Smoker's World of Hollywood – FDA Warning Letter, Dec 13, 2023

The FDA issued a Warning Letter to Ben Z Maizil on December 12, 2023, following a review of the website https://www.smokersworldhw.com. The review determined that electronic nicotine delivery system (ENDS) products were offered for sale or distribution to U.S. customers without required marketing authorization.

The identified violations include the sale of "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order. Specifically, the products cited are Lost Mary OS5000 Disposable Vape - Black Strawnana, Elf Bar BC5000 Disposable Vape - Sakura Grape, and Funky Republic Ti7000 Disposable Vape - Peach Pie. These products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because required notice or information was not provided.

The letter emphasizes that all tobacco products, including ENDS containing nicotine from any source, must comply with the FD&C Act and its implementing regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation of sales and a plan for future compliance.