FDA WARNING_LETTER - Vape N Juice - November 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Jeremy Petrocelli and Adam Fitzgerald of Vape N Juice on November 19, 2021, following a review of their website, https://www.vpnjuice.com. The review determined that e-liquid products, specifically "Apple Crumble," were manufactured and offered for sale or distribution in the U.S.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The "Apple Crumble" e-liquid is considered a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

While the firm is a registered manufacturer with over 14,600 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0002248, covering 7,771 products, received a Marketing Denial Order on September 16, 2021. Products with a Marketing Denial Order are among the FDA's highest enforcement priorities.

The letter requires a written response within 15