# FDA WARNING_LETTER - Pure Vapor USA LP - June 22, 2021

Source: https://www.keypedia.com/records/warning_letter/pure-vapor-usa-lp/e2c4a82a-b423-43cf-9064-382ab7d04187

> FDA WARNING_LETTER for Pure Vapor USA LP on June 22, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pure Vapor USA LP
- Inspection Date: 2021-06-22
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to PURE VAPOR USA LP after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically PURE VAPOR Pipe 10MG 10ML e-liquid, which are deemed tobacco products. The FDA found that this product is a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 absence of required notice or information under section 905(j). The letter also cites prohibited acts under sections 301(k) for holding an adulterated/misbranded product for sale and 301(p) for failing to provide a required report. PURE VAPOR USA LP, a registered manufacturer with over 1,400 listed products, is responsible for ensuring compliance. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, injunction, or detention of imported products.

## Related Officers

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

Company: https://www.keypedia.com/companies/pure-vapor-usa-lp/2c15bad4-fc18-40e8-9868-027dc95b306c

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