Inspections, Compliance, Enforcement, and Criminal Investigations
H.J. Bailey Co.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229
NOV 03 2009
VIA FEDERAL EXPRESS
H.J. Bailey Co.
1105 Green Grove Rd.
Neptune, NJ 07753-2517
Re: Djarum Bali Hai 20S, Djarum Filter 20S, Djarum Black 20S
Dear Mr. Roth:
The Food and Drug Administration (FDA) reviewed your website at the Internet address, http://www.Hjbailey.com October 5, 2009, and determined that your website has been offering for sale Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S to businesses 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 an artificial or natural flavor that is a characterizing flavor 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 Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S are cigarettes and contain clove that is a characterizing flavor of the tobacco products. A review of the labeling on your website for each of the above stated products revealed the following: "DJARUM Bali Hai 20 CLOVE CIGARETTES," "Export Quality DJARUM SPECIAL 20 KRETEK Clove Cigarettes," and "DJARUM BLACK 20 KRETEK Clove Cigarettes."
If Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S contain clove that is a characterizing flavor of the tobacco products, your Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S 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, Djarum Bali Hai 20S, Djarum Filter 20S, and Djarum Black 20S 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 or taking 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.
Please note that adulterated or misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.
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 Product, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850, (240) 276-4017, or send via email to FDAFlavoredCigaretteTask Force@FDAHHS.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. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products