FDA WARNING_LETTER - http://www.smokeandshop.com

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Schvedov after reviewing his website, http://www.smokeandshop.com, which offers cigarette products for sale in the United States. The FDA determined that several products violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the firm sells "modified risk tobacco products" (MRTPs), such as those labeled "Light," "Mild," or implying reduced substance levels (e.g., Benson & Hedges Light Gold, Camel Mild, R1 cigarettes). These products are considered MRTPs under FD&C Act section 911(b)(2)(A) and require an FDA order for sale. Selling them without such an order makes them adulterated under section 902(8).

Additionally, the website offers flavored cigarette products, including Rich Aroma Apple and Kiss Strawberry Superslims, which purport to contain characterizing flavors. This violates FD&C Act section 907(a)(1)(A), rendering them adulterated under section 902(5). If these products do not contain characterizing flavors, their labeling and advertising are false or misleading, making them misbranded under sections 903(a)(1) or 903(a)(7)(A).

The FDA requires immediate correction of all identified violations and similar issues, ensuring full compliance across all sales and promotional platforms. A written response detailing corrective actions, dates of discontinuance, and a compliance plan must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product detention.