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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Riverside Bait and Canoe Rental 8/7/14

  

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
August 7 2014
VIA UPS
 
Riverside Bait and Canoe Rental
Attn: Site Manager
14605 East 676 Road
Stockton, MO 65785    
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13MO004204A1B1
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Riverside Bait and Canoe Rental 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 June 5 and 10, 2014, an inspector representing the FDA completed a two-part inspection of the establishment, located at 14605 East 676 Road, Stockton, MO 65785. 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.
 
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 June 5 and 10, 2014, two-part inspection include the following: 

1.  A minor was able to buy Pall Mall Red cigarettes on June 10, 2014, at approximately 1:36 PM 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 Pall Mall Red cigarettes on June 10, 2014, at approximately 1:36 PM. 

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).
 
The listed violations cause your cigarettes 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.
 
Previously, on October 13, 2011, CTP issued a Warning Letter to Riverside Bait & Canoe Rental for violations observed on July 19, 2011. During that 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. 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 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 violations and preventing future violations. Include a telephone number and address. Note your reference number of 13MO004204A1B1 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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