# FDA WARNING_LETTER - Inhale Hookah & Accessories - July 09, 2019

Source: https://www.keypedia.com/records/warning_letter/inhale-hookah-accessories/4e12e192-a7ca-4dbe-8a7d-258500cae4bc

> FDA WARNING_LETTER for Inhale Hookah & Accessories on July 09, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Inhale Hookah & Accessories
- Inspection Date: 2019-07-09
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Inhale Tobacco following a review of their website, inhaletobacco.com, which revealed the manufacture and sale of waterpipe tobacco products in the U.S. These products are subject to FDA jurisdiction under the FD&C Act.

The letter identifies two primary violations:
1.  **Sales to Minors:** Inhale Banana Cream Pie waterpipe tobacco was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act.
2.  **Failure to Include Required Nicotine Warning Statement:** Several waterpipe tobacco products (e.g., Inhale Bump’n Grind, Inhale Banana Cream Pie, Inhale Cinapple) advertised and sold on the website lacked the mandatory "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement, as required by 21 C.F.R. § 1143.3(a) and (b). This omission causes the products to be misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the labeling and/or

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Valerie Huin](https://www.keypedia.com/people/valerie-huin/8df04e26-36aa-4f66-ab17-53cf12c5ee24)

Company: https://www.keypedia.com/companies/inhale-hookah-accessories/379a577c-ef9a-4da6-b59a-8489651e52cc

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