Before I read the thread about substantial equivalency, I believed that Bill Godshall was most likely wrong regarding what the FDA could realistically do. And like tombaker I also felt that showing substantial equivalence would be reasonably easy, because from a logical perspective, it should be. The same reasons tombaker states are the reasons I thought it wasn't going to turn out nearly as bad as others said it could. But once I read that substantial equivalency thread it became painfully clear that logic has thus far played no part whatsoever in the reasoning that the FDA has ALREADY used to turn down substantial equivalence claims for other tobacco products. If they treat applications for the substantial equivalency of electronic cigarettes the same way they are currently treating claims for other tobacco products, then it will be clear that Bill Godshall had it right all along.
Why the FDA can NOT make illegal E-Cigs (false concern), Usage Bans in Public are the REAL problem
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I'm talking about poor people. I have some relatives in that category. There will be neighbors willing to help the landlord evict by telling on folks. There will be people who vape OUTSIDE their door or going in our out, especially if inebriated...or tired from working 2 jobs.
"Unenforceable" laws never get enforced on me, I'm a rich white older woman. But I've seen laws that are never enforced on me enforced on my black nephews and their friends, and on my young, rebellious, tatooed friends from Science Fiction clubs....and it adds up, over time, to a ball and chain on the ankles of folks. As my sister says, "a lot of poor people pay more in fines than middle-class folks pay in taxes."
It's a different planet, almost, for these folks.
At same time, what I hear OP saying is that while FDA may move in that direction, they will be challenged in court and stand to lose. If we are going with 'what FDA has done in past' then let's also go with FDA's past record in court, and realize FDA doesn't always look so pretty exercising its authority and thinking it is always right and accurate in following the law.
Bill Godshall has posted at least three times regarding his knowledge of those prepared to file lawsuits if it comes to that.
And if the OP had said it the way you just said it from the start, I might have even "liked" his post.
But clearly, that's not how this thread started, nor how it developed.
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My concern with this is, who will challenge it in court? I'd like to know what Bill knows there. The biggest companies (with the money to sue) pretty much sell cig-a-likes, so will they challenge the things we are most concerned about? Will they care about unlimited flavors? Will they care about refill bottles? Will they care about higher nicotine strengths?
The larger companies will be more likely to have the resources to provide all of the "evidence" for substantial equivalency, because their pre-filled cartridges/flavors/strengths most closely resemble what was on the market before 2007. So, they'd only be likely to sue (obviously, this is just a guess) only if the FDA deems e-cigarettes to be regulated under the existing tobacco regulations and doesn't grandfather in ANY e-cigarettes. But if the FDA grandfathers in pre-2007 e-cigarettes, but otherwise regulates other products in such a way to severely limit the flavors, refill bottles and nicotine strengths that don't concern them, will they still bother to sue? Are there any companies that sell refill bottles (with many flavors and higher nicotine strengths) that have the wherewithal to sue the FDA?
I had similiar fears and this was something I debated with Jman8 recently - but as he pointed out, a number of these cigalike companies (V2, Green Smoke) have banded together to create SFATA which seems to be campaigning not just for the cigalike market but for e-liquid and mods too (Epic Juice and ProVape are members for example).
I can't see much interest from BT-owned e-cig brands in ensuring that the mod/e-liquid market remains open, competitive and healthy but hopefully brands such as V2, Green Smoke and their fellow SFATA members do..?
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I honestly wish folks would keep up with the reality of the legal framework of what the FDA can and can not do. I am simply saying abundant evidence that you are legally wrong all over the place, and Bill Godshall is legally wrong also. If folks don't believe you can be wrong on the legal front, so be it, but folks continue to extrapolate out, on a premise that is for lack of a better word... Wrong.
Instead of believing and hoping and guessing, everyone would be best to read what is being done. This is what is being done.
http://www.e-cigarette-forum.com/fo...ing-substantial-equivalence-requirements.html Please keep up to date.
Here is the exact lanugage of the proposed methods to determine Substantial Equivalence, and its a complete contradiction to the fear mongering. Speicifially it says that if you change a product and say why that change is made, and its a safe thing, there is a reasonable chance you will get a very easy passing grade. Facts kinda blow away FUD don't they?
An order under section 910 is not required, however, if a manufacturer
submits a report under section 905(j) of the FD&C Act (21 U.S.C.
