Bell Discount Cigarettes 12/20/12
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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
DEC 20, 2012
Bell Discount Cigarettes
Attn: Site Manager
4350 Gage Avenue
Bell, CA 90201
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
Reference Number: 13CA000311
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Bell Discount Cigarettes 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 October 17, 2012, an inspector representing the FDA completed an inspection of the establishment, located at 4350 Gage Avenue, Bell, CA 90201. During this inspection the establishment was in violation because it has a self-service display of cigarette tobacco and smokeless tobacco in a facility not restricted to adults at all times and it offered flavored cigarette tobacco 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 October 17, 2012, inspection include the following:
1. The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to cigarette tobacco and smokeless tobacco without restricting the facility to adults at all times. Specifically,the inspector observed an unlocked case containing cigarette tobacco and smokeless tobacco in a customer accessible area in 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 as the establishment is open to the general public during business hours. 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 Top Wildfire Flavor Triple Infused Velvet Peach cigarette tobacco, which is 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 cigarette tobacco is adulterated.
If, however, this cigarette tobacco does not contain a characterizing flavor, it is 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 velvet peach 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 13CA000311 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, contactAaron 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products