FDA WARNING_LETTER - Covadonga Cigars Inc.

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Gomez regarding the website http://cigarplace.biz, which offers cigar products for sale in the U.S. An FDA investigation revealed that a person younger than 18 years of age purchased a "Cuban Honeys Cherry Robusto Single Cigar" from the website.

This sale constitutes a violation of 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including cigars, to individuals under 18. Consequently, the "Cuban Honeys Cherry Robusto Single Cigar" is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because it was sold in violation of regulations prescribed under section 906(d) of the FD&C Act, specifically 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 further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining