Russ WareThe FDA has issued warning letters to six retailers and manufacturers after Center for Tobacco Products (CTP) staff observed the promotion or marketing of unauthorized e-cigarette products at a tobacco/vape industry trade show.
The offending companies were subsequently investigated and found to be breaching the Federal Food, Drug, and Cosmetic Act by offering the products for sale or distribution to customers in the United States. The FDA announcement did not name the trade show where the unauthorized products were initially spotted by its staff, nor do the warning letters.
John Verbeten, Director of CTP’s Office of Compliance and Enforcement, said:
“Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows. We remain committed to identifying and taking action against those breaking the law, including at these events.”
Five more warning letters were issued alongside those resulting from the trade show investigation. These letters targeted online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.
Recipients of FDA warning letters have 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional actions such as an injunction, seizure, and/or civil money penalties. The FDA has increasingly shown that it is not taking the enforcement of the FD&C Act lightly. Over 690 warning letters have been issued to retailers in the last year, and over 140 civil money penalties (of up to $20,678 per offense) have been sought.
Tobacco Products Named in the Warning Letters
The unauthorized products named in the latest FDA warning letters are all disposables and include:
- Mr Fog Max Air – Apple Blueberry Ice
- Mr Fog Switch 5500 – Raspberry Sour Apple
- Mr Fog Max 1000 – Hyper
- RAZ Vape DC25000 – Razzle Dazzle
- RAZ Vape TN9000 – Sour Mango Pineapple
- RAZ Vape TN9000 – Tropical Storm
- Mood Bar Air 6000 – Blood Orange
- Mood Bar Air 6000 – Blue Magic
- Mood Bar Air 6000 – Passion Fruit Guava Citrus
- Breeze Prime 6000 – Strawberry Apple
According to the 2024 National Youth Tobacco Survey, published in September, Breeze is the second-most popular brand among U.S. middle and high school students (19.9%) and Mr. Fog is the third-most (15.8%). Elf Bar remains the most popular brand among underage vapers, with 36.1% of respondents listing it as their favorite. The 2024 NYTS also shows that during 2023-2024, e-cigarette use among U.S. youth dropped by nearly 25%, a decrease from 2.13 million users to 1.63 million.
Versed Vaper Team
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