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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Safeway 2/12/14


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 


February 12 2014
Attn: Site Manager
1751 Highway 95
Bullhead City, AZ 86443    
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13AZ000572AB
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Safeway 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 October 22, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 1751 Highway 95, Bullhead City, AZ 86443. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor.
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 October 22, 2013, two-part inspection includes the following: 

1.  A minor was able to buy Camel Crush Regular Fresh cigarettes on October 22, 2013, at approximately 3:14 PM in the establishment.  

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(a).
The listed violation causes your cigarettes to be “misbranded” under section 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. 
Previously, on July, 26, 2012, CTP issued a Warning Letter to Safeway for a violation observed on June 4, 2012. During that inspection the establishment was in violation because you or your employee sold cigarettes to a minor. You are receiving another Warning Letter because the violation observed during your most recent inspection occurred outside the statutory period for FDA to seek a CMP at this time. Please be advised that additional violations observed during any subsequent inspection may lead to a CMP, according to the schedule provided below,no-tobacco-sale order, seizure, and/or injunction.
The CMP schedule is as follows: 

Number of Violations
Civil Money Penalty
$0.00 w/ warning letter
Second within a 12 month period
Third within a 24 month period
Fourth within a 24 month period
Fifth within a 36 month period
Sixth within a 48 month period

See 21 C.F.R. § 17.2; Guidance for FDA and Tobacco Retailers, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers, September 2013 (available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
We will periodically inspect your establishment and review your promotional activities (e.g., website{s}) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. 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. Specifically, Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents provides additional information on compliance with retailer responsibilities http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm252758.htm.
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 13AZ000572AB 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 Aaron Weisbuch at (301) 796-9362 or via email at Aaron.Weisbuch@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.
 Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products 
cc:      William Harris
           Senior Corporate Counsel
           Safeway Inc.
           Legal Division
           5918 Stoneridge Mall Road
           Pleasanton, CA 94588-3229


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