FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

[Rossum]

It is encouraging that the FDA is seeking comments though.

Correct me if I'm wrong here, but my understanding is that a public comment period the normal, required process for all new federal regulations. Those comments then become part of the record for that regulation, but the agency issuing the regulation is under no obligation to pay any attention whatsoever to those comments (other than publishing them).

 

[Jay-dub]

Looks like there's only one way to interpret things Tom. You either believe CASAA 100% or ANTz 100% and there's obviously no in-between. I'm appalled that someone would come into a clique-ish community and offer a different perspective. We don't cotton to you free-thinker types 'round here. Instead of considering your words I'm going to mock you because I often mock that which I don't understand.

I see parallels.

 

[DC2]

Correct me if I'm wrong here, but my understanding is that a public comment period the normal, required process for all new federal regulations. Those comments then become part of the record for that regulation, but the agency issuing the regulation is under no obligation to pay any attention whatsoever to those comments (other than publishing them).

That is correct, but I still don't understand why they are taking comments regarding (specifically) the requirements for substantial equivalence.

They already have standards for substantial equivalence, and they have been using and following those standards.
Perhaps they are considering how they might adjust those standards, which can only be a good thing.

The standards could not possibly get any harder to comply with, so any adjustments would have to be for the better.

 

[DC2]

Looks like there's only one way to interpret things Tom. You either believe CASAA 100% or ANTz 100% and there's obviously no in-between. I'm appalled that someone would come into a clique-ish community and offer a different perspective. We don't cotton to you free-thinker types 'round here. Instead of considering your words I'm going to mock you because I often mock that which I don't understand.

I see parallels.

If he would make a coherent and factual argument, people would be listening.
As far as I'm concerned, he is doing neither.

You are free to think what you want.
And you are equally free to post your thoughts about it, just like we are.

 

[Sundodger]

Looks like there's only one way to interpret things Tom. You either believe CASAA 100% or ANTz 100% and there's obviously no in-between. I'm appalled that someone would come into a clique-ish community and offer a different perspective. We don't cotton to you free-thinker types 'round here. Instead of considering your words I'm going to mock you because I often mock that which I don't understand.

I've found in 56+ years that those that claim to be free thinkers, tolerant and deeply caring of all things are usually the least open minded or deeply caring. It's just a way for them to feel good about themselves. I on the other hand have my prejudices and am well aware of them. Some are for very good reason (IMO) others are not and I try and adjust my thought process accordingly to overcome them.
Saying that you must believe 100% what CASAA says is bull headed and just wrong as it is with the ANTZ. Look, people learn prejudice to things, learn not to trust things or those that have proven to not be what they consider on their side, good for them, or just doesn't make sense. ANTZ, the FDA, BP, BT and politicians nicely fit into this category like it or not.
If Mr. Baker would have come here and tried to explain his side WITHOUT immediate attacks on CASAA and Bill Godshall maybe he'd have a little more credibility. As of now I see none, it looks like someone that got kicked out of a club and is here just to bash them.
I 100% agree with him that the bans are very important, but no more than what the FDA may do, we need to fight on all fronts to insure vaping is not regulated or taxed to the extent that most just go back to smoking.
I really don't understand what is so hard to see about any of this.

 

[DustyZ]

The OP of this thread posted some very good information that is available for public comment. If you read it, the guides for substantial equivilance are very reasonable, and something that E-Cigs should be able to hurdle with ease. People seem worried that small shops brewing in their backroom will not be able to sell e-juice online. I doubt it, because the ablity to get past the hurdles won't be so hard. If they don't want to be a member of MEMBERS | AEMSA frankly I don't care if they continue, sorry. AEMSA members will be able to get their papers filled out, they will help each other. AEMSA is a real orgainizaiton making a difference. I see a lot of posts by CASAA but their website is not up to date with anything in the way of accomplishments except from years ago, and those I debate if CASAA was just simply in attendance. I guess I am a tough grader. Not sorry.

Yes I read, and I read what the OP post. I read Sottera. You can read some of what I post below, I did not write it. I am not here to spoon feed everyone the raw information that can be read.

