Partnering with the Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA) released new data yesterday from the 2020 National Youth Tobacco Survey (NYTS), which shows that electronic cigarette (e-cigarette) use has significantly declined among youth in the US. At the same time, the FDA also issued warning letters to companies who sell or distribute unauthorized e-cigarettes or other electronic nicotine delivery systems (ENDS) products to remove them from the market.
The actions are part of the FDA’s continuing commitment to curtailing the use of e-cigarettes among youth (of middle school and high school age).
In a press announcement on the data, the FDA stated: “Youth use of e-cigarettes remains a public health crisis that is affecting children, families, schools and communities, and we will do everything possible to stop it – including new actions we are taking today.”
The CDC cites that the use of any tobacco product by youths is unsafe — including e-cigarettes, as they contain nicotine — which is highly addictive, can harm the developing adolescent brain and can increase risk for future addiction to other drugs.
E-cigarettes work by producing an aerosol through heating of a liquid that usually contains nicotine, flavorings and other chemicals that help to make the aerosol. Users inhale this aerosol into their lungs. As with regular cigarettes, bystanders can also breathe in the aerosol when the user exhales into the air.
The NYTS data shows that compared to 2019, 1.8 million fewer youth are currently using e-cigarettes. This encouraging information comes after an alarming two-year period where e-cigarette use, or vaping, was on a sharp rise.
E-cigarette use has increased among US youth since 2011. The incorporation of appealing flavors and product innovations are some of the factors that have contributed to this increase.
In 2020 alone, approximately one in five high school students (19.6 percent; 3.02 million) and one in 20 (4.7 percent; 550,000) middle school students reported the current use of e-cigarettes. While this is a decrease of 7.9 percent among high school students and 5.8 percent decrease among middle school students compared to 2019, a total of 3.6 million American youth continue to use e-cigarettes, which the FDA remains highly concerned about.
In January of this year, the FDA implemented a policy prioritizing enforcement against the manufacture, distribution and sale of certain unauthorized flavored prefilled pod or cartridge-based e-cigarettes (excluding tobacco or menthol).
E-Cigarette Trends Among Middle School and High School Users
Of current users, 22.5 percent of high school, and 9.4 percent of middle school consumers reported daily e-cigarette use.
Among current users, more than eight in ten reported using flavored e-cigarettes – this represents 84.7 percent of high school users (2.53 million) and 73.9 percent of middle school users (400,000), demonstrating the popularity of flavored ENDS among youth users. The most common flavor types were fruit, mint and menthol, followed by candy/desserts or other sweets. Among middle school students, candy or sweet flavors ranked higher than mint and menthol.
Despite an overall preference for fruit flavored e-cigarettes, menthol e-cigarette use was quite prominent, representing nearly one half of flavored prefilled pod or cartridge users and one quarter of flavored disposable product users.
Among both current high school and middle school e-cigarette users, the most commonly used device type was prefilled pods or cartridges (48.5 and 41.3 percent, for high school and middle school users, respectively), followed by disposables (26.5 and 21.5 percent) and tanks (14.8 and 15.2 percent).
In fact, the NYTS data shows that there have been dramatic increases in disposable e-cigarette use among youth. In 2020, disposable e-cigarettes use went from 2.4 percent in 2019 to 26.5 percent in 2020 among high school e-cigarette users, and from three percent to 15.2 percent in middle school users.
FDA Warning Letters
The survey’s findings coincided with the FDA’s premarket review submission deadline, which is a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the agency.
“Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. Companies must demonstrate that each product meets the applicable statutory criteria for receiving marketing authorization, such as whether marketing the product is appropriate for the protection of the public health,” said the FDA.
The FDA has stated that it will “make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization.”
As part of this, the FDA also issued warning letters yesterday to three companies who sell or distribute unauthorized ENDS products, notifying them to remove the products from the market.
The companies included are:
- XL Vape LLC (which conducts business as Stig Inc.): a popular disposable e-cigarette brand among youth. The federal health agency warned the company to entirely remove their disposable e-cigarettes from the market because they do not have the required premarket authorization
- Flavour Warehouse LTD (which conducts business as Vampire Vape)
- Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids
The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, which are commonly marketed and/or appeal to youth, said the FDA.
The FDA said that these warning letters are the latest in the series of actions it has taken in the past weeks and months to help prevent youth from initiating use of any tobacco product. In late July, the agency issued warning letters to ten companies, including Puff Bar, warning the companies to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they lacked the required premarket authorization.
The agency is working to ensure that these illegally marketed products are no longer sold, and that the products will not be reintroduced on the market until the companies have applied for and receive marketing authorization from the FDA
“The warning letters issued today underscore our concern with the rise in youth use of disposable e-cigarettes and the notable use of menthol-flavored e-cigarettes. As we have said many times, the FDA will take action against any ENDS product – regardless of whether it is cartridge-based, disposable, flavored, or otherwise – if it is targeted to kids, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent youth access,” said the FDA.
Based on emerging data, the FDA continues to be vigilant and is responding strongly to the public health crisis. The new NYTS data has helped enforce the FDA’s current actions and will help inform its future steps. As the latest survey has shown, flavored disposable ENDS will be an enforcement priority for the agency.
As part of its efforts to combat the youth e-cigarette public health crisis, the FDA has committed to focusing on product review and enforcement of ‘youth-appealing’ products and investing in campaigns to educate youth about the dangers of e-cigarette use. “We will remain vigilant in monitoring the marketplace, expanding our public education efforts and using our regulatory authority – changing course as necessary – to further ensure all tobacco products, and e-cigarettes in particular, are not marketed to, sold to, or used by kids. If we see a product that is targeted to kids, we will not hesitate to target that product.”
The FDA strongly warns that their “message to companies that sell youth-appealing products without marketing authorization is that they risk action by the FDA.” They went on to say that they “are prepared to take additional actions in the future to hold companies accountable for marketing any e-cigarette products that are appealing to youth.”