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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bashas’ 4/24/14

  

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 

 

WARNING LETTER
April 24 2014
 
VIA UPS
 
Bashas’
Attn: Site Manager
8035 East Indian School Road
Scottsdale, AZ 85251   
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number: 13AZ001154AB 
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Bashas’ 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 December 30, 2013, and January 2, 2014, an inspector representing the FDA completed a two-part inspection of the establishment, located at 8035 East Indian School Road, Scottsdale, AZ 85251. During this inspection the establishment was in violation because you or your employee sold smokeless tobacco 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 December 30, 2013, and January 2, 2014, two-part inspection includes the following: 

1.  A minor was able to buy Red Man smokeless tobacco on December 30, 2013, at approximately 1:55 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 smokeless 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.
 
Previously, on September 22, 2011, CTP issued a Warning Letter to Bashas’ Inc. d/b/a Bashas’ Supermarket #7 for violations observed on June 16, 2011. During that inspection the establishment was in violation because you or your employee sold cigarettes to a minor and failed to check identification to verify purchaser’s age. Subsequently, on December 20, 2012, CTP issued a Warning Letter to Bashas’ for a violation observed on October 12, 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
First
$0.00 w/ warning letter
Second within a 12 month period
$250
Third within a 24 month period
$500
Fourth within a 24 month period
$2,000
Fifth within a 36 month period
$5,000
Sixth within a 48 month period
$10,000

 
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 13AZ001154AB 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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