Now that the comment period for the Food and Drug Administration’s proposed “deeming regulations” has closed, attention is shifting back to state and local legislative approaches to e-cigarettes. (See our comments to FDA.)
While federal regulations ultimately have supremacy, state and local governments around the country are considering e-cigarette policies such as how to tax them, local usage bans, and bans on sales to minors. Two of these issues are now playing out in a fascinating way in Missouri, where Governor Jay Nixon has vetoed a bill that should be seen as a model for how to properly regulate these products at the state level.
The challenge of how to regulate e-cigarettes at any level of government is about getting the right balance between considerations such as product safety and protecting youth, versus the risk of a regulatory scheme which would have the effect of discouraging adult smokers from switching to these dramatically less harmful products.
Mitch Zeller, the FDA’s chief tobacco regulator summed up his approach in a recent interview with the Robert Wood Johnson Foundation. He said,
… if at the end of the day people are smoking for the nicotine, but dying from the tar, then there’s an opportunity for FDA to come up with what I’ve been calling a comprehensive nicotine regulatory policy that is agency-wide and that is keyed to something that we call the continuum of risk: that there are different nicotine containing and nicotine delivering products that pose different levels of risk to the individual.”
Zeller hit the nail on the head about how to think about reaching the right balance, with the continuum of risk in mind:
Right now the overwhelming majority of people seeking nicotine are getting it from the deadliest and most toxic delivery system, and that’s the conventional cigarette. But if there is a continuum of risk and there are less harmful ways to get nicotine, and FDA is in the business of regulating virtually all of those products, then I think there’s an extraordinary public health opportunity for the agency to embrace some of these principles and to figure out how to incorporate it into regulatory policies.”
In Missouri, the legislature codified Zeller’s well-reasoned strategy by banning the sales of e-cigarettes to minors, and, simply enough, defining e-cigarettes as vapor products. Such a definition would have the effect of ensuring that e-cigarettes are not inappropriately taxed and regulated as tobacco products, at least not without deliberation of the legislature. The bi-partisan bill garnered 127 votes in the house, with only 19 votes in opposition. It was approved 27-4 in the senate.
Yet last month, under pressure from a shrinking number of activist groups who deny the potential public health benefits of e-cigarettes, Governor Jay Nixon vetoed this common-sense approach.
The governor’s veto message feebly attempted to justify his action, but doesn’t even pass the laugh test. He writes,
First, Missouri law should not limit the regulation of products derived from tobacco that contain a highly addictive chemical and carcinogenic, noxious chemicals. Not unlike traditional tobacco cigarettes, these products may carry significant health risks to users and others through direct and secondhand inhalation in a manner not unlike traditional tobacco cigarettes.”
It is as if the governor thumbed his nose at the FDA’s Mitch Zeller, who cautioned against this unlimited regulatory approach to e-cigarettes. But Nixon goes further. He awkwardly manages, twice in one sentence, to equate non-combustible tobacco-free e-cigarettes with actual cigarettes. That’s exactly the opposite approach called for by Zeller.
Governor Nixon’s veto message continues,
Second, … Senate Bill No. 841 would harm the health of Missourians because it would contravene and undermine more comprehensive proposed federal regulation.”
Governor Nixon should know better. State law cannot “contravene” federal regulations, even if legislators wanted to. Federal regulations have supremacy. More importantly, the bill passed by the legislature would do nothing to “undermine” proposed federal regulations.
Let’s put aside the fact that the comment period for the FDA’s proposed rule closed only last week and the agency must review and take into account a reported 81,881 comments, some of which exceed 100 pages, before any final regulation is developed. No state law could contravene or undermine regulations that haven’t been finalized yet. The bottom line is that the governor and the activists who pressured him to veto the bill admit that they want to regulate and tax e-cigarettes like tobacco products such as cigarettes.
Those moves are not only unsupported by the science, but would violate the very essence of the regulatory approach the FDA seeks to pursue, as Mitch Zeller described it. The FDA recognizes that there is a “continuum of risk: that there are different nicotine containing and nicotine delivering products that pose different levels of risk to the individual.” Those products should be regulated differently. Governor Nixon, however, goes out of his way to equate, rather than differentiate the products.
Ironically, if the governor gets his way and the legislature does not override the veto, minors in Missouri would be permitted to purchase e-cigarettes from unscrupulous sellers. What’s worse, the table would be set to for bureaucrats in the governor’s office to undermine the will of an overwhelming majority of members of both parties in both houses of the legislature, as well as the strategy sought by the FDA, by regulating and taxing e-cigarettes as if they were cigarettes.
Indeed, if the veto is allowed to stand, it would contravene the very principle central to the FDA’s planned approach to the regulation of e-cigarettes as outlined by Mr. Zeller.
The legislature should act swiftly to overturn the governor’s misguided veto.