I see you only joined ECF this month. Bill Godshall has been at the forefront of helping the e-cig consumer since 2009. He has great knowledge of the anti-smoking organizations and the people running those organizations. He is anti-smoking,but very supportive of tobacco harm reduction. HE knows what he is talking about. He also knows the players at the FDA,CDC.etc. so it would be wise to listen to him. H e is not trying to pick a fight--he has given his time freely to help our movement and most of the people who have worked since 2009 to keep vaping available respect and appreciate his help and mentoring. You might join CASAA and learn the history of this fight and also become familiar with those who have actually given their time and shared their expertise with all of us. I think you will appreciate those in CASAA who have done so much for us.
FDA opens comment periods on two issues regarding Substantial Equivalence Requirements
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Join CASAA and read the history of the attempt to ban ecigs beginning in 2009. I think you might begin to understand. These people have worked as volunteers helping all of us. Please have an understanding of the history of all that has gone before you. Joining CASAA will be the first step. Time,volunteering,and donations are needed from everyone. We all need to do our part. It is hurtful to see people who have donated their time freely be vilified--especially by those who really do not know the history. I think you might feel differently when you understand all that has gone before you. It would be wonderful if you joined this effort.
Amen. The FDA is a very real threat to vaping as it is today, in my opinion. If our fears are wrong and nothing happens, we will have merely wasted a little time on a forum discussing it. Why some are so intent to persuade us to think there is nothing to worry about with the FDA boggles my mind, unless they are trying to save us from wasting our time? Perhaps I really am that ignorant on the subject and need saving.... If you don't think the flood is coming, step aside and leave those of us that do, alone on the arc to discuss and prepare for the possible flood.
As I see it, the act is the actual threat to vaping because, it would seem, that a majority of Americans are okay throwing any and all tobacco products under the bus, in the name of 'saving the children' from nicotine addiction.
In my experience of vaping (indoors in public places), the general public seems at the very least neutral about eCigs, and possibly willing to be favorable towards them. Yet, because they don't get into all the intricacies about vapor/eCig devices, they have far less knowledge about the topic than us vapers, and more importantly, less knowledge about just how relatively harmless it really, truly is. The act reads throughout like tobacco products (of any kind) need to be regulated and controlled very very strictly. Which if ANTZ type of people, and organizations, aren't a myth, just makes the act carry more weight with general public, as in how can 'we' not control these products and possibly be able to protect our kids? Now, I don't think it is actually (ever) about the kids, but at same time, it is very challenging to leave that out of the equation or downplay it without coming across as callous. But the 'kid card' can be played on every single issue facing vaping, and it makes for an uphill battle.
I also personally think the act on principle must be founght against and not just deal with it from only an eCig perspective. Meaning, fighting for all tobacco rights, including traditional cigarettes. Yet, I don't expect every or many vapers to go along with that, and do expect general public to likely remain ignorant on vaping issues for awhile, perhaps indefinitely. It looks like smoke - is enough for many people, and as long as it does and smoking is deemed evil by majority of Americans, it just seems like it will be uphill battle indefinitely. Not to mention the idea / common perception that it is nicotine that is the worst element about smoking.
In my experience of vaping (indoors in public places), the general public seems at the very least neutral about eCigs, and possibly willing to be favorable towards them. Yet, because they don't get into all the intricacies about vapor/eCig devices, they have far less knowledge about the topic than us vapers, and more importantly, less knowledge about just how relatively harmless it really, truly is. The act reads throughout like tobacco products (of any kind) need to be regulated and controlled very very strictly. Which if ANTZ type of people, and organizations, aren't a myth, just makes the act carry more weight with general public, as in how can 'we' not control these products and possibly be able to protect our kids? Now, I don't think it is actually (ever) about the kids, but at same time, it is very challenging to leave that out of the equation or downplay it without coming across as callous. But the 'kid card' can be played on every single issue facing vaping, and it makes for an uphill battle.
I also personally think the act on principle must be founght against and not just deal with it from only an eCig perspective. Meaning, fighting for all tobacco rights, including traditional cigarettes. Yet, I don't expect every or many vapers to go along with that, and do expect general public to likely remain ignorant on vaping issues for awhile, perhaps indefinitely. It looks like smoke - is enough for many people, and as long as it does and smoking is deemed evil by majority of Americans, it just seems like it will be uphill battle indefinitely. Not to mention the idea / common perception that it is nicotine that is the worst element about smoking.
Please make sure there are no further personal attacks in this thread or it will be closed, posts will be deleted, and Members will receive infractions including bans.
These issues are important, and deserve being debated in a reasonable way. At present there are no facts because we await regulation, which may take any of a thousand possible forms. Please calm down and do not attack others for their views. All views are valid, in this situation.
These issues are important, and deserve being debated in a reasonable way. At present there are no facts because we await regulation, which may take any of a thousand possible forms. Please calm down and do not attack others for their views. All views are valid, in this situation.
Just joined ECF yes, but been around a lot longer here and in years so you will have to forgive me if I like to look at both sides of the coin and make my own decisions. I just don't jump on the wagon because it happens to be going in my direction. If two, three or many people have opinions or facts even I like to read, see and or listen to as many as possible. I have seen things happened in the past where someone used a forefront agenda to gain notoriety for the purpose of gaining there own hidden agenda. Now this is a general statement and not pointing fingers at anyone here.
We have a multi front war going on and if you lose focus on one side it will bite you bad. The more experience politicians know this and will use it. They will take mistakes of other wording in laws and re do it to meet their views and goals.
I do appreciate all those who have focus their time and energy on this subject however time and energy does not mean they are always right.
This is just my opinion.
You know what's the worst thing about all this?
All of this may have distracted us from focusing on the real subject of this thread.
The FDA has asked for comments regarding exemptions from substantial equivalence requirements.
The conversation has been so thoroughly misdirected that we haven't even discussed the original topic.
And it seems to me that that the original topic could be important, and is worth exploring.
All of this may have distracted us from focusing on the real subject of this thread.
The FDA has asked for comments regarding exemptions from substantial equivalence requirements.
The conversation has been so thoroughly misdirected that we haven't even discussed the original topic.
And it seems to me that that the original topic could be important, and is worth exploring.
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Well stated. Wasting your time trying to persuade others not to waste their time is, well, a waste of time.
Agreed. Post #2 of this thread does help I think in going forward. And as that posts notes, it is important for vendors to comment on this. For general public (vaping consumers), it is challenging to understand what our fair contribution could be. If it amounts to, "I like vaping. Vaping saved my life. Please don't ban vaping," I'm thinking that is not the commentary for this 'request for comments.' At same time, I still feel like commenting!
This docket says:
Okay, great! I have an opinion on that.
It then goes onto say
And is where I feel me, as vaping consumer am not sure where I fit in exactly.
My response to #1, being fair minded, would be a yes - it is necessary for proper performance of FDA to collect information on equivalency. And no or undecided on whether the information will serve a practical utility.
#2 - Helps to read lower portion of the docket where it reads
It says this and more. I'm thinking more than 500 requests would come in if it has to do with each and every flavor additive for eCigs. Also thinking, hire more people to make things go faster, but then realizing we are talking about government, and many would rather see FDA decimated than getting larger, so not sure how to answer this given current reality.
The pro-vaper, less educated on legal issues part of me says forego the flavors count as additive claim and this addresses methodology while also easing up the burden of what FDA and manufactures are up to. But not sure if that is fair minded. So the scientific advisory committed ought to be deciding factor here, even while pro-vapers and anti-vapers will want to weigh in on this issue.
And I recognize flavors aren't the only issue when it comes to eCigs and equivalency, nor are eCigs the only tobacco products covered in the act. But for me they are #1 issue of concern, and is what I care to speak most to.
#3 - from vaping perspective depends entirely on a) whether eCigs are included in the act, still waiting on this FDA, b) whether special rules will be in place for eCigs and c) whether appeals to special rules will be determined immediately or say 4 years from now. As I'm writing this mainly from pro-vaping perspective, it is challenging to speak to #3.
