FDA WARNING_LETTER - Mr. Smokey Tobacco Corp d/b/a Smoke Shop/The Boss Tobacco - May 31, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Nadim Muqedi, located at 8580 Stirling Rd #102, Hollywood, FL, following a review of the website https://hqdfume.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the United States.

The identified violations pertain to the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Puff Plus Vape 800 Puffs Mixed Berries" and "Puff Plus Vape 800 Puffs Peach Ice" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lacked an FDA marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notice or information under section 905(j).

The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement. The recipient is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation of sales/distribution and a plan for future compliance. Failure to comply may result in regulatory or legal actions such as civil money penalties