FDA Big news coming out of FDA

[skoony]

@SmokeyJoe
Do you think this proposal may in part be due to whats happening in England?
Regards
Mike

 

[Oliver]

No, @skoony, I don't. But I do think the FDA will use PHE's stance to justify their deeming, once it's issued....

Please note: the FDA is now in possession of the first wave of PATH data. I've heard that within this data set is serious population-level evidence that vaping is having a big effect on smoking rates.

I'd like to say that the PATH data will be incontestable and, given that the FDA spent $120m on it, I'd imagine they'll take it's findings seriously.

What that means in terms of policy is anyone's guess, but I think we've just seen an opening salvo.

also, I think this rule is a response to the Cole bill specifically.

 

[Bad Ninja]

While neither of the 2 propositions are true, let me ask if you are a vaper that gets colds still? And if yes, how many per year? And how does this compare to your pre-vaping days? I'm very curious as I've already done informal survey plus have own experience that suggests what I stated before.

Please, any vaper reading this, feel free to respond to these questions. I know some of you still get colds, but I'm thinking many do not. Either an incredible coincidence or possibly, just maybe there's something about vaping.

I haven't really been sick since early adolescence.
See, I'm allergic to penicillin, and most antibiotics. I try to eat right and stay in good shape so I really don't get colds or the flu.
My immune system is very strong.
Never had a flu shot in my life.

 

[Chip H.]

I strongly believe the comparison with the regulated supplements industry is a category error. E-Cigs work in what they are intended to do, as has been seen at the population level, and as expected by the entire cannon of research into nicotine supplementation. Supplements are a mixed bag of snake-oil, minerals and vitamins, and powerful drugs.

Agree that "value-wise" comparing the two is a category error, but it is illustrative as a caution against the "they're going to take our PVs!!!" sentiment from so many.

Not only is there very little in the way of scientific evidence for the efficacy or safety of a massive chunk of the supplement industry, very often what scientific evidence exists demonstrates very real risks and harm, and yet this stuff is available in every drugstore and department store HBA section. Objectively, if the FDA's goal was to prevent fleecing and potential harm of consumers, much of this stuff should just be outright banned pending clinical studies demonstrating empirical evidence of benefits and harms that would be weighed in any subsequent approval process. However, given consumer sentiment and industry lobbying, all we have is relatively strict enforcement for the labeling and product claims.

Even when such companies play very loosely with FDA regs to take advantage of uninformed consumers, nothing is done. My poster child for this is Lipozene. Because they did fund a clinical study they get to legally air commercials that are technically correct while keeping the context hidden behind disclaimers (mainly: although, yes, people lost weight compared to placebo controls, the *amount* of weight loss was far too little to amount to a hill of beans). They market like mad and sell a common vegetable fiber source at about $0.70/gram even though the exact same fiber extract is widely available from multiple sources for around $0.04/gram. On two objective fronts the company is pure sleaze; their product only marginally performs as advertised AND consumers are being subjected to a 1700% mark up because their marketing *implies* it is a drug instead of a common vegetable fiber source available from nearly any supplement supplier, yet it's all perfectly legal.

So, while time may prove me wrong, given the size and rate of growth of this industry, it is doubtful we are going to see anything that much different than what happened to the supplement industry. We'll get some warning labels, packaging and labeling requirements, manufacturing standards, known inhalation risks like diketones will likely have an upper content threshold for juices, possibly some questionably justified limitations on advertising, but mostly they will sit back and wait for further studies. If they didn't move on ephedra supplements until some high profile deaths, I just can't see them taking a chainsaw to the vaping industry given the current lack of evidence regarding a need to more heavily regulate.

