FDA WARNING_LETTER - E-Cig POD USA LLC d/b/a e-cig POD - November 09, 2022

The FDA issued a Warning Letter to E-Cig POD USA LLC d/b/a e-cig POD on November 9, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "e-cig POD Grape Drink 5.0% e-liquid product" without the required premarket authorization. This product is considered a "new tobacco product" because 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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The FDA states that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The company must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products, and a plan for future compliance. Failure to comply may lead to further regulatory action.