10 November 2015

Swedish Match/FDA MRTP Update! 10 November 2015.

When I first wrote about an article on the Modified Risk Tobacco Product label back in August of 2014, I was hopeful, but reserved in my enthusiasm. Today, I was pleasantly surprised to see what the latest FDA press release said.

"The marketing orders are for eight Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. The PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse. The FDA’s review also determined that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively. The marketing orders are product-specific and do not apply to other tobacco products."

Granted, at the bottom of the press release it says, "Today’s PMTA actions are marketing authorizations and do not constitute MRTP authorizations." So, it doesn't seem like a 100% approval of MRTP. But, it does look as though the FDA has recognized the claims of Swedish Match as factual and we are on our way to an approval.

1 comment:

  1. Excellent news! And... should we get approval on this the EU is in all likelihood going to start feeling the pressure to review this matter, undoubtedly. Regulatory nannies, take heed! Gotta love truth!