FDA WARNING_LETTER - Cigsway - May 24, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to cigsway.com after reviewing its website and determining that cigarette products were offered for sale or distribution in the U.S. The FDA identified two primary categories of violations. Firstly, several cigarette products, including Camel Compact Filters, Pall Mall King Nano Blue, and Parliament Reserve, were deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). This is because they are modified risk tobacco products (MRTPs) sold or distributed without a required FDA order, making explicit or implicit representations of lower risk, reduced substance levels, or being free of certain substances, using descriptors like "mild," "light," "low tar," and "low nicotine." Secondly, the firm offered Dunhill Fine Cut Blue (clove) cigarettes, which are purported to contain a characterizing flavor. Such flavored cigarettes are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Alternatively, if the product lacks a characterizing flavor, it is misbranded under sections 903(a)(1) or 903(a)(7)(A) for false or misleading labeling. The FDA requires a written response within 15 working days detailing corrective actions, discontinuation of violative sales/advertising, and a compliance plan. Failure to comply may result in civil money penalties, seizure, injunction, or import detention/refusal.