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  1. Compliance Actions and Activities

WARNING LETTER

www.tobaccosmokes.net


Delivery Method:
Electronic Mail

Recipient:
www.tobaccosmokes.net


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 

 

SEPT 1, 2015

VIA Electronic Mail
 
To: support@tobaccosmokes.net
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.tobaccosmokes.net  and determined that the cigarette and cigarette tobacco and/or roll-your-own tobacco 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, cigarette tobacco, and roll-your-own 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 several cigarette and cigarette tobacco and/or roll-your-own tobacco 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. 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. Finally, FDA has determined that several smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the webpages regarding smokeless tobacco products fail to include any health warning label statements.   
 
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.tobaccosmokes.net, revealed that you sell or distribute cigarettes and cigarette tobacco and/or roll-your-own tobacco,which arelisted or described as being “Light,” “Ultra Light,” or using similar descriptors, for example: “Berley Light Soft 100,” “Berley Ultra Light Soft King,” Camel Blue (“Camel Lights Box”), Capri 120’s (“Capri Filter Lights 120,” “Capri Menthol Light 120”), “Davidoff Premium Light FSC,” “Grand Prix Light SP 100,” Kent HD (“Kent Lights Nr. 1,” “Kent Premium Lights Nr. 8,” “Kent Super Lights Nr. 4”), “Kool XL Blue Mild Box KG FSC,” L&M Marine Blue (“L&M Mixx Blue Marin Super Slims,” also described as “Lights (blue)”), L&M Blue (“L&M Motion Blue (mini),” also described as “Lights (blue)”), Lucky Strike Blue (“Lucky Strike Lights Box”), Marlboro Gold Original (“Marlboro Lights (Gold)”), Marlboro Gold Accent (“Marlboro Accent (Ultra Lights)”), Marlboro (“Marlboro Ultra Lights (Silver)”), “More Light Menthol Box 100,” Pall Mall (“Pall Mall Lights Box,” “Pall Mall Ultra Lights Box”), Pall Mall Blue (“Pall Mall Blue (Lights) Box,” “Pall Mall SS Lights Box”), Parliament Aqua Blue (“Parliament Lights Box”), Parliament Silver Blue (“Parliament Extra Lights Box”), “Shield Ultra Light 100,” “Silver Light Soft King,” “Sonoma Light SP 100,” “Tahoe Light SP King,” “Tareyton Light Soft 100,” “Tucson Ultra Light SP King,” “USA Ultra Light 100,” “U.S.A. Gold Ultra Light 100,” “Vantage Ultra Light 100,” “Viceroy Light Box King,” Vogue brand (described as “light”), “Wave Ultra Light King Box,” and “KY’s Best RYO Light 6 oz.” In addition, you sell or distribute cigarette products that are described as having a reduced level of/exposure to a substance.  Specifically, the website includes the following claims: all light and ultra-light cigarettes are described as having “reduc[ed] tar levels” and “lower nicotine levels”; “Camel 99 Light Box 100,” “Camel Light Box King,” and “Camel Lights 100’s,” described as “Low Tar”; and “L&M Lights (Blue),” “L&M Mixx Blue Marin Super Slims,” “L&M Motion Blue (mini),” “Marlboro Lights (Gold),” “Marlboro Accent (Ultra Lights),” and “Marlboro Ultra Lights (Silver),” described as “low tar.”
 
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,” “Ultra Light,” or similar descriptors to describe these products or describes them as 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 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 100’s (strawberry), Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims, Richmond Cherry Super Slims, and Sobranie Slims Mints.
 
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 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 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, strawberry, cherry, or mint as a characterizing flavor of the tobacco products.
 
Health Warning Statement Violations
 
Additionally, our review of website, http://www.tobaccosmokes.net, revealed that  the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Beechnut, Bruton, Camel, Copenhagen, Cougar, Garrett, Grizzly, Hawken, Honest, Husky, Kodiak, Longhorn, Red Seal, Redwood, Renegade, Rooster, Skoal, and Timberwolf.  Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
 
WARNING: This product can cause mouth cancer.
 
WARNING: This product can cause gum disease and tooth loss.
 
WARNING: This product is not a safe alternative to cigarettes.
 
WARNING: Smokeless tobacco is addictive.
 
A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. § 387c(a)(7)(A)), if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. 
 
Because the webpages regarding smokeless tobacco products donot include any health warnings, your smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).   
 
In addition, we note that you are required to follow all other applicable federal laws and regulations.  For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402), requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco.  Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA. 
 
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 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, RW1500367, 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
 
cc:
 
Wang Zheng
Nicenic International Group Co. Limited
support@nicenic.net
admin@nicenic.net
 
privacy@iisp.com
 
abuse@iweb.com
 
net-admin@noc.privatedns.com
 
root@tobaccosmokes.net