Hamburg letter helps clarify FDA’s naivety regarding e-cigarettes

by Carl V Phillips

The great mystery of the proposed FDA regulation of e-cigarettes is what benefit they think the proposed regulations would have.  As we have pointed out (here and here), the proposed regulations seem to impose costs — in the form of what is basically busy-work — without offering any apparent benefits.  A letter to the NYT from FDA Commissioner Hamburg suggests that FDA has absurd faith in the value of that busy-work (though we cannot rule out the alternative explanation, that FDA knows as well as expert observers do that it is worthless, and they are just intentionally imposing costs and lying about their motives).

I will set aside her background lies (e.g., the claim that e-cigarettes are “completely unregulated”) and focus on the single claim about what benefits the regulations would offer:

When it is finalized, e-cigarette companies will be required to report the levels of harmful and potentially harmful chemicals or chemical compounds delivered by their products. But we cannot enact a rule on reporting or restricting e-cigarette emissions until this foundational rule-making is completed, which is one of our highest priorities.

For those who are not familiar with the FDA tobacco regulatory process, the harmful and potentially harmful chemicals (HPHC) rules require that manufacturers test their products to determine the quantities of a particular list of chemicals.  Cigarette manufacturers are also required to test the smoke.  It is completely ambiguous as to whether e-cigarette vapor would have to be tested.  It is obviously not mentioned in the Tobacco Control Act itself, and the draft deeming regulations (in one of their many glaring omissions of obviously important information) repeatedly refer to the HPHC rules without clarifying this.

Indeed, the ambiguity is worse than that:  It is easy to answer the question “what is in this” when “this” is processed tobacco leaf with a bit of paper.  It is rather more difficult when the product is a disposable e-cigarette.  Do they want to know the quantity of the listed chemicals that are in the product overall, including the battery?  Presumably they will figure out that they are talking only about the liquid (and maybe produced vapor), but they have not gotten that straight yet.  They emphasize that e-cigarettes will be subject to HPHC reporting. They do not explain what that means.

So part of the apparent problem is that FDA has not even thought through the simple lawyer points, let alone the science.  But that is just the start of the problems. The biggest flaw in their faith in HPHC reporting is simply this:  The HPHC reporting process has proven to be utterly useless busy-work.

FDA has been collecting HPHC information on cigarettes and smokeless tobacco for years.  They have no idea what to do with this information.  They are required to report it, but without inadvertently and misleadingly communicating that products with lower quantities are less harmful than others.  Good luck with that.  They are, indeed, at an utter loss as to how to do so, and so have been putting it off.  The story is no better in terms of making other use of the information. That “inadvertently and misleadingly” in this case is legitimate.  Unlike the typical ANTZ rhetoric about “misleading” people into realizing that low-risk products are really low-risk, this is a case where there genuinely is no reason to believe the differences within a product category matter enough that anyone should care.

It is expected that FDA will eventually exercise its authority to ban some product SKUs that have higher levels of particular chemicals.  There is no evidence this will be good for people’s health (perhaps a little bit, but undoubtedly too little to measure).  Cigarettes, even with lower quantities of some of these molecules, will still be very harmful.  Smokeless tobacco will still be immeasurably close to harmless.  The HPHC numbers will mainly serve as an excuse to ban some products, which is what they really want to do.  If they picked the SKUs to ban at random, it would have basically the same effect.

The problems with this exercise become worse in the context of e-cigarettes.  The particular list of HPHC chemicals is not the right list for e-cigarettes.  Most of them are a complete waste of time to measure (e.g., e-cigarettes are never going to produce enough PAHs or TSNAs to matter), while other molecules or compounds that are more of an issue with e-cigarettes are not on the list.  It is worth noting that even if the list were the right list, we do not have any evidence that higher levels pose a measurable risk, as with smokeless tobacco.

FDA thinks they are going to address that ignorance.  They are wrong.  Hamburg continues:

The F.D.A. is committed to the science-based regulation of these products to better protect public health. Where the science does not exist, we are able to finance the research to answer key questions related to e-cigarette safety and consumer behavior, including four studies that will focus on the contents of e-cigarette vapor.

After those of you who have read the last ten posts here finish laughing at that first sentence, consider what they are proposing to do.  Four studies on vapor. There have already been enough studies on vapor to assure us that there are no significant systematic risks from it, as reported by Burstyn (2014) — which, incidentally, is not among the 200 references in their “science-based” proposed regulations, even though it is, by far, the most important paper on the topic of e-cigarettes and health.  Four more studies of the contents of vapor are not going to add much to that.

Indeed, it is not clear that the literally thousands of studies of the contents of vapor that would be required by the HPHC reporting (assuming it requires testing of vapor) would add much useful knowledge.  Studies of the right potential contaminant or pyrolysis chemicals might be useful for improving manufacturing.  But FDA is fixated on the wrong chemicals and measures.

Of course, improving production does not seem to be part of the plan.  The proposed regulations would be a de facto ban on 99% of e-cigarette products out there (assuming they are able to exert jurisdiction over them), due to the enormous cost of compliance with the busy-work.

I keep waiting for something to come out of FDA that suggests they have a clue about what to do to make tobacco products — e-cigarettes or others — better for consumers.  But there is nothing.  Instead, there is a stream of claims that effectively say “if we just impose some random regulations, that will make things better.”  It is difficult to know whether these are (a) genuinely naive, (b) purely a hidden agenda to try to drive products off of the market with busy-work while pretending it serves some purpose, or (c) the classic “bureaucrat” stereotype of giving regulators a hammer and them doing what comes naturally.