CASAA Call to Action: The demise and death of Vaping will occur on 8-8-16. I’m sorry but you don’t have two or three years from the release of the Final Rule on 5-10-16. Exactly how was this date determined? Let me explain with an overview and I will due my best to not dive down into the weeds which tends to confuse vapers which is understandable.
The Final Rule was published in the Federal Registry on 5-10-16. That’s the day the clock started ticking and the death sentence was issued. Vendors, Manufactures, B&Ms and everyone else on the face of the planet which falls under the definition of a Tobacco Manufacturer or Tobacco Product has 90 days to introduce new stuff and or tweak Vaping gear/supplies if they wish to remain on the market and avoid getting a PMTA. Ninty days equals the date Vaping died which is 8-8-16. What’s this remain on the market mean? If a given Vaping product/component which is legislated and deemed a Tobacco Product under the Final Rule is on the market and for sale before 8-8-16 then they are granted two years to remain on the market with the identical product without the requirement to obtain a PMTA which almost no one can afford except BT. ONLY and I repeat ONLY if their product does not change in some fashion will they be granted this two years to remain on the market. That’s the rub and aspects of it could be very dangerous so lets dive down.
Some vendors I have spoken with are rushing to get their new and or improved vaping product on the market before the kill date of 8-8-16. This gives them another two years for sales but they can’t change and or alter anything with their product on or after 8-8-16 without first obtaining a PMTA. Some vendors may let quality control fly out the window in an effort to reach market before the kill date of 8-8-16. Other vendors have suspended R&D and have no plans to introduce any new products. Lets look at the implications for Vapers with a few “what if” scenarios. All of which will require a PMTA on or after 8-8-16:
- eJuice company: I changed my VG/PG supplier
- eJuice company: I changed my NIC supplier
- eJuice company: I changed the “formula” by 0.25% because my vapers didn’t like the spice tone
- Mod manufacturers: No more firmware upgrades via eScribe, ProVape, name your vendor
- Mod manufacturers: Yes, we know it sometimes auto fires but tweaking it requires a PMTA. We are very sorry that some batteries vented
- Mod manufacturers: We can fix the bug for your screen via a firmware fix but that will require a PMTA which we can’t afford
- Vaping Battery Vendors: Sorry, we closed shop because we can’t afford a PMTA and neither can Sony, Samsung, etc.
- Atomizer/toper manufacturers: Yes, we know it leaks like a sieve and we already have a fix. This means a change to the product and a PMTA so we can’t release it.
- Atomizer/toper manufacturers: We spent a year of R&D developing this fantastic topper but couldn’t meet the kill date of 8-8-16 so we stopped and it will not be introduced
- Your local B&M: Sure, some of our in house mixes suck eggs but changing the “formula” requires a PMTA
- Your local B&M: Sorry, we no longer do “builds”. Since each build is unique in some way. This makes each build a “New” component part and requires a PMTA
Trust me. I could list dozens more “what if” scenarios. The bottom line is innovation via new products ends on 8-8-16 and so does any improvements and or tweaks to products. In some respects, Vaping gear and or supplies becomes more dangerous. This sad state of affairs is contrary to the public health credo the desk killers at the FDA preach. Exactly the opposite! With the real goal of handing the Vaping industry to BT via a very few BT manufacterers producing closed systems for Vaping.
Finally, here is a link dump for confirmation and additional reading:
The Final Rule.
Draft Guidance on PMTA
Dr. Siegel: FDA Regulations Present an Imminent Threat to the Safety of the Public: Urgent Changes are Needed