FDA WARNING_LETTER - Aro Tobacco

The FDA's Center for Tobacco Products issued a Warning Letter on December 14, 2016, to ARO Tobacco, following a review of their website, http://www.arotobacco.com. The review determined that cigar products, specifically "Clubs Montecristo MM CP 20’s cigar," were offered for sale and distribution in the United States.

The primary violation identified was the sale of a "Clubs Montecristo MM CP 20’s cigar" to a person younger than 18 years of age, which constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because the sale violated 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to individuals under 18. "Clubs Montecristo MM CP 20’s cigar" is classified as a "covered tobacco product" under 21 C.F.R. § 1140.3 and 21 C.F.R. § 1100.2.

ARO Tobacco is required to immediately correct this violation and any similar ones, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations