FDA WARNING_LETTER - VapeNico - May 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Vapenico.com on April 30, 2024, following a review of their website, which revealed the sale and distribution of electronic nicotine delivery system (ENDS) products in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the FDA cited Esco Bars Disposable 2500 Puffs - Blueberry Ambrosia, Funky Republic Ti7000 Disposable 7000 Puffs - Pink Bomb, Hyde N-Bar Mini 2500 Puffs - Minty O"s, Elf Bar EBDESIGN TE6000 Disposable 6000 Puffs - Hawaii Punch, and Cali Bar Disposable Vape Pen - Orange Soda. These products are considered "new tobacco products" because they 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. Vapenico