FDA WARNING_LETTER - mjm distribution inc - May 28, 2021

On May 28, 2021, the FDA issued a Warning Letter to Michael Cotellese of MJM Distribution, Inc., following a review of their website, https://mjmdistribution.net. The FDA determined that e-liquid products, specifically Artifact Vapor Craft e-liquids: Buckland, Skullflower, and Widow's Walk, were manufactured and offered for sale or distribution in the U.S. without the required premarket authorization.

These e-liquids are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or an exemption, neither of which was in effect. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 50 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 11