• 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

Cigarette Box II 1/24/13

  

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 

 

WARNING LETTER
JAN 24, 2013 
VIA UPS
 
Cigarette Box II
Attn: Site Manager
3668 Castro Valley Boulevard
Castro Valley, CA 94546
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13CA001769
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Cigarette Box II was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.
 
On January 10, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 3668 Castro Valley Boulevard, Castro Valley, CA 94546. During this inspection the establishment was in violation because it offered flavored cigarette tobacco for sale.    
 
This inspection revealed that the establishment sells, distributes, advertises, and/or promotes cigarettes, cigarette tobacco, and/or smokeless tobacco, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the January 10, 2013,inspection includes the following:
 

1. Our compliance check inspection revealed that you offer for sale Wildfire Cherries Jubilee cigarette tobacco, Wildfire Island Margarita cigarette tobacco, and Wildfire Sunrise Strawberry cigarette tobacco, which are purported to contain artificial or natural flavors that are characterizing flavors 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, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
 
As of September 22, 2009, cigarettes and cigarette 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 packages of flavored cigarette tobacco are adulterated.
 
If, however, these packages of cigarette tobacco 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 cherry, margarita, and strawberry as characterizing flavors of the tobacco products.
 
A retailer must NOT offer for sale any cigarettes or cigarette tobacco that contains an artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the product. In addition, a retailer must NOT offer for sale any cigarettes or cigarette tobacco for which the label or labeling is false or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).
 
You should immediately correct the violation listed above. Failure to correct the violation may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
 
The violation indicated in this letter may not be a complete list of violations at the establishment. The establishment must comply with all the applicable laws and regulations. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts.    
 
You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violation and preventing future violations. Include a telephone number and address. Note your reference number of 13CA001769 in your response and mail it to:
 
SP-WL Response
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
 
If you have any questions, contact Ms. Sashka Mannion at (301) 796-3010 or via email at Sashka.Mannion@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.
 
 
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
Return to Tobacco Retailer Warning Letters Main Page