Monthly Archives: June 2017

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 2)

by Carl V Phillips

In the previous post, I gave some background about the new proposed rule from FDA’s Center for Tobacco Products (CTP) that would cap the concentration of the tobacco-specific nitrosamine (TSNA) known as NNN allowed in smokeless tobacco products (ST). Naturally, I think you should read that post, but to follow the scientific analysis which begins here, you do not need to.

Before even getting to the even worse nonsense about NNN itself, it is worth addressing CTP’s key premise here: They claim that ST causes enough cancer risk, specifically oral cancer, that reducing the quantity of the putatively carcinogenic NNN could avert a lot of cancer deaths. Continue reading

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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1)

by Carl V Phillips

I am a bit late to analyze this proposed FDA rule, which was promulgated on Inauguration Day. But it is still open for comments, and I will be submitting these posts (though for reasons I will get to shortly, these and all other comments are probably moot except as for-the-record background).

Before getting to the substance it is worth noting that this is really the first bit of genuine regulation proposed by the FDA Center for Tobacco Products (CTP) in its eight years. Despite CTP reportedly approaching $4 billion in cumulative expenditures, it has only implemented a few inconsequential rules that were specifically required by the enabling legislation, and has never actually created a standard or specific requirement like a real regulator. Instead, everything it has done has been what I have dubbed weaponized kafkaism. The variation on the word “kafkaesque” refers, of course, to Kafka’s horror stories of bureaucratic (in the pejorative sense) rules that create injustice via impossible procedural burdens. “Weaponized” refers to turning something that is harmful but not malign into a tool for intentionally inflicting harm. CTP has turned filing and paperwork hurdles into a weapon. Continue reading

Time to stop measuring risk as “fraction of risk from smoking”?

by Carl V Phillips

I ran across a tweet touting a press release out of the Global Forum on Nicotine (GFN) meeting (a networking meeting, mostly of e-cigarette boosters) that made the claim that snus is 95% less harmful than smoking. This was variously described as being based on “new data”, “new data analysis” and “the latest evidence”, but with no further explanation of where the number came from. Since the presenter was Peter Lee, those of us who know who’s who can surmise that it is a statistical summary of existing published studies, because that is what Peter does. There is nothing necessarily wrong with that (though for reasons I will explain in an upcoming post, it is potentially suspect in this context). but it is certainly not new data or the latest evidence.

Oh, and it is clearly wrong. Continue reading