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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CigarWebService 6/25/12

  

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

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

VIA UPS and Electronic Mail

CigarWebService   
Karel Van der Peijl     
Turfschip 199     
Amstelveen, 1186 XH
Netherlands

To:  webmaster@cigarwebshop.nl

WARNING LETTER

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites, http://www.cigarwebshop.net, http://www.cigarwebshop.com, http://www.heerenvanruysdael.com, http://www.rookwaren.com, and http://www.tabakwebshop.com, and determined that your cigarette tobacco products listed are offered for sale to U.S. customers.  FDA believes these websites are affiliated with one another because Cigar Web Service states on these websites that it owns these websites, and these websites have the same contact information, registrant, registrar, IP address, website operator, host, and mail service.  Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and 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 and cigarette 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 your Brookfield cigarette tobacco is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote it as a modified risk tobacco product without an FDA order in effect that permits such promotion.  Additionally, FDA has determined that your Pink Elephant Vanilla Flavor cigarettes 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)).  You can find the FD&C Act and the Code of Federal Regulations through links on FDA’s homepage at http://www.fda.gov.

You describe a product that you offer for sale on your websites, http://www.cigarwebshop.net, http://www.cigarwebshop.com, http://www.heerenvanruysdael.com, http://www.rookwaren.com, and http://www.tabakwebshop.com, as being mild by referring to it as such in product advertising and adding the qualifier, “mild,” to the product name.  Specifically, our review of your websites revealed that you offer for sale the following cigarette tobacco: “Brookfield (mild American blend).”

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)). 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 your websites use the descriptor “mild”  for the above-listed product, the product is a modified risk tobacco product. Because these products are offered for sale to U.S. customers 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, review of your websites, http://www.cigarwebshop.net, http://www.cigarwebshop.com, http://www.heerenvanruysdael.com, http://www.rookwaren.com, and http://www.tabakwebshop.com, revealed that you offer for sale Pink Elephant Vanilla Flavor cigarettes, 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:

[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.

As of September 22, 2009, cigarettes 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 cigarettes are adulterated.

If, however, these cigarettes 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)) as their labeling is false and misleading because it makes the representation that the product contains vanilla as a characterizing flavor of the tobacco product. 

You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on these websites, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 importation 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 promotion, advertising, sale, and/or distribution of these tobacco products. 

Please note your reference number, RW1200019, in your response and direct your response to the following address:

PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850. 

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.    

Sincerely,

/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

 


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