FDA seeks comments on the Swedish Match MRTP application
The Modified Risk Tobacco Product (MRTP) application submitted by Swedish Match has been determined to be complete and filed by the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
This is a significant accomplishment because it is the first time a regulatory agency is seriously considering a claim for a harm reduction product. As required by the Tobacco Control Act, CTP has made the application publicly available and has established a public docket for receiving and posting comments. Perhaps recognizing the historic implications of the application, CTP has decided on an unusually long comment period –180 days—and has noted that comments received in the first 90 days will be considered before referring the application to the FDA Tobacco Product Scientific Advisory Committee (TPSAC).
The Swedish Match application is for ten products in the General branded line of snus sold in the US. All of the products are manufactured in Sweden according to the Swedish Match product quality standard GOTHIATEK®, and all have the same health and risk profile.
This is a significant accomplishment for the Company and reflects our long term commitment to quality, public health and regulatory science.
Stakeholders and the general public are encouraged to read the Swedish Match MRTP application and submit comments to the federal docket: http://www.regulations.gov/#!docketDetail;D=FDA-2014-N-1051. You may also review the application narrative--, http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-1051-0003-- to read the Summary, on pages 83-131.
This application is representative of our company’s commitment to high quality standards and public health. Swedish Match will now routinely interact with representatives from the CTP Office of Science throughout the completion of this process.
Read the press release Swedish Match submits a Modified Risk Tobacco Product (MRTP) application.