FDA WARNING_LETTER - Vaperistas, LLC - May 31, 2023

On May 31, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Myles Eastwood and Michael Bragado of Vaperistas, LLC, following a review of their website, https://www.vaperistas.com. The FDA determined that the website offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, specifically Hyde Edge and Hyde Rebel, which are considered tobacco products under section 201(rr) of the FD&C Act.

The core violation is that these ENDS products are "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. They were not commercially marketed in the U.S. as of February 15, 2007, and do not have 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 because required information was not provided under section 905(j).

The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Vaperistas is required to submit a written response within 15 working days detailing actions taken to address