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WARNING LETTER

Northerner Scandinavia, Inc.


Delivery Method:
UPS andElectronic Mail

Recipient:
Recipient Name
Frank Svandal
Northerner Scandinavia, Inc.

33 S 7th St 2nd Floor

Allentown, PA 18101
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 

 

DEC 16, 2014

VIA UPS andElectronic Mail
 
Frank Svandal, CEO
Northerner Scandinavia, Inc.                       
33 S 7th St 2nd Floor
Allentown, PA 18101
f.svandal@northerner.com
 
 
WARNING LETTER
 
Dear Mr. Svandal:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.northerner.com, http://www.swedish-snus.com, http://www.snusdistribution.com, and your webpages, https://www.facebook.com/northerner.com and https://twitter.com/northerner_com, and determined that your smokeless tobacco products listed there are offered for sale and distributed 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 certain of your smokeless tobacco products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because the products are new tobacco products that are required to have premarket review and do not have a marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and for which a notice or other information respecting the products has not been provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).  Additionally, FDA has determined that several of your smokeless tobacco products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.  Finally, FDA has determined that several of your smokeless tobacco products are misbranded under section 903(a)(1) (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 websites and webpages regarding smokeless tobacco products fail to include any health warning label statements. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Premarket Review Violations
 
Section 910(a)(2) of the FD&C Act (21 U.S.C. § 387j(a)(2)) requires premarket review of new tobacco products, subject to certain exceptions. Under section 910(a)(1) of the FD&C Act (21 U.S.C. § 387j(a)(1)), a “new tobacco product”  includes “any tobacco product . . . that was not commercially marketed in the United States as of February 15, 2007.” The FD&C Act permits a tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence (SE) report was submitted by March 22, 2011, to remain on the market pending FDA’s review of the report (“provisional” tobacco products).  In the event that FDA finds under section 910(a)(3) of the FD&C Act (21 U.S.C. § 387j(a)(3)) that the provisional tobacco product is not substantially equivalent to a predicate tobacco product commercially marketed in the United States as of February 15, 2007, and issues an order that the product is not substantially equivalent (NSE), the provisional tobacco product will be subject to premarket review under section 910(a)(2)(A) of the FD&C Act (21 U.S.C. § 387j(a)(2)(A)). A product that is required by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(a)).  A product is misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) if a notice or other information respecting it is not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).
 
Our review of your websites, http://www.northerner.com and http://www.swedish-snus.com, revealed that you sell or distribute to customers in the United States the following smokeless tobacco products for which FDA issued NSE orders on August 28, 2014: Ariva Mint and Ariva Wintergreen.  Because these products are required to have premarket review and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)), they are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)).  In addition, because (subsequent to the NSE orders) a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)).
 
FDA posts a list of tobacco products that are adulterated and misbranded due to an NSE order. This list can be found by visiting FDA’s website at http://www.fda.gov/tobacco and searching for “Misbranded and Adulterated NSE Tobacco Products” using the search box.
 
Modified Risk Tobacco Product Violations
 
You sell or distribute products that you describe on your websites,http://www.northerner.com and http://www.swedish-snus.com, as being mild by referring to them as such in product labeling or advertising and adding the qualifier “mild” to the product names.  Specifically, our review of your websites revealed that you sell or distribute products listed as:
 
  • Thunder Ultra Frosted brand snus, described as: “Each portion of Thunder Raw Frost contains approximately 21 mg of Nicotine yet the way it’s delivered is rather mild.”
  • Catch Pure Mint brand snus, described as: “We think that Catch Pure Mint White would be great for the new snus user due to it’s [sic] relatively mild Nicotine content.”
  • Northerner Licorice/Lemon snus and White Bite Fresh Citrus Mint snus, described as: “Nicotine Strength Mild.”
 
In addition, you sell or distribute products that you describe on your websites, http://www.northerner.com, http://www.swedish-snus.com, and http://www.snusdistribution.com, as containing a reduced level of a substance or as presenting a reduced exposure to a substance.  Specifically, our review of your websites revealed that you sell or distribute products listed as:
 
  • CatchDry Licorice brand snus, described as: “a great snus for those who want to experience a licorice flavored snus in a lower Nicotine version.”
  • Jakobsson’s Fläder brand snus, described as: “the perfect snus for the snus user that’s new to ES due to it’s [sic] Nicotine level being on the lower end of ES.”
  • Skruf Slim Fresh White brand snus, described as: “a great snus for the snus user looking for something with a fresh mint flavor and a lower Nicotine content.”
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance.  
 
Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).  Because your websites use the descriptor “mild” or similar descriptors for the above listed products or represent that such products contain a reduced level of a substance or present a reduced exposure to a substance, these products are modified risk tobacco products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
Health Warning Statement Violations
 
FDA has alsodetermined that certain of 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 websites and webpages regarding smokeless tobacco products do not include any health warning label 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. 
 
Our review of your website, http://www.snusdistribution.com, and the webpages, https://www.facebook.com/northerner.com and https://twitter.com/northerner_com, revealed that the website and webpages regarding the following smokeless tobacco product brands that you offer for sale in the United States do not include any health warning statements: Gotlandssnus, Jakobsson’s, Offroad, Thunder, Gotländskt, Catch, Phantom, Grov, General, Copenhagen, Göteborgs, Lundgrens, Odens, and Northerner brands of snus. Because your websites and webpages regarding smokeless tobacco products do 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, 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 promotional materials on these websites, on any other websites (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 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, RW1400244, 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 UPS and Electronic Mail
 
cc:
 
Nicki M. Beck, President
Northerner Scandinavia, Inc.
201 E Strawberry Ave., Mechanicsburg, PA 17055-3376
 
Rick Charles, Director US Sales/ Distribution
Northerner Scandinavia Inc.
2944 Betz Ct., Orefield, PA 18069
rickcharles@northerner.com
 
uv9jf3kz55c@networksolutionsprivateregistration.com
 
compliance@privacyprotect.org
 
achapman@northerner.com
 
abuse@web.com
 
support@resell.biz
 
legal@instra.com
 
ripe-interest@amazon.com
 
mazinger@amazon.com
 
ec2-abuse@amazon.com
 
kuyper@amazon.com
 
aes-noc@amazon.com
 
sheehan@amazon.com