Brookside Cafe 9/27/12

WARNING LETTER

SEP 27, 2012

VIA UPS

Brookside Cafe
Attn: Site Manager
6 Fuller Street
Ludlow, MA  01056

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number:  12MA002805

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Brookside Cafe 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 July 13, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 6 Fuller Street, Ludlow, MA  01056.  During this inspection the establishment was in violation because a minor purchased cigarettes from a vending machine in the establishment, you or your employees failed to check identification to verify purchaser’s age, and the establishment has a vending machine that sells cigarettes 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 violations observed during the July 13, 2012, inspection include the following:

1. A minor was able to buy Marlboro cigarettes on July 13, 2012, at approximately 4:39 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 Marlboro cigarettes on July 13, 2012, at approximately 4:39 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).
 
3. The establishment has a vending machine that provides a consumer direct access to cigarettes without restricting the facility to adults at all times.  Specifically, a minor entered the establishment and purchased cigarettes from the vending machine.

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 vending machine 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. § 1140.14(c).

The establishment fails to ensure that minors are neither present nor permitted to enter at any time.  During the inspection, a minor was able to enter the establishment and purchase cigarettes.  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 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 12MA002805 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