Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwdiscount4cigscom-08072015
Timestamp: 2020-01-24 06:36:54
Document Index: 112693233

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

www.discount4cigs.com - 08/07/2015 | FDA
www.discount4cigs.com - 08/07/2015
www.discount4cigs.com August 07, 2015
www.discount4cigs.com
To: support@discount4cigs.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.discount4cigs.com and determined that your cigarette products listed there are offered for sale or distributed 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 of your cigarette products 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 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)) 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.discount4cigs.com, revealed that you sell or distribute cigarette products which are listed or described as being “Lights,” “Ultra Lights,” “Premium Lights,” “Super Lights,” “mild,” or using similar descriptors, for example: Bond Special Selection (“Bond Lights (Special Selection)”), Chesterfield Agate Super Slims 100’s (described as having “mildness”), Chesterfield Ivory Super Slims 100’s (described as having “mildness”), Chesterfield Red (Classic) (described as having “mildness”), Davidoff Gold Slims (“Davidoff Slim Lights 100’s” and “Davidoff Slim Gold (Lights) 100s”), Esse Super Slims Menthol 100’s (described as “mild”), Gauloises Blondes Filter (described as “mild”), Kent HD (“Kent Lights Nr. 1 (Infina),” “Kent Premium Lights Nr. 8 (Futura),” and “Kent Super Lights Nr. 4 (Neo)”), L&M Blue Label (“L&M Lights (Blue)”), L&M Silver Label (“L&M Super Lights (Silver Label)”), Lucky Strike Blue (“Lucky Strike Lights (Blue)” and described as “mild”), Marlboro Gold Accent (“Marlboro Accent (Ultra Light)”), Marlboro Gold Original (“Marlboro Lights (Gold)”), Muratti Silver Slims 100’s (described as “light” and “mild”), Pall Mall Blue (“Pall Mall Blue (Lights)”), Pall Mall (“Pall Mall Lights (Blue)”), Pall Mall Super Slims Blue (“Pall Mall Super Slims Blue (Lights) 100’s”), Pall Mall (“Pall Mall Ultra Lights (Amber)”), Sobranie Cocktail (described as “mild” and “light”), Sovereign Slims Ultra (“Sovereign Slim Ultra Lights 100’s”), West Silver Compact (described as “light”), and West Silver Fusion (described as “light”).
In addition, you also sell or distribute products that are described as having a reduced level of/exposure to a substance. Specifically, the website includes the following claims: Kent HDi Blue, Kent HDi Silver, Kent HDs Blue Super Slims 100s, Kent HDs Silver Super Slims 100s, Kent INFINA Nanotek (mini), Kent Lights Nr. 1 (Infina), Kent Nanotek Futura (mini), Kent Neo Nanotek (mini), Kent Nr. 6 (Spectra), Kent Premium Lights Nr. 8 (Futura), Kent Super Lights Nr. 4 (Neo), and Kent Convertibles, are all described as having a “filter . . . used to decrease the tar and nicotine intake while smoking” and “safer than other brands”; Virginia S. Menthol Super Slims 100’s, Virginia S. Pink Super Slims 100’s, Virginia S. Violet Super Slims 100’s, Virginia Slims Super Slims Blue 100’s, Virginia Slims Super Slims Filter 100’s, Virginia Slims Super Slims One 100’s, Virginia Slims Uno (black) 100’s, and Virginia Slims Uno (white) 100’s, are all described as “very light on the nicotine content”; and West Stream Tec and West Stream Tec Lights (Silver), are described as having a “filter [that] removes the impurities.”
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 that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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)).
The above listed products are modified risk products because the website uses the descriptors “Lights,” “Ultra Lights,” “Premium Lights,” “Super Lights,” “mild,” or similar descriptors or presents products as having a reduced level of/exposure to a substance for the above listed 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.discount4cigs.com, revealed that you offer for sale the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito (mini), Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, and Sobranie Slims Mints 100’s. These products are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
Cigarettes, cigarette tobacco, and roll-your-own tobacco 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 cigarette products are 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 their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, strawberry, cherry, or mint as a characterizing flavor of the tobacco products.
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. 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 import into the United States are subject to detention and refusal of admission.
Please note your reference number, RW1500335, in your response and direct your response to the following address:
Privacy Protection Service Inc. d/b/a PrivacyProtect.org
net-admin@noc.privatedns.com
abuse@iweb.com
domain@wmsolution.org