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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vitalie Rotaru 9/30/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

 

VIA UPS and VIA Electronic Mail
 
SEPT 30, 2011
 
Vitalie Rotaru
Main Street
Modena, New York 12548
sales@discount-cigarettes.us
vrotari@gmail.com
 
WARNING LETTER
 
Dear Mr. Rotaru:
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website http://www.discount-cigarettes.us, and determined that your cigarette product(s) listed there are offered for sale to U.S. customers. 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, 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 you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Kiss Strawberry Superslim, Kiss Fresh Apple Superslim, Esse Aura Green Apple, Esse Aura Pink Strawberry, Richmond Cherry, Aroma Rich Apple, Aroma Rich Rum & Cherry, and Lady Rose Slims 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
You describe products that you offer for sale on your website http://www.discount-cigarettes.us as being light, or some variation thereof, by referring to them as such in product advertising and adding the qualifiers “light,” “Lights,” and “Super Lights” to the product descriptions. Specifically, our review of your website revealed that you offer for sale Pall Mall Blue, L&M Blue Label, and Bond Street Fine cigarettes with the following product descriptions:
  • “Pall Mall cigarettes [are] currently sold as a Canadian discount brand in Red (full-flavour) and Blue (light).” [emphasis removed]
  • “Due to new labeling regulations in Europe banning the use of the word ‘lights’ names of some cigarette brands have been changed, i.e. L&M Lights are now L&M Blue Label.”
  • “Bond Street Fine Cigarettes (Super Lights)”
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)). 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 website uses the descriptor “light,” or some variation thereof, for the above-listed products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers 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)).
 
Additionally,our review of your website http://www.discount-cigarettes.us revealed that you offer for sale the following cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product: Kiss Strawberry Superslim, Kiss Fresh Apple Superslim, Esse Aura Green Apple, Esse Aura Pink Strawberry, Richmond Cherry, Aroma Rich Apple, Aroma Rich Rum & Cherry, and Lady Rose Slims. You specifically advertise your Lady Rose Slims cigarettes as “Rose flavor.” 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 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 cigarettes are adulterated.
 
If, however, these cigarettes 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)) as their labeling is false and misleading because it makes the representation that the products contain apple, cherry, rose, rum & cherry, or strawberry as a characterizing flavor of the tobacco products.
 
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 importation 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. 
 
Please direct your response to the following address:
 
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850. 
 
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.    
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
 
VIA UPS
 
cc:
 
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