against e-cigarette manufacturers may begin to rise in places like Arizona—if potential plaintiffs find that they have a plausible case for defective design based on manufacturers’ use of flavored e-liquid. Depending on the facts of the given case and an Arizona court’s decision to employ the consumer expectations test or the risk-utility test, it appears any given case could go either way.