FDA WARNING_LETTER - Dr. Vape It, LLC - January 06, 2022

The FDA issued a Warning Letter to Dr. Vape It, LLC on January 6, 2022, following a review of submissions and inspection records. The FDA determined that Dr. Vape It, LLC manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the Dr. Vape It Blue Raspberry 12mg e-liquid product was found to be commercially marketed in the U.S. without an FDA marketing authorization order, as it was not commercially marketed as of February 15, 2007. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required notice or information under section 905(j).

The letter emphasizes that marketing new tobacco products without statutory premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Dr. Vape It, LLC, a registered manufacturer with over 1,500 listed products, is responsible for ensuring all tobacco products comply with the FD&C Act and FDA regulations.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative