Tag Archives: Swedish Match

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

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Remember, what the US government wants to do to ecigs, they have already done to smokeless tobacco

by Carl V Phillips

Well, a lot has happened during my blog hiatus. I trust I do not need to tell anyone interested in THR that things in the US e-cigarette world “got real”, with the US FDA finally moving ahead with “deeming” e-cigarettes. Why, exactly, it was suddenly more real that it was for the last year or two — during which it was clear that this was coming soon — I will leave to the behavioral economists. But it does seem to have changed the mood. The last time I posted here, CASAA membership was about 70,000 and today is north of 110,000 and climbing fast. So this is probably a good time to give people new to this world a primer, and remind everyone else, that the US government has a long history of being hostile toward THR.

Few who actively oppose FDA’s plans need any additional reasons to object to them. It is sufficient to know that this is not actually regulation, but a de facto ban of the entire category that might — or might not — be followed by granting exceptions to the ban for a handful of closed-system e-cigarettes. (I will detail why this is the right way to think about it in my next post.) But there are people on the fence. Perhaps more important, there are many opponents of banning e-cigarettes who are naively optimistic, expecting reasonable behavior from our government once they implement this rule. Continue reading

TPSAC meeting on Swedish Match MRTP application: is there a scientist in the house?

by Carl V Phillips

The FDA just concluded the meeting of their Tobacco Product Scientific Advisory Committee (TPSAC) to review the MRTP application by Swedish Match to change the incorrect warning labels on their smokeless tobacco products. They applied for removal of the warnings that say that the products cause diseases that they do not actually seem to cause (meaning: to a measurable degree, of course) and to replace them with a warning statement that says while no tobacco product is safe, these are substantially lower risk than smoking. (Background on that here, here, and here.) In other words, they were asking to be able to state something that is beyond doubt and not be forced to make claims that are not supported by the science.

So how do you think this extremely reasonable and clearly valid supplication to the FDA went? Continue reading

New York Times Editorial Board lies about smokeless tobacco labeling

by Carl V Phillips

The New York Times Editorial Board has come out against allowing the “warning” label changes that Swedish Match requested in their MRTP application. They probably did not set out to actively mislead their readers like, say, ANTZ “researchers” do. But when they summoned up all their expertise and experience as, um, reporters on politics and current events, somehow they got this bit of scientific analysis wrong. Shocking. Their lies appear to be the “claim to be expert on something you do not actually understand” type, though I suppose we cannot rule out that they were intentionally trying to mislead. This is combined with them clearly not having a clue about who to believe in this arena. (Hint: The industry tends to be almost impeccably honest and maximally knowledgeable when it comes to the science. Regulators fail on both those counts. And the vast majority of academic “researchers” in this area do not even try to be either honest or knowledgeable.) Continue reading

More on the FDA and MRTP

by Carl V Phillips

In the previous post, I linked to CASAA’s comment to the FDA re Swedish Match’s MRTP application, wherein they ask to be able to change the “warning” labels on their smokeless tobacco products to not “warn” about risks that do not exist and to move a bit(!) closer to communicating the low risk of these products as compared to smoking. Clive Bates also weighed in on this, via this post and his own comment to FDA on the application. It is worth following up on some of his points and some others. Continue reading

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.

 

Why the most important ecig news of the week is Swedish Match’s MRTP application

by Carl V Phillips

Swedish Match broke the ice for the FDA’s “Modified Risk Tobacco Products” process this week, boldly applying for the removal of misleading warning labels on their smokeless tobacco products in the USA.  There is no point in me writing about the details of that, since Rodu already covered it nicely (read that if you do not already know about it).  But no THR blog could possibly let this enormous event pass without comment, so I will take another angle on it, to point out why those interested in e-cigarettes (most of the readers of this blog) should consider this important news (good and bad) regarding e-cigarettes. Continue reading