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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tobacco & More Express 7/2/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

 

WARNING LETTER
July 2 2014
VIA UPS
 
Tobacco & More Express
Attn: Site Manager
1082 McClellan Highway
Harts, WV 25524
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
       Reference Number:  14WV000537AB
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Tobacco & More Express 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 16 and 21, 2014, an inspector representing the FDA completed a two-part inspection of the establishment, located at 1082 McClellan Highway, Harts, WV 25524. During this inspection the establishment was in violation because it has a self-service display of cigarette tobacco and 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 April 16 and 21, 2014, two-part inspection includes the following: 

1.  The establishment has a self-service display or “impersonal” mode of sale that provides a consumer direct access to smokeless tobacco without restricting the facility to adults at all times.  Specifically, an inspector observed customer-accessible displays containing cigarette tobacco and smokeless tobacco on the main sales floor. In addition, a minor entered the establishment and accessed a display of smokeless tobacco. 

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.  During the inspection, a minor was able to enter the establishment.  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 violation causes your cigarette tobacco and smokeless tobacco to be “misbranded” under 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.
 
The violation indicated in this letter may not be a complete list of violations at the establishment.
 
Previously, on April 4, 2013, CTP issued a Warning Letter to Tobacco & More Express for a violation observed on March 20, 2013. During that 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. You are receiving another Warning Letter because the violation 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 below, no-tobacco-sale order, seizure, and/or injunction.
 
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, September 2013 (available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf).
 
We will periodically inspect your establishment and review your promotional activities (e.g., website{s}) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. 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. Specifically, Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents provides additional information on compliance with retailer responsibilities http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm252758.htm.
 
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 14WV000537AB in your response and mail it to:
 
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002
 
If you have any questions, contact the Center for Tobacco Products at 1-877-CTP-1373, option 6, or via email at CTP-Compliance-WL-Correspondence@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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