Alex Freeman – FDA Warning Letter

The FDA issued a Warning Letter to Alex Freeman on November 1, 2012, after reviewing multiple websites (e.g., camel-cigarettes.net, cigarettesmall.net) registered to him, which offer cigarette products for sale to U.S. customers. These websites are considered affiliated as they redirect to pay-cigs.com for purchases.

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. This includes products described as "mild," "light," "ultra light," or "super light," or those claiming reduced levels of substances, reduced exposure, or less harm (e.g., "Camel Blue (Lights)," "Marlboro Gold – former Marlboro Lights," claims of "reduced amount of nicotine and tar," or "safer smoking experience"). These are considered modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)) and require an FDA order under section 911(a).

Additionally, products like "Kiss Super Slims Fresh Apple," "Kiss Super Slims Strawberry," "Richmond Cherry," "Richmond Cherry Gold," "Rich