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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Santa Fe Natural Tobacco Company 8/26/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229 

AUG 26 2011


VIA UPS and Fax


Nicholas A. Bumbacco
President and CEO
Santa Fe Natural Tobacco Company
One Plaza La Prensa
Santa Fe, NM 87507
Fax: 1-800-655-8265


WARNING LETTER


Dear Mr. Bumbacco:


The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website, http://www.nascigs.com, and the website for the Voodoo Experience music and art festival, http://thevoodooexperience.com, and determined that the event is sponsored in the cigarette brand name "Natural American Spirit," a tobacco product that you manufacture and promote for sale in the United States, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, this product is a tobacco product because it is made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.


Specifically, Natural American Spirit’s brand website, http://www.nasciqs.com, lists the Voodoo Experience as one of the events that it will attend. The Voodoo Experience is a music and arts festival, featuring several bands and a large-scale art exhibition. Our review of the Voodoo Experience event website, http://thevoodooexperience.com, indicated that Natural American Spirit is a "partner" of the event, which will be held from October 28 - 30, 2011. We note that you promote your partnership or sponsorship of the event on the Voodoo Experience website using the cigarette brand name "Natural American Spirit" and the cigarette brand logo of a Native American in a head-dress holding a pipe to his mouth.


Your sponsorship in the brand name and logo of "Natural American Spirit" cigarettes is a violation of 21 C.F.R. § 1140.34(c), which prohibits manufacturers, distributors, and retailers from sponsoring any musical or artistic event using the brand name or logo of a cigarette. A tobacco product that is sold or distributed 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, is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). Thus, because your Natural American Spirit cigarettes are sold and distributed to customers in the United States while in violation of 21 C.F.R. § 1140.34(c), they are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).


You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that all of your tobacco products, promotional materials, and marketing activities comply with the applicable provisions of the FD&C Act and its implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, 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 the following address:


PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
do Document Control Center
Rockville, Maryland 20850.


If you have any questions about the content of this letter, please contact Ele lbarra-Pratt at (301) 796-9235.


Sincerely,

/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products


cc:
Office of General Counsel
Reynolds American Inc.
P.O. Box 2990
Winston-Salem, NC 27102-2990