# FDA WARNING_LETTER - Hookah Design, LLC d/b/a Fumo Design, LLC - October 08, 2019

Source: https://www.keypedia.com/records/warning_letter/hookah-design-llc-dba-fumo-design-llc/2f50b469-8072-435a-92e5-c1befbd42460

> FDA WARNING_LETTER for Hookah Design, LLC d/b/a Fumo Design, LLC on October 08, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hookah Design, LLC d/b/a Fumo Design, LLC
- Inspection Date: 2019-10-08
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Daniel B. Sweitzer and Frances R. Sweitzer of Fumodesign.com on September 30, 2019, following a review of their website, which offers waterpipe tobacco products for sale in the U.S. The FDA determined that Fumari Ambrosia waterpipe tobacco is a "covered tobacco product" and is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b).

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, is required within 15 working days. The reference number for the response is RW1901188.

## Related Officers

- [Frances R. Sweitzer](https://www.keypedia.com/people/frances-r-sweitzer/08365a32-3e7d-435c-9ef1-50f3cef5ece0)
- [Daniel B. Sweitzer](https://www.keypedia.com/people/daniel-b-sweitzer/0a03cb75-dca0-4bcc-a94f-b1db1893c240)
- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/hookah-design-llc-dba-fumo-design-llc/2792934c-b167-4788-b6be-1278f917c542

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