• 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

cigarettesbuyer.com 3/23/12

  

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 UPS, VIA Electronic Mail, and VIA Fax
 
To:       CigarettesBuyer.Com
support@cigarettesbuyer.com
 
Mar 23, 2012
 
 
 
WARNING LETTER
 
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website, cigarettesbuyer.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 several of the cigarette products offered for sale on your website 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 the website cigarettesbuyer.com revealed that you offer for sale the following cigarettes: Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Rich Aroma Apple, Rich Aroma Rum & Cherry, Esse Aura Green Apple Super Slims, and Esse Aura Pink Strawberry Super Slims cigarettes which are represented as cigarettes that 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.
 
After the September 22, 2009 effective date for this provision, 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, if your above-listed cigarettes contain strawberry, apple, or rum and cherry flavors that are characterizing flavors of tobacco products, your products are adulterated under 902(5) of the FD&C Act.
 
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, strawberry, or rum and cherry as characterizing flavors 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, VIA Electronic Mail, and VIA Fax
 
cc:
 
Moniker Online Services, Inc.
Moniker Privacy Services
20 SW 27th Avenue
Suite 201
Pompano Beach, FL 33069
cigarettesbuyer.com@monkierprivacy.net
Fax: (954) 969-9155