CASAA comment on Swedish Match’s MRTP application

by Carl V Phillips

As most readers probably know, the FDA tobacco regulation include the “modified risk tobacco product” (MRTP) process, through which a manufacturer can apply to be able to make risk claims about their products (which basically boils down to: can communicate that they are lower risk than standard cigarettes). It has always been clear this process is (a) misnamed (nothing has to be modified to make this true) and (b) silly (when it is obviously true, why is this even necessary?). What has not been clear is whether FDA intends for it to work at all, or whether it just lets them pretend to offer an option and a formal process while just imposing whatever rules they want, as seems to be the case with the “substantial equivalence” process. Swedish Match has decided to invest an enormous effort in finding out, filing the only MRTP application that FDA has considered. (There have been a few other applications in the past but FDA refused to consider them, including at least one case where they basically changed their own rules to avoid doing so and then changed them back again later.)

Swedish Match filed over 100K pages (!) to basically request permission to stop printing false and misleading warning labels on their snus in the USA. They wish to remove the two currently mandated warning labels that are clearly unsubstantiated (that the products cause oral cancer and dental diseases) and change the grossly misleading “not a safe alternative to cigarettes” warning to say, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” FDA asked for comments on the application, and CASAA submitted our assessment of the implications of the label change, which you can read at our main blog at this link.