FDA WARNING_LETTER - Rocky Top Vapor, LLC - April 30, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Dave Nelson of Kwick Way Ln, Johnson City, TN, on April 9, 2021, following a review of the website https://rockytopvapor.com. The FDA determined that e-liquid products, specifically RTV LTD Berry Shake and RTV LTD Pink Lemonade, are manufactured and offered for sale as tobacco products under section 201(rr) of the FD&C Act and 21 C.F.R. § 1100.1. The primary violation is the marketing of these e-liquid products as "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) and 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 absence of required information under section 905(j). Despite being a registered manufacturer with over 470 listed products, the firm failed to comply with these critical regulatory requirements. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, product seizure, injunction, or refusal of admission for imported products.