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  5. www.smokingline.com - 10/27/2015
  1. Compliance Actions and Activities

WARNING LETTER

www.smokingline.com Oct 27, 2015

www.smokingline.com - 10/27/2015


Delivery Method:
ELECTRONIC MAIL

Recipient:
www.smokingline.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 

 

OCT 27, 2015 

VIA ELECTRONIC MAIL
 
To:       
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.smokingline.com and determined that the cigarette 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 cigarettes, are subject to Chapter IX of the FD&C Act under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
FDA has determined that several 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. Additionally, FDA has determined that several 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.
 
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.smokingline.com, revealed that you sell or distribute cigarette products that are listed or described as being “light,” “mild,” or similar descriptors, for example: “Classic Blue” (described as “lighter”), “Esse Super Slims Menthol 100s” (described as “light”), Pall Mall (“Pall Mall Lights (Blue)”), “Richmond Cherry Gold Super Slims 100s” (described as “mild”), “West Rich Blue” (described as “superlight”), and “Winston Classic” (described as “superlight”). You also sell or distribute cigarette products under the heading “Lights Cigarettes,” for example: “Bond Special Selection,” “Chesterfield Classic Blue,” “Davidoff Gold,” “Dunhill Fine Cut Dark Blue,” “Kent HDs Blue Super Slims 100s,” “Kiss Dessert (mini),” “Lucky Strike Original Silver,” “Marlboro Gold,” “Parliament Aqua Blue,” “Sobranie Blue,” “West Black Compact,” “Winston Super Slims Blue 100’s,” “Camel Black Super Slims 100s,” “Magna Balanced Blue,” “More Balanced Blue,” “Pall Mall Blue,” “Richmond Cherry Super Slims 100s” (also described as “mild”), “Richmond Klan” (also described as “mild”), and “Viceroy Blue.” Finally, you sell or distribute cigarette products under the heading “Ultra Lights Cigarettes,” for example: “Bond Special Compacts,” “Camel Black mini,” “Chesterfield Classic Bronze,” “Davidoff Blue,” “Dunhill Fine Cut Azure,” “Kent HDi Silver,” “L&M Motion Blue (mini),” “L&M Motion Silver (mini),” “Parliament Silver Blue,” “Vogue Super Slims Lilas 100’s,” “West Fusion White,” “Winston Silver,” “Marlboro Silver,” “More Subtle Silver,” “Pall Mall Azure,” “Richmond Platinum Filter” (also described as “mild”), “Sobranie Gold,” and “Viceroy Silver.”  
 
In addition, you sell or distribute cigarette products that are described as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance.  Specifically, the website includes the following claim: Glamour Super Slims 100s, described with the following statement: “‘after a couple of months from cigarettes I started terrible cough and had to change the brand. ‘Glamour’ I smoke anymore 7 years and no cough.”  You also offer for sale West Black Compact, West Fusion White, West White Compact, West Red, West Silver, West Blue, West Rich Blue, Winston Blue, Winston Classic, Winston White, Winston Super Slims 100s, Winston Silver, Winston XS and Winston XSense, described as having a “carbon filter, well, at least a little protection from harm.”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)).
 
The above listed products are modified risk tobacco products because the website uses the descriptors “light,” “mild,” or similar descriptors to describe these products or describes them as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. 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.smokingline.com, revealed that you offer for sale or distribute the following cigarette products: Aroma Rich Apple, Aroma Rich Rum Cherry, Kiss Mohito (mini), Kiss Super Slims Clubnichka 100s, Kiss Super Slims Fresh Apple 100s, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, Richmond Cherry 4 and Richmond Cherry. 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.
 
Cigarettes 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 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, mojito, strawberry, or cherry 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 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 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, RW1500402, 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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TLD Registrar Solutions Ltd.
 
Hostinger NOC
 

 

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