Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alexander-carter-05012015
Timestamp: 2020-02-27 19:56:26
Document Index: 532241784

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

Alexander Carter - 05/01/2015 | FDA
Alexander Carter - 05/01/2015
Alexander Carter May 01, 2015
cigdns@gmail.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.cigarena.com, http://www.cigshop.net, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.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 your Camel Filters cigarettes from http://www.cigarettes-shop.com and your American Legend cigarettes from http://www.discountcigarettesmall.com are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age. 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.
FDA’s investigation of the websites, http://www.cigarettes-shop.com and http://www.discountcigarettesmall.com revealed that you sold cigarette products to a minor. Specifically, during our investigation of these websites, a person younger than 18 years of age purchased Camel Filters cigarettes from the website, http://www.cigarettes-shop.com and American Legend cigarettes from the website, http://www.discountcigarettesmall.com. No retailer may sell cigarettes, cigarette tobacco and/or roll-your-own tobacco, 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. 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)).
Additionally, our review of the websites, http://www.cigarena.com, http://www.cigshop.net, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.com, revealed that you sell or distribute products listed or described in product labeling or advertising as being “light” or “mild” or using similar descriptors, including, for example::
Armada Blue (“Lighter”)
Beratt (“light”)
Blood Blue (“lighter”)
Chesterfield (“light,” “lightest,” “mild,” and “mildness”)
Classic (“milder” and “lightest”)
Doina Lux Premium (“Lighter”)
Esse (lighs) (sic)
Glamour Superslims Amber (“light”)
Golden Gate Blue (“lighter”)
Harpy 4 (“lightest”)
Hilton Silver (“the Lights are in a brilliant Silver one.”)
L&M Blue Label (“L&M Lights are now L&M Blue Label”)
LD Blue (“milder”)
Monte Carlo Blue (“lighter”)
OK Slims Blue (“mild”)
President Special (“lighter”)
Prima Lux Gold (“lighter”)
Red & White Shine Super Slims (“lighter”)
Style Selection Rose Superslims 100’s (“lighter”)
Titan Piano (“lightest”)
Vogue brand cigarettes (“light”)
West Silver (“formerly under west Light”) (sic)
Wont Silver (“lightest”)
In addition, you sell or distribute cigarette products that are described in product labeling or advertising as presenting a lower risk of tobacco-related disease, being less harmful than one or more other commercially marketed tobacco products, or having a reduced level of/exposure to a substance. Specifically, you offer for sale the following products:
Beratt brand cigarettes, described as “use of modern technology materials and equipment, as well as an effective filter system in the design of cigarettes BERATT, consisting of a ventilated composite triple acetate filter with activated carbon - Triple Acetat + Coal Filter” - ensure that the complex European level of quality and a wide range of light moderate strength and low rates of noxious substances in cigarette smoke”, which decrease in a linear sequence from BERATT XXL to BERATT L” (sic).
Cigaronne brand cigarettes, described as “Less nicotine content.”
Esse brand cigarettes, described as “low and ultra-low tar.”
Kent brand cigarettes, described as “You’ll realize that your lung condition will be out of any danger.”
Plai brand cigarettes, described as “contain no harmful substances.”
Vogue brand cigarettes, described as “small amount of tar and nicotine.”
Because the websites use the descriptors “light,” “mild,” “super lights,” “mildness,” or similar descriptors, and claims of presenting a lower risk of tobacco-related disease, being less harmful than one or more other commercially marketed cigarette products, or having a reduced level of/exposure to 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 websites, http://www.cigarena.com, http://www.cigarettesfor.us, http://www.cigarettesforsales.com, http://www.discountcigarettesbox.com, http://www.online-cigarettes-shop.com, http://www.discountcigarettesmall.com, http://www.cigarettes-shop.us, http://www.cigarettesmax.com and http://www.best-buy-cigarettes.com, revealed that you offer for sale the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Esse Aura Green Apple, Esse Aura Pink Strawberry, Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Kiss Mohito, Richmond Cherry, Richmond Cherry Gold, and Richmond Superslim Cherry.
Cigarette products 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, cherry, mojito, rum & cherry, or strawberry, as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500279, in your response and direct your response to the following address:
vrotari@gmail.com
support@cigarena.com
support@cigshop.net
support@cigarettesfor.us
support@discountcigarettesbox.com
support@online-cigarettes-shop.com
support@discountcigarettesmall.com
support@cigarettes-shop.us
support@cigarettesmax.com
support@best-buy-cigarettes.com
abuse@hostingsolutionsinternational.com
Alexander Carter - Close Out Letter 8/21/15