Vape Daugz LLC – FDA Warning Letter, Dec 21, 2021

On December 10, 2021, the FDA issued a Warning Letter to Melanie Scott and Holly Luedeman of Vape Daugz, following a review of their websites, https://www.vapedaugz.net and https://www.vapedaugz.store. The FDA determined that e-liquid products, specifically "Vape Daugz Smokey" and "Bird Daugz Buddy," were being manufactured and offered for sale or distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

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 e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lacked the necessary FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 1,000 products listed, and a Premarket Tobacco Product Application (PMTA) (STN PM0003763) was submitted on September 8, 2