In general, I would say to allow 2 tiers of information to be collected. Tier 1 is for companies that are big (however that may be defined) and are likely distributing tobacco products to a consumer base of 100,000+. Tier 2 is everything under that. Could be more tiers than this, different numbers, not extremely important at this time. Principle though is Tier 2 people wouldn't need to be as extensive in what information they must submit in order to comply with the Act. That they must comply with the act is a given. They they must comply at the same level with businesses that have substantially more resources is unfair, and burdensome to all involved. I'm thinking big companies would like this very much, but unless FDA is only looking out for big companies, it seems both unfair, and not serving quality and utility of information if company with 1/10th the customer base has to present same clarity as a much larger company. Would seem to tie things up at various level of collection and present an undue burden.
#4 - don't hire CGI (out of Canada) to handle information collection for this matter. Okay, I jest. IMO, it is a given that technology will be used on the collection process and that what we all currently know today about means, may not be what we know even 6 months from now. Thus, IT people at level of 'experts' need to make this decision, and I'd trust a panel of experts to handle this more than any layperson or manufacturer's opinion on such matters.
So, what do all you (pro) vapers think of that response? I'm open to feedback, but would prefer to use my own words and fair-mindedness when responding.
Jman wrote:And I recognize flavors aren't the only issue when it comes to eCigs and equivalency, nor are eCigs the only tobacco products covered in the act. But for me they are #1 issue of concern, and is what I care to speak most to.
It is tiresome trying to figure this thing out (partly why I have been sitting on the sidelines in these threads lately). AS we look across the pond, "They" want "equal performing products" on the market,with no contaminates.EDIT: I was thinking about contaminates in juice see here:The EU Fight, what can the US vapers do! - YouTube Depending how the FDA decides to determine "substantial equivalence", I bet this goes far beyond flavors. Hence the debate on hardware. I don't see how the FDA could possibly move the date beyond 2007, as It would create an insurmountable amount of products on the market (1000's of products), substantial equivalence would be impossible to enforce. For the sake of enforcement, I believe the FDA is going to want one acceptable e-cig model and one set of acceptable ingredients. I don't see any other way enforcement would work, short of them giving up on the idea of regulations
I hope my point makes sense
It is tiresome trying to figure this thing out (partly why I have been sitting on the sidelines in these threads lately). AS we look across the pond, "They" want "equal performing products" on the market,with no contaminates.EDIT: I was thinking about contaminates in juice see here:The EU Fight, what can the US vapers do! - YouTube Depending how the FDA decides to determine "substantial equivalence", I bet this goes far beyond flavors. Hence the debate on hardware. I don't see how the FDA could possibly move the date beyond 2007, as It would create an insurmountable amount of products on the market (1000's of products), substantial equivalence would be impossible to enforce. For the sake of enforcement, I believe the FDA is going to want one acceptable e-cig model and one set of acceptable ingredients. I don't see any other way enforcement would work, short of them giving up on the idea of regulations
I hope my point makes sense
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Jman wrote:And I recognize flavors aren't the only issue when it comes to eCigs and equivalency, nor are eCigs the only tobacco products covered in the act. But for me they are #1 issue of concern, and is what I care to speak most to.
It is tiresome trying to figure this thing out (partly why I have been sitting on the sidelines in these threads lately). AS we look across the pond, "They" want "equal performing products" on the market,with no contaminates.EDIT: I was thinking about contaminates in juice see here:The EU Fight, what can the US vapers do! - YouTube Depending how the FDA decides to determine "substantial equivalence", I bet this goes far beyond flavors. Hence the debate on hardware. I don't see how the FDA could possibly move the date beyond 2007, as It would create an insurmountable amount of products on the market (1000's of products), substantial equivalence would be impossible to enforce. For the sake of enforcement, I believe the FDA is going to want one acceptable e-cig model and one set of acceptable ingredients. I don't see any other way enforcement would work, short of them giving up on the idea of regulations
Your point makes sense, but I in no way like the thought process unless that one e cig has a decent sized battery, doesn't confuse anyone to think it's a cigarette and is currently used in my household. LOL
Sorry for the confusion of who is speaking for CASAA and when. Thanks for the clarification Kristin. After trying to play catch-up over the last several pages I'm going to let things sink in a bit. I know where my instincts lead me. Gut reaction is that the genie is out of the bottle. If the FDA/FED tried to outlaw hardware or liquids wouldn't people find work-arounds? Wouldn't there be a black market? If the black market was sustained wouldn't the FDA/FED have to re-evaluate their conclusions? So long as China and other countries are willing to manufacture the products, won't they find a way to the consumers? After going over the numbers and the science would the FDA/FED be willing to justify the expense of jobs and treasure over unfounded health concerns? Would an FDA ban would cause people to do their own flavorings if they wanted? Wouldn't that be tearing of the knobs to the regulatory controls they're supposed to create? Just some things that initially come to mind when considering the scenario...
