FDA WARNING_LETTER - Chilam Yun

The FDA issued a Warning Letter to Mr. Yun after reviewing cigarette products offered for sale to U.S. customers on http://www.ebay.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

The products, including "DJ Mix Apple Green Menthol," "DJ Mix Strawberry, Special Feel, Strawberry Flavor," "Peel Menthol Orange," and "Black Devil Rose," are purported to contain characterizing flavors. This violates section 907(a)(1)(A) of the FD&C Act, which prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. Consequently, these flavored cigarettes are deemed adulterated under section 902(5) of the FD&C Act.

Alternatively, if these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act because their labeling falsely represents the presence of apple, strawberry, orange, or rose as characterizing flavors.

Mr. Yun is required to immediately correct these violations and ensure all tobacco products comply with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products offered for import are subject to detention. A written response detailing corrective actions