I see on the top of every thread in this forum a call to action, that is years old. It mostly displaced by the Sottera decision and what the FDA has said it is giong to do......but they still have not. When CASAA puts out a battery, (voltage regulated with some nice gizmos, but its still just a power source of DC current....a battery) can be banned and taken off the market.....it shows how many years backwards, and legally wrong. Its a false protrayal of reality of what the FDA is going to do, but I won't tell you you should not donate money to those opinions, its your choice. Factually that presentation by the President of CASAA, citing Godshall.....it just junk. And as I and others are saying, screw on a LED on the end of a Provari, which would be a lovely addition to the box set, and you have an expensive flashlight. It won't come off the market, EVER, unless they themselves want to stop selling it.

So when faced with all this junk and FUD, sky is falling talk, I think its waste of time. Meanwhile tons of local bans are not a waste of time. That has always been my point. CASAA is one of many duplicative information sources of what is going on, but its entirely not effective in doing anything to stop the onlsalught of bans. CASAA has just not been the answer. And I don't want to say they are not trying, they did. Bans are rolling over people, for example the entire UC University system. Maybe its easier to work the problem of what the FDA may do years down the road. Sottera was 3 years ago. But every day, E-Cigs are being sold, large players, TV ads...time marches on.

My point has never been that I am the answer to the question, I know you folks want to go there. The question remains with or without me. I am attempting to refocus where the effort needs to happen. The FDA is a false concern, Bans are where the action is, telling someone a meeting is going down, is nice and all, but writing your Congressman, and your Senator, is going to do NOTHING. Its all on the local level.

Perhaps consider this:
Judge Merrick B. Garland concurred with the majority, but not entirely for the same reasons. Like the majority, Judge Garland agreed that based on the plain language of the Tobacco Act, Sottera’s e-cigarettes fall within meaning of “tobacco product” because the liquid nicotine used in those products is derived from tobacco plants. Therefore, e-cigarettes should be regulated as tobacco products and not drug-delivery devices. However, Judge Garland did not agree that the holding in Brown extended to the e-cigarette situation.

Rather, he stated that the Supreme Court’s decision was only meant to apply to products that actually contain tobacco which e-cigarettes do not.

According to Judge Garland, the reason the Supreme Court in Brown held that FDA did not have jurisdiction to regulate customarily marketed tobacco cigarettes as drug-devices was because such products allegedly could not be used safely for any therapeutic purpose, and would thus have to be banned by FDA if the Agency had drug-device authority over them.

However, this premise does not hold true for e-cigarettes or other tobacco-free products that deliver pure nicotine; these types of products could have therapeutic benefits and would not necessarily have to be banned. Finally, Judge Garland acknowledged FDA’s argument that its interpretation of the Tobacco Act, as the Agency charged with interpreting the new law, should be entitled to deference (i.e., Chevron deference).30 The Judge stated, however, that because there was no final agency action from FDA interpreting the new law, there was no way
to award such deference to the Agency’s position. He concluded with the following: “What the result would be were the FDA to offer a contrary statutory interpretation in the form of a regulation, I leave for the day the agency decides to take that step.”

On December 20, 2010, FDA, refusing to accept what appeared to be inevitable, filed a Petition for a Rehearing and a Rehearing En Banc, as well as a motion to reinstate the stay of the District Court’s decision to grant Sottera’s preliminary injunction, arguing that the panel’s decision was based on a “fundamental misunderstanding” of the Brown decision. FDA contended that the panel’s ruling would erode incentives for companies to develop nicotine replacement therapies, and would “exacerbate the problem of nicotine addiction and undercut an important tobacco control measure.” On January 24, 2011, the Court of Appeals unanimously denied the FDA’s en banc rehearing request and left in place the injunction preventing FDA from barring e-cigarette imports and from regulating the products as drug-devices.

The ruling underscored the panel’s original decision and forced FDA to consider the extent to which it should regulate e-cigarettes under the Tobacco Act, or appeal to the Supreme Court.

