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  5. http://www.cigars-habanos.com - 07/16/2015
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WARNING LETTER

http://www.cigars-habanos.com 16/07/2015

http://www.cigars-habanos.com - 07/16/2015


Delivery Method:
Electronic Mail

Recipient:
http://www.cigars-habanos.com


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 

 

 

JUL 16, 2015
VIA Electronic Mail
 
Luis Neves Ferreira
Puros Premium Cigars
 
 
WARNING LETTER
 
Dear Mr. Ferreira:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites, http://www.cigars-habanos.com, http://www.cigarshabanos.eu, and http://www.puros.pt, and determined that the cigarette tobacco and/or roll-your-own 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 cigarette tobacco and roll-your-own tobacco, 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.cigars-habanos.com, http://www.cigarshabanos.eu, and http://www.puros.pt, 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 you present loose tobacco products containing the description “premium rolling tobacco,” that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including Golden Virginia and Mac Baren. The overall presentation of these products on the websites strongly suggests 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 products are listed under the “Rolling Tobacco” category of the website, and are sold alongside other cigarette making accessories, such as electric cigarette injectors, rolling machines, tubes, and filters. Therefore, the products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined thatyour cigarette tobacco and/or roll-your-own tobacco products aremisbranded 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.  Additionally, FDA has determined that several 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.
 
Sales to Minors Violations
 
FDA’s investigation of the website, http://www.cigars-habanos.com, revealed that you sold cigarette tobacco and/or roll-your-own tobaccoto a minor. Specifically, during our investigation of http://www.cigars-habanos.com, a person younger than 18 years of age purchased Golden Virginia from the website.  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 this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
Flavored Cigarette Violations
 
Additionally, our review of the websites, http://www.cigars-habanos.com, http://www.cigarshabanos.eu, and http://www.puros.pt, revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco products: Mac Baren Cherry Choice and Mac Baren Vanilla Choice. 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.
 
Cigarette tobacco and/or roll-your-own tobacco that are distributed or offered for sale 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 tobacco and/or roll-your-own tobacco products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, the 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, cherry or vanilla, as a characterizing flavor of the tobacco products.
 
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), and 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 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, RW1500330, 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
 
 
 
VIA Electronic Mail
 
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Puros Premium Cigars, Lda.
 
Domain.com, LLC
 
Almouroltec Servicos de Informatica e Internet LDA
 
Register.it S.p.A.
 
TrumaxX - Consultoria Informática, Lda.

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