 

[englishmick]

So, while time may prove me wrong, given the size and rate of growth of this industry, it is doubtful we are going to see anything that much different than what happened to the supplement industry. We'll get some warning labels, packaging and labeling requirements, manufacturing standards, known inhalation risks like diketones will likely have an upper content threshold for juices, possibly some questionably justified limitations on advertising, but mostly they will sit back and wait for further studies. If they didn't move on ephedra supplements until some high profile deaths, I just can't see them taking a chainsaw to the vaping industry given the current lack of evidence regarding a need to more heavily regulate.

You may well be right here, I hope you are.

It's the "look, we did something to make them safer" factor. Like you said, pass some regulations that maybe aren't intended to outlaw vaping, but make them look relevant and busy. Give them some cover on the political front at the same time. Even if they don't decide to go for the kill, they won't want to be seen as having done nothing. That's not in the DNA of regulatory bodies.

 

[Lessifer]

Agree that "value-wise" comparing the two is a category error, but it is illustrative as a caution against the "they're going to take our PVs!!!" sentiment from so many.

Not only is there very little in the way of scientific evidence for the efficacy or safety of a massive chunk of the supplement industry, very often what scientific evidence exists demonstrates very real risks and harm, and yet this stuff is available in every drugstore and department store HBA section. Objectively, if the FDA's goal was to prevent fleecing and potential harm of consumers, much of this stuff should just be outright banned pending clinical studies demonstrating empirical evidence of benefits and harms that would be weighed in any subsequent approval process. However, given consumer sentiment and industry lobbying, all we have is relatively strict enforcement for the labeling and product claims.

Even when such companies play very loosely with FDA regs to take advantage of uninformed consumers, nothing is done. My poster child for this is Lipozene. Because they did fund a clinical study they get to legally air commercials that are technically correct while keeping the context hidden behind disclaimers (mainly: although, yes, people lost weight compared to placebo controls, the *amount* of weight loss was far too little to amount to a hill of beans). They market like mad and sell a common vegetable fiber source at about $0.70/gram even though the exact same fiber extract is widely available from multiple sources for around $0.04/gram. On two objective fronts the company is pure sleaze; their product only marginally performs as advertised AND consumers are being subjected to a 1700% mark up because their marketing *implies* it is a drug instead of a common vegetable fiber source available from nearly any supplement supplier, yet it's all perfectly legal.

So, while time may prove me wrong, given the size and rate of growth of this industry, it is doubtful we are going to see anything that much different than what happened to the supplement industry. We'll get some warning labels, packaging and labeling requirements, manufacturing standards, known inhalation risks like diketones will likely have an upper content threshold for juices, possibly some questionably justified limitations on advertising, but mostly they will sit back and wait for further studies. If they didn't move on ephedra supplements until some high profile deaths, I just can't see them taking a chainsaw to the vaping industry given the current lack of evidence regarding a need to more heavily regulate.

You may well be right here, I hope you are.

It's the "look, we did something to make them safer" factor. Like you said, pass some regulations that maybe aren't intended to outlaw vaping, but make them look relevant and busy. Give them some cover on the political front at the same time. Even if they don't decide to go for the kill, they won't want to be seen as having done nothing. That's not in the DNA of regulatory bodies.

I hope I'm wrong, but given the FDA's history of Tobacco Control there is no light touch regulation in this area. Again, unlike supplements, tobacco products already have a strict set of regulations that apply. It's not a choice, anymore, between regulation and no regulation. In the FDA mindset it is a choice between tobacco and drug, neither of which is suited for the small entrepreneurial, quick changing and advancing nature of vaping.

 

[squee]

This is why the FDA proposed these guidelines-


Supports curbed appetite suppression. Eat less while enjoying an electronic cigarette, with the added benefits of a natural appetite suppressant. Let nothing hinder your hotness!*

• Give Your Body & Weight-Loss Goals A Kick By Eating What You Like, Just Less of it!
• Ignore Your Afternoon Cravings Without Going Nuts & Still Feeling Satisfied!*
• Disposable, Fortified E-Cigarette; A More Useful Electronic Cigarette!
• Many Experts Believe That Vapor Allows The Body To Absorb & Utilize Active Supplements Easier!
• 3 Delicious, Exhilarating Flavors: Tobacco, Menthol, & Chocolate
• 1.8% Nicotine by Volume

http://www.nutricigs.com

This. This right here is why the FDA is making this rule. There are countless sites and products being marketed as weight loss products, ones that have juice with added caffeine, Vitamin C or E and some offering ......-like effects (as in, don't need a boner pill, have a boner vape instead! Woo!)