Although e-cigarettes will not require FDA’s pre-market approval to be sold, FDA will be able to use its authority under the Tobacco Act to ensure that appropriate age and marketing restrictions are in place, and also require e-cigarette manufacturers and distributors to disclose all ingredients, additives and any potentially harmful constituents used in their products.

----------------Your Tanks and Provaris, are not going to be banned.....CASAA admittedly published...it can happen.....nope, legally wrong, sorry if you don't understand. If its from the President of CASAA, it is CASAA, sorry Kristin, the President speaks for the Organization, that is why they are the President.

You just continue to go into long diatribes about CASAA, you state that they were formed by community vapers, then you mention AEMSA as a REAL organization, reality check here, AEMSA was also formed by Vapers and those who were/are e-liquid manufacturers and wanted to put some standards into the process of producing safe e-juices etc. If it wasn't for Vapers, neither of these organizations would have been formed, and each of them in their own way contributes greatly on the different aspects of the business.

That said, as typical of you to skirt questions, create extremely long diatribes in regards to those who either question what your qualifications are or what your factual resources are so they can be reviewed by others, in addition those that have questions for you, you either ignore them, state they are long winded, which with the length of your posts is highly laughable that you even dare to make such a comment. You also are not providing and credibility as to what your roles is other then to go into these long winded posts without any real substance and only appears that your sole purpose is to slam others that are actually trying to do something positive in relation to e-cigarettes and the community as a whole. What have you contributed other then copied information, total supposition on the issues regarding them and what is or is not legal. If you have no legal background in any way with the way you are trying present yourself is with a know it all attitude and spouting off what can and cannot be done. So until such a time that you step up to the plate with more then just a big bag of hot wind, I will just leave you to continue to put your foot in your mouth. Not trying to be rude, however you don't answer any direct questions posed to you, which anyone with any credibility would gladly do without hesitation. So, enjoy your attention seeking endeavors.

 

[patkin]

I had the opportunity to view "Dallas Buyer's Club" recently and jumped at it as Matthew is one of my favs (he should win for this one) although I already knew the story. I could not help thinking about the life-saving benefits of vaping all the way through it and how similar the fight against the FDA's murderous stand was while so many were also fighting for their lives and the thousands who died due, directly, to the FDA's actions. For those weakening in the face of disinformation, you might want to check it out.

 

[Talyon]

Did CASAA fire anyone lately, or did someone part this org. Under bad terms?

I do believe that CASAA does fight on the front lines informing us of pending news and legislation at the state level about bans restrictions etc etc, I don't see where u get off tombaker insinuating they only go after the FDA?

Tombaker I'm not saying your wrong on any level, moreso hoping your right but saying stuff without some proof of where u come from on your opinions is asinine. I know in your world you have tried to explain your view, but having some links to actual accounts to back up your opines would be greatly respected.

I would really like to understand your reasoning here.

 

[Fulgurant]

Looks like there's only one way to interpret things Tom. You either believe CASAA 100% or ANTz 100% and there's obviously no in-between. I'm appalled that someone would come into a clique-ish community and offer a different perspective. We don't cotton to you free-thinker types 'round here. Instead of considering your words I'm going to mock you because I often mock that which I don't understand.

I see parallels.

Do you have a specific argument to make vis-a-vis CASAA and its supporters, or do you suppose it's constructive to sit on the sidelines, spewing content-free ad hominems? Simply calling people closeminded, without condescending to support the accusation or even to comment on the subject at hand, is the antithesis of reasoned and open-minded discourse. One must always be wary of becoming what one despises.

We get it; you enjoy tom's posts because they seek to contradict a position held by people you don't like. Any other reasons why tom's argument appeals to you? Here, I'll start you off with an example list, featuring the bits of his position that I like or agree with:

1.) It is unlikely that hardware will be banned. The concern isn't so much that the FDA will declare battery tubes or kanthal wire illegal (how could they?); the issue is that restrictions on e-juice (and specifically flavored e-juice), combined with marketing restrictions on hardware, might very well drive whole segments of the e-cig industry out of business or underground. It's well and good to say that this-or-that item wouldn't become illegal, but if the manufacturer or vendor no longer has enough incentive to keep selling the item, then the legal angle becomes moot.

No one disputes (or in any case very few people dispute) that vaping will remain possible for those of us who are knowledgeable and determined; the question is whether the market will remain friendly to new and would-be vapers. Still, tom's point on hardware is at least a worthwhile observation, one that many of us have made in the past.

2.) I like tom's optimism. It is entirely possible that the FDA will err on the side of caution given the court defeat in 2010 or all of the general controversy surrounding public-health institutions in Washington these days. It's also possible that the FDA will simply do the right thing for the right reasons. I disagree with tom's interpretation of past events and his characterization of how the FDA makes decisions, but hey, maybe the dice will fall in our favor. Which leads me to 3, which is probably the most important item on the list:

3.) The urgency of the local battles sprouting up all over the country cannot be overstated. It's good that tom emphasizes those battles. He's dead wrong if he thinks the FDA fight has nothing to do with the local fights; for example, check out the latest San Francisco issue and note that the proposal cites the FDA's flawed 2009 report as nearly the entire basis for their moratorium on e-cig business -- but at least his heart's in the right place. Or so a charitable reader might assume.​

Where tom errs isn't in his sentiments, which are understandable, even laudable. Where he errs is in confusing his opinions for facts, in confusing his common-sense interpretations of statute as legally unassailable. The FDA may not act against us, but they have the power to do so. They aren't obliged to apply the substantial equivalence rule sensibly; they certainly haven't done it so far. As noted earlier, the FDA's brazen misrepresentation of evidence in 2009 is still getting tossed about, high and low -- and so nary a day goes by, even for those who work exclusively on a local level, without another reminder of just how honest and open-minded FDA is prone to be on the e-cig issue.

Worse still, tom frames every comment as an attack on the very people who have been fighting tooth and nail to preserve our access to a vibrant and innovative e-cig industry. It's not enough that he thinks CASAA's wrong about what the FDA will do; he has to proclaim CASAA idiots and/or paranoids -- in contrast, we must suppose, with tom himself, who (despite his apparently having only just discovered the e-cig issue, and despite his having accepted correction over some really pretty elementary stuff in just the last couple of weeks) we are to regard as an expert, the last word on the subject of FDA involvement in the e-cig industry.

In short (too late), what passes for substance in tom's arguments really isn't all that controversial. It might even be uplifting with some small stylistic revisions. But the devil's in the details, and the way tom writes inevitably leads readers to wonder whether he isn't just an internet blowhard seeking validation at everyone else's expense.

 

[tombaker]

....at this time substantial equivalence is clearly just about impossible.
That much is obvious from their publicly documented reasons for denying such applications.

This is exactly the type of disinformation that is going on. Substantial equivalence is not impossible. The FDA has recently approved a set of products, and unlike what you are saying they did not allow 2. AND, they did not disclose why those specific products were not deemed equivilant, instead they put out some basic guidelines.

Every BLU is exactly like every V2.....the OP has the language, which is good news.

 

[Jay-dub]

If he would make a coherent and factual argument, people would be listening.
As far as I'm concerned, he is doing neither.

You are free to think what you want.
And you are equally free to post your thoughts about it, just like we are.

Sorry if I left an impression that people weren't free to post or think what they want. I've seen patterns here from day one. You have to admit that this community can be pretty hostile to people who don't fall in line with popular sentiment. It's all good when the people defending popular sentiment slam a dissenter's intelligence, sincerity and intent. But as soon as the dissenter sinks to their level he's the bad guy. Neat.

I've found in 56+ years that those that claim to be free thinkers, tolerant and deeply caring of all things are usually the least open minded or deeply caring. It's just a way for them to feel good about themselves. I on the other hand have my prejudices and am well aware of them. Some are for very good reason (IMO) others are not and I try and adjust my thought process accordingly to overcome them.
Saying that you must believe 100% what CASAA says is bull headed and just wrong as it is with the ANTZ.

