Go Vapor LLC – FDA Warning Letter, Jan 13, 2022
The FDA issued a Warning Letter to Go Vapor LLC on January 13, 2022, for manufacturing and distributing e-liquid products without required premarket authorization. The FDA determined that Go Vapor LLC's e-liquid products, specifically "Go Vapor E-Juice Blackberry 3mg 10ml," are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007.
Under sections 910(a), 902(6)(A), and 903(a)(6) of the FD&C Act, these products are adulterated and misbranded because they lack an FDA marketing authorization order and no required notice or information was provided. The company's Premarket Tobacco Product Applications (PMTAs), STN PM0002406, covering 28,903 products, received a Refuse To File determination on August 30, 2021.
The FDA considers all new tobacco products on the market without premarket authorization to be unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Go Vapor LLC, a registered manufacturer with 271,500 listed products, must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales and distribution of non-compliant products, and a plan
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