So as someone who's trying to start a new business would the new rules apply jan 2017 or asap?
FDA So if the FDA regulations pass, does the vape industry have 24 months to adhere?
- Thread starter Strange Smile
- Start date
- th_trl_thread_readers 0
- Status
right I understand that, but with the current wording If I came out with let's say an e-liquid tommarow, when this goes down if it were not to change would we have 2 years or not?
I think your best bet would be to stick close to SFATA since they are dealing with the same question. The SBA might also have information on the regulatory process. From what I understand, the language used by the FDA isn't standard and it's vague and broad.
Someone posted this link may be a few hours ago. It appears to be to a leaked copy of the some of what the White House is considering.
http://tveca.com/tveca_docs/industry_guide_draft_tveca.pdf?mc_cid=ca32e06b7c&mc_eid=43d99185c5
I can't imagine who any player in the current market could comply except drug and tobacco companies with millions to spend.
http://tveca.com/tveca_docs/industry_guide_draft_tveca.pdf?mc_cid=ca32e06b7c&mc_eid=43d99185c5
I can't imagine who any player in the current market could comply except drug and tobacco companies with millions to spend.
Last edited:
Again, just speculation but someone mentioned that the minor ban, labels, child resistant caps, no free samples and a few other similar-type stuff could be enforced upon final rule. The application process can last up to 24 months - whether items will still be 'allowed' until applications are approved/disapproved is a good question. Most have thought that all is good for another 2 years but I'm not so sure. Perhaps IF applications are entered - those products would be 'on hold' but again, I'm just guessing.
I also read that each application will cost $333,000 - although I haven't looked that deeply into it. Whether there would have to be an application for every eliquid with a specific flavor at 0 nic and one at 6mg nic, at 12mg nic, etc. again - not sure but that is what some are suggesting.
I also read that each application will cost $333,000 - although I haven't looked that deeply into it. Whether there would have to be an application for every eliquid with a specific flavor at 0 nic and one at 6mg nic, at 12mg nic, etc. again - not sure but that is what some are suggesting.
From the TVECA Unofficial PMTA Draft Guidance, it mentions that...
275 FDA will review an ENDS PMTA consistent with the requirements of section 910(c) of the
276 FD&C Act. Under section 910(c)(1)(A), FDA must act on a PMTA "as promptly as possible, but
277 in no event later than 180 days after the receipt of an application."
FD&C Section 910
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm262073.htm
Of course, the Big Question would be can a Retailer, who meets all the Other Requirements to sell a Tobacco Product, continue to sell an e-Liquid while a PMTA Application is being Submitted for a given e-Liquid.
Some Feel they Can. Some Feel they Can't.
It would be Good to hear from Someone like TVECA or SFATA or CASAA as to EXACTLY what is going to be Likely with regards to a PMTA e-Liquid Application.
Because the TVECA Document is Unofficial and only a Draft Copy.
275 FDA will review an ENDS PMTA consistent with the requirements of section 910(c) of the
276 FD&C Act. Under section 910(c)(1)(A), FDA must act on a PMTA "as promptly as possible, but
277 in no event later than 180 days after the receipt of an application."
FD&C Section 910
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm262073.htm
Of course, the Big Question would be can a Retailer, who meets all the Other Requirements to sell a Tobacco Product, continue to sell an e-Liquid while a PMTA Application is being Submitted for a given e-Liquid.
Some Feel they Can. Some Feel they Can't.
It would be Good to hear from Someone like TVECA or SFATA or CASAA as to EXACTLY what is going to be Likely with regards to a PMTA e-Liquid Application.
Because the TVECA Document is Unofficial and only a Draft Copy.
From the link zoiD posted above:
I wonder if the FDA would actually act against a local shop who does not engage in interstate commerce. i.e. one that only does face-to-face transactions and keeps a low profile?
If there are "Grounds for Denial", I'm not sure why they Wouldn't?
Perhaps because they do not wish additional challenges to the amount of power that the Commerce Clause actually gives them? Wickard v. Filburn removed almost all limits, but Lopez started restoring some.
Does the Commerce Clause apply to the Sale of Illegal Goods?
Because isn't that what a PMTA Denied Product would be? A Product that is Not Legal to Sell?
Well, if it weren't for the absurd over-reach in Wickard, the FedGov wouldn't be able to regulate much of anything that didn't cross state lines (or the national borders).
So let's phrase it as a question: Why does the FDA itself claim all it's doing is granting or denying permission to introduce a product into Interstate Commerce?
I dunno Rossum?
All I know is that the FD&C Act has been around for a Long Time. And it has been Amended and Challenged Many Times.
I just don't know that Much about Section 910.
I would be more concerned with what your state is going to do. Once the deeming regulations are released a lot of states aren't going to wait for the FDA regulations to take effect. They are going to act on them and start hearings to put them into effect asap.
GA has already defined vaping as quite different and distinct from smoking, and in most places, not subject to the same tyrannical laws. Ga is also one of the lowest cigarette-tax states, so they have very little to gain in persecuting vapers. We also have a HUGE proportion of smokers compared to many other places, and very few here have not been touched in some way by the damage that smoking does.
Andria
I "TRIED" to read and understand this but "Legaleze" isn't a language I'm very fluent in! The thing I did notice was something about existing products as of Feb. 2007? What does that mean they're going to compare new products to? I'm not really up on the history of vaping but that seems unrealistic. Was there even any kind of Vaping "Industry back then? This looks to have alot of loopholes in it! Don't we have any Lawyers that Vape? Isn't there anyone with juice on our side?
There are people in the forum who have been following this for years and have a perspective based on that. It's a safe bet most or all of them have 100mg nic in the freezer and extra mods and atomizers in case there are severe restrictions on those in the future. I've only been aware of the vape war for a year. I'm stocking some things too.
My own perspective is governments have been collecting tobacco taxes for decades, they count on that money, it's turned them into drug dealers. Recently the cigarette business has competition, potent competition. They know ecigs could go viral and crush their comfortable business rapidly. The direction they're headed is to try and squeeze the same taxes out of vaping they are getting from cigarettes. To do that they need harsh controls. They want vapers to go along with the control stratagy. The taxes will come later and grow and grow. It's feasible because eliquid is even cheaper to make than cigarettes. A $50 bottle of nic will last me almost 4 years. It replaces almost $12,000 worth of cigarettes. If you're a drug dealer that math really really sucks.
To make us more cooperative start with some years of terror. We're in the terror phase.
- Status
Similar threads
- Locked
