Discount Tobacco Bristol 5/2/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
May 2 2013
Discount Tobacco Bristol
Attn: Site Manager
123 Farmington Avenue P-12
Bristol, CT 06010
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 13CT000585AB
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Discount Tobacco Bristol 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 January 2 and 16, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 123 Farmington Avenue P-12, Bristol, CT 06010. 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, and because the establishment has self-service displays of cigarette tobacco 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 January 2 and 16, 2013, two-part inspection include the following:
1. A minor was able to buy Pyramid Blue Kings Box cigarettes on January 2, 2013, at approximately 10:36 AM 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 Pyramid Blue Kings Box cigarettes on January 2, 2013, at approximately 10:36 AM 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 self-service displays or “impersonal” modes of sale that provide a consumer direct access to cigarette tobacco without restricting the facility to adults at all times. Specifically, the inspector observed customer-accessible cigarette tobacco for sale on the main sales floor.
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 self-service display 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. § 1140.16(c).
The establishment fails to ensure that minors are neither present nor permitted to enter at any time. On January 2, 2013, a minor was able to enter the establishment. Additionally, on January 16, 2013, the manager on duty told the inspector that minors are allowed to enter with an adult. 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 and cigarette tobacco 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 13CT000585AB in your response and mail it to:
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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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