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WARNING LETTER

marcigs.com Dec 22, 2014

marcigs.com - 12/22/2014


Delivery Method:
Electronic Mail

Recipient:
marcigs.com


United States

Issuing Office:
Center for Tobacco Products

United States


  

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

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

DEC 22, 2014

VIA Electronic Mail
 
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.marcigs.com, and determined that your cigarette products listed there are offered for sale 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 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You sell or distribute cigarette products that you describe on the website, http://www.marcigs.com, as being light or mild by referring to them as such in product labeling or advertising. Specifically, our review of the website revealed that you sell or distribute products listed as: Camel described as “Camel Mild Cigarettes,” Camel Essential Blue described as “light,” Camel White Filter described as “light” and “mild,” Marlboro Lights White Filter described as “light,” Parliament Lights/Blue 100’s described as “Parliament Lights/Blue 100’s Box Cigarettes” and “light” and Winston Blue Super Slim described as “light.” 
 
In addition, you offer for sale or distribute cigarette products on your website described as containing a reduced level of a substance or presenting a reduced exposure to a substance. Specifically, Benson & Hedges Lights Gold King Box are described as “lower levels of Tar and Nicotine”; Benson & Hedges Special Filter King Box are described as having a “smart filter for maximum Tar protection”; Camel Mild are described as “lower level of Nicotine and Tar”; Camel Essential Blue are described as “less quantities and taste of Nicotine and Tar”; Camel Light/Blue Subtle Flavour Box are described as “lower level of Nicotine and Tar”; L&M Blue/Lights are described as “lower level of Nicotine and Tar”; Marlboro Lights White Filter are described as “lower level of Nicotine and Tar”; Parliament Lights/Blue 100’s Box are described as “lower level of Nicotine and Tar”; Parliament Light/Blue King Size are described as “reduced Nicotine and Tar levels”; Winston Light/Blue King Size are described as “low level of Nicotine and Tar”; and Winston XS NanoKings (mini) are described as “lower level of Nicotine and Tar.”
 
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)). 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)). Because your websiteuses the descriptor “light,” “mild,” or similar descriptors or describes products as containing a reduced level of a substance or presenting a reduced exposure to a substance or less harm, 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)).
 
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 promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in 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 promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1400251, 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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Confluence Networks Inc.

 

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