Inspections, Compliance, Enforcement, and Criminal Investigations
Mysnus AB - Close Out Letter 5/21/12
| Public Health Service Food and Drug Administration |
| Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229 |
Department of Health and Human ServicesMAY 21, 2012
VIA UPS and Electronic Mail
To: Mysnus AB
Armin Sachs
Chief Executive Officer
c/o Swiss Post lnt'l, Soederbyvaegen 3 C
Maersta 19047
contact@mysnus.com
Dear Mr. Sachs,
The Food and Drug Administration's Center for Tobacco Products has completed an evaluation of the corrective actions you indicated on March 30, 2012 and May 7, 2012 in response to our Warning Letter dated March 12, 2012. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by no longer promoting several smokeless tobacco products on http://www.mysnus.com as modified risk tobacco products without an FDA order in effect that permits such promotion. Specifically, you removed the statement, "All products are pasteurized, with low levels of Nitrosamines," from the description of several snus products manufactured by V2 Tobacco that are offered for sale on your website, and removed the term, "mild ," from the descriptions of all snus products offered for sale on your website.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
Ele Ibarra-Pratt,
Group Leader
Promotion, Advertising, and Labeling Group
Office of Compliance and Enforcement
Center for Tobacco Products
VIA USPS and Electronic Mail
cc: Mysnus AB
Box 27104
SE-102-52
Stockholm, SE
