ATMOMIXANI E.E. – FDA Warning Letter, Sep 17, 2019
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
ID · 035e381f-3365-4323-962c-3ef72acb026b
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