CASAA comment on Swedish Match’s MRTP application

Anti-THR Lies and related topics

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…

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