Safer Solutions: The FDA authorized flavored vapes. Now what?
Mango and blueberry have made history as the first “fruity” e-cigarette flavors to receive Food and Drug Administration (FDA) approval for sale in the United States. Why is this a big deal? After six years and more than 26.6 million applications from companies seeking approval to sell vapes legally in the States, the FDA has authorized just 45 e-cigarettes for sale. Until now, all of them were menthol or tobacco flavored. The FDA said these authorizations are important because Americans who smoke cigarettes “deserve better, less harmful alternatives,” a position long advocated for by R Street.
Flavored e-cigarettes are a contentious topic in tobacco regulation, primarily due to concerns that flavors will appeal to teenagers. However, the new approvals demonstrate that the FDA considers these products “appropriate for the protection of public health”—in other words, they can play a role in smoking cessation and harm reduction for adults who smoke.
Getting a new e-cigarette on the market
Convenience store shelves are full of unauthorized, unregulated e-cigarettes. But in order for a nicotine e-cigarette to be sold legally in the United States, the FDA must review an extensive application and determine that the product is “appropriate for the protection of public health.” While this standard is not perfectly defined, the FDA has published several considerations for assessing the net harm or benefit of a new product:
- What are the risks and benefits to the overall population?
- Will the product’s availability make people more or less likely to stop smoking?
- Will the product’s availability encourage people who do not currently use any tobacco or nicotine products to start?
- Are there strong quality controls on the production of the product?
Balancing benefits to current smokers and risks to youth
Although there is evidence that adults who use non-tobacco-flavored e-cigarettes (e.g., fruit and menthol) to help them quit smoking are nearly twice as likely to succeed compared to adults who use tobacco-flavored e-cigarettes, there are concerns that these flavors may encourage youth use.
A large increase in youth e-cigarette use in the late 2010s led the Office of the Surgeon General to declare it an epidemic. Youth e-cigarette use has decreased significantly since then and is now at one-third of its 2019 peak despite the broad availability of unauthorized flavored e-cigarettes.
The FDA’s decision to authorize two fruit-flavored e-cigarettes was influenced by a novel technology that requires users to verify their age via a smartphone app in order to use the products. As with so much in tobacco harm reduction, this technology represents a tradeoff between preventing youth use and encouraging uptake by adults who smoke. R Street’s Jeffrey S. Smith wrote that older people, who smoke at the highest rates, “report low trust in digital health tools,” so the “technology—although effective as a gatekeeper—may hinder product uptake among the population that would benefit the most.”
What’s next?
The FDA’s authorization of these fruit-flavored products marks a shift in the agency’s regulatory approach and provides an example for other companies seeking approval for a non-tobacco- or menthol-flavored e-cigarette product. However, only time will tell how many more flavored products will be deemed “appropriate for the protection of public health.”
These newly authorized products will doubtlessly face continued scrutiny. Kathy Crosby, CEO and president of the nonprofit Truth Initiative, was right to say that these approvals represent “a key-test case” and that the company’s marketing of the products and the effectiveness of its age-gating technology should be closely monitored.
However, the work of harm reduction for adults who smoke does not end with regulatory approval. Misperceptions about e-cigarettes’ risk compared to combustible cigarettes abound. In 2020, only 11.4 percent of adults surveyed correctly believed that e-cigarettes are less harmful than combustible cigarettes. Even the majority of physicians are misinformed about e-cigarettes’ lower relative risk compared to combustible cigarettes. These misperceptions are associated with low rates of providers recommending e-cigarettes as a smoking cessation tool. Educating the public and the medical community to correct false narratives and shift behaviors is necessary to realize the full harm reduction potential of e-cigarettes.