387e(j) demonstrating the new tobacco product's substantial equivalence
to an appropriate predicate product, and FDA issues an order finding
the new product to be substantially equivalent to the predicate product
and in compliance with the requirements of the FD&C Act.
FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. 1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec. 1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) The modification would be a minor modification of
a tobacco product; (2) a report demonstrating substantial equivalence
is not necessary for the protection of public health; and (3) an
exemption is otherwise appropriate.
-------------We have people thinking that a Provari will be banned. But if you look at the language, you can see that, that the FDA is providing for, skipping the task for items that are simply known to be the same. The entire argument for V2 being allowed but BLU not being allowed, is obliterated.
Even the FDA does not agree with the ANY CHANGE theories of what CASAA is repeatedly professing.
Maybe now we have some proposals the dooms day preppers might not be complaining the Sky seems so much closer today, the entire thing could just fall on us.
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I think if flavors is proposed for deeming regulation, there will be a whole bunch of entities / people that suddenly care about this issue.
As one who frequents V2, they have say 10 flavors that they currently make known for sale, and then dozens of other flavors they have available but don't make well known as those are leftover from custom made orders. I would think them, and a few other major players wouldn't shy away from flavor issue because of how they appear, at first glance, based on their website. If they did, it would really be self defeating on them wanting to introduce any new flavor to the market at some point in the future.
I see higher nic strengths as one of those issues where vaping community won't all uniformly agree on what is reasonable, but is one that I think we could agree to a compromise of sorts. What my version of that compromise looks like is unlikely to please everyone reading this, but I would tend to go higher than 20 mg, and less than 40 mg for the upper limit.
Until e-cigs and cigarettes are seen as separate entities they will be lumped together. The average Joe still thinks the by-product of cigarettes is the same as e-cigarettes. I get this all time when I vape. The average lawmaker has no idea either. Nor do most people know you can puff an e-cig with NO nicotine if you want. It's going to be interesting to see how this all sorts out in court.
Chance
Chance
For more that 25 years, I have worked for, with and against the United States government. I know bureaucrats because I was once one of'em.
What Tom is telling y'all is absolutely true.
There is a reason why FDA has consistently missed deadlines on the deeming regs issue, especially with regards to electronic cigarettes. Part of that reason is that HHS, the parent cabinet agency of FDA, is all-hands-on-deck over the Obamacare rollout fiasco. But another part of the reason is that the scientists and realists within the bureaucracy of HHS realize that enforcing anything approaching a ban, or significant restriction of sales, on electronic cigarettes is administratively impossible.
Judge Leon cleaned FDA's clock in the Soterra decision. FDA knows this, and knows that any overreach feared by members of this board will be met with an immediate legal challenge, and they also know that Judge Leon will clean their clock again.
This is why I am still on record as saying that FDA will back up 10 yards and punt on the deeming regulations in regards to how they might regulate electronic cigarettes. They are in a no-win situation. There are no proposable regulations that even come close to being enforceable, and the honest scientists who work for the agency know that electronic cigarettes are a safer alternative to combustible tobacco products and actually advance the agency's goal of promoting public health and safety.
They are going to ban, restrict the sales of, or hamper the distribution of products that help people live longer and healthier? I just don't see it happening.
What Tom is telling y'all is absolutely true.
There is a reason why FDA has consistently missed deadlines on the deeming regs issue, especially with regards to electronic cigarettes. Part of that reason is that HHS, the parent cabinet agency of FDA, is all-hands-on-deck over the Obamacare rollout fiasco. But another part of the reason is that the scientists and realists within the bureaucracy of HHS realize that enforcing anything approaching a ban, or significant restriction of sales, on electronic cigarettes is administratively impossible.
Judge Leon cleaned FDA's clock in the Soterra decision. FDA knows this, and knows that any overreach feared by members of this board will be met with an immediate legal challenge, and they also know that Judge Leon will clean their clock again.
This is why I am still on record as saying that FDA will back up 10 yards and punt on the deeming regulations in regards to how they might regulate electronic cigarettes. They are in a no-win situation. There are no proposable regulations that even come close to being enforceable, and the honest scientists who work for the agency know that electronic cigarettes are a safer alternative to combustible tobacco products and actually advance the agency's goal of promoting public health and safety.
They are going to ban, restrict the sales of, or hamper the distribution of products that help people live longer and healthier? I just don't see it happening.
