The FDA just announced that they are extending the regulation deadlines by 4 years, from August 8th, 2018 to August 8th, 2022 for ENDS products. Yes, 2022.
This is still developing, and the FDA isn't expected to release a written update of the guidelines until next week at the earliest, but here's the basics:
- The grandfather date of 8/8/2007 stays in place.
- All products still have to go through a Pre-Market Tobacco Application (PMTA) process. Previously, it was due on August 8th 2018, it is now due by August 8 2022.
- Any specific regulations that have already been implemented [age restrictions, warning labels, etc.] stay. No retroactive changes to any of these.
- New guidelines and documentation concerning PMTAs and the type of research and requirements the FDA/CTP will be looking for will be issued in the upcoming months.
- The things we already have going on will keep going on. Registration dates, ingredient listings, harmful material reports will all continue to be submitted as outlined in the current deeming regs, until further notice.
This is pretty great news for the industry as a whole. We have been working towards our PMTA application process, following the timeline set forth by the deeming regs, but without nearly any specific direction from the FDA. The FDA is now saying '...Maybe alternative, less-harmful nicotine products aren't as bad as originally thought. Here's some extra time to get your stuff ready, and here's an actual roadmap and directions as to what we want to see when you turn it in.'
The bigger overall point is that FDA director Gottlieb is apparently more open to examining situations, gathering research, and making decisions based on that, versus knee-jerk, all or nothing stances that seem to have made up previous policies. This statement relays the fact that they are interested not only in ENDS, but in a full range of harm reduction, from new hardware research to reducing nicotine levels in traditional cigarettes.
These are exciting times, and this is some of the best news we could have hoped for on a Friday! Everyone enjoy your weekends, and stay tuned for updates, as the FDA releases more information.
For more information, you can read the entire press release here.