FDA Issues New Warning Letters, Continues to Address Youth-Appealing Products Based on Evolving Data
Today, the U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. After two years of disturbing increases in youth e-cigarette use, we are encouraged by the overall significant decline reported in 2020. This is good news; however, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and we acknowledge there is work that still needs to be done to curb youth use. 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 findings come as we mark today’s premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the FDA. 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. In such cases, the FDA may assess, among other things, how particular e-cigarettes or other electronic nicotine delivery systems (ENDS) could help addicted adult smokers seeking to transition away from cigarettes, while also weighing the concerning popularity of these products with young people. The FDA has been working tirelessly to ensure that we are as prepared as possible to receive, process, and review the applications in a timely manner.
In addition to the critical premarket scientific review of tobacco products, taking enforcement actions against those who violate the law remains a vital way we protect public health. Following today’s deadline, the FDA will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application. Additionally, based on several factors – including the likelihood of youth use or initiation – the FDA 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, though as the result of a court decision, the FDA will not be enforcing this requirement for “premium” cigars.
In line with its enforcement priorities, today the FDA issued warning letters notifying three companies who sell or distribute unauthorized ENDS products to remove those products from the market. The FDA issued a warning letter to XL Vape LLC (doing business as Stig Inc.), a popular disposable e-cigarette brand among youth, warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued today to Flavour Warehouse LTD (doing business as Vampire Vape) and 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, that are commonly marketed and/or appeal to youth.
These actions come as the 2020 NYTS data shows an alarming uptick in use of disposable e-cigarettes by youth. Specifically, in 2020, disposable e-cigarettes are being used by 26.5% of high school e-cigarette users (up from 2.4% in 2019) and 15.2% of middle school e-cigarette users (up from 3% in 2019). Furthermore, more than 8 out of 10 youth e-cigarette users report use of flavored products, with fruit, mint, candy, and menthol among the most commonly used. This is the first year in which the NYTS distinguished between mint and menthol products; in previous years’ surveys, youth were asked questions in which products were identified as “mint/menthol” and not further delineated.
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. The agency’s actions demonstrate that the FDA will continue to aggressively respond to this public health crisis based on evolving data. This new data will inform the FDA’s enforcement and other actions, and flavored disposable ENDS will be an enforcement priority for the agency. Our message to companies that sell youth-appealing products without marketing authorization is that they risk action by the FDA. And we are prepared to take additional actions in the future to hold companies accountable for marketing any e-cigarette products that are appealing to youth.
These warning letters are just the latest in the series of actions the FDA has taken in the past weeks and months to help ensure that youth do not begin using any tobacco product. In late July, the agency issued warning letters to 10 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 lack the required premarket authorization. The agency is working to ensure 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 if they receive marketing authorization from the FDA.
We are committed to addressing the public health crisis of youth e-cigarette use by, among other things, focusing product review and enforcement on 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, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.