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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

AJ Cigarettes 4/27/12

  

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 Electronic Mail

APR 27 2012


To: AJ Cigarettes
sales@ajcigarettes.com


WARNING LETTER


The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website www.ajcigarettes.com and determined that your cigarette products listed 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 your Black Bat Vanilla Mint Filter King (Flip Top) 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.


Our review of www.ajcigarettes.com revealed that you offer for sale Black Bat Vanilla Mint Filter King (Flip Top) cigarettes, which are purported 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 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 vanilla mint 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 vanilla mint as a characterizing flavor of the tobacco product.


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 lbarra-Pratt at (301) 796-9235 or via email at Elenita.lbarraPratt@fda.hhs.gov.
 

 

Sincerely,

/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

 

VIA UPS, VIA Electronic Mail, and VIA Fax


cc:


Whois Privacy Protection Service, Inc.
PMB 368, 14150 20th St- F1
c/o ajcigarettes.com
Bellevue, WA 98007


Fax No: 425-974-4730


Whois Agent
bhddpyff@whoisprivacyprotect.com


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850 East Parkridge Avenue, Suite 103
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