FDA WARNING_LETTER - www.123smoke.com

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

Firstly, several products, including "Kent Super Lights King Size Hard Pack" and "L&M Blue (Lights)," are promoted using descriptors like "light," "super light," or "extra light." These are considered "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. Introducing or delivering such products 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.

Secondly, the website offers flavored cigarettes such as "Aroma Rich Apple" 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. Violations of this provision result in products being adulterated under section 902(5) of the FD&C Act. If these products do not contain a characterizing flavor, they are misbranded under section 903(a)(1