I agree with you. Have you read this thread? That's at least 70% of what is going on here.

Look, people learn prejudice to things, learn not to trust things or those that have proven to not be what they consider on their side, good for them, or just doesn't make sense. ANTZ, the FDA, BP, BT and politicians nicely fit into this category like it or not.

I have, on multiple occasions, witnessed several posters here rail against the FDA, then tell a noob in the beginners forum that vaping is perfectly safe then cite the FDA's approval of the individual components of e-liquid. I've also seen many of the same people rail against BP, then post links to studies done by BP to support their arguments. It's that exact intellectual inconsistency that feeds into my willingness to believe that some claims made by CASAA are more self-serving than factual. All organizations, especially lobbyists and advocacy groups do it. It's how the game is played. The frustrating part is people want to deny it.

If Mr. Baker would have come here and tried to explain his side WITHOUT immediate attacks on CASAA and Bill Godshall maybe he'd have a little more credibility. As of now I see none, it looks like someone that got kicked out of a club and is here just to bash them.
I 100% agree with him that the bans are very important, but no more than what the FDA may do, we need to fight on all fronts to insure vaping is not regulated or taxed to the extent that most just go back to smoking.
I really don't understand what is so hard to see about any of this.

I've seen noob bashing occur here quite often. Not so fun when it goes the other way. Keep in mind, I'm not accusing you of such a thing. I'm just trying to point out the hypocrisy I figure neither of us are fans of. It's the same hypocrisy that persuades everyone that Tom is just blindly typing random gibberish but people defending against CASAA or the approach taken by CASAA always make well reasoned and factual arguments. CASAA has an agenda. It's one I happen to agree with. But don't tell me they're not willing to take liberties to increase membership and donations through interpreting many worst-case-scenarios. The means justify the ends.

 

[tombaker]

That is correct, but I still don't understand why they are taking comments regarding (specifically) the requirements for substantial equivalence.

They already have standards for substantial equivalence, and they have been using and following those standards.
Perhaps they are considering how they might adjust those standards, which can only be a good thing.

The standards could not possibly get any harder to comply with, so any adjustments would have to be for the better.

Again, posting that you have not read something, and don't understand it? How often to get to 16K, much, I think. They are asking for public comments guidelines. I say its good news, I think in post number 2 on the OP thread. The reason why its good news is because they are saying they can find that things are equivalent, if something is deleted from a grandfathered product, or a proceeding approved product......and they also talk to something being added, that the would consider not a problem also.

Added is after all a harder problem, but they saying that if it can be shown it does not impact, it can been deemed substantially equivalent. E-Cigs of anything have never applied, because until they are officially under the banner of the FDA, which they said years ago they would do, no e-Cig has even tried.....YET....some ill-informed people are saying they will be impossible to overcome.....FUD

 

[Fulgurant]

This is exactly the type of disinformation that is going on. Substantial equivalence is not impossible. The FDA has recently approved a set of products, and unlike what you are saying they did not allow 2. AND, they did not disclose why those specific products were not deemed equivilant, instead they put out some basic guidelines.

Every BLU is exactly like every V2.....the OP has the language, which is good news.

The generic reasons for denying applications are pretty discouraging. Of particular interest are the notes on predicates, flavors, and ingredients (constituents): http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf

The new Tobacco chief at FDA (Mitch Zeller) has made sympathetic noises about the length of the product-approval queue, and I certainly agree with you and others that the exemption thing is an encouraging sign, but to act as if the substantial equivalence standards as FDA has traditionally applied them will be easy to meet takes a lot of faith or a lot of naivete. Or more likely, loads of both.

And by the way, DC2 did not say that FDA had published why specific products were not deemed equivalent. "Publicly documented reasons for denying such applications," does not equal, "publicly documented reasons for denying each application." When you accuse people of lying or spreading disinformation, it's generally advisable to make absolutely sure you know what it is they said.

