# FDA WARNING_LETTER - m & k on cumberland, inc.  - July 26, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/m-k-on-cumberland-inc/731d37d3-6d5e-4fab-9409-c356f3362bed

> FDA WARNING_LETTER for m & k on cumberland, inc.  on July 26, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: m & k on cumberland, inc. 
- Inspection Date: 2022-07-26
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Naser Mesleh of Bigcloudvape.com on July 15, 2022, following a review of their website. The FDA determined that the electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold on the website are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the advertising for several ENDS and e-liquid products, including "Posh Plus – Creme Brulee" and "Naked E-Liquid Juice – All Melon," fails to include the required nicotine warning statement, making them misbranded under section 903(a)(7)(B) of the FD&C Act. Specifically, the advertising does not comply with 21 CFR 1143.3(b), which mandates the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

The FDA requires immediate corrective action to bring all tobacco products, labeling, and advertising into compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory action, including detention and refusal of admission for imported products. A written response detailing corrective actions, including dates of discontinuation of violative activities and a plan for maintaining compliance, is required within 15 working days.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/m-k-on-cumberland-inc/8a230076-394c-44a5-9a76-15bc0bf95384

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