Kingman Smoke Shop 9/13/12

WARNING LETTER

SEP 13, 2012

VIA UPS

Kingman Smoke Shop
Attn: Site Manager
2601 North Stockton Hill Road, Suite H7
Kingman, AZ  86401

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number:  12AZ000932

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Kingman Smoke Shop 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, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 2601 North Stockton Hill Road, Suite H7, Kingman, AZ  86401.  During this inspection the establishment was in violation because it has a self-service display of cigarette tobacco in a facility not restricted to adults at all times and it offered individual 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 June 5, 2012, inspection include the following:

1. The establishment has a self-service display or an “impersonal” mode of sale that provide a consumer direct access to cigarette tobacco without restricting the facility to adults at all times.  Specifically, the retailer keeps both Buglar and Top brands of roll your own cigarette tobacco packages for sale on the bottom shelf of an unlocked glass door cabinet that is accessible to the public.

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, the manager on duty told the inspector that minors are allowed to enter with an adult.  Therefore, the establishment is not restricted.  The signage which states “must be 18 to enter” 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.

2. The establishment offered for sale individual cigarettes.  Specifically, the retailer sells or distributes Marlboro Red cigarettes for individual sale for $0.50 per cigarette. There was an opened package of Marlboro Red cigarettes that was located next to the register.  The manager admitted these cigarettes were sold individually to customers for $0.50 each.  The inspector observed the manager sell individual cigarettes to two customers.

A retailer must NOT sell individual cigarettes.  Doing so violates 21 C.F.R. § 1140.14(d).

The listed violations cause your cigarettes and smokeless tobacco 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.  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 12AZ000932 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 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. 

Sincerely,

/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products