FDA WARNING_LETTER - Premium eJuice USA LLC d/b/a Vapor Lab - May 27, 2021

The FDA issued a Warning Letter to Terry Burkhead and Ryan Burkhead of My Vapor Lab after reviewing their website, https://myvaporlab.com, and determining that their e-liquid products, including Vapor Lab Boobury and Vapor Lab Tutti Fruitti, are tobacco products subject to FDA regulation. The agency found that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and are being offered for sale without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 under section 905(j). The firm, a registered manufacturer with over 92,000 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.