Belcorp of America – FDA Warning Letter, Jun 27, 2011

The FDA issued a Warning Letter to Belcorp of America on June 27, 2011, following a review of their website, http://www.belcorpfactorydirect.com, which promoted and offered cigarette products for sale in the U.S. The FDA determined that Belcorp's Galaxy Pro, Derby, Rich, and First One cigarettes were adulterated and misbranded.

The products were deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they were promoted as "modified risk tobacco products" without an FDA order. Specifically, the website used descriptors like "Gold (Formerly Lights)," "Silver (Formerly Ultra Lights)," and "Green (Formerly Menthol Lights)," which classify them as modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Introducing such products into interstate commerce without an FDA order under section 911(g) (21 U.S.C. § 387k(g)) is a violation.

Additionally, the products were misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387