Yuga Mochtar – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Mochtar after reviewing the websites http://www.cloveciggies.com and http://www.balicigar.ecwid.com, which offer cigarette products for sale in the U.S. The FDA determined these products are tobacco products under the FD&C Act.

The letter identifies two primary violations:

1. **Modified Risk Tobacco Product Violations:** Several cigarette products are deemed "adulterated" under section 902(8) of the FD&C Act because they are marketed with descriptors like "mild," "light," "low," or claims of "lower in tar and nicotine" (e.g., Djisamsoe Magnum Blue, LA Lights). These descriptors classify them as "modified risk tobacco products" under section 911(b)(2)(A)(ii) and (i) of the FD&C Act. Such products require an FDA order under section 911(g) before being introduced into interstate commerce, which was not obtained.

2. **Flavored Cigarette Violations:** Numerous cigarette products are "adulterated" under section 902(5) of the FD&C Act because they purport to contain artificial or natural characterizing flavors other than tobacco or menthol (e.g., clove, tea, fruit, cappuccino, apple, mint). This violates section 907(a)(1)(A) of