smok city inc. – FDA Warning Letter, May 1, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Ketan Sharma and Divya Sharma, operators of smokcity.com, on April 30, 2024. The FDA determined that the website offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products that are considered "tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including those containing nicotine from any source, as amended on March 15, 2022.

The key violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products Cali Bars V2 6000 - Frozen Lush, Lava Big Boy Disposable - Watermelon Bubblegum, and Elf Bar Disposable BC5000 - Blue Razz Ice were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required information under section 905(j). The letter requires a written response within 15 working days detailing actions to address violations, including discontinuing sales and a plan for compliance. Failure to comply