# FDA WARNING_LETTER - UltraUK Group d/b/a Ultra Vape - October 08, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/ultrauk-group-dba-ultra-vape/b2ce6ffe-ca63-4996-9ae3-3929a80480e6

> FDA WARNING_LETTER for UltraUK Group d/b/a Ultra Vape on October 08, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: UltraUK Group d/b/a Ultra Vape
- Inspection Date: 2019-10-08
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Andrew James regarding e-liquid products advertised and sold on ultravape.com to U.S. customers. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The letter identifies two primary violations:
1.  **Sales to Minors:** Ultravape.com sold "Dragons Blood" and "nicotine booster" e-liquids to a person under 18, violating 21 C.F.R. § 1140.14(b). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act.
2.  **Failure to Include Required Nicotine Warning Statement:** Several e-liquid products, including "Cherry with Nicotine Shot" and "Heisenberg Blue – Special Edition with Nicotine Shot," were advertised without the mandatory "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement, as required by 21 C.F.R. § 1143.3(b). This also misbrands the products under section 903(a)(7)(B) of the FD&C Act.

The FDA requires immediate corrective actions for these and similar violations to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Christopher J. Day](https://www.globalkeysolutions.net/people/christopher-j-day/4ac4bd08-13cf-4593-821e-d13a2b996dc0)

Company: https://www.globalkeysolutions.net/companies/ultrauk-group-dba-ultra-vape/c9cb624a-6797-4e36-8314-662af63cf4fa

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