FDA WARNING_LETTER - www.artcigs.com

The FDA Center for Tobacco Products issued a Warning Letter to Ms. Wicker regarding cigarette products sold on artcigs.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are adulterated under section 902(8) because they are modified risk tobacco products sold without an FDA order.

The violation stems from the website's use of descriptors like "light," "mild," or similar terms in product labeling or advertising, which designates them as modified risk tobacco products under section 911(b)(2)(A)(ii). Specific examples include "Davidoff Lights Slims," "Dunhill King Size Button Blue/Light," "Marlboro Light/Gold Box," "R1 Minima Slim Line 100s is one of the mildest lines," and "Superkings Blue 100 (Lights)." Additionally, products listed under a "Lights Cigarettes" heading, such as American Legend White and Parliament Light/Blue, are cited.

Under section 911(a), modified risk tobacco products cannot be introduced into interstate commerce without an FDA order. Failure to comply renders the products adulterated per section 902(8).

The letter requires immediate correction of these violations and similar ones, ensuring all tobacco products and related advertising comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-