Tag Archives: FDA

FDA pseudo-regulation of e-cigarettes: what possible benefit?

by Carl V Phillips

Continuing the assessment of FDA’s proposed regulation (as far as we can anticipate what it says). For background, see the CASAA newsletter and the recent posts here. As already noted, the proposed “regulation” is really a ban on sales of all existing e-cigarettes with a provision that will probably (but might not) allow a handful of closed-system products, that FDA hand picks, back on the market. But whether regulation or ban, it can only be justified in order to solve problems. So what problems is it ostensibly solving? To understand the proposal or respond to it, it is necessary to identify those — as a separate point from looking at the downsides — and address what benefits might result. Continue reading

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

FDA “regulation” of e-cigarettes would not actually be regulation

by Carl V Phillips

A recent news poll asked people, “Do you believe e-cigarettes should be regulated by the FDA like tobacco products?”, and 57% said “yes”. The main lesson from that is that people who are clueless about survey research should not be allowed to do survey research. Any moderately competent researcher would realize that answers to that question are meaningless when the respondents have no idea what they are being asked. If forced to field such a question, an honest researcher would have also asked one or more questions about how FDA regulates tobacco products and, after discovering that not a single respondent was anywhere close to right (I am pretty confident that would be the result), would dismiss the responses to the first question as meaningless.

An honest and skilled researcher only asks questions such that the respondent actually knows what they are answering: “Do you believe that FDA should ban all e-cigarette products, followed by allowing a few of the largest companies to spend $20 million per product to beg permission to allow a product or two onto the market, applications which FDA would then grant or deny based not on any rules but on their political whim or political connections, with the result being less than 20 expensive and low-efficiency products remaining on the market?” That is the question the respondents were answering, they just did not know it. No doubt some respondents still would have said “yes” — haters gonna hate — but not nearly as many. Continue reading

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

Dear @FDATobacco: Stanton Glantz’s junk science reflects upon you

by Carl V Phillips

Dear FDA Center for Tobacco Products:

I know you did not create Stanton Glantz. His intense barrage of patently absurd junk science predates your existence. You did not cause him to become the combination of utterly innumerate and/or sociopathic (it has always been difficult to be sure how much his utter disregard for real science is explained by each of these). But you own him now, thanks to the fact that you fund him and his minions, and so his nonsense is now on you. You claim to be about science. Are you? Continue reading

More on the FDA ecig workshop

by Carl V Phillips

Those of you who watched my contribution to the workshop (which you can do by following the link in yesterday’s post) probably found the most memorable observation to be the one about San Francisco. But I am rather prouder of not missing a beat regarding a later question. Leading into that, there was a rambling multi-part question to the panel, which a couple of others responded to bits of. I took the mic last to respond to the phrase “renormalizing smoking” in the question. Continue reading

Notes from the FDA e-cigarette workshop

by Carl V Phillips

I have several posts worth of material to cover on the themes presented here. I’ll see if I can get to them. In the meantime, some random thoughts about the third FDA Center for Tobacco Products workshop on e-cigarettes that took place on Monday and Tuesday of this week. As with the previous workshops, it was a mixed bag of good science from industry and a few others, sneaking in amidst the utter junk from the “public health” types. At this one, the mix was perhaps almost up to 50-50, which is a lot better than the previous ones.  Continue reading

California ecig “regulation” hearing: a catalog of lies (part 2)

by Carl V Phillips

Continuing from the previous post, you will recall that we established that California Senator Mark Leno is absolutely hilarious when he tries to talk about science — assuming you can maintain a sense of humor about someone who is spouting lies in support of a bill that would inflict a great deal of harm with no apparent benefits. He continues by suggesting he also does not understand how lawmaking works, or even his own bill. Sadly, it is not nearly as funny as his attempts to talk science. Continue reading