FDA WARNING_LETTER - blb7 llc - August 23, 2022

The FDA issued a Warning Letter to Brian Buchanan, owner of The Vape Mall, on August 12, 2022, following a review of the website https://thevapemall.com. The review determined that e-liquid products, including "TFN Vape Juice Aqua Berry Blast," "TFN Vape Juice Dragon Juice," and "TFN Vape Juice Green Sour Apple," were manufactured and offered for sale or distribution in the United States.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source and being intended for human consumption. The FDA asserts that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation identified is the marketing of these "new tobacco products" without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter mandates a written response within 1