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Cigsway was cited for selling cigarette products through its website that violated the Family Smoking Prevention and Tobacco Control Act. The company's products were found to be adulterated because they were marketed as modified risk tobacco products without required FDA approval, and several cigarette products were also adulterated or misbranded for purporting to contain characterizing flavors. FDA determined that Cigsway's labeling and advertising explicitly or implicitly represented that their products presented lower health risks, contained reduced harmful substances, or were free of certain substances—all claims requiring pre-market FDA authorization.