FDA WARNING_LETTER - Ohm Men Vape Shop LLC - March 24, 2022

The FDA issued a Warning Letter to Ohm Men Vape Shop LLC on March 24, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "Big Mike’s Tonics Dragon’s Blood 3mg 30ml" e-liquid without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The FDA cited sections 301(k) and 301(p) of the FD&C Act, which prohibit acts resulting in adulterated or misbranded products and the failure to provide required reports. The company is a registered manufacturer with over 150 listed products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and