# FDA WARNING_LETTER - Vapor Amor - July 23, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/vapor-amor/71cb8fc0-ed80-44df-822d-ba74731ebd8e

> FDA WARNING_LETTER for Vapor Amor on July 23, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapor Amor
- Inspection Date: 2021-07-23
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Vapor Amor LLC after determining the company manufactures and distributes e-liquid products, which are deemed tobacco products subject to FDA regulation. Specifically, the firm was found to be manufacturing, selling, and/or distributing "Iced Tahiti Twist 6mg e-liquid product" without the required premarket marketing authorization. This product is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. As a registered manufacturer with over 1,600 listed products, Vapor Amor LLC is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including the discontinuation of violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/vapor-amor/0f6431ce-6644-42f6-8925-4ffdf3cd5850

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