In another Dilbert meets Kafka moment, the FDA, both directly and indirectly through NIH/NIDA, has been telling researches that they are planning to require researchers to get an “Investigational New Drug” (IND) approval for any studies of e-cigarettes.

What this means is that, at the same time that the FDA is sitting quietly while e-cigarettes are being aggressively marketed, including with unsupported claims that they are effective smoking cessation aids (which allows, even in the current legal environment, to regulate them as drugs right now),  and in the face of skyrocketing use by kids,  the FDA is poised to throw up roadblocks to independent research on the effects of e-cigarettes.

Not only will this substantially slow down research, but it will limit the scope of what is studied.  What we need is to understand the effects of e-cigarettes as used in the real world, not some highly stylized “research” e-cigarettes function.

Neal Benowitz has written an important letter to Mitch Zeller, head of the FDA Center for Tobacco Products.  His letter is worth quoting in full:

I understand that the FDA is considering requiring an ITP/IND prior to allowing federally-funded research on electronic cigarettes.   While such a request might make sense for e-cigarettes for which a therapeutic indication is being sought, it is a terrible idea for e-cigarette research more broadly.  My concerns are as follows:

1.            The use of e-cigarettes in the U.S. population is increasing exponentially over time.  Physicians and other health care providers and policy makers are seeking information on which to base advice for patients or the general public regarding use of e-cigarettes.  Any delays in generating any new research data would be highly detrimental to this process.

2.            Relatively few data are available on e-cigarettes by which to determine the risks vs. benefits of e-cigarette use in populations. Clinical and policy decisions should be made on the basis of data.

3.            More than four hundred e-cigarette products are currently on the market. These have widely differing designs, including variable liquid composition, different chamber size, different batteries, different nicotine and constituent delivery, and different particulate size and distribution.  It would be impossible to obtain the necessary data on manufacturing and safety of constituents for the various products to obtain an ITP/IND in a timely manner, if at all.

4.            NIDA could develop a prototype e-cigarette for research, but this prototype would take considerable time to develop and would be limited to one or a few design characteristics.  These limitations would result in a great delay in gaining information on e-cigarette pharmacology and safety and would have limited application to many products on the market now and in the future.

5.            There are critical unanswered questions related to use patterns, nicotine delivery, addiction liability and safety that can be studied in people using their chosen e-cigarette products.  Such research is not necessarily part of a research program to gain approval for therapeutic use.

6.            Requiring an ITP/IND or NIDA e-cigarette prototype will paralyze much of the research that has been funded (or submitted for possible funding) and which is critical to inform public health.

In summary, data on the addiction liability and safety of various e-cigarette products are desperately needed to inform public health decisions.  Requiring an ITP/IND for e-cigarettes would delay needed research and would be detrimental to public health. I strongly urge the FDA not to require an ITP/IND for e-cigarette research, other than that intended to support application for a therapeutic indication.

This letter has been bouncing around among researchers who care about e-cigarettes and generated a lot of support.

In response, Maciej L. Goniewicz, an Assistant Professor of Oncology in the Department of Health Behavior and the Division of Cancer Prevention and Population Sciences Roswell Park Cancer Center, who has done some of the best research on nicotine and carcinogen exposure from real e-cigarettes, observed that

For me current approach by FDA is currently blocking all my projects on >safety, toxicity and use of the products. None of this projects is a smoking cessation study. Since I got back to States I have prepared few projects and grant proposals on ecig safety.  And now FDA is paralyzing all my efforts. Recently, we got the opinion that even for  nicotine-free e-cigarettes we need IND.  We can’t monitor nicotine cravings, withdrawal system, even reduction in smoking in any of these studies because FDA claims this is “therapeutic indication”.  It looks like nowadays, the only research we can do are laboratory studies or studies on established users.

In short, the FDA is doing nothing to regulate e-cigarettes but is making it harder for independent researchers to collect the data needed to inform the public and policymakers (and the FDA) about the actual effects of e-cigarettes.

The IND process was established to allow pharmaceutical companies who want to test drugs or make therapeutic claims about them to collect the data they need to win FDA approval for those drugs or claims.  It would be appropriate for the FDA to require the e-cigarette companies (and researchers they support) to go through this process.  To date, none of the e-cigarette companies have done so.  And, from their perspective, why bother?  The FDA is doing nothing to regulate the therapeutic claims they are making.

But it makes no sense to require investigators studying the effects of e-cigarettes on the market to go through this process.

I urge other researchers who have been or will be affected by this decision to write Zeller and post their comments as replies to this blog post so that the whole community will have access to their thoughts.