DC Vapor, Inc. – FDA Warning Letter, Feb 12, 2021

On February 12, 2021, the FDA issued a Warning Letter to Barry Vuong regarding e-liquid products sold on dcvapor.com. The FDA's Center for Tobacco Products reviewed the website and determined that e-liquid products are manufactured and offered for sale or distribution in the U.S., classifying them as tobacco products under section 201(rr) of the FD&C Act.

The letter states that certain e-liquid products, specifically Signature Series - Frujuze - Galaxy Reloaded, Signature Series - Brefest - Jax, and Pound Town - Festival, are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the violative labeling, advertising, sale, and/or distribution, and a plan for maintaining compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction. The firm is a registered