G & M Tobacco 2/7/13
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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
FEB 7, 2013
G & M Tobacco
Attn: Site Manager
1675 North Perris Boulevard, Suite A17
Perris, CA 92571
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violation
Reference Number: 13CA001806
Dear Sir or Madam:
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that G & M Tobacco 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 January 17, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 1675 North Perris Boulevard, Suite A17, Perris, CA 92571. During this inspection the establishment was in violation because it offered flavored cigarettes and 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 violation observed during the January 17, 2013, inspection includes the following:
1. Our compliance check inspection revealed that you offer for sale: Dhyan Grape cigarettes, Visions French Vanilla cigarettes, Visions Chocolate Mint cigarettes, Visions Clove cigarettes, Visions Wintermint cigarettes, Visions Cherry cigarettes, Wildfire: Island Margarita cigarette tobacco, Wildfire New York Vanilla cigarette tobacco, Wildfire Velvet Peach cigarette tobacco, Wildfire Cherries Jubilee cigarette tobacco, Gudang Garam Clove cigarettes, Liquid Zoo Coconut Flavor cigarettes and Liquid Zoo Mint Flavor cigarettes. These cigarettes and cigarette tobacco products are each 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 and cigarette tobacco products are adulterated.
If, however, these cigarettes and cigarette tobacco products 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 Grape, French Vanilla, Chocolate Mint, Clove, Wintermint, Cherry, Island Margarita, New York Vanilla, Velvet Peach, Cherries Jubilee, Coconut and 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 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.
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 13CA001806 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 Ms. 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