Inspections, Compliance, Enforcement, and Criminal Investigations

Swedish Match North America Inc 5/22/13

  

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
 

MAY 22, 2013

VIA UPS
 
Mr. Gerard J. Roerty, Jr.
Vice President, General Counsel & Secretary
Swedish Match North America, Inc.
P.O. Box 13297
7300 Beaufont Springs Drive, Suite 400
Richmond, Virginia 23225
 
 
WARNING LETTER
 
Dear Mr. Roerty:
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) investigated Swedish Match North America, Inc.’s (SMNA) “General Original Lounge Adult Only Smokeless Tobacco Sampling Facility” at the Kentucky Speedway on June 28, 2012 and reviewed your PRNewswire press release dated July 4, 2012, presented under the heading “Jet/Set/Go! With General Snus” and subheading “Dallas Contest Winners Take Off for Unforgettable Weekend” for the Maxim Splash Pool Party.  SMNA is the manufacturer of General snus, a brand of smokeless tobacco product, which is sold and distributed to customers in the United States.  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), snus is a tobacco product because it is 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 Warning Statement Violations
 
FDA has determined that your General snus tobacco products are misbranded under sections 903(a)(7)(A) (21 U.S.C. § 387c(a)(7)(A)) and 903(a)(8)(B)(i) (21 U.S.C. § 387c(a)(8)(B)(i)) of the FD&C Act because you failed to include the required warning statements on your smokeless tobacco product advertisements, as required under section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) (15 U.S.C. § 4402).  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. In addition, section 903(a)(8)(B)(i) of the FD&C Act (21 U.S.C. § 387c(a)(8)(B)(i)) provides that a tobacco product is deemed misbranded unless “the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product . . . a brief statement of the . . . relevant warnings, precautions, side effects, and contraindications . . . ” 
 
On June 28, 2012, FDA conducted an investigation of your “General Original Lounge Adult Only Smokeless Tobacco Sampling Facility” (“sampling facility”) located at the Kentucky Speedway.  Our investigation revealed that you advertised General snus tobacco products in violation of section 3(b)(1) of CSTHEA. Specifically, you displayed a sign with the words “General ORIGINAL LOUNGE” on the inside of your sampling facility.  You also displayed a sign with the words “FREE SNUS SAMPLES” outside the sampling facility. The two signs lacked the relevant warning label statement, as required under section 3(b)(1) of CSTHEA.  Section 3(b) of the Smokeless Tobacco Act, as amended, requires that advertisements for smokeless tobacco products bear one of the following 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.

Because your “General ORIGINAL LOUNGE” smokeless tobacco product advertisement for General brand snus and “FREE SNUS SAMPLES” tobacco product advertisement did not include any of the warnings required under section 3(b)(1) of CSTHEA, your General snus brand smokeless tobacco products are misbranded under sections 903(a)(7)(A) (21 U.S.C. § 387c(a)(7)(A)) and 903(a)(8)(B)(i) (21 U.S.C. § 387c(a)(8)(B)(i)) of the FD&C Act.
 
Brand Name Sponsorship
 
Additionally, FDA has determined that your General brand smokeless tobacco products are also misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sponsored the Jet/Set/Go! With General Snus promotion at a Dallas Maxim Splash Pool Party and private jet trip to Las Vegas event under the General brand, in violation of 21.C.F.R section 1140.34(c).  Based on a description of the event included in your press release in PRNewswire dated July 4, 2012, titled “Jet/Set/Go! With General Snus: Dallas Contest Winners Take Off for Unforgettable Weekend” the Maxim Splash Pool Party and private jet trip to Las Vegas event appears to be a social or cultural event.  Under 21 C.F.R. section 1140.34(c), no manufacturer, distributor, or retailer may sponsor or cause to be sponsored any athletic, musical, artistic, or other social or cultural event, or any entry or team in any event, in the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. Smokeless tobacco products that are sold or distributed in the United States in violation of 21 C.F.R. section 1140.34(c) are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).       
 
Conclusion and Requested Actions
 
We also note that your tobacco advertisements for General brand snus were disseminated in violation of your FDA-approved warning plan. Section 3 of CSTHEA requires that the warning label statements be displayed “in accordance with a plan submitted by the tobacco product manufacturer . . . and approved by, the [FDA].” 
 
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 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. 
 
Please note your reference number, RW1300085, 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 Elenita.IbarraPratt@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

Page Last Updated: 11/21/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.