FDA WARNING_LETTER - Vapor Plus OK LLC - November 09, 2021

The FDA issued a Warning Letter to Nadeem Khan of Vapor Plus OK LLC on November 5, 2021, following a review of their website, https://vaporplusok.com. The FDA determined that the company manufactures and sells e-liquid products, which are considered tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Scotch Cake (9mg and 15mg)" was found to be a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter notes that Vapor Plus OK is a registered manufacturer with over 14,100 products listed with FDA. The company's Premarket Tobacco Product Application (PMTA) STN PM0003782, submitted on September 9, 2020, received a Refuse to File determination on August 24, 2021 (covering 82 products) and a Marketing Denial Order on September 7, 2021 (covering 3,816 products). These products, lacking