I am listening to Mitch Zeller, the new director of the FDA Center for Tobacco Products, address the TMA Annual Meeting. I will try to summarize his main points as he speaks:
1. The FDA is committed to enhancing communication with all stakeholders, including the tobacco industry.
2. The FDA has three immediate priorities:
a. To deal with the backlog of substantial equivalence determinations.
b. To deal with the menthol issue.
c. To issue regulations regarding alternative tobacco products (e.g., electronic cigarettes, dissolvable tobacco).
3. The FDA is close to releasing scientific guidance regarding substantial equivalence applications, and is close to making decisions on many of those applications.
4. The FDA is relatively close to releasing decisions and/or regulations regarding menthol cigarettes and alternative tobacco products. However, no definite timeline can be provided at this time.
5. In terms of modified risk products: although a product may greatly reduce harm at the individual level, the agency must look at population-level effects, including whether the marketing of the product will lead to higher rates of smoking initiation and/or lower rates of smoking cessation.
6. In terms of his long-term view of what the FDA can do to reduce tobacco-related disease, the development of tobacco product standards is critical and can play a major role.
In response to questions posed by the audience, here is a quick summary of my take-away:
1. It is clear that the agency is going to be doing something about menthol. It is not clear what, but my sense of Mitch's response to a question on this issue is that there is something underway at the agency regarding menthol.
2. The FDA is happy to meet with any and all stakeholders to obtain their input.
3. The CTP will be much more responsive to industry queries moving forward.