Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwbuyclovecigarettescom-07242015
Timestamp: 2020-07-07 23:16:12
Document Index: 410309133

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

www.buyclovecigarettes.com - 07/24/2015 | FDA
www.buyclovecigarettes.com - 07/24/2015
www.buyclovecigarettes.com July 24, 2015
www.buyclovecigarettes.com
Kah Seong Chuah
sales@buyclovecigarettes.com
Dear Mr. Chuah:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.buyclovecigarettes.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)).
Our review of the website, http://www.buyclovecigarettes.com, revealed that you sell or distribute the cigarette products listed or described as being “mild” or using similar descriptors: Gudang Garam Surya Slim, Gudang Garam Surya Slim Menthol, Sampoerna Avolution, and Sampoerna Avolution Menthol.
The above listed products are modified risk tobacco products because the website uses the descriptor “mild” or similar descriptors to describe these products. Because these products are sold or distributed to customers in the United States 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, our review of the website, http://www.buyclovecigarettes.com, revealed that you offer for sale or distribute cigarette products, for example: Bentoel Biru (clove), Djarum Black Cappuccino (cappuccino, clove), Djarum Super (clove, fruit), Djarum Black Tea (tea, clove), Djarum Coklat (clove), Dji Sam Soe 234 (clove), Gudang Garam International (clove), Gudang Garam Surya Slim (clove), Sampoerna Avolution (clove), and Wismilak Diplomat (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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, clove, tea, cappuccino, or fruit as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500338, in your response and direct your response to the following address:
care@cigarettesfactory.com
dnsadmin@gator4166.hostgator.com
legal@hostgator.com