JDVapour LLC d/b/a McVapour E-Cig’s & Novelties – FDA Warning Letter, Jan 31, 2022

On January 31, 2022, the FDA issued a Warning Letter to JDVapour LLC d/b/a McVapour ECig’s & Novelties, 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 section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "McVapour Spearmint 6MG 50ML" e-liquid without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 company is a registered manufacturer with over 5,800 listed products. While a Premarket Tobacco Product Application (PMTA), STN PM0001230, was submitted on September 8, 2020, it received a Marketing Denial