Vapeoholic LLC – FDA Warning Letter, Feb 12, 2021

The FDA issued a Warning Letter to Vincent Roxas of vapeoholic.com on February 12, 2021, following a review of their website. The FDA determined that e-liquid products, specifically "Banana Creme Pie" and "Caramel Cappuccino," are 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 is the marketing of "new tobacco products" without required premarket authorization. The e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order 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.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,400 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing