Vape MD – FDA Warning Letter, Dec 15, 2021

The FDA issued a Warning Letter to Vape MD, identifying that the company manufactures and distributes e-liquid products, specifically "Vape MD PMS 120ml 0mg/ml e-liquid product," for commercial distribution in the United States. These products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that the aforementioned e-liquid product is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because a notice or information required by section 905(j) was not provided. The failure to provide such a report is also a prohibited act under section 301(p).

Vape MD, a registered manufacturer with over 600 listed products, is responsible for ensuring all tobacco products comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15