Smoke Shop 1/10/13
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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
JAN 10, 2013
Attn: Site Manager
13055 Riverdale Drive, Suite 400
Minneapolis, MN 55448
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 13MN001165
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that 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 December 10, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 13055 Riverdale Drive, Suite 400, Minneapolis, MN 55448. During this inspection the establishment was in violation because it has self-service displays of cigarette tobacco and smokeless tobacco in a facility not restricted to adults at all times and it offered flavored 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 December 10, 2012, inspection include the following:
1. The establishment has self-service displays or “impersonal” modes of sale that provide a consumer direct access to cigarette tobacco and smokeless tobacco without restricting the facility to adults at all times. Specifically,the inspector observed self-service displays of cigarette tobacco and smokeless tobacco in customer accessible areas throughout the establishment.
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. 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 above listed violation causes your cigarette tobacco and smokeless tobacco to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c).
2. Our compliance check inspection also revealed that you offer for sale Nat Sherman New York Cut Mint cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1 )(A) of the FD&C Act (21 U.S.C. § 387g(a)(1 )(A)) provides:
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.
If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain mint as characterizing flavors of the tobacco products.
A retailer must NOT offer for sale any cigarettes or cigarette tobacco that contains an artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the product. In addition, a retailer must NOT offer for sale any cigarettes or cigarette tobacco for which the label or labeling is false or misleading. Doing so is prohibited by section 301 of the FD&C Act (21 U.S.C. § 331).
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 13MN001165 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