Deeming Regulations have been released!!!!

[Lessifer]

No. Neither the regulations nor the guidelines to date prohibit any particular substances or materials, either in e-liquids or devices, nor are any specific substances or materials identified as permissible.

That's one of the most objectionable aspects of this whole thing. The FDA admits it doesn't know what's OK and what's not, so it has placed the entire burden on manufacturers to perform elaborate studies in order to spoon feed information to the FDA which it admits it has to have in order to become sufficiently educated on the products to enable it to properly regulate them.

vaping products are being treated much like new prescription drugs as opposed to recreational products. The FDA doesn't tell BP what to put in drugs. BP concocts a new drug, conducts all kinds of tests, submits the information, and then the FDA decides if its OK to market the drug. The cost of bringing a new drug to market averages $2.5 billion, which is roughly the cost of 27 F18 jet fighter planes.

Treating vaping products the same as new drugs is the wrong approach because there are already millions of people vaping. Many people have been vaping for 7 years or longer. That's vastly more people vaping for longer periods of time than new drug testing involves. So there's already plenty of readily available information on their safety. What would elaborate and costly clinical trials tell us that we don't already know or can't easily determine?

That's what I thought, I remembered seeing a list of compounds but was pretty sure it was just a list of things that manufacturers should specifically note the levels of. If they were to truly use a science based approach, would a chemical like diacetyl be completed restricted, or would it be something that would be acceptable under a certain level? Given that the research linking diacetyl to B.O. is murky at best.

 

[Rossum]

That's what I thought, I remembered seeing a list of compounds but was pretty sure it was just a list of things that manufacturers should specifically note the levels of. If they were to truly use a science based approach, would a chemical like diacetyl be completed restricted, or would it be something that would be acceptable under a certain level? Given that the research linking diacetyl to B.O. is murky at best.

Oh, technically, it's not restricted. Then again, technically, the FDA isn't banning open systems either. But when it gets down to brass tacks, do you think the FDA is more or less likely to approve a system like Vuse if the juice contains diketones or other substances that they think might be "of concern"?

 

[Alexander Mundy]

They don't know.....isn't everyone aware that something must have new regulations passed before they can know what is in it nowadays?

 

[oplholik]

That seems to be the way now.

 

[Lessifer]

Oh, technically, it's not restricted. Then again, technically, the FDA isn't banning open systems either. But when it gets down to brass tacks, do you think the FDA is more or less likely to approve a system like Vuse if the juice contains diketones or other substances that they think might be "of concern"?

It depends on which FDA I'm thinking of:

1. The FDA that I "knew" prior to this whole vaping thing: I would hope they would investigate the safety of diketones further than they have been.

2. The FDA that hates vaping and everything to do with it: Nope, I think they'd find any reason to deny an application.

3. The FDA that wants their authority to stand: They're going to approve something, and I think meeting their hardware standards are more important than the content of the liquid, but that's just my opinion.

 

[bigdancehawk]

That's what I thought, I remembered seeing a list of compounds but was pretty sure it was just a list of things that manufacturers should specifically note the levels of. If they were to truly use a science based approach, would a chemical like diacetyl be completed restricted, or would it be something that would be acceptable under a certain level? Given that the research linking diacetyl to B.O. is murky at best.

It's a matter of pure speculation. But if I were a manufacturer investing very large sums of money hoping to get a product approved, I would do everything possible to avoid a detectable level.

One problem with getting vaping products approved, in contrast to drugs, is that drugs are intended to treat or prevent diseases. So it's entirely possible to get a drug approved even though it produces harmful side effects in a significantly large percentage of patients. But if the benefits outweigh the harmful effects, the drug can gain approval. Vaping, OTOH, doesn't treat or prevent any diseases, unless one views smoking as a disease. Other than smoking cessation/reduction, there is no benefit (as the FDA defines "benefit"), against which to weight any level of possible harm, however slight or unlikely.

So, the only benefit of vaping which the FDA might consider is smoking cessation or, less likely, reduction. Ironically, the FDA prohibits marketing vaping products for smoking cessation without first seeking and obtaining approval to market them as "modified risk" products. The chances of getting a vaping product approved as such are remote, IMO. Swedish Match presented the first modified risk application, accompanied by decades of scientific and epidemiological studies compiled at vast expense. The odds of it being approved are unknown. What e-cigarette company is going to do that without some basis for calculating the probable outcome?

 

[Lessifer]

It depends on which FDA I'm thinking of:

1. The FDA that I "knew" prior to this whole vaping thing: I would hope they would investigate the safety of diketones further than they have been.

2. The FDA that hates vaping and everything to do with it: Nope, I think they'd find any reason to deny an application.

3. The FDA that wants their authority to stand: They're going to approve something, and I think meeting their hardware standards are more important than the content of the liquid, but that's just my opinion.

ETA: by hardware standards I mean a closed system, that can be easily tracked, taxed, and fits nicely on the shelf with the other tobacco products.