A buddy of mine runs a shop, and he makes his own e-liquid. He is confused on what to do with the OP's information..Where do I need to send him and what does he need to say or fill out to get his voice heard.
He would go to the docket...
http://www.noticeandcomment.com/FDA-2013-N-1588-fdt-22171.aspx
And then he would click on the "Primary Document" to register his opinion and leave any comments.
http://www.noticeandcomment.com/FDA-2013-N-1588-fdt-22171.aspx
And then he would click on the "Primary Document" to register his opinion and leave any comments.
You've got two intertwined themes here.
The first is: Would people be able to continue to vape if the FDA made it difficult or even illegal. Yes, of course, the hard core among us could continue, albeit at some minor risk, just like some people currently engage in other activities surreptitiously. It doesn't take much room in the freezer or much of an investment to stock up a enough high-test nic to last many years and everything else can be made or imported on the sly. I've said it before and I'll say it again: Nothing the FDA could possibly do will affect me much personally. But the real issue is continued accessibility of good (i.e. effective) stuff to those who haven't switched yet.
The second is: Once they close the doors, will the government re-legalize or remove excessive regulation because there are work-arounds? To this, I would look at historical precedent and note that it's extremely rare for that to happen. It's been said that there are two kinds of people in this world, those who want to control how others behave and those who don't. Government is full of the former because the latter have no interest in being a part of the government.
So, you don't think the FDA understands that they can't regulate something they've pushed onto the black market? I can still gamble on the web though according to US law I'm not supposed to. I think that maneuver right there may leave congress and regulators hesitant to cut off revenue for a product that people will continue to receive through international means. There are so many ways to get around restrictions on hardware and chemicals that it's pointless. Like online gambling, they'd only cut off their own ability to collect tax revenue and enforce regulation. If the products can still be found online, they will still be purchased.
From what I've read on the FDA site, they haven't done any impact studies on proposed regulations because they haven't even decided which proposed regulations should have enough merit to be put forward as a decisive regulation scheme. They're seeking input on which proposals they should study for domestic and international impact. "FDA intends to issue a proposed rule extending FDAs tobacco product authorities beyond the above products to include other products like e-cigarettes. For further details, please see the Unified Agenda entry describing this rulemaking." "Intends to issue a proposed rule" doesn't sound like definitive language to me. View Rule - I've been watching this page since it was created and have seen no change whatsoever. Still in the proposed rule stage. Still waiting for quantifiable research on the products themselves, and the cost benefit analysis of rules once they get accepted as viable proposals.
I'd think you'd want to get as many people as possible invested as manufacturers and retailers to increase the impact of heavy-handed regulations. If anything, shouldn't we be worried that fears of imminent destruction have stifled growth in the industry and helped the regulators by keeping the number of people and businesses effected to a minimum?
Look at the FDA's scientific findings on e-cigs that have been put out. One official, non-reviewed study:
Abstract: "Electronic cigarettes, or e-cigarettes, are battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol. Depending on the brand, e-cigarette cartridges typically contain nicotine, a component to produce the aerosol (e.g., propylene glycol or glycerol), and flavorings (e.g., fruit, mint, or chocolate). Potentially harmful constituents also have been documented in some e-cigarette cartridges, including irritants, genotoxins, and animal carcinogens. E-cigarettes that are not marketed for therapeutic purposes are currently unregulated by the Food and Drug Administration, and in most states there are no restrictions on the sale of e-cigarettes to minors. Use of e-cigarettes has increased among U.S. adult current and former smokers in recent years; however, the extent of use among youths is uncertain."
