FDA WARNING_LETTER - vaporcafeonline.net

The FDA issued a warning letter to Vapor Cafe, operated by Wholesaleplus LLC, following an inspection of their website, https://vaporcafeonline.net, which revealed the sale of electronic nicotine delivery system (ENDS) products to U.S. customers. The inspection identified that products such as Lost Vape Orion Bar Disposable – 50K, Fruity Nectar, and Juicy Peach are being marketed without the necessary FDA premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially available before February 15, 2007, and lack the required marketing authorization order.

The FDA"s jurisdiction over these products is based on amendments to the FD&C Act, which now includes products containing nicotine from any source. As a result, the ENDS products offered by Vapor Cafe are deemed adulterated and misbranded, violating sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA requires Vapor Cafe to take immediate corrective actions to address these violations, including ceasing the sale and distribution of the non-compliant products. The company must submit a written response within 15 working days detailing their compliance plan and any actions taken. Failure to comply may result in regulatory actions such as civil penalties, product seizure, or injunctions. The FDA emphasizes that this letter serves as a notice and an opportunity for the company to rectify the issues.