FDA WARNING_LETTER - B-X Vapor - April 30, 2021

On April 9, 2021, the FDA issued a Warning Letter to Steven Tyler Propst regarding e-liquid products manufactured and sold via https://b-xvapor.com. The FDA determined that products like "B-X Vapor Dad’s Milk" and "B-X Vapor Watermelon Crack" are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007.

These products are in violation because they lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, they 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 per section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,100 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative activities and a plan for future compliance