FDA WARNING_LETTER - Vape Craft Inc. - December 07, 2021

On November 19, 2021, the FDA issued a Warning Letter to Maxfield Hulker of Vape Craft Inc. following a review of their website, vapecraftinc.com. The FDA determined that e-liquid products, including "Vape Craft Glazed Flakes" and "Vape Craft Strawberry Milk," were manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The FDA stated these e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization. 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 noted that Vape Craft Inc. is a registered manufacturer with over 8,400 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0002357) submitted on September 9, 2020, resulted in a Refuse to File determination for