# FDA WARNING_LETTER - JDVapour LLC d/b/a McVapour E-Cig’s & Novelties - January 31, 2022

Source: https://www.keypedia.com/records/warning_letter/jdvapour-llc-dba-mcvapour-e-cigs-novelties/0713ea5a-fe91-481e-949b-e3e752c2c9cf

> FDA WARNING_LETTER for JDVapour LLC d/b/a McVapour E-Cig’s & Novelties on January 31, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: JDVapour LLC d/b/a McVapour E-Cig’s & Novelties
- Inspection Date: 2022-01-31
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On January 31, 2022, the FDA issued a Warning Letter to JDVapour LLC d/b/a McVapour ECig’s & Novelties, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "McVapour Spearmint 6MG 50ML" e-liquid without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed 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 information under section 905(j).

The company is a registered manufacturer with over 5,800 listed products. While a Premarket Tobacco Product Application (PMTA), STN PM0001230, was submitted on September 8, 2020, it received a Marketing Denial

## Related Officers

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

Company: https://www.keypedia.com/companies/jdvapour-llc-dba-mcvapour-e-cigs-novelties/aa8dd052-135b-47e1-a945-b790375376d5

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