Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/original-cigarettes-indonesia-02182016
Timestamp: 2019-08-25 20:57:49
Document Index: 486168822

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

Original Cigarettes Indonesia - 02/18/2016 | FDA
Original Cigarettes Indonesia - 02/18/2016
Original Cigarettes Indonesia Feb 18, 2016
Original Cigarettes Indonesia
Attn: Muhammad Rasyidi
sales@cigarettesoriginal-indonesia.com
originalcigarettes@yahoo.com
Dear Mr. Rasyidi:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://cigarettesoriginal-indonesia.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, includingcigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
Our review of the website http://cigarettesoriginal-indonesia.com revealed that you sell or distribute cigarette products,which arelisted or described as being light or using similar descriptors, for example: Marlboro Gold (“Marlboro Lights Gold,” “Marlboro Lights,” “Marlboro Gold (Light),” and “Gold Pack or Marlboro Gold means light version”), and Marlboro Ment[h]ol (GREEN) (“Marlboro Lights Menthol”).
Additionally, our review of the website http://cigarettesoriginal-indonesia.com revealed that you offer for sale or distribute cigarette products, for example: Djarum Black Menthol (clove), Djarum Black Slim (clove), Djarum Black Tea (clove, tea), Djarum Super (clove, fruity), Gudang Garam International (clove), Gudang Garam Surya Exclusive (clove), Sampoerna 234 (Clove), and Wismilak Kretek (clove).
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 productsare adulterated 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, clove, tea, or fruit as a characterizing flavor of the tobacco products.
Please note your reference number, RW1600459, in your response and direct your response to the following address:
herjanto@dharsono.com
Original Cigarettes Indonesia - Close Out Letter 7/7/16