FDA WARNING_LETTER - www.balicigar.com

The FDA's Center for Tobacco Products reviewed balicigar.com and found that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Several products are deemed adulterated under section 902(8) of the FD&C Act because they are promoted as "modified risk tobacco products" without an FDA order. This includes products described as "mild" (e.g., "Sampoerna A Flava Click Mint 12" as "Mild Clove Cigarettes") or as containing reduced levels of substances (e.g., "L.A. Lights 16" as "lower in tar and nicotine," and "U Mild 16" and "X Mild 16" as "low tar and low nicotine cigarettes"). Such descriptors classify them as modified risk tobacco products under section 911(b)(2)(A)(ii) and (i) of the FD&C Act, requiring an FDA order for introduction into interstate commerce.

Additionally, numerous flavored cigarettes (e.g., various "clove," "cappuccino," "spice," "tea," "fruit," "orange," or "mint" flavored products) are adulterated under section 902(5) of the FD&C Act, violating section 907(a)(1)(A) which prohibits characterizing flavors (other than tobacco or