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  5. smokin4free.com@iprivacyltd.com - 09/30/2014
  1. Compliance Actions and Activities

WARNING LETTER

smokin4free.com@iprivacyltd.com Sep 30, 2014

smokin4free.com@iprivacyltd.com - 09/30/2014


Delivery Method:
Electronic Mail

Recipient:
smokin4free.com@iprivacyltd.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 20993-0002 

SEPT 30, 2014 

VIA Electronic Mail
 
 
To:  support@smokin4free.com

 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.smokin4free.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 (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 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.smokin4free.com, as being 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. Specifically, our review of the website revealed that you sell or distribute cigarette products including, but limited to: Marlboro Silver (“Marlboro Ultra Lights (Silver)”) and further described Marlboro as “lighter” and for “mild smokers,” Bond Special Selection (“Bond Lights (Special Selection)”), Camel Blue (“Camel Lights (Blue)”), Davidoff Gold Slims (“Davidoff Slim Lights (Gold) 100s”), Esse cigarettes described as “mild,” Karelia cigarettes described as “mild” and giving a “mild and cool feeling,” Kent HD Futura (“Kent Premium Lights NR8 (Futura)”), L&M Blue (“L&M Lights (Blue)”), Lucky Strike Blue (“Lucky Strike Lights (Blue)”) and described as “mild,” Magna Blue (“Magna Blue (Lights)”), Monte Carlo cigarettes described as “mild,” More Silver (“More Super Lights (Subtle Silver)”), Pall Mall Super Slims Blue (“Pall Mall Super Slims Blue (Lights)”), Parliament Silver Blue (“Parliament Extra Lights (Silver Blue)”), Sovereign Slims Ultra (“Sovereign Slims Ultra Lights”), and Winston Silver (“Winston Super Lights (subtle silver)”).
 
Additionally, you sell:
  • Aroma Rich Apple Super Slim cigarettes, which are described as having “lower levels of nicotine and tar”
  • Gauloises cigarettes, which are described as “better in terms of health” and that the “filters . . . help reduce the amount of tar and nicotine inhaled, thereby reducing its harmful side effects”
  • Esse cigarettes, which are described as “low- and ultra-low tar cigarettes”
  • Lucky Strike cigarettes, which are described as having “contained less nicotine and tar compared to other brands”
  • Muratti cigarettes, which are described as “contain[ing] a lower amount of nicotine and hence are less harmful to the smoker”
  • President Special Stars, which are described as having “lower content of nicotine”
  • Richmond cigarettes, which are described as having “less quantity of nicotine” and as “us[ing] a platinum filter that impedes penetration of dangerous gases and tars.”
 
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 websiteuses the descriptors “Lights” “mild,” or similar descriptors for the above listed products, presents that the products contain a reduced level of a substance, or presents a reduced exposure to a substance, 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.smokin4free.com, revealed that you offer for salethe following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito(mini), Kiss Super Slims Fresh Apple 100’s, Kiss Super Slims Clubnichka 100’s (strawberry), 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, the 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 product(s) contain, for example, apple, rum cherry, mojito, strawberry, cherry, or mint as a characterizing flavor of the tobacco product(s).
 
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, RW1400235, 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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