Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/northerner-scandinavia-inc-12162014
Timestamp: 2019-06-18 11:31:47
Document Index: 687307432

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

Northerner Scandinavia, Inc. - 12/16/2014 | FDA
Northerner Scandinavia, Inc. - 12/16/2014
Northerner Scandinavia, Inc. 16/12/2014
Northerner Scandinavia, Inc.
33 S 7th St 2nd Floor
Frank Svandal, CEO
f.svandal@northerner.com
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.
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)).
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)).
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.
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)).
Please note your reference number, RW1400244, in your response and direct your response to the following address:
Nicki M. Beck, President
201 E Strawberry Ave., Mechanicsburg, PA 17055-3376
Rick Charles, Director US Sales/ Distribution
2944 Betz Ct., Orefield, PA 18069
rickcharles@northerner.com
uv9jf3kz55c@networksolutionsprivateregistration.com
compliance@privacyprotect.org
achapman@northerner.com
support@resell.biz
legal@instra.com
ripe-interest@amazon.com
mazinger@amazon.com
kuyper@amazon.com
sheehan@amazon.com