FDA WARNING_LETTER - RAD Glass Inc d/b/a Ohmies Vape Shop - June 03, 2022

On June 3, 2022, the FDA issued a Warning Letter to RAD Glass Inc d/b/a Ohmies Vape Shop, specifically addressing Ms. Alyssa Cox and Mr. Uhl. The letter states that Ohmies Vape Shop manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of "Ohmies Mango e-liquid products" without the required premarket authorization. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, 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 absence of required notice or information. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

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/or injunction. The company, a registered manufacturer with over 1,000 listed products, is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and distribution of the violative products, and