FDA WARNING_LETTER - MJ Asset Holdings, LLC d/b/a Marco's Vapor - October 21, 2021

The FDA issued a Warning Letter to MJ Asset Holdings, LLC d/b/a Marco's Vapor for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, including "Custom Clouds NERDZ," "WHITE FOX," "TIGER’S BLOOD," "SKYWALKER," and "CANYON," are tobacco products under the FD&C Act and require premarket authorization. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization orders or exemptions.

Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or notice. The failure to provide a required report under section 905(j) is also a prohibited act. Although a Premarket Tobacco Product Application (PMTA) was submitted (STN PM0002311), it received a Marketing Denial Order on September 3, 2021, covering 5,950 products. The FDA considers products without pending applications or with Marketing Denial Orders as high enforcement priorities.

Marco's Vapor must respond within 15 working days, detailing actions to address violations, including discontinuing sales/distribution and a plan for