| Public Health Service Food and Drug Administration |
Center for Tobacco Products |
Department of Health and Human ServicesDEC 14 2010
VIA UPS
RJ Lackey
Registered Agent
Cherokee Brands, LLC
Cherokee Tobacco Company, LLC
Firebird Manufacturing, LLC
341 Main Street, Suite 302
Danville, VA 24541
WARNING LETTER
Dear Mr. Lackey:
The Food and Drug Administration (FDA) recently reviewed your websites, www.cherokeebrands.com (Cherokee Brands website), www.cherokeetobacco.com (Cherokee Tobacco website); and www.firebirdmanufacturing.com (Firebird website). FDA has determined that your products, Cherokee Blue (formerly Cherokee Lights), Cherokee Sky (formerly Cherokee Ultra Lights), and Cherokee Menthol Gold (formerly Cherokee Menthols Lights), are adulterated under section 902(8) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 387b(8)), as amended by the Family Smoking Prevention and Tobacco Control Act. Additionally, all of your Cherokee brand cigarettes are misbranded under section 903(a)(7)(B) of the Act (21 U.S.C. § 387c(a)(7)(B)) in that your company is in violation of FDA's Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 21 C.F.R. Part 1140, prescribed under Section 906(d) of the Act (21 U.S.C. § 387f(d)). You can find the Act and the FDA regulation through links on FDA's homepage at www.fda.gov.
Our review of your websites revealed the following content:
• The Cherokee Tobacco website contains a "To all Cherokee Tobacco Customers" letter that states, "In accordance with the new FDA Regulations, we are no longer permitted to use 'light' and 'ultra light' on our cigarettes. Over the coming weeks, we will be changing our style names. Full Flavor will be Red, Light will be Blue, Ultra Light will be Sky, Menthol will be Menthol Green and Menthol Light will be Menthol Gold."
• The Firebird website bears images of the package designs and/or cigarette schematics for your products labeled: "Cherokee Light Kings," "Cherokee Menthol Light Kings," "Cherokee Ultra Light 100s," and "Cherokee Ultra Light Kings" cigarettes.
Products using labels, labeling, or advertising with the descriptors "light," "mild," or "low," or similar descriptors are "modified risk tobacco products" under section 911 (b)(2) of the Act (21 U.S.C. § 387k(b)(2)). No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911 (g) of the Act (21 U.S.C. § 387k(g)). The effective date for manufacturers to stop introducing these products into domestic commerce without an FDA order was July 22,2010. You do not have an order in effect for your modified risk tobacco products, as listed above, and therefore, these products are adulterated.
In addition, our review of an article in the Gazette Virginian from October 1, 2010, and the website for the 2010 Halifax County Fair, www.halifaxcountyfair.com, indicated that Cherokee Brands, LLC was a "Premiere Sponsor" of that event, which was held from October 5 - 9, 2010. Specifically, the event was sponsored using the name "Cherokee Brands, LLC," which includes the brand name of your tobacco product, "Cherokee" cigarettes. Your sponsorship is a violation of 21 C.F.R. § 1140.34(c), which prohibits a manufacturer, distributor, or retailer from sponsoring any social or cultural event using a brand name of a cigarette alone or in conjunction with any other word. Section 903(a)(7)(B) of the Act deems a product to be misbranded if there is a violation of regulations prescribed under section 906(d) of the Act, including 21 C.F.R. Part 1140. Subsequent sponsorship of such events may lead to FDA enforcement action.
You should immediately correct the violations stated above and take any necessary action to bring your tobacco products into compliance with the Act. The violations discussed in this letter do not necessarily constitute an exhaustive list of your violations, and it is your responsibility to ensure that your tobacco products comply with the applicable provisions of the Act. Failure to ensure full compliance with the Act may result in FDA initiating regulatory action without further notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, seizure, and/or injunction.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products. Please direct your response to me at the following address: Office of Compliance and Enforcement, c/o Document Control Center, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850. If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235. We remind you that only written communications are considered official.
Sincerely,
/S/
Ann Simoneau, J.D.
Acting Director
Office of Compliance and Enforcement
Center for Tobacco Products
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