Heavenly Smoke Inc – FDA Warning Letter, Dec 2, 2010

On October 7, 2009, the FDA reviewed the website http://www.heavenlysmoke.com and found it was offering Gudang Garam Clove Cigarette, Djarum Clove Cigarette, and Sampoerna Clove Cigarette products for sale in the United States. These products are classified as tobacco products under section 201(rr) of the FFDCA.

The FDA determined that these products are represented as cigarettes containing artificial or natural flavors, specifically clove, which is a characterizing flavor. This violates section 907(a)(1)(A) of the FFDCA, which prohibits cigarettes from containing characterizing flavors other than tobacco or menthol. Since the September 22, 2009, effective date, such flavored cigarettes are considered adulterated under section 902(5) of the FFDCA.

If the products do contain clove as a characterizing flavor, they are adulterated. If they do not, their labeling is false and misleading, making them misbranded under section 903(a)(1) of the FFDCA.

Heavenly Smoke was instructed to immediately cease marketing and selling these products to U.S. consumers or take other actions to achieve compliance. Failure to comply could result in regulatory actions including seizure and injunction. As the company is not located in the U.S., adulterated or misbranded products are subject to detention and refusal of admission