Inspections, Compliance, Enforcement, and Criminal Investigations
Harrington Wine & Liquors, Inc 7/21/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
JUL 21 2011
Harrington Wine & Liquors, Inc.
Attn: Site Manager
10 Summer Street
Chelmsford, MA 01824
Re: Reference Number: 11MA21853
Dear Sir or Madam:
On May 10, 2011, an inspector representing the United States Food and Drug Administration (FDA) completed a compliance check inspection of your establishment located 10 Summer Street, Chelmsford, MA 01824. Your establishment sells cigarettes and/or smokeless tobacco products. The sale, distribution, advertising, and promotion of your tobacco products must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21, Code of Federal Regulations (C.F.R.), Part 1140. You are legally responsible for complying with these regulations and for ensuring that your employees comply with these regulations.
This compliance check inspection revealed that your tobacco products are misbranded within the meaning of section 903(a)(7)(B) of the FD&C Act, 21 U.S.C. § 387c(a)(7)(B), in that they are sold or distributed in violation of 21 C.F.R. Part 1140. The violations identified at your establishment include, but are not limited to, the following:
1. Failure to sell cigarettes or smokeless tobacco in a direct, face-to-face exchange without ensuring that no person younger than 18 years of age is present or permitted to enter, at any time, as required by 21 C.F.R. §§ 1140.16(c)(1) and 1140.16(c)(2)(ii).
For example, your establishment has a self-service display that provides a consumer direct access to tobacco products without your ensuring that no person younger than 18 years of age is present or permitted to enter the establishment at any time. Specifically, you have a wall-mounted display of cigarettes located in a customer accessible part of your establishment. It is your responsibility to take appropriate measures, such as checking identification upon entry, to ensure that no person younger than 18 years of age is present or permitted to enter the establishment at any time.
2. Failure to ensure that all violative self-service displays, advertising, labeling, and other items that are located in your establishment are removed or are brought into compliance with requirements of 21 C.F.R. Part 1140, as required by 21 C.F.R. § 1140.14(e).
For example, the self-service display located in your establishment is violative because you failed to ensure that no person younger than 18 years of age is present, or permitted to enter, at any time and you have not removed it or brought it into compliance with the requirements of 21 C.F.R. Part 1140.
You should immediately correct the violation(s) by ceasing the violative marketing, sale, and/or distribution of tobacco products to consumers at your establishment. Failure to correct the violation(s) may result in regulatory action being initiated by the FDA without further notice. These actions may include, but are not limited to, a civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and explaining your plan for discontinuing the violative marketing, sale, and/or distribution of your tobacco products. As part of your response, please include a phone number and an email address at which we may contact you and make note of any discrepancies in the contact information related to your business or corporate entity.
Your response should specify the reference number identified at the beginning of the letter and be addressed to:
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
The violation(s) discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your tobacco products comply with the applicable provisions of the FD&C Act, as amended by the Tobacco Control Act and applicable regulations.
If you have any questions about the content of this letter, please contact Jill Sager at (301) 796-9197 or via email at Jill.Sager@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products