Northland Vapor Company, LLC – FDA Warning Letter, Oct 26, 2021

The FDA issued a Warning Letter to Brett Erpelding of Northland Vapor Company on October 20, 2021, following a review of their website, northlandvapor.com. The FDA determined that e-liquid products manufactured and sold by the company, including "Mint Chip," "Jungle N°4," and "Loopies," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter notes that Northland Vapor Company is a registered manufacturer with over 800 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0003045) submitted on September 9, 2020, covering 140 products, received Marketing Denial Order determinations on September 17, 2021.

The FDA requires a written response within