Modified risk application damaged but not sunk

The US Food and Drug Administration’s Tobacco Products Scientific Advisory Committee has concluded that Swedish Match North America’s (SMNA) General snus should not be allowed to carry Modified Risk Tobacco Product (MRTP) warning labels.

Last year, SMNA made an MRTP application to the FDA in which it sought to have changed or eliminated, in respect of its General-branded snus, three of the four warning labels currently carried by smokeless tobacco products in the US. No change was sought to the warning declaring that this product is addictive.

Under the application, one of the changes would see the inclusion of a warning stating, in effect, that while no tobacco product was safe, General snus presented substantially fewer risks to health than do cigarettes.

Such a warning would represent a sea change and the application has been closely watched by both the public health community and tobacco companies.

Some commentators have concluded that the committee’s findings have sounded the death knell of the application, but others argue that the committee’s only other recommendation to date has not been taken up by the FDA.

The FDA is due to reach a conclusion by August of this year.