FDA WARNING_LETTER - E-Cig Vape Lounge LLP - November 18, 2021

The FDA issued a Warning Letter to E-Cig Vape Lounge LLP on November 18, 2021, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product," specifically "Vape eliquids Vanilla Bean 10mg nicotine e-liquid product," without the required premarket authorization. This product 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/or injunction. The company, a registered manufacturer with over 2,500 listed products, is responsible for ensuring all its tobacco products comply with the FD&C Act and FDA regulations.

E-Cig Vape Lounge LLP must submit a written response within 15 working days, detailing corrective actions, including dates of discontinued sales/distribution of