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

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.