# FDA WARNING_LETTER - Northerner Scandinavia, Inc. - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/northerner-scandinavia-inc/5bed033d-af85-40bd-8aef-1dc694eb92e4

> FDA WARNING_LETTER for Northerner Scandinavia, Inc. on Unknown Date. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Northerner Scandinavia, Inc.
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Mr. Svandal regarding smokeless tobacco products sold and distributed in the U.S. via websites (northerner.com, swedish-snus.com, snusdistribution.com) and social media (Facebook, Twitter).

The FDA determined several products are adulterated and misbranded. Specifically:
1.  **Premarket Review Violations:** Ariva Mint and Ariva Wintergreen smokeless tobacco products were found to be "new tobacco products" that lack required premarket marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated (section 902(6)(A)). Additionally, a notice or other information was not provided as required by section 905(j), rendering them misbranded (section 903(a)(6)). FDA had issued Non-Substantially Equivalent (NSE) orders for these products on August 28, 2014.
2.  **Modified Risk Tobacco Product Violations:** Products described as "mild" (e.g., Thunder Ultra Frosted, Catch Pure Mint, Northerner Licorice/Lemon, White Bite Fresh Citrus Mint) or implying reduced substance levels/exposure (e.g., CatchDry Licorice, Jakobsson’s Fläder, Skruf Slim Fresh White) are considered "modified risk tobacco products" under section 9

## Related Officers

- [Rick Charles](https://www.keypedia.com/people/rick-charles/01c65b87-64fa-469b-a712-a48af7906241)
- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Nicki M. Beck](https://www.keypedia.com/people/nicki-m-beck/a514fc7b-eb6b-4cce-b1e5-63dc6677564f)

Company: https://www.keypedia.com/companies/northerner-scandinavia-inc/07d34dff-ce1d-4f2c-9993-1eb9e7dfe023

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374