Inspections, Compliance, Enforcement, and Criminal Investigations
Heavenly Smoke Inc 11/3/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
TO: Support@heavenlysmoke.com, email@example.com
FROM: Food and Drug Administration
RE: Gudang Garam Clove Cigarette, Djarum Clove Cigarette, and Sampoerna Clove Cigarette
DATE: November 3, 2009
The Food and Drug Administration (FDA) reviewed your website at http://www.heavenlysmoke.com. on October 7, 2009, and determined that your website has been offering Gudang Garam Clove Cigarette, Djarum Clove Cigarette, and Sampoerna Clove Cigarette products for sale to consumers in the United States. Under section 201 (rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), 21 U.S.C. § 321(rr), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.
According to the information and materials on your website we reviewed, your products listed above are represented as cigarettes that contain artificial or natural flavors that are characterizing flavors of the products and, as such, are adulterated and/or misbranded. Section 907(a)(1)(A) of the FFDCA, 21 U.S.C. § 387g(a)(1)(A), provides, as part of the tobacco product standards, a "special rule for cigarettes" as follows:
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
After the September 22, 2009 effective date for this provision, flavored cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FFDCA, 21 U.S.C. § 387b(5).
Your website represents that Gudang Garam Clove Cigarettes, Djarum Clove Cigarettes, and Sampoerna Clove Cigarettes are cigarettes and contain clove that is a characterizing flavor of the tobacco products. Specifically, your website lists these products under the heading "Clove Cigarettes" and identifies them as "Gudang Garam Clove Cigarette," "Djarum Clove Cigarette," and "Sampoerna Clove Cigarette."
If your Gudang Garam Clove Cigarette, Djarum Clove Cigarette, and Sampoerna Clove Cigarette products contain clove that is a characterizing flavor of the tobacco products, your products are adulterated under section 902(5) of the FFDCA, 21 U.S.C. § 387b(5), because they are represented as cigarettes and fail to comply with the special rule for cigarettes detailed in section 907(a)(1)(A) of the FFDCA, 21 U.S.C. § 387g(a)(1)(A). If, however, your products do not contain a flavor, herb, or spice that is a characterizing flavor of the tobacco products, they are misbranded under section 903(a)(1) of the FFDCA, 21 U.S.C. § 387c(a)(1), as their labeling is false and misleading because it makes the representation that the products contain clove that is a characterizing flavor of the tobacco products.
You should immediately correct this violation by ceasing the marketing and sale of your products to consumers in the United States or take other appropriate action to bring your products into compliance with the requirements of the FFDCA. Failure to correct this violation may result in regulatory action being initiated by the FDA without further notice. These actions may include, but are not limited to, seizure and injunction.
As you are not located in the United States, please note that adulterated or misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your products listed above to be adulterated and/or misbranded products that cannot be legally sold to consumers in the United States.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and explaining your plan for discontinuing the marketing and sale, or relabeling, of these tobacco products. Please direct your response to Ann Simoneau, Regulatory Counsel, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850, (240) 276-4017, or send via email to FDAFlavoredCigaretteTaskForce@FDA.HHS.GOV. We remind you that only written communications are considered official.
The violation discussed in this letter does not necessarily constitute an exhaustive list. It is your responsibility to ensure that your tobacco products comply with the applicable provisions of the FFDCA, as amended by the FSPTCA, that are currently in effect.
Lawrence R. Dayton, M.S.P.H., M.D.
Director, Center for Tobacco Products