Seditious Vapours, LLC d/b/a Butt Out Labs – FDA Warning Letter, Sep 7, 2021

The FDA issued a Warning Letter to Matthew Berger regarding e-liquid products manufactured and sold through buttoutecigs.com. The FDA determined that products like "Butt Out Seven Reserve Line Major Tom" and "Butt Out Seven Reserve Line Gigi" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,200 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