FDA WARNING_LETTER - Evolution Enterprises Ltd.

The FDA's Center for Tobacco Products issued a Warning Letter to Mr. Burc regarding the website http://www.go4cigs.com, which offers cigarette products for sale or distribution in the United States. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the sale and distribution of "modified risk tobacco products" without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act. Specifically, the website sells L&M Blue (described as "L&M Light (Blue)") and Parliament (described as "Parliament Light (Aqua Blue)"). Parliament Light (Aqua Blue) is further described as "contain[ing] less nicotine and tar."

These products are classified as modified risk tobacco products under section 911(b)(2)(A)(ii) for using descriptors like "light" or similar terms, and under section 911(b)(2)(A)(i) for representing reduced levels of substances (nicotine and tar). Section 911(a) prohibits introducing modified risk tobacco products into interstate commerce without an FDA order.

The FDA requires immediate correction of these violations and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure