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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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University Smoke Shop 11/7/13

  

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
November 7 2013
 
VIA UPS
 
University Smoke Shop
Attn: Site Manager
4519 University Way Northeast
Seattle, WA 98105
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13WA002973
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that University Smoke Shop 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 September 18, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 4519 University Way Northeast, Seattle, WA 98105. During this inspection the establishment was in violation because it offered flavored cigarettes 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 September 18, 2013, inspection includes the following: 

1.  Our compliance check inspection also revealed that you offer for sale Sweet Dreams Mint flavored 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, 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 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 mint 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 13WA002973 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 Steven Singhaus at (301) 796-6829 or via email at Steven.Singhaus@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
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