FDA WARNING_LETTER - www.usatobaccoonline.com - May 01, 2013

The FDA's Center for Tobacco Products issued a Warning Letter to usatobaccoonline.com after reviewing their website, 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 identified two main violations: 1. **Modified Risk Tobacco Product Violations:** The website promotes products using descriptors like "Lights," "Ultra Lights," and "Super Lights" (e.g., "Davidoff Gold (Lights)," "Kent Super Lights"). Under section 911(b)(2)(A)(ii) of the FD&C Act, such descriptors classify these as "modified risk tobacco products." Introducing or delivering these into interstate commerce without an FDA order under section 911(g) is prohibited, rendering them adulterated under section 902(8) of the FD&C Act.

2. **Flavored Cigarette Violations:** The website offers "Aroma Rich Apple," "Aroma Rich Rum & Cherry," and "Kiss Fresh Apple Super Slims," which are purported to contain characterizing flavors. Section 907(a)(1)(A) of the FD&C Act prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. Products violating this are adulterated under section 902(5) of the FD&C Act. If these products do not contain a