FDA WARNING_LETTER - VapeL1FE, LLC - December 27, 2022

The FDA Center for Tobacco Products issued a Warning Letter to John Gyorfi regarding e-liquid products sold on vapel1fe.com. The FDA determined that products like "Lollipop," "Icy Blast," and "Rain Dance" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

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 sold 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, as no required notice or information was provided under section 905(j).

The letter emphasizes that unlawfully marketed new tobacco products are subject to enforcement actions, including civil money penalties, seizure, and injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may lead to further FDA action.