FDA WARNING_LETTER - Smoke City Vapes - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Smoke City Vapes following a review of their website, https://smokecityvapes.com. The FDA determined that the company offers electronic nicotine delivery system (ENDS) products for sale or distribution in the United States. These products, including Lava 2 Mango 4PK Pods, Lava 2 Strawberry 4PK Pods, and Elf Bar – Summertime, are considered "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and contain nicotine from any source. The primary violation is the marketing of these new tobacco products without the required premarket authorization order, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. As a result, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide necessary information as required by section 905(j). The FDA requires Smoke City Vapes to submit a written response within 15 working days, outlining actions taken to cease the violative sale and distribution of these products and detailing a plan for maintaining compliance. Failure to address these violations may result in significant regulatory and legal actions, including civil money penalties, product seizure, or injunction.