Inspections, Compliance, Enforcement, and Criminal Investigations
Tobacco Patch 3/14/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
MAR 14, 2013
Attn: Site Manager
10623 Northeast 8th Street, Suite A
Bellevue, WA 98004
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 12WA004887AB
Dear Sir or Madam:
This Warning Letter is notification from the Center for Tobacco Products (CTP), United States Food and Drug Administration (FDA), advising you that Tobacco Patch was observed to be in violation of federal tobacco laws and regulations. Violations of 21 C.F.R 1140 were observed during an inspection that occurred on February 28, 2011, and during a two-part inspection that occurred on November 20 and December 6, 2012. Please be advised that additional violations observed during any subsequent inspection may lead to a civil money penalty (CMP), according to the schedule provided later in this document, and/or a No-Tobacco-Sale Order. Your response is requested in 15 working days.
On November 20 and December 6, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 10623 Northeast 8th Street, Suite A, Bellevue, WA 98004. During this inspection the establishment was in violation because it has a self-service display of smokeless 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 violation observed during the November 20 and December 6, 2012, inspection includes the following:
1. The establishment has aself-service display or an “impersonal” mode of sale that provides a consumer direct access to smokeless tobacco without restricting the facility to adults at all times. Specifically, the inspector observed a customer-accessible display of General Snus smokeless tobacco on a glass counter.
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 as the establishment is open to the general public during business hours. 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.
Previously, on April 28, 2011, CTP issued a Warning Letter to Murad Baluch, Owner, or Site Manager, Tobacco Patch for violations observed on February 28, 2011. During this inspection the establishment was in violation because it sold tobacco to a minor. You are receiving another Warning Letter because the violations observed during your most recent inspection occurred outside the statutory period for FDA to seek a CMP at this time. Please be advised that additional violations observed during any subsequent inspection may lead to a CMP, according to the schedule provided later in this document, and/or a No-Tobacco-Sale Order.
The listed violation causes your smokeless tobacco to be “misbranded” under section 903 of the FD&C Act (21 U.S.C. § 387c).
You should immediately correct all violations. 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 12WA004887AB in your response and mail it to:
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
The CMP schedule is as follows:
Number of Violations
Civil Money Penalty
$0.00 w/ warning letter
Second within a 12 month period
Third within a 24 month period
Fourth within a 24 month period
Fifth within a 36 month period
Sixth within a 48 month period
See 21 C.F.R. § 17.2; Guidance for FDA and Tobacco Retailers, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers, March 2011 (available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
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