 

[rothenbj]

Well stated Fulgurant. I've been around here a long time and seen the legal battles and regulations that have already been put in place that hinder the move away from cigarettes. One of the huge laws put in place in 2010 was the PACT Act (Prevent All Cigarette Trafficking). However the act not only effected cigarettes, but all tobacco products. It governs the collection of taxes on, and trafficking in, cigarettes and smokeless tobacco. It also set up product registration requirements.

Prior to PACT, we were able to purchase snus in many different varieties from Sweden, get reasonable shipping costs and have product delivered with little effort. After PACT, anything sold had to be registered so the number of products available quickly decreased. What caused more of an issue, USPS was not allowed to deliver product and adult signature was required leaving only UPS as their shippers.

Today I still buy from Sweden, but my orders are large to spread out the $30 shipping cost. A new user either has to take a leap of faith or buy what you can find in a local B&M which are still few and far between. How does this effect E cigs?

At minimum, the FDA may declare E cigs to be a smokeless product without placing it under the PACT regulations. That would immediately result in the end of small orders, require UPS to be the shipping agent and require a signature for delivery. I don't believe hardware would be an issue, but liquid would automatically be effected. Beyond that, who knows. However sitting back and not getting a voice before regulation could and probably would be disastrous.

 

[Talyon]

Again, posting that you have not read something, and don't understand it? How often to get to 16K, much, I think. They are asking for public comments guidelines. I say its good news, I think in post number 2 on the OP thread. The reason why its good news is because they are saying they can find that things are equivalent, if something is deleted from a grandfathered product, or a proceeding approved product......and they also talk to something being added, that the would consider not a problem also.

Added is after all a harder problem, but they saying that if it can be shown it does not impact, it can been deemed substantially equivalent. E-Cigs of anything have never applied, because until they are officially under the banner of the FDA, which they said years ago they would do, no e-Cig has even tried.....YET....some ill-informed people are saying they will be impossible to overcome.....FUD

Please send some of what your Vapeing. I want to believe......

All joking aside, believe what u must as it's all for the same end game, isn't it?

 

[DC2]

Sorry if I left an impression that people weren't free to post or think what they want. I've seen patterns here from day one. You have to admit that this community can be pretty hostile to people who don't fall in line with popular sentiment. It's all good when the people defending popular sentiment slam a dissenter's intelligence, sincerity and intent. But as soon as the dissenter sinks to their level he's the bad guy. Neat.

That's pretty much human nature for the most part, isn't it?
There is a segment of every kind of community that can be pretty hostile to those that work against popular sentiment.

If one intends to do that, one should have a thick skin.
And one should be ready to remain calm and state their case clearly.

But if it's his treatment that you're concerned about, just remember how this all started.

 

[tombaker]

We get it;

Excellent post.
1. The FDA can not just do anything, they will have a huge battle with the big boys (BLU V2 NJOY) if they try to go crazy. Its been 3 years since Sottera, if they could just go crazy, they would. And the evidence of the harms of E-Cigs is not there to justify.
2. CASAA is responding to the above, because I don't know why. Lawyers have analyzed what the FDA can do or not. Those lawyers won in the highest appeal court.
3. Look at the top of the thread, CASAA gives what 8 hours notice on a hearing tonight. Very late, still good its there, but very late. The FDA can not do anything for many months or years, and thats if they are going to do anything......MEANWHILE, stuff like South San Francisco gets noticed not at all. Yes an email blast late is nice, better than nothing. But its like saying we only lost 28 chickens last night, lets get serious about the one we see in that Fox's mouth over there, we might be able to save it. The CASAA is simply not effective in stopping local bans. Simple google searchs locate other cities lining up, for months, that are just not anywhere on the CASAA radar. Things that can be tracked, and stopped.

4. CASAA puts out that VV battaries can be banned, and that the FDA is signaling it with the topic of the OP. Its just wrong. Is this not specific enough?
5. The focus on the FDA is meaningless if South San Francisco gets a temporary moratorium made into a permanent.
6. CASAA had nowhere on its site any information about South San Francisco until hours before the meeting.
7. The Sottera decision is clear, I posted the text from the Appeals judge supporting E-Cigs, the FDA has not been able to work around it for years. I have cited, and this very OP thread, is about the specific language....which again....is good news.

The local bans are the problem, and if you think that CASAA is on the job, fine, but if you look at what is happening, CASAA is entirely ineffective, with its listed successful campaigns all from years ago. Since then, NY, the entire University of California system of Colleges, S.SF, and the list is much larger than those.

I suppose you think that BLU and Njoy would be doing TV ads, since they understand the FDA is about to ban the world.....Or they may know better, and worry not about being so high profile.

 

[DC2]

Again, posting that you have not read something, and don't understand it?

I said I DID read it, and I understood pretty much every word of it.
What I did not understand is WHY they are asking for comments on substantial equivalence exemptions.

They are asking for public comments guidelines. I say its good news, I think in post number 2 on the OP thread.

I agree that it might be good news, and it most certainly can't be bad news because the news on substantial equivalence can not get much worse.

And the problem I have with your comments in the second post of this thread are well-documented...
You seem to be ignoring how the FDA has so far been treating substantial equivalence, in favor of your own "logical" opinion of how it will work.

The reason why its good news is because they are saying they can find that things are equivalent, if something is deleted from a grandfathered product, or a proceeding approved product......and they also talk to something being added, that the would consider not a problem also.

You say if something is added or deleted from a grandfathered product, no problem, but this is what it really says...

Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
tobacco product and that the manufacturer must submit the request and
all information supporting it to FDA.

An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec. 25.40.

The part I bolded is exactly why there is concern for how the FDA has been denying substantial equivalence in so many cases thus far.


And even if we get past that, we are still just talking about grandfathered products here.
Those products that are not grandfathered are not even eligible to apply for this exemption to substantial equivalence.

 

[DC2]

The local bans are the problem, and if you think that CASAA is on the job, fine, but if you look at what is happening, CASAA is entirely ineffective, with its listed successful campaigns all from years ago. Since then, NY, the entire University of California system of Colleges, S.SF, and the list is much larger than those.

No, CASAA is entirely WAY too small, powerless, and underfunded.
And you are most certainly not helping.

Now that the "enemy" is onto us, they are marshaling their enormous resources and preparing well in advance.
They are also trying to sneak a lot of these bans through without notice these days.

We are starting to lose more often because they are getting serious about beating us, and bringing money into the equation.

And as for CASAA being ineffective, I would hardly call things like this being ineffective...
http://www.e-cigarette-forum.com/fo...ion/511758-what-has-casaa-been-up-lately.html

 

[Jay-dub]

Do you have a specific argument to make vis-a-vis CASAA and its supporters, or do you suppose it's constructive to sit on the sidelines, spewing content-free ad hominems? Simply calling people closeminded, without condescending to support the accusation or even to comment on the subject at hand, is the antithesis of reasoned and open-minded discourse. One must always be wary of becoming what one despises.

I don't see the point in reposting the same links already posted in this very thread multiple times; then trying to persuade people to interpret the subject matter of those links one way or another. If you want me to post links to examples of some of our more prominent posters being hypocrites and cannibals I could accommodate. My specific argument about CASAA and it's supporters (I'm a member now btw, not sure if that qualifies as support) may be addressed here: http://www.e-cigarette-forum.com/fo...-equivalence-requirements-8.html#post11813231 and if you're still interested I could elaborate.

We get it; you enjoy tom's posts because they seek to contradict a position held by people you don't like.

NO. I'm not like that. I don't follow people around for weeks harassing them or make fun of them when I believe they won't find out about it either. You have me mistaken. I enjoy Tom's posts because he's offering an honest opinion without coddling people's egos. He's challenging the norms here and even the people he pisses off are probably better for it. He's demeanor is no better or worse than many in this very thread and if not for the lack personal familiarity of Tom, I doubt this thread would be so full of muck. He makes some good points but for me it's really not news that exaggerations are made to support one point or another. So, I don't see why it's so ludicrous to point out that CASAA is not immune to that same behavior.