Shady Jack’s Saloon 10/17/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
October 17, 2013
Shady Jack’s Saloon
Attn: Site Manager
1432 North Broadway
St. Louis, MO 63102
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 13MO003480
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Shady Jack’s Saloon 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 August 7, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 1432 North Broadway, St. Louis, MO 63102. During this inspection the establishment was in violation because it has a vending machine that sells cigarettes 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 August 7, 2013, inspection includes the following:
1. The establishment has a vending machine or other electronic or mechanical device that provides a consumer direct access to cigarettes without restricting the facility to adults at all times.
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 vending machine 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. § 1140.14(c).
The establishment fails to ensure that minors are neither present nor permitted to enter at any time. During the inspection, the owner told the inspector that minors are allowed to enter with a parent to eat until 11:00 PM. Therefore, the establishment is not restricted. A lockout device is insufficient to meet the requirements of the law. 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 cigarettes 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.
Additionally, the vending machine has a selection button marked “Marlboro Lights 100’s.” Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not match the corresponding product are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c) in that the name on the button is false and/or misleading.
A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco for which the label, labeling, or advertising is false and/or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331). Therefore, if the package from the manufacturer does not say “Marlboro Lights 100’s,” your vending machine selection button cannot say “Marlboro Lights 100’s.” Moreover, retailers are only allowed to sell products marked “low,” “light,” or “mild” by the manufacturer if the product was manufactured before June 22, 2010, and distributed by the manufacturer before July 22, 2010. If the products do not meet those criteria, they are not covered by the limited exception described in the previous sentence.
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 13MO003480 in your response and mail it to:
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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products