FDA WARNING_LETTER - Edelveis Enterprises Limited

The FDA's Center for Tobacco Products reviewed six websites (buy-cigarettes-online.net, cigarette-shop.org, eurocheapcigarettes.com, cigarette-store.net, discount-cigarettes-store.net, cheapcigarette.org) affiliated with Edelveis Enterprises Limited, determining they offer cigarette products for sale in the U.S. These products are subject to FDA jurisdiction under the FD&C Act.

The FDA found several products adulterated under section 902(8) of the FD&C Act because they are promoted as "modified risk tobacco products" without an FDA order. This includes products labeled "light," "super light," "premium light," and "ultra light," such as "Kent White Infina N1 (Lights)" and "Pall Mall Amber (Ultra Lights)." Additionally, descriptions like "Wanna be safe – choose Kent" and "provides less harmful chemicals than a full flavor cigarette" contribute to this violation.

Furthermore, products like "Lady Rose," "Kiss Fresh Apple Superslims," and "Sobranie Mints" are adulterated under section 902(5) of the FD&C Act because they contain characterizing flavors (rose, apple, mint) other than tobacco or menthol, which is prohibited for cigarettes as of September 22, 2009. If these products do not contain such flavors, they are misbranded under section 903(a)(1)