FDA's new regulations for e-cigarettes 08-08-16 - End of vaping devices 2018 in the US?
- Thread starter Hogni
- Start date
Hogni
Honi soit qui mal y pense
Thanks all for your worthful posts and mentions.
All we can see up to date is that classification isn't so easy and my concerns were legitimately for opening this thread. We'll have to wait what courts will decide.
But I think I'll try to buy all my US items of VAS until mid of '18. Better be safe than sorry.
All we can see up to date is that classification isn't so easy and my concerns were legitimately for opening this thread. We'll have to wait what courts will decide.
But I think I'll try to buy all my US items of VAS until mid of '18. Better be safe than sorry.
Tranquility
Well-Known Member
Notwithstanding the prying of one's vapcap from one's cold dead hands (Even without a specific Constitutional provision to vape.), the devices are going to be regulated. This latest holding makes that pretty clear. The court's focus was on the issues discussed here. Most especially the regulation under tobacco rules for things that have nothing to do with tobacco. The aromatherapy dodge is not going to work. The decision is pretty robust and until Trump gets enough conservative justices in who feel Chevron was decided wrong enough to overcome that precedent, the deference to FDA rules and decisions will be maintained.
That being said, all that the devices do is make hot and then run some air through to make it hot. The DIY crew here makes it clear some people are going to vape no matter what the FDA says. There is nothing that can be done to stop it when a heat gun can flow through a tube of cannabis to make vapor. ("Restrict butter knives and stoves!" might be the clarion call a years ago.) Even regulators who hate the fact the tech can be used for cannabis have to recognize the risk-reduction benefits to vaping devices over a bit of tin foil, and apple and combustion and know that making rules and administrative decisions must follow certain rules and administrative decisions in order to be enforceable. I suspect that rulemaking process is where those with enough vape profits to afford lobbyists are going to focus. As to if they can defeat the tobacco companies interests that are aligned in some areas and contrary to in others is the question.
That being said, all that the devices do is make hot and then run some air through to make it hot. The DIY crew here makes it clear some people are going to vape no matter what the FDA says. There is nothing that can be done to stop it when a heat gun can flow through a tube of cannabis to make vapor. ("Restrict butter knives and stoves!" might be the clarion call a years ago.) Even regulators who hate the fact the tech can be used for cannabis have to recognize the risk-reduction benefits to vaping devices over a bit of tin foil, and apple and combustion and know that making rules and administrative decisions must follow certain rules and administrative decisions in order to be enforceable. I suspect that rulemaking process is where those with enough vape profits to afford lobbyists are going to focus. As to if they can defeat the tobacco companies interests that are aligned in some areas and contrary to in others is the question.
Deleted Member 1643
Well-Known Member
Have been following US tobacco regulations professionally for about five years. US FDA appears to be regulating by inaction. For example, only two modified risk product applications have been reviewed in that time (the second, currently under review, is for Philip Morris' interesting electrically heated cigarette). The first (Swedish Match snus) was denied - years after it was submitted.
Several hundred new product applications have been submitted, but only a few have progressed to review. Most were rejected early on procedural grounds. So far, the only marketing orders granted are for Swedish Match snus products. Rejected new product applications are not made public, so it's unknown what new products were the subjects of these applications.
There's been virtually no enforcement of new tobacco regulations to date, but FDA's Center for Tobacco products is funded at hundreds of millions of dollars from tobacco manufacturers' user fees. Should FDA choose to enforce its regulations, it could have the resources to do so.
This strategy is expected to produce a chilling effect on innovation. What manufacturer can afford to develop new products for the US market when it will take years for FDA to review them and they will almost certainly be denied access in the end?
Under new anti-regulatory US administration, expect legislative efforts to modify the FSPTCA to gain ground. Know of two currently - one would modify the predicate date for substantial equivalence so that ENDS products would not have to meet the FSPTCA's high standard (appropriate for the protection of the public health) in order to remain on the market. The other would create a separate product class for ENDS.
For the moment, FDA's attention does not appear to be focused on products used primarily for cannabis, but it's suspicious that these products have been named in FDA rules and guidance. Time (probably quite a lot of it) and cannabis-specific lawsuits would tell.
Several hundred new product applications have been submitted, but only a few have progressed to review. Most were rejected early on procedural grounds. So far, the only marketing orders granted are for Swedish Match snus products. Rejected new product applications are not made public, so it's unknown what new products were the subjects of these applications.
