FDA WARNING_LETTER - African Spirit Tobacco Limited

The FDA Center for Tobacco Products reviewed africanspirittobacco.com and found cigarette and/or roll-your-own tobacco products offered for sale in the U.S., including "Air cured Burley," "Virginia Flue Cured," and "Low Nicotine Tobacco." The website's presentation, including descriptions of tobacco use in cigarettes, "Cigarette tubes," and FAQ regarding rolling cigarettes, indicates these are "cigarette tobacco" and/or "roll-your-own tobacco" products under the FD&C Act.

The FDA determined these products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. Specifically, "Low Nicotine Tobacco" is described as "lighter," "mild," and "low in nicotine." Such descriptors or claims of reduced substance levels classify them as "modified risk tobacco products" under section 911(b)(2)(A) of the FD&C Act. Introducing these into interstate commerce without an FDA order under section 911(g) is a violation.

The letter demands immediate correction of these and similar violations, ensuring all tobacco products and related labeling/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. A written response detailing corrective actions, including discontinuation of violative sales/