Inspections, Compliance, Enforcement, and Criminal Investigations
Discount Smoke Shop 10/10/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
OCT 10, 2013
Discount Smoke Shop
Attn: Site Manager
704 North Bishop Avenue, Suite 1
Rolla, MO 65401
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 13MO001717AB
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 Discount 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 January 28, 2012, and during a two-part inspection that occurred on June 17 and 20, 2013. 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 June 17 and 20, 2013, an inspector representing the FDA completed a two-part inspection of the establishment, located at 704 North Bishop Avenue, Suite 1, Rolla, MO 65401. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor.
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 June 17 and 20, 2013, two-part inspection includes the following:
- A minor was able to buy Pall Mall Red cigarettes on June 17, 2013, at approximately 9:10 AM 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).
Previously, on February 23, 2012, CTP issued a Warning Letter to Discount Smoke Shop for violations observed on January 28, 2012. During that inspection the establishment was in violation because it sold smokeless tobacco to a minor and failed to check the minor’s identification. 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 cigarettes to be “misbranded” under section 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. 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 violation and preventing future violations. Include a telephone number and address. Note your reference number of 13MO001717AB 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 Aaron Weisbuch at (301) 796-9362 or via email at Aaron.Weisbuch@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