 

[Kent C]

Oh, technically, it's not restricted. Then again, technically, the FDA isn't banning open systems either. But when it gets down to brass tacks, do you think the FDA is more or less likely to approve a system like Vuse if the juice contains diketones or other substances that they think might be "of concern"?

In this study,
EHP – Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes

Brand B was deduced to be Vuse/RJR and the two flavors - menthol and original tobacco were found to have <LOD = not detected above the laboratory limit of detection (LOD), 0.05 μg.... for Diacetyl, 2,3-Pentanedione, Acetoin

EHP Table Viewer

While they have other flavors, I'm guessing they may have at least diacetyl in mind to avoid. Again - guessing No mention of it in the FAQ at Vuse......

 

[Rossum]

In this study,
EHP – Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes

Brand B was deduced to be Vuse/RJR and the two flavors - menthol and original tobacco were found to have <LOD = not detected above the laboratory limit of detection (LOD), 0.05 μg.... for Diacetyl, 2,3-Pentanedione, Acetoin

EHP Table Viewer

While they have other flavors, I'm guessing they may have at least diacetyl in mind to avoid. Again - guessing No mention of it in the FAQ at Vuse......

Right. Because Vuse was designed from scratch, as a complete system, to have the best possible chance to be "approved" by the FDA. It would be an utterly stupid move on Reynolds' part to have anything in their liquids that would be of "concern" to the FDA. BT may be many things, but I do not think that they are stupid.

 

[Lessifer]

It's a matter of pure speculation. But if I were a manufacturer investing very large sums of money hoping to get a product approved, I would do everything possible to avoid a detectable level.

One problem with getting vaping products approved, in contrast to drugs, is that drugs are intended to treat or prevent diseases. So it's entirely possible to get a drug approved even though it produces harmful side effects in a significantly large percentage of patients. But if the benefits outweigh the harmful effects, the drug can gain approval. Vaping, OTOH, doesn't treat or prevent any diseases, unless one views smoking as a disease. Other than smoking cessation/reduction, there is no benefit (as the FDA defines "benefit"), against which to weight any level of possible harm, however slight or unlikely.

So, the only benefit of vaping which the FDA might consider is smoking cessation or, less likely, reduction. Ironically, the FDA prohibits marketing vaping products for smoking cessation without first seeking and obtaining approval to market them as "modified risk" products. The chances of getting a vaping product approved as such are remote, IMO. Swedish Match presented the first modified risk application, accompanied by decades of scientific and epidemiological studies compiled at vast expense. The odds of it being approved are unknown. What e-cigarette company is going to do that without some basis for calculating the probable outcome?

I'm aware of all that. The problem is, what does "appropriate for the protection of public health" mean?

If it were me, the highest diketone liquid on record would be an improvement over cigarettes and would therefore be appropriate for the protection of public health.

They don't see it that way though. Relative safety compared to other tobacco products is only of minimal concern, when applying for PMTA. MRTP is a whole other maze of ambiguity.

 

[bigdancehawk]

ETA: by hardware standards I mean a closed system, that can be easily tracked, taxed, and fits nicely on the shelf with the other tobacco products.

Can you imagine the uproar if a couple of thousand PMTPAs were submitted and Zeller went to Congress asking for increased funding? Assume it takes 100 man hours to review one application. (It's probably a lot more than that) So one person could do 20 per year. Do the math. They have to make it so difficult and expensive that very few companies will attempt it.

 

[Lessifer]

Can you imagine the uproar if a couple of thousand PMTPAs were submitted and Zeller went to Congress asking for increased funding? Assume it takes 100 man hours to review one application. (It's probably a lot more than that) So one person could do 20 per year. Do the math. They have to make it so difficult and expensive that very few companies will attempt it.

I've actually seen a couple of things that look like they're at least attempting to conform to what the FDA says they want, without being cigalikes. Proprietary connections, sealed tanks, but also at least attempting to provide a somewhat decent vape. I don't think they're on the market yet, but I assume they're working as fast as they can.

Some in the industry aren't too happy about that, maybe they see it as selling out, I don't know. I think you can fight for a better regulatory environment for vaping AND try to ensure your company will survive and that vapers will have something if things don't go our way.

 

[skoony]

Brand B was deduced to be Vuse/RJR and the two flavors - menthol and original tobacco were found to have <LOD = not detected above the laboratory limit of detection (LOD), 0.05 μg.... for Diacetyl, 2,3-Pentanedione, Acetoin

Thanks for the info @Kent C .

I do not know your thoughts on this issue but why do i have a sneaking suspicion that the standard allowance for none BT juice will be much,much stricter?

Regards
Mike

 

[mattiem]

clipped: Vaping, OTOH, doesn't treat or prevent any diseases, unless one views smoking as a disease. Other than smoking cessation/reduction, there is no benefit (as the FDA defines "benefit"), against which to weight any level of possible harm, however slight or unlikely.

