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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Mysnus AB 3/12/12

  

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

Public Health Service
Food and Drug Administration
 
Silver Spring, MD 20993 

 

 

 

 

MAR 12 2012
 
VIA UPS and Electronic Mail

 
To: Mysnus AB
      Box 27104
      SE-102-52
      Stockholm, SE
      contact@mysnus.com

WARNING LETTER
 

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed the website, http://www.mysnus.com, and determined that your smokeless tobacco products listed are offered for sale to U.S. customers. 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), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco products, are subject to FDA jurisdiction under section 901 (b) of the FD&C Act (21 U.S. C. § 387a(b)).

FDA has determined that some of your smokeless tobacco products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion.

You describe several snus products offered for sale to U.S. customers on http://www.mysnus.com as containing a reduced level of a substance. Specifically, your website http://www.mysnus.com displays the following promotional statement for the Thunder, Phantom, Offroad, and Norstrommen snus products you offer for sale to U.S. customers: "All products are pasteurized, with low levels of Nitrosamines." You also describe smokeless tobacco products that you offer for sale on http://www.mysnus.com as being mild by referring to them as such in product advertising. For example, your promotional material refers to Goteborgs Prima Fint Loose as "A mild snus."

A tobacco product is 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)) if, among other things, its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. A tobacco product with a label, labeling, or advertising that uses the descriptors "light," "mild," or "low," or similar descriptors is also a "modified risk tobacco product" under section 911 (b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)).

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)). Because your website includes claims that the snus products offered for sale on your website contain a reduced level of a substance, present a reduced exposure to a substance, or are less harmful than other commercially marketed tobacco products and because it uses the descriptor "mild" for snus products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an 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)).

You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 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 lbarra-Pratt at (301) 796-9235 or via email at Elenita.lbarraPratt@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: Mysnus AB
     Armin Sachs
     c/o Swiss Post Int'l, Soederbyvaegen 3 C
     Maersta 19047
     contact@swedishsnus.com