That's not true.
The proposed rules are already written and in the hands of the Office of Management and Budget.
If approved, they will be proposed.
We are talking about the same Congress and regulators who are still sticking to their war on drugs even though it has proven as much of a failure as Prohibition and created a dangerous, crime-ridden black market? The one that banned online gambling and thought its infinite powers would prevent a black market? The one that continuously increases taxes on cigarettes, knowing full well it reinforces and builds a black market for cigarettes? The one that banned certain guns that are still pretty easy to find on the black market? When has Congress ever hesitated because its regulations could create a black market? They are so arrogant, they think all citizens will just obey their laws and they can stop black markets.
I'm not worried about that at all. I see new sites/stores opening every day AND the tobacco industry investing in e-cigs. I think they are crazy (small companies and stores), but it seems the warnings of what MIGHT happen isn't scaring off too many entrepreneurs. Heck, one of CASAA's board members just opened a store in Maryland!
But it would be great if more of the hundreds of manufacturers and retailers got involved!
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You don't know how happy I am to see this language. And I appreciate DC2's correction. So, the OMB is still reviewing the cost/benefits to proposed regulations. Are those results adopted immediately or are they on the table for feedback first? And what are these statuses:
Priority: Economically Significant
then at the bottom:
Regulatory Flexibility Analysis Required: Yes
Government Levels Affected: Undetermined
Federalism: Undetermined
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
Could CASAA update the site? There's outdated information about the FDA's pending regulations in the spring of '13 on the "printable materials" section. Thanks to everybody willing to talk this out even though it got messy. Sorry, if in the heat of the moment, I made any unseemly accusation, insinuation or insult. PM if you feel I slighted you and I'd be glad to apologize personally.
The above statement is self contradicting, its logically false the proposed rules are waiting for approval to be proposed.. Moreover its not what is happening.
What has been given to the OMB, is the language that various specific type of Tobacco, will be included into the definition of Tobacco, which is governed by the 2009 Tobacco Control Act. The Deeming, is in the hands of the OMB as they have oversight of Costs, associated with Congressional programs, like the FDA. OMB governs costs only, not rules. I don't think that anyone with the knowledge of the OMB thinks they can guide the rules in application, they can stop a program that would have massive cost effects.
The proposal for Deeming is published. It clearly contradicts the logical fallacy, that CASAA seemingly is guided on.
So it goes like, Deem "these products" as of the law, go through the hoops (like the OMB, public comments, etc) to get the Deeming Rule, as done, in place....then the FDA has the authority given it by the 2009 Tobacco Control Act to do as the act enables. The FDA can not go outside of the act, as they already were told by the highest court of appeals, they can not.
The 2009 Act, has significant limitations built with in. As an organization CASAA, does not understand the limitations of the 2009 Law, and is creating huge amounts of needless Fear, Uncertainty, and Doubt (FUD), based on arguments of the "potentially can happen" which are not legally founded.
Here is what is proposed. You can read it. Once this is in place, then the FDA can use the 2009 Act. There are not a set of proposed regualtions, and CASAA should know this. There is only the proposed Deeming Rule. With lots of FUD you can extrapolated entirely wrong on the law, dire dire ramifications. (Even if true, ones that would be held up for years, which is the local bans are TODAY, effect people TODAY, and not some theoretical game of predictions, precluded by law)
The Proposed Deeming Rule, here it is:
View Rule
it enables, that is why the Office of Management and Budget takes a peak, how big are these costs, the OMB is not the actor, its the purse?
Yes it specifically lists Electronic Cigarettes
Some selected Quotes:
The proposed rule has two parts: one part deems all tobacco products to be subject to the FD&C Act; the other part proposes additional provisions that would apply to newly-deemed products as well as to other covered tobacco products. The proposed deeming action differs from most public health regulations in that it is an enabling regulation.
"In other words, in addition to directly subjecting newly-deemed "tobacco products" to the substantive requirements of Chapter IX of the FD&C Act, it enables FDA to issue further public health regulations related to such products"
Its very concerning to see false information, and false fears, being promulgated out, while local bans are where nearlly all the effects to Vapers exist today. (I am only talking USA, nothing about the EU)
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