FDA WARNING_LETTER - www.cigarettesplace.com

The FDA's Center for Tobacco Products reviewed http://www.cigarettesplace.com and determined that cigarette products offered for sale to U.S. customers are adulterated. The products are considered tobacco products under section 201(rr) of the FD&C Act.

The violation stems from the sale and distribution of "modified risk tobacco products" without an FDA order, as required by section 911(a) of the FD&C Act. Specifically, the website uses descriptors like "Lights" in product names and descriptions for Benson & Hedges 100’s Premium Filter, Merit Filter, and Rothmans King Size, which classifies them as modified risk tobacco products under section 911(b)(2)(A)(ii). Selling these products without an FDA order in effect under section 911(g) renders them adulterated under section 902(8) of the FD&C Act.

The letter requires immediate correction of these violations and similar issues across all promotional materials and platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco 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 within 15 working days, referencing RW1300146.