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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Des Moines Smoke Shop 4/4/13

  

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
APR 4, 2013
 
VIA UPS
 
Des Moines Smoke Shop
Attn: Site Manager
21636 Marine View Drive South
Des Moines, WA 98198
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 12WA004878AB
 
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 Des Moines Smoke Shop 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 April 18, 2011, and during a two-part inspection that occurred on November 14 and December 3, 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 14 and December 3, 2012, an inspector representing the FDA completed a two-part inspection of the establishment, located at 21636 Marine View Drive South, Des Moines, WA 98198. 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 and because it offered flavored cigarettes for sale.
 
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 November 14 and December 3, 2012, two-part inspection include the following: 

1.      The establishment has a self-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, unlocked cooler containing Camel smokeless tobacco on top of a glass counter 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 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 June 9, 2011, CTP issued a Warning Letter to Ayesha Corporation d/b/a Des Moines Smoke Shop for violations observed on April 18, 2011. During that 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 violations cause your cigarettes and smokeless tobacco to be “misbranded” under section 903 of the FD&C Act (21 U.S.C. § 387c).
 
The CMP schedule is as follows:
 

Number of Violations
Civil Money Penalty
First
$0.00 w/ warning letter
Second within a 12 month period
$250
Third within a 24 month period
$500
Fourth within a 24 month period
$2,000
Fifth within a 36 month period
$5,000
Sixth within a 48 month period
$10,000

 
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 athttp://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
 

2. Our November 14 and December 3, 2012, two-part inspection also revealed that you offer for sale Lurya Gudang Garam De Luxe Clove cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:

 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
 
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.
 
If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain clove as a characterizing flavor of the tobacco products.
 
A retailer must NOT offer for sale any cigarettes or cigarette tobacco that contains an artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the product. In addition, a retailer must NOT offer for sale any cigarettes or cigarette tobacco for which the label or labeling is false or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).
 
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 12WA004878 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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