Tag Archives: PMTA

FDA’s snus PMTA approval — what it seems to mean

by Carl V Phillips

FDA issued its first ever approval of “new” tobacco products under the PMTA process that I have discussed before (most recently a few days ago in the context of their proposed ban of all existing e-cigarettes). If you were to read the FDA’s press release about it or the news stories — which basically amounts to the same thing, given the quality of health science reporting — you might come away thinking that this was something major. And it kind of is, just not for the reasons FDA wants people to believe.

The details, as best as they can be pieced together, are explained by Larry Waters, whom I trust on these matters. Basically, Swedish Match wanted to upgrade the eight snus products they sell via bricks-and-mortar stores in the U.S. market, from the 2011 versions of these products to improved current versions that are the same as (or at least more similar to — the public is not told of such details) what they are selling in Sweden now. They apparently applied through both the PMTA (premarket tobacco application) and SE (substantially equivalent) processes, and were granted the former. Note: This should not be confused with Swedish Match’s MRTP application to change the warning labels on their products, which is an entirely different matter. However, I saw a claim that the PMTA application was quietly piggybacked on their MRTP application, making it much easier for them than it would normally be — but I am really not sure of the details there. Continue reading