FDA WARNING_LETTER - www.smokingtimes.com

The FDA Center for Tobacco Products issued a Warning Letter to Smokingtimes.com after reviewing their website and determining that their cigarette products are offered for sale in the U.S. The FDA determined that several products are adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products without an FDA order.

Specifically, the website uses descriptors like "Light," "Ultra Light," "Extra Light," "Super Light," or "Mild" in product names and advertising for products such as Bond Lights, Camel Lights, Marlboro Lights, and Winston Lights. Under section 911(b)(2)(A)(ii) of the FD&C Act, products using such descriptors are considered "modified risk tobacco products." Section 911(a) prohibits the introduction of modified risk tobacco products into interstate commerce without an FDA order under section 911(g). Violations of section 911(a) result in adulteration under section 902(8).

The FDA requires immediate correction of these violations and similar ones, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may lead to further actions, including 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 of violative promotion