FDA WARNING_LETTER - www.dynamicwd.com

The FDA's Center for Tobacco Products issued a Warning Letter to Dynamicwd.com after reviewing their website and determining that their cigarette products are offered for sale in the United States. The FDA found that several products are adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products (e.g., "Lights," "Ultra Lights") without an FDA order. Specific examples include "Marlboro Gold" and "Winston Silver."

Additionally, the FDA determined that flavored cigarettes, such as "Aroma Rich Apple" and "Richmond Cherry," are adulterated under section 902(5) of the FD&C Act, as they contain characterizing flavors (other than tobacco or menthol) which is prohibited for cigarettes. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling.

The letter requires immediate correction of all violations and similar issues, ensuring compliance with the FD&C Act and FDA regulations across all promotional materials. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products are also subject to detention and refusal of admission into the U.S. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required