bjwholesale.net – FDA Warning Letter, Aug 26, 2025

The FDA issued a warning letter to B&J Wholesale, located at 13388 Monte Vista Street, Suite A, Chino, CA, following an inspection of their website, https://bjwholesale.net. The inspection, conducted by the Center for Tobacco Products, identified violations related to the sale of electronic nicotine delivery system (ENDS) products, specifically the Spaceman Prism 20k Disposable, Apple Kiwi Ice, and Funky Republic Ti7000 Rechargeable Disposable Device, Rainbow Cloudz. These products are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not marketed in the U.S. before February 15, 2007, and lack the required FDA marketing authorization.

The regulatory framework mandates that new tobacco products must have a premarket authorization order to be legally marketed in the U.S. The products in question are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act due to the absence of such authorization and necessary notifications.

The FDA requires B&J Wholesale to address these violations promptly. The company must submit a written response within 15 working days detailing corrective actions, including cessation of violative sales and plans for compliance. Failure to comply may result in regulatory actions, including penalties, seizure, or injunctions. The letter serves as a formal notification and an opportunity for the company to rectify the issues.