# FDA WARNING_LETTER - Global Tobacco LLC d/b/a X2O Vapes - March 10, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/global-tobacco-llc-dba-x2o-vapes/894643f4-5eb9-4a02-bc28-b39947b7bb99

> FDA WARNING_LETTER for Global Tobacco LLC d/b/a X2O Vapes on March 10, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Global Tobacco LLC d/b/a X2O Vapes
- Inspection Date: 2020-03-10
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Munir M. Meghani after reviewing the website https://x2ovapes.com, which offered electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA determined that the "Mango Pod (4 Pack) Vape Juice" product is a "new tobacco product" that was not commercially marketed before February 15, 2007, and lacks the required 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 notice under section 905(j). Furthermore, the failure to provide the required report is a prohibited act under section 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative activities and outlining a plan for future compliance. Failure to address these violations may lead to civil money penalties, seizure, injunction, and refusal of admission for imported products.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Munir Meghani](https://www.globalkeysolutions.net/people/munir-meghani/3b04707a-8377-44fb-b97c-646ca041f4e5)
- [Swetha Duggirata](https://www.globalkeysolutions.net/people/swetha-duggirata/a5dfa9b6-b679-436a-b3ec-bc11a6c409d4)

Company: https://www.globalkeysolutions.net/companies/global-tobacco-llc-dba-x2o-vapes/b177c1b8-f526-465b-8712-90dccb9a2b26

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