podkingelfbar.com – FDA Warning Letter, Jul 22, 2025

The FDA issued a Warning Letter to the company operating the website https://www.podkingelfbar.com, located at 18035 Billabong Crescent Ct, Cypress, TX, for violations related to the sale of electronic nicotine delivery system (ENDS) products. The inspection revealed that the company offers products like Lost Mary OS5000 Elf Bar Disposable Vape - Cranberry Soda and Elf Bar BC5000 - Tropical Rainbow Blast for sale in the U.S. without the necessary premarket authorization, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act mandates that new tobacco products, which include those not marketed before February 15, 2007, must have a marketing authorization order. The products in question are deemed adulterated and misbranded due to the absence of such authorization. The FDA"s jurisdiction over these products was extended by the Consolidated Appropriations Act, 2022, to include all nicotine-containing products, regardless of the nicotine source.

The company is required to cease the sale and distribution of these unauthorized products and submit a written response within 15 working days, detailing corrective actions and compliance plans. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The company is advised to ensure all tobacco products and related marketing comply with FDA regulations. The response should be sent to the FDA"s Center for Tobacco Products, with reference number RW2502306.