Retailers Given 15 Working Days to Respond with Corrective Action or Risk Enforcement
On August 23, 2023, FDA issued warning letters to 15 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys, and drinks. Since the appearance of these illegal products can be deceiving, the agency is also seeking to raise awareness among parents, teachers, and other adults headed into the new school year.
“The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”
The unauthorized products described in the warning letters include e-cigarettes that:
- Feature youth-appealing characters from TV shows, movies, and video games, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario;”
- Are designed to look like youth-appealing school supplies, such as highlighters, and toys like Nintendo Game Boy and digital cameras;
- Imitate youth-appealing drinks such as Starbucks and Dunkin Donuts coffee cups, soda, and water bottles.
The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product. In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act. The retailers were given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
“CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, J.D., M.B.A, director of the Office of Compliance and Enforcement within FDA’s Center for Tobacco Products. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”
These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth. As of August 2023, FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.
As youth head back to school across the United States, it is important for parents, teachers, and other adults to be aware of these illegal youth-appealing products, which can be deceiving and easily concealed. FDA recently launched the Vaping Prevention and Education Resource Center, which is an online hub with free science-based lesson plans and materials for teachers, including how to spot stealth and disposable e-cigarettes and to help students understand the dangers associated with e-cigarette use and nicotine addiction. In addition to content designed for teachers, there are also materials for parents and teens.
Source: U.S Food & Drugs (FDA)