Vape.com – FDA Warning Letter

The FDA issued a Warning Letter to Betty Vape, located at 711 Signal Mountain Rd, Chattanooga, TN, on September 9, 2025, following a review of their website, which revealed the sale of electronic nicotine delivery system (ENDS) products in the U.S. These products, including Arctic Mineral Water Kangvape Onee PRO 7000 Puffs Disposable Vape and Spearmint Esco Bar 6000 Puffs Disposable Vape, are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to containing nicotine. The FD&C Act, amended by the Consolidated Appropriations Act, 2022, requires such products to have premarket authorization to be legally marketed in the U.S.

The FDA found that Betty Vape"s products lack the necessary marketing authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively. The company is required to cease the sale and distribution of these products and ensure compliance with the FD&C Act. Betty Vape must submit a written response within 15 working days detailing corrective actions taken, including discontinuation dates of the violative sales. Failure to comply may result in enforcement actions such as civil penalties or product seizures. The letter serves as a notice and opportunity for the company to address these violations.