On November 16th, 2022, the US Food and Drug Administration issued warning letters to five companies for marketing 15 different electronic cigarette products without authorization. Each product's packaging appeared like a toy, food, or cartoon character, potentially encouraging use by youth. No manufacturer submitted a pre-market application for any unauthorized product.
The warning letter describes unauthorized products, including electronic cigarettes.
Designed to resemble toys and attract young people, these electronic products include items such as glow sticks, Nintendo gaming consoles, and walkie-talkies. Characters from popular TV shows, movies, and video games that are popular among young people are also featured, such as The Simpsons, Family Guy, Splatoon, Rick and Morty, Minions, and Baby Shark. Some products even mimic food items, like popsicles.
The design of these products is a blatant attempt to target children," said Dr. Brian King, Director of the Center for Tobacco Products at the FDA. "The goal of quitting smoking requires using cartoon characters on the product packaging to be successful.
The FDA has issued warning letters to the following companies and their products:
Wizman Limited and its Wizvapor product, Shenzhen Fomote Technology Co. Ltd and its products R Vapes and M Vapes, and Shenzhen Zhiying Technology Co. Ltd's Ruthless Vape have all been named in the international market.
A warning letter has been issued to recipients informing them that e-cigarettes without marketing authorization may be adulterated and mislabeled. The Federal Food, Drug, and Cosmetic (FD&C) Act prohibits the sale or distribution of these products to US consumers. Failure to promptly correct the violation may result in the FDA taking further action, such as an injunction, seizure, and/or civil money penalty. In addition, there appears to be a risk of detention or refusal of entry for products imported to the United States that have been mislabeled or adulterated. Retailers and distributors should communicate with their suppliers to discuss possible options for unapproved products in their inventory.
Dr. King said that the FDA is committed to preventing young people in our country from being exposed to tobacco products. He added that the agency will continue to hold companies responsible for illegal sales of electronic cigarettes, particularly those that shamelessly target young people.
Today's warning signifies another step by the FDA in its ongoing efforts to remove illegally sold tobacco products from the market. As of October 28th, the FDA has issued over 440 warning letters to companies selling illegal e-cigarettes containing tobacco-derived nicotine, and over 60 warning letters to companies selling illegal products containing non-tobacco-derived nicotine. On October 18th, the DOJ, on behalf of the FDA, filed a lawsuit in federal court against 6 companies for continuing to manufacture, sell, and distribute their products illegally despite previous warnings from the FDA and failing to submit premarket applications for their e-cigarette products.
Warning Letter on the Full Compliance and Enforcement of the Cigarette Tax Law and the National Youth Tobacco Survey Results
The FDA, a sub-agency of the US Department of Health and Human Services, is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, vaccines, and other biological products, as well as medical devices. It also oversees the safety and security of our country's food supply, cosmetics, dietary supplements, products that release electronic radiation, and tobacco regulation.
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