Vapeoholic LLC – FDA Warning Letter, Sep 22, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Vincent Jay A. Roxas on September 22, 2022, following a review of the website https://www.vapeoholic.com. The review determined that e-liquid products, specifically "Basuka Bubble Gum" and "Crayons 69," are manufactured and offered for sale in the U.S. 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 primary violation is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack 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 because required notices or information under section 905(j) were not provided.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products and