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

Source: https://www.keypedia.com/records/warning_letter/rocky-top-vapor-llc/6dc1e510-18a0-4f27-9ba9-e6ef1c0c91bc

> FDA WARNING_LETTER for Rocky Top Vapor, LLC on April 30, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rocky Top Vapor, LLC
- Inspection Date: 2021-04-30
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Acting Director](https://www.keypedia.com/people/ele-ibarra-pratt/c1e13bd6-9779-4877-a361-7b4bac089697)

Company: https://www.keypedia.com/companies/rocky-top-vapor-llc/28687b72-962e-4154-bf64-260b445fc5a8

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374