Credit where due: FDA

by Carl V Phillips

I’m back.  Sorry for the long absence — for obvious reasons, the blog loses out to paid work, family vacation, and (the only bit that is actually of interest to you) preparing a presentation for and attending the Tobacco Merchants Association meeting last week.  A bit more about TMA in a later post.  Today I want to focus on what was said about and by FDA at that meeting.

First, the good news:  In a presentation at the meeting, the head of TMA, Farrell Delman, pointed out that FDA had changed their website in a few places to make clear that the CDC estimated deaths from smoking are from smoking and not tobacco.  (I did not note which specific pages Farrell showed in his talk, but here (pdf) is one example I just found.)  As regular readers know, blaming “tobacco” or “tobacco products” for the risks from smoking is probably the most pervasive anti-THR lie.  It perpetuates the misperception that smoke-free tobacco/nicotine products create a substantial health risk.

Unfortunately, the change is not universal, but I will choose to embrace Farrell’s optimism for the moment.  We can hope that the remaining instances of the misleading “tobacco” bundling language are either dated info releases that would not be appropriate to change (the government is really not allowed to memory hole past statements) or places where they have just not yet noticed they need to make the change (like here or the sidebar here — hint, hint!).

And, of course, no doubt if you followed those links you noticed various other bits of anti-THR misinformation that still remain.  But any steps in the right direction are good news.  Pervasive myths are not fixed in a day.

Also on the frustrating side was the continued emphasis, as seen in the presentation of David Ashley, the CTP science chief, of the supposed possibility that low-risk products could lead to an increase in total population health risk by attracting new users who avoid smoking because of the risks (my liberal paraphrase of a couple of much less detailed bullet points).  Simple arithmetic shows that is impossible, but FDA has to emphasize it because it is so clearly enshrined in their enabling legislation.  This relates closely to my presentation at TMA, so I will comment more in a post about that (probably at EP-ology, but I will cross-post something here).

Back to the good news:  Mitch Zeller, the new head of the FDA’s tobacco unit (CTP) presented at the meeting and took questions.  So did Ashley.  Kathy Crosby, the new head of communications, had a prominent role in a panel.  The significance of this should not be underestimated.

During the Q&A for Zeller’s presentation, CASAA questioned CTP about the lack of consumer (i.e., the primary stakeholders in all of this) representation in their proceedings.  He invited us to submit a formal request, which we will send today or tomorrow.  It appears certain that this will give us a chance to present the consumer views to CTP in a special meeting.  It is less certain whether we will have a spot on the agenda for future hearings where other stakeholder presentations (industry, etc.) are included, but we are making every effort to ensure that consumers are given a place at the table.  We will keep you posted (and might recruit you to support our request should it seem useful).

In his presentation, Zeller made clear that the top priorities for the CTP currently include the “deeming regulation” that would bring e-cigarettes and some other products under FDA jurisdiction.  (Contrary to what you sometimes read, they are not currently regulated by FDA as a tobacco product, but probably will be.)  Whether this is done in a way that makes e-cigarettes better (i.e., serves the consumers’ interest, as FDA regulation is supposed to do) or in a way that threatens innovation or their very existence (serving the interests of the anti-tobacco extremists, who want to prevent harm reduction) remains to be seen.

Another stated priority is to get through some of the backlog of applications.  Unfortunately this does not matter much for real consumer interests, since as far as we can tell the overwhelming majority of these are just “substantial equivalence” applications by cigarette makers who just want approval for some insignificant change of their products.  It does not appear that there are any “MRTP” applications pending.  (That is the misnamed category that would allow harm reduction claims about a product — it is “modified risk tobacco products”, though the products that really matter are not modifications of existing products, but entire categories that have always been very low risk compared to smoking.  The misnomer itself is an anti-THR lie because it is designed to hide the fact that different categories of products have hugely different risks, though that is not the fault of FDA, but rather of the ANTZ that wrote the legislation that created CTP and their mission.  At least lawmakers changed the ANTZ’s proposed wording that would have completely forbidden any claims comparing low risk products to smoking, an obvious attempt to prevent THR.)  We believe there is at least one MRTP application in the pipeline, though unfortunately it is not for a low-risk product.

And on a less recent note, many of you may recall that FDA rebuffed attempts by the ANTZ at University of California San Francisco to make CTP their own private activist organization by threatening to boycott if stakeholders (in that case, industry) were allowed to even present their views.  (Though, of course, they showed up at the hearing to announce they were not showing up at the hearing.  We cannot expect them to be honest even in their protests, after all.)  CTP did not make any public response to this attempt to subvert the American political system, but they clearly did not give in.

I guess the bottom line is that we are in far from a perfect world, with regard to THR-related regulation, but it looks like a much better world than existed a year ago.