# FDA WARNING_LETTER - Hakooh LLC - September 27, 2019

Source: https://www.keypedia.com/records/warning_letter/hakooh-llc/efeee6f5-d846-4666-b46d-7c69fcf2b414

> FDA WARNING_LETTER for Hakooh LLC on September 27, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hakooh LLC
- Inspection Date: 2019-09-27
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to HookahShisha.org after reviewing its website, https://www.hookahshisha.org, and determining that electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold are tobacco products subject to FDA jurisdiction. The primary violation identified is that several ENDS and e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This misbranding stems from the failure of the website's advertising to include the required nicotine warning statement, specifically "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R § 1143.3(b). The letter cites examples of non-compliant products. The firm, as a manufacturer, packager, importer, distributor, or retailer, is required to immediately correct this violation and any similar deficiencies to bring all tobacco products and related advertising into compliance with the FD&C Act. A written response detailing corrective actions, including dates of discontinuance of violative activities and a plan for sustained compliance, is required within 15 working days. Failure to comply may lead to further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.

## Related Officers

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

Company: https://www.keypedia.com/companies/hakooh-llc/7067c2fb-0e07-4e31-8b87-b29b1d125c45

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