Companies Must Stop Marketing Unauthorized Products Or Risk Enforcement, According to FDA
The U.S. Food and Drug Administration issued warning letters Nov. 16, 2022, to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.
The unauthorized products described in the warning letters include e-cigarettes that:
- Are designed to look like toys and youth-appealing electronics like glow sticks, Nintendo Game Boy, and walkie-talkies;
- Feature youth-appealing characters from TV shows, movies, and video game characters, including “The Simpsons,” “Family Guy,” “Squid Game,” “Rick and Morty,” “Minions,” and “Baby Bus;” or
- Imitate foods like popsicles.
“The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”
The FDA issued warning letters to:
- Wizman Limited doing business as Wizvapor
- Shenzhen Fumot Technology Co., Ltd. doing business as R and M Vapes
- Shenzhen Quawins Technology Co., Ltd.
- Ruthless Vapor
- Moti Global
The warning letters notify the recipients that e-cigarettes without a marketing authorization order are adulterated and misbranded, and that selling or distributing these products to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. are at risk of being detained or refused admission. Retailers and distributors should communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said Dr. King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”
Today’s warning letters mark another step in the FDA’s continued efforts to remove illegally marketed tobacco products from the market. Through Oct. 28, the FDA has issued more than 440 warning letters to firms marketing illegal e-cigarettes containing tobacco-derived nicotine, and more than 60 warning letters to firms marketing illegal products containing non-tobacco nicotine. On Oct. 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers who failed to submit premarket applications for their e-cigarette products and continued to illegally manufacture, sell, and distribute their products, despite previous warnings from the FDA that they were in violation of the law.
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.
