- Delivery Method:
- Electronic Mail
- Issuing Office:
- Center for Tobacco Products
| || |
Department of Health and Human Services
|Food and Drug Administration|
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
JUNE 30, 2105
VIA Electronic Mail
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.beclassifieds.com and determined that the cigarette products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor. Additionally, FDA has determined that several of your cigarette products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sell them in violation of section 21 C.F.R. § 1140.16(b).
Flavored Cigarette Violations
Our review of the website, http://www.beclassifieds.com, revealed that you offer for sale or distribute the following cigarette products: Djarum Black 16 (clove), Djarum Black Cappucino 16 (sic) (cappuccino, clove), Djarum Super 12 (clove, fruit), Gudang Garam International (clove), Gudang Garam Merah 12 (clove), Gudang Garam Professional (clove), and Gudang Garam Surya 16 (clove).
These products are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
[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 . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
Cigarettes that are distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, clove, fruit preserves, or cappuccino as a characterizing flavor of the tobacco products.
Minimum Cigarette Package Size Violations
Additionally, our review of the website, http://www.beclassifieds.com revealed that you offer for sale or distribute the following individual cigarette packages which contain 16 cigarettes per package: Gudang Garam Professional, Gudang Garam Surya 16, Djarum Black 16, and Djarum Black Cappuccino 16. In addition, you offer for sale or distribute the following individual cigarette packages which contain 12 cigarettes per package: Gudang Garam Merah 12, Gudang Garam International, and Djarum Super 12.
Under section 21 C.F.R. §1140.16(b), no retailer may sell or cause to be sold any cigarette package that contains fewer than 20 cigarettes to U.S. customers. Cigarettes that are sold or distributed to customers in the United States in violation of 21 C.F.R. §1140.16(b) are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import 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 of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov
Please note your reference number, RW1500323, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Product
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