Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/httpwwwokcigarettescom-06182015
Timestamp: 2020-08-07 16:19:59
Document Index: 94720928

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

http://www.okcigarettes.com - 06/18/2015 | FDA
http://www.okcigarettes.com - 06/18/2015
http://www.okcigarettes.com June 18, 2015
http://www.okcigarettes.com
To: BF052A4CA0A44F4789B44B41584B2D7D.protect@whoisguard.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.okcigarettes.com and determined your 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 cigarette products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your Pall Mall cigarettes (“Pall Mall Lights (Blue)”) are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that your “Richmond Cherry” cigarettes 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.
Our review of the website, http://www.okcigarettes.com, revealed that you sell or distribute the following cigarette product,which islisted or described as being “light,” or using similar descriptors: Pall Mall Lights (Blue).
The above listed product is a modified risk tobacco product because the website uses the descriptor “light,” or similar descriptors to describe this product. Because this product is 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)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally,our review of the website, http://www.okcigarettes.com, revealed that you offer for sale or distribution the following cigarette product: Richmond Cherry.
If, however, the cigarette product does not contain a characterizing flavor, it is 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 itslabeling or advertising is false or misleading because it makes the representation that the product contains, for example, cherry as a characterizing flavor of the tobacco product.
Please note your reference number, RW1500329, in your response and direct your response to the following address:
Linode Network Operations
http://www.okcigarettes.com - Close Out Letter 9/22/15