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  5. Swisher International, Inc. - 11/02/2015
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WARNING LETTER

Swisher International, Inc. 02/11/2015

Swisher International, Inc. - 11/02/2015


Delivery Method:
UPS

Recipient:
Swisher International, Inc.

459 East 16th Street

Jacksonville, FL 32206
United States

Issuing Office:
Center for Tobacco Products

United States


  

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

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

NOV 2, 2015

VIA UPS
 
Peter J. Ghiloni
President
Swisher International Inc.
459 East 16th Street,
Jacksonville, FL 32206
 
 
 
WARNING LETTER
 
Dear Mr. Ghiloni:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the webpagehttps://www.facebook.com/SwisherXtreme and visited two “free sample” events; we determined that your smokeless tobacco products, the brand names of which are included on the website and on branded t-shirts worn at such events, are offered for sale or distribution to customers 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), these products 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)).
                                                                                                                                    
FDA has determined that your Kayak smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your webpage and branded t-shirts that display the name of your smokeless tobacco products fail to include any health warning label statements. 
 
Health Warning Statement Violations
 
Our review of your webpage, https://www.facebook.com/SwisherXtreme, revealed that it contains labeling and/or advertisements for your Kayak brand smokeless tobacco products that you offer for sale or distribute in the United States, but does not include any health warning statements. Specifically, the Facebook page for Swisher’s SwisherXtreme brand included photos of Swisher employees standing in front of and outside of a facility while wearing t-shirts displaying the Kayak logo. The Facebook page did not include any health warning statements.
 
Additionally, on June 11, 2015, FDA investigators witnessed Swisher employees wearing t-shirts bearing the brand name Kayak without any health warning statements, during Swisher’s free sample event at the Parker County Frontier Days and Livestock Show, in Weatherford, TX. FDA investigators also photographed Swisher employees wearing t-shirts bearing the brand name Kayak, without any health warning statements, on June 25, 2015, during FDA’s investigation of Swisher’s free sample event at the Watermelon Thump event in Luling, TX.
 
FDA has determined that your smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your webpage and branded t-shirts bear the brand name of your smokeless tobacco products and do not include any health warning statements. 
 
Section 3(b) 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) requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
 
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.
 
A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)), 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 and/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. 
 
Because this webpage does not include any health warnings, your smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).    
 
In addition, because FDA investigators observed and documented Swisher employees wearing t-shirts bearing the brand name Kayak without any health warning statements during Swisher’s free sample event at the Parker County Frontier Days and Livestock Show in Weatherford, TX, and similarly observed and documented t-shirts bearing the brand name Kayak without any health warning statements being worn by Swisher employees at an Luling Watermelon Thump event in Luling, TX, your smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
 
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 (15 U.S.C. § 4402), 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 labeling and/or advertising on this webpage, on any other webpages (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise, 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 import 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 labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA’s homepage at  http://www.fda.gov.
 
Please note your reference number, RW1500422, in your response and direct your response to the following address:
 
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 
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 Electronic Mail
 
cc:
 
 
Christopher L. Casey
Senior VP, General Counsel
459 E. 16th St.
Jacksonville, FL 32206
 

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