Nobody is saying Tom cannot be right about what they WILL DO. We know it is possible and we'd love to see it. But that is not the same as saying 1. The FDA has no other LEGAL or even wild-@@@ choice, or 2. That CASAA does not understand any of the law or history (much of the good parts of the history occurred due to CASAA efforts) or 3. That CASAA is ignoring local issues and spreading FUD without any basis in reality.
So without the people and groups putting pressure on Congress do you think they would be punting at all? It took the lawsuit to stop them once, without someone fighting this they would just do what they want, IMO. I say now is not the time to back off, now is the time to continue the pressure on Congress to make sure the FDA IS listening.
How does this jive with the FDA submitting their proposed ecig regulations to OMB for approval?
J.R.
That is correct. For anyone who has read the bill and followed the issue the FDA clearly has the authority to regulate electronic cigarettes up to banning any and all e-liquid (and quite possibly devices, though I am not quite clear on that) not on the market by February 15, 2007. Anyone who says otherwise simply doesn't understand the law. The intentions of the FDA, at least as of 2009 where made clear when they tried to classify electronic cigarettes as a medical device that would have been a de-facto ban.
It remains to be seen what their current intentions are and what they are going to do, but claiming the FDA has no authority as the OP appears to be doing is so far out in left field its laughable.
The FDA did loose in court when they tried to claim electronic cigarettes where a medical device and they did overstep their authority, but the current situation is completely different as the FDA has clear authority to regulate e-cigs as a tobacco product and has repeatable said that is what they are going to do.
And to all this, I see it as simply not enforceable and at most creating a black market that will be, undoubtedly, successful. They (or we) can find ways to make it challenging to vape, but we will find ways to still do it, to make a profit from doing it and to legally challenging all those who seek to ban it.
When I first came to ECF, I asked in my first thread, just change this (then) current CTA to 'de-facto ban' and I can get on board. Leave it as is, without specifying the de-facto part, and it is hard to get into the fear mongering that is rampant. Now, I go look at CTA's and they seem toned down in language from how I recall them being worded. But perhaps this is all just in my head. I do recall several, or very many, vapers stocking up prior to April 2013, cause they were certain, a full outright ban was going to be put into place at that time. And on hindsight, that does look exactly like those who reacted with extreme fear from how to 'properly' view the turning of the millennium and the day after 12/21/12.
But one of these days the doomsayers and those preaching 'the end is near' will be right. So, can't entirely rule out their ultimate concern.
There was no serious reason to worry about 12/21/12, but I and many thousands of others worked our a@@es off to prevent disasters at the turning of the millenium, including a full-on Wall Street rehearsal OF THEIR UPGRADED SYSTEMS a couple of months in advance. And IMO CASAA and other THR advocates also prevented the disaster of April 2013 by working their behinds off, traveling, advocating, getting press, etc. I think there's a reason the FDA never posted our thousands of comments on their website (I think they put up the first 17!) and the subsequent delays are related.
There is a difference between random doomsaying vs. self-preventing prophesy.
The FDA isn't swayed by letters and campaigning. They haven't issued the proposals because they are a government agency. Government agencies are notorious for taking their time to do anything. It could be years until they do anything substantial concerning e-nic. The so called zero hours of October and December have come and passed. All we will see in 2014 are age restrictions and a promise of more studies.
Then we ought to be covered on all near future disasters moving forward with regards to eCig regulations.
If not covered, then working behinds off prior to April 2013 was simply, at best, a delay mechanism?
Btw, I think CASAA and THR advocates may have missed NYC in their travels of 2013.
How so? We sent our Legislative Director to the NYC hearing to speak, wrote letters, did interviews and several Calls to Action.
https://www.youtube.com/watch?v=euXUTPlRp1E
CASAA: CASAA's Testimony to the New York City Council regarding proposed ordinance to include e-cigarettes in NYC Smoke-Free Air Act
CASAA: (UPDATED!) NYC CTA Indoor Use Ban Hearing 12-18-13
If only it were the "honest scientists who work at the agency" calling the shots. But it's TPSAC doing that and the panel is heavily weighted with anti-tobacco and ties to the pharmaceutical industry folks.
Alleged Conflict of Interest on FDA Tobacco Panel | Competitive Enterprise Institute
Roster of the Tobacco Products Scientific Advisory Committee
Honestly, why would the FDA be any more afraid of the e-cig issue than the EU? They had little hesitation creating ridiculous regulations for e-cigarettes, even after being stopped from regulating them as drugs.
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