Monthly Archives: November 2015

FDA and e-cigarettes: the dangers of radical policy action

by Carl V Phillips

If U.S. FDA had succeeded in banning e-cigarettes in 2009 as they did a decade before that, it would have been a bad policy action for many reasons. It would have served no legitimate purpose, violated the mission and spirit (and, according to Judge Leon, the letter) of the FD&C act, violated the ethical norms of free society, dramatically lowered the welfare of many people while making pretty much no one better off, and hurt the public’s health. But at least it would have been a fairly conservative incremental policy. Relatively few people were using the products and had not been doing so for very long. A few small businesses depended on it. It turns out that enormous benefits would have been lost. But at the time, the action would have been a relatively modest departure from the status quo.

This contrasts sharply with the present FDA plan to ban e-cigarettes (for that is what it is) which has all those other negative characteristics and additionally suffers from being a radical departure from a status quo in which millions of Americans use e-cigarettes at least occasionally, and probably hundreds of thousands rank them in importance below only basic necessities, friends, and family. A multifaceted industry and an entire culture have formed around them. The changes in the world that would be brought about by the ban are staggering.  Continue reading

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

Sunday Science Lesson: Why people mistakenly think RCTs (etc.) are always better

by Carl V Phillips

I recently completed a report in another subject area which explains and rebuts the naive belief by non-scientists (including some who have the title of scientists but are clearly not really scientists) that some particular epidemiologic study types are always better, no matter what question you are trying to answer. I thought it might be worthwhile to post some of that here, since it has a lot of relevance to studies of THR.

Readers of this page will recall that I recently posted talking-points about why clinical trials (RCTs) are a stupid way to try to study THR. A more detailed version is here and the summary of the summary is: RCTs, like all study designs have advantages and disadvantages. It turns out that when studying medical treatments, the advantages are huge and the disadvantages almost disappear, whereas when trying to study real-world behavioral choices of free-living people the disadvantages are pretty much fatal and what are sometimes advantages actually become disadvantages. Similarly, some other epidemiologic study designs (e.g., case-control studies) are generally best for studying cancer and other chronic diseases, which are caused by the interplay of myriad factors that occurred long before the event, but are not particularly advantageous for studying things like smoking cessation. Asking someone why he thinks he got cancer is utterly worthless, but asking someone why he quit smoking can provide pretty good data. 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