FDA WARNING_LETTER - www.smokerslobby.com

The FDA Center for Tobacco Products issued a Warning Letter to Smoker's Lobby regarding cigarette products offered for sale on www.smokerslobby.com. The FDA determined these products are tobacco products under the FD&C Act.

The primary violation is the sale and distribution of "modified risk tobacco products" without an FDA order. The website uses descriptors like "Lights" (Camel Blue, Chesterfield Classic Blue), "Ultra Lights" (Chesterfield Classic Bronze), or similar claims implying reduced harm or substance levels. Specific examples include Camel One ("very low content of nicotine and tar"), Karelia ("low content of carbon monoxide," "less harmful," "unique filter"), Kool Menthol ("reduced tar content"), Parliament ("filter was to prevent the smoker from inhaling a part of tars"), and Richmond ("low nicotine content").

These products are deemed adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without the required FDA order under section 911(g). The letter mandates immediate correction of these violations and similar issues, ensuring all tobacco products and related advertising 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. Adulterated and misbranded imported products are subject to detention. A written response detailing corrective actions, including discontinuation dates and compliance plans, is required within 15 working days