FDA WARNING_LETTER - Good Life Vapor LLC - September 01, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Good Life Vapor LLC following a review of their website, goodlifevapor.com, which revealed electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products are classified as tobacco products under the FD&C Act and are subject to FDA regulation, including the deeming rule effective August 8, 2016. The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, ENDS products such as Myle Pods - Sweet Mango and Juno Pods were found to be commercially marketed despite not being available in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders or exemptions under section 910(a) 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 absence of required notice under section 905(j). Good Life Vapor is mandated to immediately correct these violations, cease the sale and distribution of non-compliant products, and submit a written response within 15 working days detailing their corrective actions and compliance plan. Failure to comply may result in further FDA regulatory action, including the detention and refusal of admission for imported products.