FDA WARNING_LETTER - Big Ds Vape House - June 11, 2019

On May 17, 2019, the FDA issued a Warning Letter to Dennis Carman of Big D's Vape House, LLC, following a review of their website, bigdsvapehouse.com. The FDA determined that e-liquid products, specifically Banana Nut Bread e-liquid, were manufactured and offered for sale or distribution in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

The letter cited two primary violations: 1. **Sales to Minors:** The Banana Nut Bread e-liquid was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). 2. **Misleading FDA Approval Claims:** A statement on the website's search engine description, "Big D's Vape House Sells FDA approved handcrafted e-juice and vaping supplies since June 14, 2014," violates section 301(tt) of the FD&C Act (21 U.S.C. § 331(tt)). This statement misleads consumers into believing the tobacco