FDA WARNING_LETTER - Vapingfly - February 01, 2024

On January 31, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Vapingfly.com after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale or distribution in the United States. These products are considered tobacco products under the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The FDA identified that Vapingfly.com is marketing "new tobacco products" without the required premarket authorization. Specifically, the letter cited the sale of Elf Bar CR500 Disposable Pod Vape Kit (Watermelon Lemon, Sour Apple, Berry Peach) and Elf Bar 600 Disposable Pod Vape Kit (Mango, Strawberry Grape). These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided. The FDA mandates that Vapingfly.com submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction