E-Vaped Co – FDA Warning Letter, Aug 19, 2021

The FDA issued a Warning Letter to E-Vaped Co for manufacturing and distributing e-liquid products, specifically E-Vaped 30ml Nicotine 48, without required marketing authorization. These products are deemed tobacco products subject to FDA regulation. The E-Vaped 30ml Nicotine 48 e-liquid 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. Consequently, the product is adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice under section 905(j). The letter also states that acts related to adulterated or misbranded products, and failure to provide required reports, are prohibited acts under sections 301(k) and 301(p) respectively. E-Vaped Co, a registered manufacturer with numerous listed products, is responsible for ensuring compliance. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.