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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gatlinburlier, INC 8/28/13

  

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 28, 2013

VIA UPS and Electronic Mail
 
Ira T. Lapides
Gatlinburlier, INC.
611 Parkway, Suite D1
Gatlinburg, TN 37738
HelpDesk@GatlinBurlier.com
 
 
WARNING LETTER
 
Dear Dr. Lapides:
 
The Center for Tobacco Products ofthe U.S. Food and Drug Administration (FDA) recently reviewed your websites, www.gatlinburlier.com and www.gbtobacco.com, and determined that your smokeless tobacco products listed there are promoted for sale to customers in the United States. FDA believes these websites are affiliated with one another because each website contains the same contact information and reference to your establishment “The Gatlinburlier” located in  Gatlinburg, TN. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the 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 advertise on your website are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco,are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
Health Warnings Statement Violations
 
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 any of the relevant warning label statements 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.  
 
Our review of your websites, www.gatlinburlier.com and www.gbtobacco.com, revealed that you promote for sale the following smokeless tobacco products without the required warnings: Big Orange Chew; Chewey Cherry; Connecticut Broadleaf Chew; Johnny Applesweet; Juicy Chew; Mountain Man Chaw; New Dew Chew; Nuts-To-You-Chew; Rocking Chair Chew; Semi-Sweet Chew; Special Peach Chew; Sweet Chew; Wild Possum Chew; Winter Ice; Oliver Twist Golden Mild Sunberry; Oliver Twist Original; Oliver Twist Tropical flavors; and Oliver Twist Wintergreen.  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 do 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, we note that you are required to follow all other 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. Quarterly rotation must be done “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” and approved by FDA. 
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, or any other websites or media in which you advertise, or retail establishment(s) comply with each applicable provision of the FD&C Act and FDA’s 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 note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.
 
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 and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1300096, in your response and direct your response to the following address:
 
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 Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
/S/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products 
 
 
VIA UPS and Electronic Mail
 
cc:
 
The Gatlinburlier
603 Skyline Drive
Gatlinburg, TN 37738
 
ira@SMOKY-MTNS.COM
 
will@metatronics.com
 
domainmanager@maileig.com