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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Walgreens #10438 10/18/12

  

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

OCT 18 2012

VIA UPS

Walgreens #10438
Attn: Site Manager
203 South Street
Morristown, NJ  07960

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violations 
     Reference Number:  12NJ005039

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Walgreens #10438 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 August 06, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 203 South Street, Morristown NJ  07960.  During this 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.

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 violations observed during the August 06, 2012, inspection include the following:

1. A minor was able to buy Newport Box 100s cigarettes on August 06, 2012, at approximately 2:01 PM ET 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).
    
2. No one in the establishment checked the minor’s identification before the sale of Newport Box 100s cigarettes on August 06, 2012, at approximately 2:01 PM ET.

A retailer MUST check a photographic identification that includes a date of birth for any person under the age of 27 who attempts to purchase cigarettes, cigarette tobacco, and/or smokeless tobacco.  Failure to do so violates 21 C.F.R. § 1140.14(b)(1).

The listed violations cause your cigarettes to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c). 

You should immediately correct the violations listed above.  Failure to correct the violations 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 violations 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 violations and preventing future violations.  Include a telephone number and address.  Note your reference number of 12NJ005039 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 Carisa Bergen at (301) 796-2990 or via email at Carisa.Bergen@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

 

cc: James D. Figura
     Walgreen Co.
     104 Wilmot Road, MS #1434
     Deerfield, IL  60015

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