FDA WARNING_LETTER - www.cigseasy.net

The FDA's Center for Tobacco Products issued a Warning Letter to cigseasy.net after reviewing their website and determining that they offer cigarette products for sale or distribution in the United States. These products are subject to FDA jurisdiction as tobacco products.

The FDA identified two primary violations:

1. **Modified Risk Tobacco Product Violations:** The website sells or distributes cigarette products using descriptors like "Lights," "mild," "low," "ultra lights," "super light," or "Extra Lights," or claims implying reduced harm, nicotine, or tar (e.g., "low levels of tar and nicotine," "reduces the harmful effects," "special 'stream tech' filter...filtering out some of the impurities," "low nicotine content"). These products are considered "modified risk tobacco products" under section 911(b)(2)(A)(ii) and 911(b)(2)(A)(i) of the FD&C Act. Selling or distributing such products without an FDA order under section 911(g) renders them adulterated under section 902(8) of the FD&C Act.

2. **Flavored Cigarette Violations:** The website offers cigarette products purported to contain artificial or natural characterizing flavors (e.g., Apple, Rum & Cherry, Mojito, Strawberry, Cherry, Mint). Section 907(a)(1)(A) of the FD&C Act prohibits