So, the only benefit of vaping which the FDA might consider is smoking cessation or, less likely, reduction. Ironically, the FDA prohibits marketing vaping products for smoking cessation without first seeking and obtaining approval to market them as "modified risk" products. clipped

Another thread was posted just this morning about no more colds since vaping came into their lives. I am pretty sure the FDA doesn't want to hear reports like that but it seems to be one of the numerous benefits of vaping. One person did come in and point out that it was just because we are no longer smoking but I don't believe that is all it is. Non-smokers still get a cold or the flu just like so many of us smokers did. I truly believe the lack of respiratory ills has a direct link to the pg/vg in our e-liquid.

If it weren't for the fact that too much money is being lost, the FDA and health agencies would be all over this fact. I really hope that someday they will get their heads out of the money bag (as opposed to sand) and see what a miracle this truly is. Sadly, I don't see this happening in my lifetime

 

[Opinionated]

Ironically you bring this up about Libertarians.. I would have thought this would have been one of the things I would have seen all over the FB pages I am on.. Not much really.. I have seen 1 link..
The Rest of the Story: Tobacco News Analysis and Commentary: FDA E-Cigarette Deeming Regulations are a Disaster for Public Health

Other than that..
And for the ill informed on why i say this is because of the following..
The Vape community is a legit modern day free market without no government intervention at all.. This is a big thing because the only other place you see this is on the black market.. We have done a very good job with policing ourselves..

The 2nd thing here is invading individual rights to do what they want.. The idea we decide to vape instead of smoking is taking our right to ourselves and to be able to make our own decision to vape. This falls under the 9th amendment to the Bill of Rights..

You know, it's funny you brought this up because I have been in utter amazement at how cool this has been. I believe this is the first time in my life that I actually saw up close and personal how a truly free market works. To see everything in action like this was one of the coolest experiences.

We saw people wanting this or that feature and manufacturing responded, people said no we won't sacrifice safety, and manufacturing responded.. the government didn't once need to step in, the consumers literally drove the entire market. It was very nice to experience and see.

For a while, I saw the reality of a philosophy I read about and believed in come to life in such awesome perfection in how it truly works.. this is what the market should be like. Open. Free.

 

[Bronze]

Another thread was posted just this morning about no more colds since vaping came into their lives. I am pretty sure the FDA doesn't want to hear reports like that but it seems to be one of the numerous benefits of vaping. One person did come in and point out that it was just because we are no longer smoking but I don't believe that is all it is. Non-smokers still get a cold or the flu just like so many of us smokers did. I truly believe the lack of respiratory ills has a direct link to the pg/vg in our e-liquid.

If it weren't for the fact that too much money is being lost, the FDA and health agencies would be all over this fact. I really hope that someday they will get their heads out of the money bag (as opposed to sand) and see what a miracle this truly is. Sadly, I don't see this happening in my lifetime

IMO, it stands to reason that cases of bronchitis would be lower as well.

 

[retired1]

Another thread was posted just this morning about no more colds since vaping came into their lives. I am pretty sure the FDA doesn't want to hear reports like that but it seems to be one of the numerous benefits of vaping. One person did come in and point out that it was just because we are no longer smoking but I don't believe that is all it is. Non-smokers still get a cold or the flu just like so many of us smokers did. I truly believe the lack of respiratory ills has a direct link to the pg/vg in our e-liquid.

If it weren't for the fact that too much money is being lost, the FDA and health agencies would be all over this fact. I really hope that someday they will get their heads out of the money bag (as opposed to sand) and see what a miracle this truly is. Sadly, I don't see this happening in my lifetime

Making claims like that would be considered a "medical claim" and you would have to have reams of data to prove it in order to advertise it. FDA doesn't care about that as they know it would be virtually impossible to validate it. However, what they would do is slam any company who attempted to use that as a selling point, and rightfully so as it's an unproven medical claim.

 

[mattiem]

Making claims like that would be considered a "medical claim" and you would have to have reams of data to prove it in order to advertise it. FDA doesn't care about that as they know it would be virtually impossible to validate it. However, what they would do is slam any company who attempted to use that as a selling point, and rightfully so as it's an unproven medical claim.

I understand that we can't make claims like that (except between ourselves) without definitive proof but we that have been vaping for a while are living proof that it has made a very big difference in the number of or the severity of respiratory ailments.

I am just saying that if the money hungry alphabets cared one whit about the health of those they are supposed to care about they would look into the positives we have experienced from vaping instead of slamming the door shut, locking it and throwing away the key.

 

[skoony]

Making claims like that would be considered a "medical claim" and you would have to have reams of data to prove it in order to advertise it. FDA doesn't care about that as they know it would be virtually impossible to validate it. However, what they would do is slam any company who attempted to use that as a selling point, and rightfully so as it's an unproven medical claim.

@retired1 ,100% correct.

I might add the FDA doesn't care if it is 100% true.

Regards
Mike

 

[Fozzy71]

IMO, it stands to reason that cases of bronchitis would be lower as well.

I have asthma and switched to vaping so I could ride my bicycle more/longer. I haven't touched my inhaler since I started vaping. Kicking myself for not trying vape gear sooner.