The FDA PMDA deadline has been moved to 9/9/20. You've got a little extra time to stock up.
https://www.khlaw.com/Files/43253_Order re Limited Remand.pdf
https://www.khlaw.com/Files/43253_Order re Limited Remand.pdf
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Yay!! This is the very best news I’ve heard in what feels like a very long time!!! Thanks for sharing it!
Dang. That's another five months I'm not sure my wallet can handle!
Just kidding about the dang part. That's great news.
Just kidding about the dang part. That's great news.
Please tell me I'm not dreaming (I'm very low budget and even though I'll be OK for awhile, I am in no way "set")
So there is light at the end of the tunnel? Or at least the tunnel is longer and I don't need to worry so soon if the batteries in my flashlight run out ( I know... batteries will still be available) I was just going to bed for the night... might just sleep a little better after the good news
So there is light at the end of the tunnel? Or at least the tunnel is longer and I don't need to worry so soon if the batteries in my flashlight run out ( I know... batteries will still be available) I was just going to bed for the night... might just sleep a little better after the good news
Wait a minute! Just checked out your link... what does that mean? Please don't post something like this if it doesn't apply to entire US and the current situation (FDA and May 2020) I'm tired and maybe don't get what's going on, so can someone clarify this for me. I think I'll wait for further confirmation before I get my hopes up.
The way it reads is that the Judge granted the motion to extend the deadline, then punted all further proceedings back down to the district court (where the case was originally argued) with the caveat that his court receive an update every 30 days.
The case was remanded from the appeals court to the District court yesterday, where the judge has said in a previous indicative ruling that if the case was remanded back to him that he would grant the extension.
It applies nationwide, except for new York who appears to have legislation in play that doesn't care what the FDA says or does, so they will have their own appeals of their own legislation.
But for the rest of the U.S., it means we get the extension for the deadline, now to be September 9, 2020.
The way I read it, nothing is 100% official yet in terms of the PMTA deadline extension. But the the fact that the 4th Circuit Courts has remanded the case to the Maryland District Court is a good step.
The district court still has to officially issue the extension on the PMTA deadline, however the district court judge, Grimm, has stated preciously that he would.
And I don't mean to be a party-pooper, rather just being realistic, but before you think you can breathe easy in terms of stocking up...
- The PMTA deadline is about PMTA applications for manufacturers. As @Opinionated stated, states can ban, tax and restrict vaping products as they wish.
- The PMTA deadline has nothing to do with any taxes (and hefty ones at that) that may be imposed on nicotine base.
One piece of good news I just now uncovered is that the FDA rejected the House Oversight's Committee's request to ban (aka "clear the market of") vape products due to corona virus "concerns".
FDA Rejects Subcommittee’s Call to Temporarily Remove E-Cigarettes Despite Potential Risks to Coronavirus Patients
Source: https://oversight.house.gov/news/press-releases/fda-rejects-subcommittee-s-call-to-temporarily-remove-e-cigarettes-despite
FDA has rejected the Subcommittee’s call to clear the market of all e-cigarettes during the coronavirus crisis despite e-cigarettes’ potential to create worse coronavirus outcomes. FDA relayed that it had not even discussed this option. FDA is still at stage one: reviewing available literature and studies to determine whether vaping is a risk factor for coronavirus. FDA would not even commit to temporarily withholding, during the duration of this crisis, approvals of Premarket Tobacco Product Applications e-cigarette companies need to submit to permanently stay on the market. That means that FDA may grant approval to sell e-cigarettes before it knows if they exacerbate coronavirus problems.
The PMTA deadline is itself a ban on all vapor products on the market because after that date no product can be sold in the United States that hasn't at the least filed a premarket tobacco application..
Which as of today, no one has done yet outside of the heat not burn thing...
I think nicotine base is something different (although they want to tax it heavily still) but ejuice isn't...
It won't matter what Congress does if vape manufacturers don't file for FDA approval in order to sell to the U.S. market. As it stands, the day after deeming the FDA can shut down every vape shop in the U.S., since theres nothing they can legally sell thats related to nicotine vaping.
Yes, but it's not a ban until it is fully enforced. From what I understand, there is a one-year "grace period" after the PMTA deadline (whenever that deadline is) to get "unapproved" products off the market.
I've not heard anything about a grace period... where did you get that from?
Okay, since you took off I looked myself.. lol. (Make me work or something.. haha)
I found this:
"The FDA guidance has no effect on the May 11 PMTA deadline. Virtually all open system products currently being sold will become illegal on May 12. Only those that have a PMTA accepted for review will receive a one-year reprieve."
FDA's New “Flavor Ban Lite” Ignores May PMTA Deadline - Vaping360
So its likely you just misunderstood the nature of the reprieve, it's only applicable to those who have filed for approval, which no one has yet done.
Probably from the deeming regs thread. But I can't remember. Information overload. It could be BS, but I remember thinking it was legit info what I first read about it.
Ahh, we must have posted at the same time... I found the language it's just not in the context you were thinking.
Look above your post which I quoted..
I don't understand what you mean when you say that no one has "filed for approval". Are you saying that no one has filed for PMTA yet?
Just the heat not burn people (Phillip Morris) that I know of has even filed. (Edit to add: and Vuse)
Innokin etc, no one has filed yet for approval.. (filed = PMTA = premarket tobacco application = filed their application for approval)
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RJR submitted for VUSE products. There may be more, but it's seems to be hard information to come by.
October 2019
The First Vape PMTA Has Been Submitted to the FDA - Vaping360
They filed for their oldest Vuse product to be safe not knowing what the FDA will or will not accept.
That's not vaping... that's a cartomizer; back to the really old days of vaping...
But this is exactly why no one is filing... no one knows what the FDA will reject, and the cost of filing the application (as their needs to be studies behind it etc) is so high no one's willing to be the test monkey with their money.
After we hear what the FDA says about VUSE, then Juul may or may not file.
But few of the open system manufacturers even have the money to file, and almost no ejuice manufacturers as the market saturated among a plethora of companies instead of concentrated in only a few... Without the money of BT or BP, very few manufacturers will be able to afford to submit an application...
The best chances are the larger Chinese based manufacturers like Innokin, but they are unlikely to take the chance without seeing what the FDA is approving, and then submit accordingly.
For instance, if the FDA is approving closed systems, then companies will submit for their closed systems and so forth.
Therefore, legal vaping in the U.S. as a whole will be pretty much wiped out for a solid couple years and only God knows what it will look like after that.
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I thought there were some reports here recently about several juice manufacturers filing. May be my imagination but I seem to recall some had put that on their home pages.
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