FDA WARNING_LETTER - VapeOtine - November 09, 2023

On November 8, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating vapeotine.com, identifying the sale of unauthorized electronic nicotine delivery system (ENDS) products. The FDA reviewed the website and determined that ENDS products listed are offered for sale or distribution 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 violations identified include offering "Bang XL Disposable 600 Puffs – XL Banana Ice" and "Cali Bars Disposable Vape by Cali Grown – Blue Razz" without the required premarket authorization. These are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction