APA questions Food & Drug Administration’s draft rules for tobacco research

The American Psychological Association routinely works with partner organizations to provide feedback to various executive branch agencies on activities related to the science of tobacco control. Some of that feedback is broad in scope, as with recent recommendations to the Departments of Health and Human Services, Labor and Treasury requesting that they issue a new Frequently Asked Questions (PDF, 544KB) document to clarify insurance coverage benefits for individuals who seek to quit their use of tobacco. Other times, it is focused on a specific, nuanced issue like the cost-benefit analyses that the Food and Drug Administration (FDA) used to estimate the “loss of pleasure” that tobacco users would suffer from quitting. 

Recently, the FDA issued draft guidance to set the rules for conducting research with Investigational Tobacco Products (ITPs). In addition to traditional combustible products, the rules are likely to apply to the myriad array of Electronic Nicotine Delivery Systems (ENDS), more commonly known as electronic cigarettes or vaporizers, which are becoming more prevalent in the nicotine marketplace and represent a significant new route of exposure to those initiating the use of tobacco products. (The liquefied nicotine in ENDS is derived from tobacco plants, rather than synthesized, and is thus considered a tobacco product.) The guidance that the FDA has developed for research with ITPs is modeled on the rules for research with pharmaceutical/chemical compounds that fall within regulations for Investigational New Drug (IND) applications.  

This has led to a concern among many in the tobacco research community. They note that the information routinely provided to the FDA about a chemical compound studied as an IND simply is not available for commercially available ENDS. The product design specifications for ENDS are proprietary, and the manufacturers are generally not willing to share them with outside researchers. Scientists interested in studying off-the-shelf ENDS have had to abandon research plans that have received funding and IRB approval for lack of technical product information.

APA and its partner organizations are asking for a practical approach (PDF, 474KB) that allows scientists engaged in tobacco product research to keep up with an ever-changing landscape of ENDS designs. In addition to pointing out research hurdles in the draft guidance, the comments request that the FDA engage in public hearings involving the scientific community to flesh out the full range of issues raised by research with ENDS before finalizing its guidance. The FDA has been receptive to similar requests in the past and such meetings have been critical for framing tobacco use research as the marketing of tobacco products has evolved.

Stay tuned for future updates on this topic. You may contact Geoff Mumford of APA’s Science Government Relations Office with any questions or comments.