# FDA WARNING_LETTER - Vape Tampa Bay and Downtown Vaporium LLC - June 13, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/vape-tampa-bay-and-downtown-vaporium-llc/b3f0f098-df25-4a02-bb17-6dc01b1cd52f

> FDA WARNING_LETTER for Vape Tampa Bay and Downtown Vaporium LLC on June 13, 2023. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Vape Tampa Bay and Downtown Vaporium LLC
- Inspection Date: 2023-06-13
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Andrew Nawoichik of Downtown Vaporium after reviewing their website, https://downtown-vaporium.myshopify.com. The FDA determined that e-liquid products offered for sale are tobacco products under section 201(rr) of the FD&C Act, especially following the March 2022 amendment extending jurisdiction to products containing nicotine from any source. The primary violation identified was the sale of Orchard Blends by Five Pawns – Nana Berry e-liquid to an individual under 21 years of age. This action constitutes a violation of section 906(d)(5) of the FD&C Act, rendering the product misbranded under section 903(a)(7)(B) of the FD&C Act. The letter emphasizes the retailer's responsibility to ensure compliance with all applicable provisions of the FD&C Act and FDA's implementing regulations, including age restrictions. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, and/or injunction. The firm is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. The FDA also reminded the firm about premarket authorization requirements for "new tobacco products."

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Andrew Nawoichik](https://www.globalkeysolutions.net/people/andrew-nawoichik/4288f12e-58c6-45ad-920e-c5ba94f05732)

Company: https://www.globalkeysolutions.net/companies/vape-tampa-bay-and-downtown-vaporium-llc/85bf99e2-5ac2-493f-b101-9ae1b8d0d697

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