Top Notch Smoke Shop LLC – FDA Warning Letter, Nov 9, 2023

The FDA issued a Warning Letter to Beshoy Sorial of Top Notch Smokes on November 8, 2023, following a review of their website, topnotchsmokes.com. The review determined that the company offers electronic nicotine delivery system (ENDS) products for sale or distribution in the United States without the required premarket authorization.

The FDA cited specific ENDS products, including "Elf Bar BC5000 Disposable Vape - 5000 Puffs Sakura Grape" and "Lava Big Boy 7000 Puff Disposable Vape Watermelon Bubble Gum," as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products, including those containing nicotine from any source (as per the expanded definition under the Consolidated Appropriations Act, 2022), must comply with the FD&C Act and its regulations. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.