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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Northwest Tobacco Emporium 11/14/13

  

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 14, 2013 
VIA UPS
 
Northwest Tobacco Emporium    
Attn: Site Manager
645 West Washington Street, Suite #6
Sequim, WA 98382                                            
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13WA004227
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Northwest Tobacco Emporium 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 17, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 645 West Washington Street, Suite #6, Sequim, WA 98382. During this inspection the establishment was in violation because it has a self-service display of cigarette tobacco in a facility not restricted to adults at all times.       
 
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 17, 2013, inspection includes the following: 

1. The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to cigarette tobacco without restricting the facility to adults at all times. Specifically, the inspector observed a display table containing various brands of cigarette tobacco located in an area of the establishment that is open to customers. 

A retailer MUST sell cigarettes, cigarette tobacco, and/or smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer and cannot use a self-service display unless a retailer ensures that minors are neither present nor permitted to enter at any time. Failure to do so violates 21 C.F.R. § 1140.16(c).
 
The establishment fails to ensure that minors are neither present nor permitted to enter at any time. During the inspection, the manager on duty told the inspector that minors are allowed to enter with an adult. Therefore, the establishment is not restricted. It is your responsibility to ensure that no person younger than 18 years of age is present or permitted to enter the establishment at any time, or to ensure that all cigarettes, cigarette tobacco, and/or smokeless tobacco products are only sold in a direct, face-to-face exchange.
 
The listed violation causes your cigarette tobacco to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c). 
 
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 13WA004227 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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