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WARNING LETTER

Amarico SA 07/08/2015

Amarico SA - 08/07/2015


Delivery Method:
ewinpay@yahoo.com

Recipient:
Amarico SA


United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

AUG 7, 2015 

VIA Electronic Mail
 
Amarico SA
 
 
WARNING LETTER
 
 
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.   
 
Modified Risk Tobacco Product Violations
 
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.”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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 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)).
 
Flavored Cigarette Violations
 
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.
 
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:
 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
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.
 
Health Warning Statement Violations
 
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:
 
WARNING: This product can cause mouth cancer.
 
WARNING: This product can cause gum disease and tooth loss.
 
WARNING: This product is not a safe alternative to cigarettes.
 
WARNING: Smokeless tobacco is addictive.
 
A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. § 387c(a)(7)(A)), if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. 
 
Because your webpages regarding smokeless tobacco products do not include any health warnings, your smokeless tobacco products aremisbranded 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)).   
 
In addition, we note that you are required to follow all other applicable federal laws and regulations.  For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402), requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco.  Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
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 submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500316, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
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