CASAA presents at FDA listening session in San Diego
San Diego -- April 5, 2014
The Office of Science in the Center for Tobacco Products held a public listening session, in conjunction with the annual meeting of the American Association for Cancer Research (AACR), this past Saturday. Senior staff from the Office of Science was present to hear relevant presentations from members of the public.
CASAA director Elaine Keller attended the event with a presentation written by her and CASAA's Scientific Director, Dr. Carl Phillips, PhD. Below is the transcript of the prepared presentation, with corresponding slides.
SUBMITTED AS ABSTRACT
A large portion of the science related to low-risk alternatives to smoking seems predicated on informing the regulatory question “should these products be caused to disappear, or at least be marginalized from the public view?” But since neither of these is a possibility in a free society, the research efforts designed to promote bans and the responses designed to head-off bans do nothing to improve regulations. Useful regulatory science must be premised on the reality on the ground, not the questionable and unattainable goals of a vocal minority. Such science would help determine what real-world regulation would benefit consumers with improved safety (e.g., specific features of e-cigarettes that should be sought or avoided) and improved understanding (e.g., accurate warning labels on smokeless tobacco). It would also help serve broader policy goals (e.g., moving away from the currently denigrated e-cigarette advertising to messaging that encourages harm reduction without glorifying any product).
E-cigarettes: the need for useful regulatory science, not unhelpful broadsides
Here is a quick bit about CASAA. We are a public health and consumer NGO, not an industry group.
Regulatory science is applied research, designed to provide information needed to make better regulations. For it to be useful, it needs to address real-world questions about improving the lives of consumers, not the unrealistic wishes of a fanatic small minority. Most of the research about e-cigarettes that is funded and conducted by the tobacco control industry, as well as an unfortunate portion of that supported by the FDA itself, would only be useful for informing regulation if the regulatory question were, “should e-cigarettes disappear.”
This is not a useful question. No respectable regulator – any regulator who considers scientific information to be part of the regulatory process – is considering banning this category, given the enormous public health benefits that it provides. The most recent contribution to the science on that point is a representative survey in France that estimated that 1% of the population (not 1% of smokers, 1% of the entire population) has already quit smoking because of e-cigarettes.
Moreover, even if there were a complete ban tomorrow, there would still be a million e-cigarette users in this country, and the number would continue to grow because it would be almost impossible to enforce.
Real regulatory science is reality-based and addresses serious questions. The reality is that e-cigarettes exist and will continue to exist, and that is a very good thing for consumers. Given that reality, there are ways that regulation can help make them better and eliminate the minor unwanted effects that have been observed.
Perhaps the most obvious case of useless research is the flurry of recent scaremongering about unintentional poisonings from e-cigarettes. There is no serious doubt that e-cigarette liquid and smaller hardware components present a nonzero hazard for small children. But also, that this is not a dire hazard, as evidenced by the difficulty in ingesting a seriously toxic dose of nicotine, as well as lack of any documented cases of serious injuries or deaths from accidental exposure. Many household products poison many more people The goal should be to reduce the risk, not pretend it can be eliminated.
Thus, if someone wants to do useful research about the real-world, rather than trying to simply attract attention and lobby for their fantasies of a world without e-cigarettes, they would be trying to figure out how reduce the poisoning risk via physical means and messaging. While much of this is fairly obvious, if this is a genuine worry -- and not just a stalking horse for vilifying the category -- then effort should be devoted to understanding this and not just sensationalizing statistics that offer no practical guidance.
A much more complicated issue is encouraging science that will improve the quality of e-cigarettes in terms of minimizing the already very low health risks. The largest manufacturers -- primarily the major tobacco companies -- have the capacity to conduct research on their very standardized products and perfect them. But the large community of consumers who prefer non-standardized products, and the thousands of small businesses who cater to them, could use some help in improving their products. The proper role of regulators in a free society is to help make the world better for consumers, not to curtail their actions because it is inconvenient to allow them freedom. The “Food” half of the FDA understands this and acts accordingly, and that should be the model for e-cigarette regulation, not CDER.
There is every reason to believe that some hardware configurations and some liquid ingredients are slightly more hazardous than others. (We emphasize “slightly” and remind everyone that there is overwhelming evidence that they all pose trivial risk compared to smoking. There is no evidence to suggest there is any substantial hazard from any device or liquid on the market.) Obvious candidates for research are hardware that allows overheating, hardware that uses solid components that are vulnerable to pyrolysis, and flavorings. Some molecules that are safe as ingested flavorings may not be safe to inhale. Regulations that are designed to help consumers and not hurt them could impose restrictions based on information about what is more or less hazardous. But no such science exists. Creating it would be a very good use of public research resources, since the small manufacturers do not have the capacity to do it themselves.
Much of the regulatory controversy around e-cigarettes relates to allegations of marketing to children or to adults who are not the target for tobacco harm reduction -- that is, people who are not looking for an alternative to smoking. The main problem there is, of course, that FDA explicitly prohibits marketing of the products in any way that implies they can do what they do. Thus the marketing pitches cannot use that message. The situation is even worse for smokeless tobacco, where the mandated safety warnings actively misinform consumers and discourage smokers from switching.
While regulation of the messaging and possibly changing the harmful existing rules is probably not going to happen in the near future, science takes time and needs to be started in anticipation of future regulation. It would be useful to know what messages are most likely to persuade smokers or would-be smokers to switch to e-cigarettes or smokeless tobacco, and that are less likely to persuade those who would be abstinent to start. While it is not really clear that the latter is a legitimate worry, worries about it are widely hyped and influence policy making. Widespread public communication about e-cigarettes will not be stopped, no matter what restrictions are imposed on manufacturers. So science that deals with reality, rather than a fantasy of making e-cigarettes become invisible again, should focus on how to direct the communication in socially preferred directions, rather than useless shrill claims that it is causing some new “epidemic”.
There are many other areas where reality-based science could improve public health and regulation of low-risk tobacco and nicotine products. These include: -Realistic (rather than scaremongering) research on any environmental hazards from vaping. While FDA is unlikely to govern place bans on usage, scientifically uninformed local governments look to the federal government for guidance. Honest regulatory science in this area involves not just finding a few molecules and tricking chemophobic people into worrying about them. It requires honest assessments of actual risk like those done by OSHA or EPA.
-What product characteristics are most beneficial for tobacco harm reduction? Questions like this tend to be best answered by industry research and experience. But many federally-funded researchers appear to be quite interested in product characteristics, so are likely to be going down this path. They should be steered toward doing work that is useful for regulation. Moreover, there is serious concern that regulations might restrict exactly those characteristics -- such as attractive flavoring and high nicotine strength -- that our research shows are crucial for helping many people quit smoking. We believe that the science will show that the consequences of such restrictions would be almost entirely negative for consumers and public health.
To reiterate in conclusion, useful research on e-cigarettes, as well as other low-risk alternatives to smoking, needs to be based on reality. Moreover, the proper role of regulations is to benefit consumers, not to deny them the right to make reasonable choices for themselves. A huge portion of the current research would only be of benefit if the regulatory question at hand were “should e-cigarettes cease to exist.” Since that is not going to happen, the research is just self-serving prohibitionist rhetoric that provides no useful information to FDA or the world.