|Subject:||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Issuer:||Center for Tobacco Products|
|Issued:||Aug. 22, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
VIA UPS, and Electronic Mail
AUG 22, 2012
Jl.pemuda gg. guntingan no. 38
Dear Mr. Fakhri:
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website, http://www.coffeecigarette.com, and determined that your cigarette products listed there are offered for sale to U.S. customers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and 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 of your cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that several of your 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)). You can find the FD&C Act and the Code of Federal Regulations through links on FDA’s homepage at http://www.fda.gov .
You describe products that you offer for sale on your website, http://www.coffeecigarette.com, as being mild by referring to them as such in product advertising and adding the qualifier, “mild,” to the products’ descriptions. For example, our review of your website revealed that you offer for sale the following cigarettes described as “mild”: Gudang Garam Surya Slim; Gudang Garam Surya Slim Menthol; Gudang Garam Nusantara; Sampoerna A Flava; and Mild Filtered Clove Cigarettes (Sample Packs). In addition, you describe several products that you offer for sale on your website as containing reduced levels of substances. For example, you describe Bentoel Star Mild cigarettes as “low tar and nicotine cigarettes,” and U Mild and X Mild cigarettes as “low tar and low nicotine cigarettes.”
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptors “low” and “mild” or similar descriptors for the above listed products, and includes claims that products contain a reduced level of a substance, present a reduced exposure to a substance, or are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, review of your website, http://www.coffeecigarette.com, revealed that you offer for sale the following cigarettes which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products: Bentoel Biru; Bentoel Inter Biru; Bentoel Sejati; Bentoel Star Mild Menthol; Bentoel Star Mild; Class Mild; Djarum 76; Djarum Black; Djarum Black Menthol; Djarum Brown; Djarum Coklat; Djarum LA Lights Menthol; Djarum LA Lights; Dji Sam Soe Classic; Dji Sam Soe Filtered; Dji Sam Soe Magnum; Dji Sam Soe Super Premium Refill; Gudang Garam International; Gudang Garam Merah; Gudang Garam Professional; Gudang Garam Signature Lights; Gudang Garam Signature Menthol; Gudang Garam Signature; Gudang Garam Surya Slim Menthol; Gudang Garam Surya Slim; Gudang Garam Surya; Gudang Garam Nusantara; Sampoerna A Flava; Sampoerna A Mild Menthol; Sampoerna A Mild; Sampoerna Hijau; U Mild; Wismilak Diplomat; Wismilak Special Classic; Wismilak Special Filtered; Wismilak Kretek Slim; and X Mild; Djarum Black Cappuccino; and Djarum Super. 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.
As of September 22, 2009, cigarettes marketed and sold 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 cigarettes are adulterated.
If, however, these cigarettes 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)) as their labeling is false and misleading because it makes the representation that the products contain clove, fruit, or cappuccino as a characterizing flavor of the tobacco products.
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 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 of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products.
Please note your reference number, RW1200024, in your response and direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov .
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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