Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amarico-sa-08072015
Timestamp: 2019-06-16 22:49:21
Document Index: 259565585

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 4402']

Amarico SA - 08/07/2015 | FDA
Amarico SA - 08/07/2015
Amarico SA 07/08/2015
ewinpay@yahoo.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites, www.cigarettes-enligne.biz, www.achat-cigarettes.net, www.euro-cig.com, www.la-civette.euro-cig.com, www.online-cigarettes-tobacco.com, www.cheapcigs.eu, www.goodsmoking.com, www.all-cigs.com, www.cigarettes.euro-cig.com, www.sale.euro-cig.com, www.cigarettes.all-cigs.com, and www.cigs.euro-cig.com, and determined that the cigarette, cigarette tobacco and/or roll-your-own tobacco, and smokeless tobacco 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, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco 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 the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, offer for sale or distribute cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.”
We note that on the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, you present loose tobacco products that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including Domingo, Excellent, Harvest, and Mac Baren. The overall presentation of these products on the websites strongly suggest that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, the websites offer for sale or distribute “Domingo Tobacco”; “Excellent Tobacco,” with “ROLL YOUR OWN” on product images; “Harvest Tobacco”; and “Mac Baren Tobacco,” with “PREMIUM ROLLING TOBACCO” on the product images. Therefore, the products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
FDA has determined that several cigarette products areadulterated 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. FDA has also determined that several cigarette and cigarette tobacco and/or roll-your-own tobacco 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. Finally, FDA has determined that several smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the webpages regarding smokeless tobacco products fail to include any health warning label statements.
Our review of the websites, www.cigarettes-enligne.biz, www.achat-cigarettes.net, www.euro-cig.com, www.la-civette.euro-cig.com, www.online-cigarettes-tobacco.com, www.cheapcigs.eu, www.goodsmoking.com, www.all-cigs.com, www.cigarettes.euro-cig.com, www.sale.euro-cig.com, www.cigarettes.all-cigs.com, and www.cigs.euro-cig.com, revealed that you sell or distribute the following cigarette products, which are described as being “Lights”: Ardath (“Ardath Lights”). Additionally, our review of http://www.cigarettes-enligne.biz revealed that you sell or distribute the following cigarette product: Cigaronne (“Cigaronne Exclusive Slims Lights”). Finally, our review of the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, revealed that you sell or distribute the following cigarette product: Lambert & Butler Gold (described as “light”). In addition, you sell or distribute cigarette products that are described as having a reduced level of/exposure to a substance. Specifically, the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, include the following claims: Silk Cut brand, described as being “low tar,” “lower tar,” and having “half the tar content of stronger brands.”
The above listed products are modified risk tobacco products because the websites use the descriptors “Lights” or similar descriptors, or are described as having a reduced level of/exposure to a substance. 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, www.cigarettes-enligne.biz, www.achat-cigarettes.net, www.euro-cig.com, www.la-civette.euro-cig.com, www.online-cigarettes-tobacco.com, www.cheapcigs.eu, www.goodsmoking.com, www.all-cigs.com, www.cigarettes.euro-cig.com, www.sale.euro-cig.com, www.cigarettes.all-cigs.com, and www.cigs.euro-cig.com, revealed that you offer for sale or distribute cigarette products, for example: Bentoel brand (clove), Class Mild (clove), Djarum brand (clove), Gudang Garam brand (clove), Kiss Clubnichka Superslims (strawberry), Kiss Fresh Apple Superslims, Laguna Mild 16 (Filtered) (clove), Nikki Super 12 (Filtered) (clove), Niko International 12 (Filtered) (clove), Richmond Cherry Gold, Sampoerna brand (clove), Senior 12 (Filtered) (clove), Sukun Executive 12 (clove), Sunkun Orange 10 (unfiltered) (clove), Sumber Baru 12 (Filtered) (clove), U Mild 16 (Filtered) (clove), Ultra Special 16 (Filtered) (clove), Wismilak brand, and X Mild 16 (Filtered) (clove). Review of the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, also revealed that you offer for sale or distribute the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Colhida Cappuccino, Colhida Cherry Brandy, and Gudang Garam International (clove). Review of the website, http://www.cigarettes-enligne.biz, also revealed that you offer for sale or distribute the following cigarette product: Lady Rose (rose flavor). Finally, review of the websites, http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com, revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco products: Domingo Mango, Domingo Strawberry, Excellent Apple, Excellent Cherry, Excellent Mango, Excellent Vanilla, Harvest Cherry, Harvest Coffee, Harvest Peach, Harvest Strawberry, Harvest Vanilla, Mac Baren Cherry Choice, Mac Baren Vanilla Choice 40 gr., and Mac Baren Vanilla Choice 50 gr.
Cigarettes and cigarette tobacco and/or roll-your-own tobacco that are distributed or 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 cigarettes and cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette and cigarette tobacco and/or roll-your-own tobacco 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, clove, cappuccino, tea, strawberry, cherry, apple, rum & cherry, cherry brandy, rose, mango, vanilla, coffee, or peach as a characterizing flavor of the tobacco products.
Additionally, our review of http://www.cigarettes-enligne.biz and http://www.cigarettes.all-cigs.com revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Gawith Apricot, Gletscher Prise, Ozona Cherry, and Ozona President. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on these websites, on any other websites (including e-commerce, social networking, or search engine websites),” “in this publication, any other publication, and any other media in which you advertisecomply 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, RW1500316, in your response and direct your response to the following address:
orders@achat-cigarettes.fr
info@achat.cigarettes.fr
denise@euro-cig.com
jasmin@All-Cigs.com
office@euro-cig.com
claudia@euro-cig.com
ramona@euro-cig.com
info@la-civette.euro-cig.com
cigarettes_support@hotmail.com
info@All-cigs.com
orders@all-cigs.com
orders@euro-cig.com
julia@cigarettes.euro-cig.com
office@cigarettes.euro-cig.com
Leann@cigarettes.euro-cig.com
Federica@cigarettes.euro-cig.com
Solange@cigarettes.euro-cig.com
info@cigarettes.euro-cig.com
claudia@euro-cigs.com
office@euro-cigs.com
info@euro-cigs.com
orders@euro-cigs.com
orders@sale.euro-cig.com
info@sale.eurocig.com
office@sale.euro-cig.com
jasmin@sale.euro-cigs.com
jasmin@cigs.euro-cig.com
office@cigs.euro-cig.com
info@cigs.euro-cig.com
info@goodsmoking.com
Ewin Soft and Trade SRL
comarint2001@yahoo.com
EwinPay Ltd.
support@ewinpay.com
contact@psi-usa.info
hostmaster@ip.ro
abuse@ip.ro
hostmaster@jump.ro
mxhost@ro.gmail.com
Feliciano Yuri
info@yfmg.com
AnourAdlani
abuse@iv.lt
miroslav.stanis@balt.net
Amarico SA - Close Out Letter 9/11/15