Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwbeclassifiedscom-06302015
Timestamp: 2019-07-20 22:23:19
Document Index: 188233301

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 1140', '§ 387', '§ 387', '§1140', '§1140', '§ 387']

www.beclassifieds.com - 06/30/2015 | FDA
www.beclassifieds.com - 06/30/2015
www.beclassifieds.com Jun 30, 2015
www.beclassifieds.com
To: sales@Beclassifieds.com
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).
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).
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)).
Please note your reference number, RW1500323, in your response and direct your response to the following address: