• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

az-smokes.com 9/5/14

  

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 20993-0002 

SEPT 5, 2014

VIA Electronic Mail
 
 
To: support@az-smokes.com
      support@az-smokes.net
 
 
WARNING LETTER
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.az-smokes.com and http://www.az-smokes.net, and determined that 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 your cigarette products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(a).  Additionally,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 your Sobranie Mint cigarettes 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.
 
 
Sales to Minors Violations
 
FDA’s investigation of your website, http://www.az-smokes.com revealed that you sold a tobacco product to a minor. Specifically, during our investigation of your website, a minor purchased a tobacco product from this website. No retailer may sell cigarettes or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a).   Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140.  A person younger than 18 years of age purchased Lucky Strike Red cigarettes from your websiteBecause these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
Modified Risk Tobacco Product Violations
 
You sell or distribute products that you describe on your websites, http://www.az-smokes.com and http://www.az-smokes.net, as being light, ultra light, extra light, super light, or mild by referring to them as such in product labeling or advertising and adding the qualifiers “Light,” “Ultra Light,” “Extra Light,” “Super Light,” or “Mild,” to the product names. Specifically, our review of your websites revealed that you sell or distribute products listed as: “Camel Mild” (Camel Orange), “Davidoff Lights” (Davidoff Gold), “Davidoff Lights Slims” (Davidoff Slims), Gala brands described as “light,”  “Lucky Strike Lights” (Lucky Strike), “Marlboro Gold Lights” (Marlboro Gold), “Marlboro Lights Menthol” (Marlboro Menthol), Nat Sherman described as “milder blends,” “Pall Mall Lights” (Pall Mall), “Pall Mall Super Slims Lights,” “Parliament Lights,” “Parliament Extra Lights,” “Rothmans Red Special Mild” (Rothmans), “Strand Lights” (Strand Blue), “Viceroy Lights,” “Viceroy Ultra Lights,” “Winston Lights” (Winston), and “Winston Super Lights” (Winston Super). Additionally, you describe Gala brand cigarettes as “a low nicotine cigarette…”.
 
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 websites use the descriptors “Light,” “Ultra Light,” “Extra Light,” “Super Light,” or “Mild,” or similar descriptorsor describe a product as containing a reduced level of a substance 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 investigation of your website, http://www.az-smokes.comrevealed that you offer for sale Sobranie Mints cigarettes, which arepurported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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 Sobranie Mints cigarettes are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, the cigarette product does not contain a characterizing flavor, it is 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 its labeling or advertising is false or misleading because it makes the representation that the product contains, for example, mint as a characterizing flavor of the tobacco product.
 
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, RW1400190, 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:
 
Marc.haven@gmail.com
abuse@enom.com
gabi@alsysdata.net
domainadmin@alsys.ro
 

 

 
-