There's been virtually no enforcement of new tobacco regulations to date, but FDA's Center for Tobacco products is funded at hundreds of millions of dollars from tobacco manufacturers' user fees. Should FDA choose to enforce its regulations, it could have the resources to do so.
This strategy is expected to produce a chilling effect on innovation. What manufacturer can afford to develop new products for the US market when it will take years for FDA to review them and they will almost certainly be denied access in the end?
Under new anti-regulatory US administration, expect legislative efforts to modify the FSPTCA to gain ground. Know of two currently - one would modify the predicate date for substantial equivalence so that ENDS products would not have to meet the FSPTCA's high standard (appropriate for the protection of the public health) in order to remain on the market. The other would create a separate product class for ENDS.
For the moment, FDA's attention does not appear to be focused on products used primarily for cannabis, but it's suspicious that these products have been named in FDA rules and guidance. Time (probably quite a lot of it) and cannabis-specific lawsuits would tell.
Tranquility
Well-Known Member
Marijuana was mentioned in the footnotes of the decision described by the article I linked. I did not read the amicus on the case, but I bet at least one dealt with the cannabis-specific issue. I don't know why one might believe a cannabis-specific lawsuit(s) would come to the conclusion the FDA can't regulate vapes or enforce its decisions on them--at least to the point of actually putting up the cash in the hope of a different result. I think the decision was "bad" in that some of the logic escapes me. It is "good" in that it is written very well with required facts determined and (seemingly) proper legal analysis that will make it hard to be overturned on appeal. From now on, the predicate facts determined by the court will be the basis for any legal appeal later. (Unless, on appeal, the appellate court holds no reasonable jurist could hold such facts true.)
I enthusiastically support the two paths being discussed mentioned to mitigate the problem. (At least from our point of view. I suspect Sessions might not find the issue a problem.) I note, both paths still allow regulatory coverage over the devices. (With one regulation saying no regulation for grandfathered in ENDS.)
HighSeasSailor
Well-Known Member
KeroZen
Chronic vapaholic
"According to the FDA's own economic analysis, 99 percent of vapor products wouldn't even have had an application put forward, let alone been approved."
Pretty much what the initial plan was laying out!
This is excellent news really!
Pretty much what the initial plan was laying out!
This is excellent news really!
Deleted Member 1643
Well-Known Member
Thanks, @HighSeasSailor! Looking forward to more specific guidance, a new approach for US FDA.
Summer
Long Island, NY
We can breathe easier until 2022:
http://vaping360.com/fda-deeming-postponed/
https://www.nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html
Thank the gods that be.
http://vaping360.com/fda-deeming-postponed/
https://www.nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html
Thank the gods that be.
Planck
believes in Dog
The FDA deeming would have devastated the US vapor market as originally written.
It's reefer madness again.
Anyone interested in learning more about this could start here;
http://www.ecigarette-politics.com/
https://www.gov.uk/government/news/...armful-than-tobacco-estimates-landmark-review
https://www.e-cigarette-forum.com/forum/forums/e-cigarette-summit-videos.927/
It's reefer madness again.
Anyone interested in learning more about this could start here;
http://www.ecigarette-politics.com/
https://www.gov.uk/government/news/...armful-than-tobacco-estimates-landmark-review
https://www.e-cigarette-forum.com/forum/forums/e-cigarette-summit-videos.927/
Deleted Member 1643
Well-Known Member
There's currently an open opportunity for public comment on repealing or revising regulations. The FDA's deeming rule is an excellent target. Regardless of whether you think e-cigarettes are a health risk or opportunity, the current US administration is clearly unconcerned with public health. (Politically, a little left of George McGovern, but why not make lemonade?)
The US government we knew and loved is largely intact, and many such opportunities for public participation can be easily found. FDA will likely respond to your comment, which can be submitted from the above link. Many FDA CTP meetings are open to the public and provide opportunity for oral comment from the floor as well as personal interaction with your public servants, who are approachable and happy to chat. Do this professionally and see very few private citizens. Mostly other advocates and representatives of the regulated community (in this case, tobacco manufacturers). Never see even professional cannabis advocates nor read their comments.
The US government we knew and loved is largely intact, and many such opportunities for public participation can be easily found. FDA will likely respond to your comment, which can be submitted from the above link. Many FDA CTP meetings are open to the public and provide opportunity for oral comment from the floor as well as personal interaction with your public servants, who are approachable and happy to chat. Do this professionally and see very few private citizens. Mostly other advocates and representatives of the regulated community (in this case, tobacco manufacturers). Never see even professional cannabis advocates nor read their comments.
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