Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cigs-shopnet-03132015
Timestamp: 2019-07-19 13:53:55
Document Index: 363847047

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

cigs-shop.net - 03/13/2015 | FDA
cigs-shop.net - 03/13/2015
cigs-shop.net Mar 13, 2015
cigs-shop.net
To: support@dutyfreepay.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.cigs-shop.net, and determined that your cigarette products listed there are offered for sale 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 your Pall Mall Red cigarettes are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(a). Additionally, 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. Finally, 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
FDA’s investigation of your website, http://www.cigs-shop.net, revealed that you sold a tobacco product to a minor. Specifically, during our investigation of your website, a minor purchased a tobacco product from this website. No retailer may sell cigarettes or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140. A person younger than 18 years of age purchased Pall Mall Red cigarettes from your website. Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
You sell or distribute products that you describe on the website, http://www.cigs-shop.net, as being light or mild by referring to them as such in product labeling or advertising. Specifically, our review of the website revealed that you sell or distribute cigarette products described as but not limited to:
Glamour Blossom Aroma Superslims described as “light”
Golden Gate Blue described as “light,” “milder”
Silk Cut Silver described as “light”
Kent Blue Futura described as “light,” and “mild”
Salem Gold described as “mild”
Winston XS Blue described as “milder,” and “light”
Karelia White described as “mild,” and “lightest”
Karelia Blue 100’s described as “mild”
Camel White described as “light”
American Legend White described as “light”
Davidoff ID Blue described as having “lower amounts of Tar and Nicotine”
Winston Blue Super Slims described as having “lower tar and nicotine levels”
State Express 555 Mandarin International Pearl described as having “lower levels of Nicotine and Tar”
Silk Cut Silver described as “low in nicotine and have a low tar content.”
Kent Blue Futura described as having “less tar and nicotine”
Gauloises Blondes Red described as: “low-tar”
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)). Because the website uses the descriptors “light,” “mild,” or similar descriptors for the above listed products, or describes certain products as containing a reduced level of a substance, these products are modified risk tobacco 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.cigs-shop.net, revealed that you offer for sale the following cigarette product: Dunhill International, described as having a “sweet taste of plum extract,” which is purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
If, however, this 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 its labeling or advertising is false or misleading because it makes the representation that the product contains, for example, plum as a characterizing flavor of the tobacco product.
Please note your reference number, RW1500264, in your response and direct your response to the following address:
noc@netrouting.com