FDA WARNING_LETTER - Smok"n Hot Vapors - August 08, 2025

The FDA issued a warning letter to Smok’n Hot Vapors, located at 278 East Lake Mead Parkway, Suite B, Henderson, NV, on August 7, 2025, following a review by the Center for Tobacco Products. The inspection revealed that the company sells and distributes electronic nicotine delivery system (ENDS) products in the U.S. without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are classified as tobacco products because they contain nicotine intended for human consumption. The FD&C Act mandates that new tobacco products, which were not commercially available in the U.S. before February 15, 2007, must have a marketing authorization order.

The specific violation identified was the sale of the Foger Switch Pro Kit Blueberry Watermelon 5% Nicotine, which lacks the necessary FDA marketing authorization, rendering it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act. The company is required to cease the unlawful marketing of these products and ensure all tobacco products comply with the FD&C Act and FDA regulations. Smok’n Hot Vapors must submit a written response within 15 working days detailing corrective actions taken, including cessation dates of violative sales and plans for maintaining compliance. Failure to comply may result in regulatory actions such as civil penalties, seizure, or injunction. The company is advised to address all violations promptly to avoid further enforcement actions.