FDA WARNING_LETTER - RSB Tobacco Inc

The FDA issued a Warning Letter to RSB Tobacco, Inc. after reviewing their website, rsbtobacco.com, and determining their products are manufactured and sold in the U.S. The FDA classified "The Good Stuff" brand as "cigarette tobacco" and "roll-your-own tobacco" under the FD&C Act, despite being labeled "pipe tobacco," due to its presentation and implied use for making cigarettes.

The primary violation identified is the promotion of "The Good Stuff Gold" ("Light"), "The Good Stuff Silver" ("Ultra Light"), and "The Good Stuff Menthol Gold" ("Light" and "Our Milder Blend") as modified risk tobacco products without an FDA order. These descriptors ("light," "ultra light," "milder") classify them as modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act. Introducing such products into interstate commerce without an FDA order (section 911(a)) renders them adulterated under section 902(8) of the FD&C Act.

RSB Tobacco is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative promotions, and a compliance plan is