FDA WARNING_LETTER - Davidus Cigars, Ltd

The FDA's Center for Tobacco Products reviewed the website http://www.davidus.com and determined that Davidus Cigars, Ltd. sold Castro Brothers Vanilla Petit Corona cigars (Bundle of 25) to a person younger than 18 years of age. This sale constitutes a violation of 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors.

Consequently, the product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), as it was sold in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140.

The FDA requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products offered for import are also subject to detention.

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 this case is RW1600634