B & L Lounge 11/29/12
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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
NOV 29, 2012
B & L Lounge
Attn: Site Manager
1700 Port Street
New Orleans, LA 70117
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 12LA005381
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that B & L 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 September 8, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 1700 Port Street, New Orleans, LA 70117. During this inspection the establishment was in violation because it has a vending machine with false and/or misleading buttons marked “low tar” or “light.”
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 September 8, 2012, inspection includes the following:
1. The establishment has a vending machine with a selection button marked “Marlboro Light 100’s.” The cigarettes stocked to correspond with the “Marlboro Light 100’s” button are not labeled as such. Cigarettes, cigarette tobacco, and/or smokeless tobacco with labels, labeling, or advertising that do not correspond to the actual 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. In addition, the button uses the term “light.” Cigarettes with labels, labeling, or advertising that use the descriptor “low tar” or “light” are misbranded under section 903 of the FD&C Act (21 U.S.C. § 387c), in that the descriptive terms are false and/or misleading. Labeling or advertising cigarettes as “low tar” or “light” is misleading to consumers. Congress has found many smokers mistakenly believe that “low tar” and “light” cigarettes cause fewer health problems than other cigarettes.
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).
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 “Salem Lights,” “Salem Light 100’s,” and “Kool Mild Blue.” 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 packages from the manufacturer do not say “Salem Lights,” “Salem Light 100’s,” or Kool Mild Blue,” your vending machine selection buttons cannot say “Salem Lights,” “Salem Light 100’s,” or “Kool Mild Blue.” 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 12LA005381 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 Carisa Bergen at (301) 796-2990 or via email at Carisa.Bergen@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
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