# FDA WARNING_LETTER - ATMOMIXANI E.E. - September 17, 2019

Source: https://www.keypedia.com/records/warning_letter/atmomixani-ee/035e381f-3365-4323-962c-3ef72acb026b

> FDA WARNING_LETTER for ATMOMIXANI E.E. on September 17, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ATMOMIXANI E.E.
- Inspection Date: 2019-09-17
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Michail Konstantinos Potamianos regarding e-liquid products advertised and sold on https://vapemart.atmomixani.gr to U.S. customers. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA identified two primary violations:
1.  **Sales to Minors:** An Atmos Lab Strawberry e-liquid product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act.
2.  **Failure to Include Required Nicotine Warning Statement:** Several e-liquid products (e.g., Atmos Lab Caramela, Liqua American Blend) advertised on the website lacked the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b), causing these products to be misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act due to misleading advertising/labeling.

The letter requires immediate corrective

## Related Officers

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

Company: https://www.keypedia.com/companies/atmomixani-ee/a74ea01b-bacf-4b28-98ab-fc874f061a59

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