FDA to Hold Public Listening Session – E-Cigs Likely to be Discussed
By Lindsay Fox Posted March 12, 2014
The FDA’s Center for Tobacco Products has announced it will be holding a public listening session to discuss “any topic relevant to science-based regulation of tobacco products” on April 5th in San Diego. Although it hasn’t been explicitly stated that e-cigs will be under discussion, it seems extremely likely given the stated goals of the event and the impending announcement that the FDA will regulate e-cigarettes. It’s scheduled for between 6:00 and 8:30 PM (PST), planned to coincide with the American Association for Cancer Research’s (AACR) annual meeting.
Why Are They Holding the Session?
The stated aim of the session is to allow the public to have a say on the issues related to tobacco product regulation, and as such there is no requirement to attend the AACR event in order to get involved. Senior staff members from the Center for Tobacco Products’ Office of Science will be there to listen to presentations from the public, which can last up to ten minutes each. Since e-cigs are likely to be discussed, this may be a great opportunity for vapers who can make it to the session to get their views across.
Any issue relevant to evidence-based tobacco product regulation can be discussed, but they’re particularly looking for presentations relevant to the key issues identified by Mitch Zeller in a webinar from late last year:
- Preventing youths from taking up tobacco
- Encouraging adult tobacco users (they didn’t specify smokers) to quit
- Reducing the harms and addictiveness of products
- Developing a science base and regulation to reduce tobacco-related disease, disability and death.
What it Means for the FDA’s Looming E-Cigarette Regulation
Based on the FDA’s previous activities, it would seem that things aren’t looking too good when it comes to e-cig regulation. However, this decision – and their other activities, such as listening to presentations from researchers such as Dr. Farsalinos – offers a glimmer of hope that they may provide at least some reasonable concessions to vapers. It might not be perfect, but it’s some indication that they’re trying to work with vapers and experts to come up with something reasonable.
Of course, there is a chance that this isn’t a good sign at all; it could be a calculated move to placate concerns about their possible approach. E-Cig Advanced do rightly point out that the time of the session isn’t ideal (who really wants to do something like this on a Saturday evening?), but admittedly it does also give people the best chance of at least being off work that day.
It also seems that this indicates that the proposed regulations won’t be announced at least until after then. They could do it before, but it seems they aren’t particularly in a rush to announce their plans. For vapers, the issue is that the regulatory approach to tobacco harm reduction products is often overly restrictive. If what we’ve seen proposed for e-cigs from Europe and in places across the US is anything to go by, we can rest assured that there will be something overly prohibitive and lacking in scientific basis in there somewhere.
The stakes really are high. If they make moves like the EU’s arbitrary limit on nicotine level and limitations on the maximum bottle-size for e-liquids (a measly 10 ml), it could effectively undermine e-cigs as a technology in the US. Even if the results of the public comments are ignored, this is one of the only chances vapers have to really try to get the message across to the regulators directly.
They’re looking for comment on the issues, and if you’d like to speak, they’ve created a registration form you can use to submit your request. However, ordinary vapers concerned about the issues can simply attend, and if there is enough time, audience members who haven’t previously registered will be allowed to comment more briefly. It isn’t going to be broadcast online, but they will make the full transcript available after the session.
It might not be much, but if you’d like to have your voice heard on the issues, this may be the only opportunity you have until the announcement is made. More importantly, the session could give vapers an idea of how the FDA is likely to approach the issue. We might finally be able to breathe easy, or we may have to fight for our right to vape like never before.
Here are the full details for the session:
Public Listening Session for the Office of Science, Center for Tobacco Products, FDA
April 5, 2014
6:30 p.m. to 8:30 p.m.
San Diego Convention Center
Room 28 DE
San Diego, California