George Nicolas – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Nicolas, identifying violations related to cigarette products sold on his websites: http://www.ineed-vip.com, http://www.payless-vip.com, and http://www.123-vip.com.

The FDA determined that several products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are promoted as modified risk tobacco products without an FDA order. Specifically, products like "Kent Super Lights King Size Hard Pack" and "L&M Blue (Lights)" use descriptors such as "Light," "Super Lights," or "Extra 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 websites offer flavored cigarettes, including "Aroma Rich Apple," "Aroma Rich Rum & Cherry," and "Kiss Fresh Apple Super Slims." These products are adulterated under section 902(5) of the FD&