FDA WARNING_LETTER - http://www.onlythebest4u.info

The FDA's Center for Tobacco Products reviewed the website http://www.onlythebest4u.info and found cigarette products offered for sale to U.S. customers. These products are subject to FDA jurisdiction under the FD&C Act.

The FDA determined several cigarette products are adulterated under section 902(8) of the FD&C Act because they are "modified risk tobacco products" sold without an FDA order. Specifically, products labeled "Lights" or "Ultra Lights" (e.g., Marlboro Gold, Parliament Aqua Blue, Marlboro Silver) are considered modified risk tobacco products under section 911(b)(2)(A)(ii) and require an FDA order for sale under section 911(a). Their sale without such an order renders them adulterated.

Additionally, several cigarette products (e.g., Aroma Rich Rum Cherry, Kiss Mohito, Richmond Cherry) are offered for sale purporting to contain artificial or natural characterizing flavors. This violates section 907(a)(1)(A) of the FD&C Act, which prohibits characterizing flavors (other than tobacco or menthol) in cigarettes, making these products adulterated under section 902(5). If these products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling/advertising.