This week, CASAA took two steps to help gain consumers better representation in tobacco product regulation. First, we nominated our Scientific Director, Dr. Carl V Phillips, to serve on the Tobacco Products Scientific Advisory Committee (TPSAC) for FDA’s Center for Tobacco Products. CTP has repeatedly assured the public that it intends to make sure consumers have a seat at the table. (As you may know, consumers and those of us who organize to represent them have been relegated to supplicant status to date http://antithrlies.com/2013/12/10/dear-fda-ctp-nothing-about-us-without-us/ ) This will be a make-or-break test for their commitment, since it is difficult to imagine anyone more qualified to serve on that committee than Dr. Phillips.
We nominated him primarily for the consumer representative slot on the committee (which to date has been held by an extremist prohibitionist who is about as far from representing consumers as is possible), but also for any open slot, since he is also one of the most accomplished and broadly knowledgeable scientists in the area of the modern world of tobacco products (if you want more details on that, here is our nomination letter). We believe he may be the only genuine consumer representative nominated this round, and know that he is among the most qualified scientists. If his nomination is rejected, it can only be interpreted as the FDA not being honest about welcoming consumer participation in the process.
Second, we had a very successful meeting with the White House Office of Information and Regulatory Affairs (OIRA; part of the Office of Management and Budget), which is currently reviewing FDA’s proposed regulations of e-cigarettes. As you know, FDA has written regulations that “deem” e-cigarettes to be tobacco products, and thus to be under the jurisdiction of their Center for Tobacco Products, and that contain other (as of yet, unknown) details about the regulation of e-cigarettes. OIRA is the office responsible for reviewing all regulations to basically make sure they are not unnecessarily burdensome. The testimony that CASAA (in the persons of Elaine Keller and Julie Woessner) delivered can be found here.
If you read that, you will notice that it is not just a generic broadside that says “e-cigarettes are great, and everything is fine, so regulation is bad.” While that is often the right approach with politicians, dealing with different offices requires different approaches, and we realized that a generic plead would not be useful for persuading them or aiding their decision. Thus, we based our analysis not on pleading about the wonders of the category, but on the regulatory economics arguments and other technical points that we believed would resonate with OIRA. Apparently it worked, because they were attentive, asked a lot of questions, and kept us there well past our scheduled time so that they could continue to ask more. We do not want to overstep by providing any details about what they said, but we will go as far as to say that they seemed to believe that the points had merit and did go to the basis on which they have to make their decision.
To summarize our testimony, we presented the great benefits and limited costs created by the current e-cigarette market, and argued that therefore almost any restrictive regulation would have a poor cost-benefit performance. We emphasized how the current Center for Tobacco Products regulatory process was already overburdened, with a huge backlog of applications awaiting action, and that e-cigarettes would dramatically complicate this process even more. In particular, we pointed out that the MRTP process (by which a product can get approval to enter the market and/or make health claims on the basis of being low risk) is currently nonfunctional. Thus, while it might appear on paper that particular FDA regulations were reasonably flexible, in practice requiring these approvals was functioning as a de facto ban. We did not suggest that the FDA’s motives or goals were bad, just that the combination of workload, decisions to date, and the constraints of the Tobacco Act make it almost impossible for them regulate e-cigarettes in a way that is beneficial rather than harmful.
OIRA seemed genuinely pleased to hear from real consumer representatives (in contrast with some decision-makers we have dealt with) and especially pleased that we brought them a cogent and fact-based analysis that focused on the decision criteria that they need to use, rather than just expressing opinions about what a perfect world would look like. Before the meeting, we did not really think there was much hope that OIRA or the White House would intervene to change what might be some bad proposed regulations. While it is far from certain that it will happen, we are now optimistic that they are seriously considering doing so.