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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Blue Plate Cafe 8/23/12

  

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

AUG 23, 2012

VIA UPS

Blue Plate Cafe
Attn: Site Manager
180 Woodford Avenue
Plainville, CT  06062

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number: 12CT000503

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Blue Plate 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 April 25, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 180 Woodford Avenue, Plainville, CT  06062.  During this inspection the establishment was in violation because it 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 violation observed during the April 25, 2012, inspection includes the following: 

1. The establishment has a vending machine that provides a consumer direct access to cigarettes without restricting the facility to adults at all times.

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, the manager on duty told the inspector that minors are allowed to enter with a parent.  Therefore, the establishment is not restricted.  The signage on the vending machine stating that it is illegal for anyone under 18 to possess or purchase tobacco products is insufficient to meet the requirements of the law.  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 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.

Additionally, the establishment has a vending machine with selection buttons marked “Marlboro Lights,” “Marlboro Lights 100’s” and “Merit Ultra Lights.”  Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not match the corresponding product are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c) in that the name on the button is false and/or misleading.

A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco for which the label, labeling, or advertising is false and/or misleading.  Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).  However, retailers are allowed to sell products marked “low,” “light,” or “mild” by the manufacturer if the product was manufactured before June 22, 2010, and distributed by the manufacturer before July 22, 2010.  If the products do not meet those criteria, they are not covered by the limited exception described above.  Therefore, if the packages from the manufacturer do not say “Marlboro Lights,” “Marlboro Lights 100’s” or “Merit Ultra Lights,” your vending machine selection buttons cannot say “Marlboro Lights,” “Marlboro Lights 100’s” or “Merit Ultra Lights.”

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 12CT000503 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 Ms. Sashka Mannion at (301) 796-3010 or via email at Sashka.Mannion@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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