FDA WARNING_LETTER - www.123-cigs.com - May 01, 2013

The FDA's Center for Tobacco Products issued a Warning Letter to 123-cigs.com after reviewing their website and determining that their cigarette products are offered for sale in the United States. The FDA found several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

**Violations and Deficiencies:**

1. **Modified Risk Tobacco Product Violations:** The website promotes products using descriptors like "Lights," "Super Lights," or "Ultra Lights" (e.g., Davidoff Gold (Lights), Kent Super Lights). Under section 911(b)(2)(A)(ii) of the FD&C Act, such products are considered "modified risk tobacco products." Introducing or delivering these products into interstate commerce without an FDA order under section 911(g) of the FD&C Act 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 SS cigarettes, 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.