• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Casual Lounge 8/23/12


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

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229


AUG 23, 2012


Casual Lounge
Attn: Site Manager
65 West Floyd Avenue
Englewood, CO  80110

Re:  FDA Warning Letter Regarding Tobacco Retailer Inspection Violation 
       Reference Number:  12CO000346

Dear Sir or Madam:

This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Casual Lounge 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 20, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 65 West Floyd Avenue, Englewood, CO  80110.  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 April 20, 2012 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.  Specifically, the inspector observed a vending machine containing cigarettes by the entrance to the establishment, in an area accessible to patrons.

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, an employee on duty told the inspector that minors are allowed to enter the establishment before 9 PM if accompanied by an adult.  Therefore, the establishment is not restricted. Unplugging the vending machine 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 establishment has a vending machine with selection buttons marked “Camel Lights”, “Marlboro Lights”, and “Marlboro Ultra Lights”.  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).  However, retailers are 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 above.  Therefore, if the package from the manufacturer does not say “Camel Lights”, “Marlboro Lights”, or “Marlboro Ultra Lights”, your vending machine selection buttons cannot say “Camel Lights”, “Marlboro Lights”, or “Marlboro Ultra Lights”.

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 12CO000346 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 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

Return to Tobacco Retailer Warning Letters Main Page