FDA WARNING_LETTER - Ohm City Vapes Inc. - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Roy Niazov, operating ohmcityvapes.com, after reviewing the website and determining that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the U.S. These products are deemed tobacco products under the FD&C Act and are subject to FDA regulation.

The primary violation identified is the sale of "new tobacco products" without required premarket authorization. Specifically, Puff Bar Pods Juul Compatible – Strawberry, Skol Pods Juul Compatible – Double Apple, Skol Pods Juul Compatible – Mango, and Original Cinnaroo by Cloud Thieves were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern regarding "Original Cinnaroo by Cloud Thieves" due to its packaging imitating food products appealing to children, like Cinnamon Toast Crunch, raising concerns about youth appeal and use.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and advertising, and a plan for future compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.