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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.200cigarettes.biz 7/9/14

  

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

JUL 9, 2014

VIA Electronic Mail
 
 
To: support@200cigarettes.biz  
 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.200cigarettes.biz, 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 (the 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 cigarettes 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. Additionally, FDA has determined that several of your cigarette 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. 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 products that you describe on the website, http://www.200cigarettes.biz, as being light, super light, ultra light, or mild, by referring to them as such in product labeling or advertising and adding the qualifiers “Lights,” “Super Lights”, “Ultra Lights,” or “Mild” to the product names or product descriptions. Our review of the website revealed that you sell or distribute, including but not limited to, cigarette products listed as: “Bond Lights (Special Selection),” Bond Fine (Super Lights) described as “are very light,” Karelia light cigarettes described as “Karelia light cigarettes are mild,” “Kent Super Lights Nr.4 (Neo),,” “L&M Lights (Blue),” “Lucky Strike Lights (Blue),” “Marlboro Accent (Ultra Lights),” “Pall Mall Ultra Lights (Amber),” Sovereign Slims Ultra described as “Sovereign Slim Ultra Lights 100’s,” Virginia Slims brand described as “Virginia Slims are mild,” and “Winston Lights (Balanced Blue).”
 
You also describe cigarette products you offer for sale on your website as having a lower risk of tobacco-related disease or being less harmful, containing a reduced level of a substance than one or more other commercially marketed tobacco products. You offer for sale the following products described as:  
 
  • “Virginia Slims are mild, perfect for an easier and healthier smoking experience.”
  • “the Bond Mild (Light) cigarettes are as named are mild as they contain lower amount of nicotine and tar; and similarly Bond Fine (Super Lights) are very light and it caters to people who like very low amount of nicotine and tar.”
  • “Karelia light cigarettes are mild and they contain lower nicotine than the classic type.”
  • “The Light variety was targeted at people who prefer mild and soft flavored cigarettes. The main reason being they contain less nicotine and tar compared to regular cigarettes.”
  • “And for smokers who like light variety, this brand has introduced Muratti One cigarettes which contain extremely low rate of nicotine.”
  • “The light variants are made up of low levels of tar and nicotine; this reduces the harmful effects of these two substances on the human body.”
 
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 the website uses the descriptors “Lights,” “Super Lights,” “Ultra Lights,” “Mild” or similar descriptors, and describes products as having a lower risk of tobacco-related disease or being less harmful or containing a reduced level of a substance than one or more other commercially marketed tobacco products, for the above listed products, 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)).
 
Flavored Cigarette Violations
 
Additionally,our review of the website,http://www.200cigarettes.biz, revealed that you offer for sale the following cigarettes: “Aroma Rich Apple,” “Aroma Rich Rum & Cherry,” “Kiss Mohito (mini),” “Kiss Super Slims Clubnichka 100’s” (strawberry image), “Kiss Super Slims Fresh Apple 100’s,” “Richmond Cherry,” “Richmond Cherry 4,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry Super Slims 100s,” and “Sobranie Slims Mints 100’s,” which 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.
 
As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco 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 cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette 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, apple, rum & cherry, mohito, strawberry, cherry, or mint 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 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, RW1400177, in your response and direct your response to the following address:
 
PAL-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
 
cc:
 
support@200cigarettes.biz
 
support@iprivacyltd.com
 
abuse@joker.com
 
abuse@noc.privatedns.com