# FDA WARNING_LETTER - Vape E's Ltd - June 15, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/vape-es-ltd/869602a5-3f42-4cb2-8ec6-6dcfe15b3e40

> FDA WARNING_LETTER for Vape E's Ltd on June 15, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vape E's Ltd
- Inspection Date: 2021-06-15
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Vape E’s Ltd, identifying that the firm manufactures and distributes e-liquid products, specifically "Igor Chemist Absolutely Tobacco 30mL 6mg/mL e-liquid product," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that the "Igor Chemist Absolutely Tobacco 30mL 6mg/mL e-liquid product" is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA states that the firm is a registered manufacturer with over 163,100 products listed. The failure to obtain marketing authorization or provide required reports constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vape

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.globalkeysolutions.net/companies/vape-es-ltd/ed76d3b0-cad0-436b-a045-e922319fface

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