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U.S. Department of Health and Human Services

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Enforcement Actions

Pamco Inc. d/b/a Tar Heel Tobacco 4/19/12

  

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 

APR 19 2012
 

VIA UPS


Pamco Inc., d/b/a Tar Heel Tobacco
3193 Peter's Creek Parkway F
Winston-Salem NC, 27127-4710
Registered Agent: Patrick Shehan

WARNING LETTER



Dear Mr. Patrick Shehan:


The Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) recently reviewed your advertisements presented in the Winston-Salem Journal in December 2011 promoting smokeless tobacco products for sale ("smokeless tobacco product advertisements") in the United States. Under section 201 (rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the products you advertised are
tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco products, are subject to FDA jurisdiction under section 901 (b) of the FD&C Act (21 U.S.C. § 387(a)). You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.


FDA has determined that your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you failed to include in your smokeless tobacco product advertisements the relevant warnings required under section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P. L. 111-31, 123 Stat. 1846). Under section 903(a)(7)(A) of the FD&C Act, (21
U.S.C. 387c(a)(7)(A)), a tobacco product is misbranded if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201 (n) of the FD&C Act (21 U.S.C. 321 (n)), in determining whether labeling or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.


Your smokeless tobacco product advertisements in the Winston-Salem Journal promote smokeless tobacco products by advertising "moist/chew" products with the Kayak, Grizzly, Stokers, and Bowie Box brands. Section 3(b) of the Smokeless Tobacco Act, as amended, requires that advertisements for smokeless tobacco products bear one of the following warning labels:


WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.


Because your smokeless tobacco product advertisements did not include any of the required warnings, your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).


In addition, you are required to follow all applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. This must be done "in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer" and approved by FDA.


You should immediately correct the violations stated above and take any necessary actions to bring your smokeless tobacco product advertising into compliance with the law. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that you comply with the applicable provisions of the FD&C Act and applicable regulations. Failure to ensure full compliance may result in FDA initiating further action without notice, including, but not limited to, civil money penalties,
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.


Please address your response to:


PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o 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 or via email at Elenita.lbarraPratt@fda.hhs.gov.

Sincerely,

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