 

[skoony]

This. This right here is why the FDA is making this rule. There are countless sites and products being marketed as weight loss products, ones that have juice with added caffeine, Vitamin C or E and some offering ......-like effects (as in, don't need a boner pill, have a boner vape instead! Woo!)

I am under the impression the government already can quash claims like this if they choose to
do so. Maybe not the FDA in general but,the regulations are already in place.
Regards
Mike

 

[Jman8]

Look, I don't think the FDA is trying to close vaping down.

I think they are just thinking about this through the paradigm available to them: The last 20 years of tobacco control, the legalese of the FSPTCA, the "continuum of harm" notion, medical treatment of smoking, etc etc etc....

I just think they're bringing in a whole load of rules that will close down businesses which are currently in the business of helping people to stop smoking. And they'll replace the incumbents with something that may not work, and with rules that may not make things clearer for consumers.

If it ain't broke, why fix it? And if it's only slightly broken why not just tighten things up?

I strongly believe the comparison with the regulated supplements industry is a category error. E-Cigs work in what they are intended to do, as has been seen at the population level, and as expected by the entire cannon of research into nicotine supplementation. Supplements are a mixed bag of snake-oil, minerals and vitamins, and powerful drugs.

The part in red is mostly what I feel like I wish to address.

Vaping market is clearly not broken and currently is the opposite of that (booming).

Because it is booming, it is impacting a whole bunch of other markets and/or political philosophies which is where the (slight) break is visibly occurring. Many people are positioning vaping to be slightly broken in need of a fix. The way you are speaking about it in this post is the common sense approach and that is amicable.

But I also find it to be naive, and I'm around 100% sure that SmokeyJoe is not naive to whatever I write after this.

I think a key thing going forward is that tightening things up could lead to breaking it further. But what trumps this, and possibly always will is that those calling forth a fix will spin whatever comes after the fix, as working, regardless of how things were in 2015 and before.

I'd really really like to use the kids vaping thing as prime example, but as this thread has to do with marketing items, I'll refrain. Though as I sit here and contemplate what I will write next, I gotta admit that the kids example is less convoluted, and is at the heart of all other proposed regulations.

To me, an inherent problem in the eCig community and industry is the assumption of who vaping is for. And this stems from previous assumption (or set of assumptions) that smoking is problem for all people that smoke. The assumption of who vaping is for is very popular and can be stated assertively as "target segment" for who vaping is primarily marketing itself to: the person that seeks to reduce cravings for smoking and hopefully eliminate all problems that come with (abusive) smoking.

But what @evan le'garde said earlier in this thread (post [HASHTAG]#293[/HASHTAG]) is the sensible counter to the assumption.

There is no reason for governing bodies to make the assumption that these electronic devices are designed exclusively for tobacco smokers who want to quit tobacco. So therefore a universal regulational would be wholely inapropriate.

This regulation is based on a complete supposition.

Thing is, that governing bodies and people concerned with vaping market who are not in the community, nor likely to ever be users, are getting this assumption from the way industry (and majority of community) has chosen to market itself. To position itself politically. That vaping is chiefly a product for smoking cessation / reduction. And as long as that is the perceived purpose of any vaping product, I see the market as slightly broken and can see why those who've been in the game of "smoking is a problem" would sit up and take notice to fix vaping, and ensure it conforms to their worldview.

Clearly vaping has entered into the mainstream, as was anticipated, and that it has become a product of it's own accord. As if it didn't need smoking before to determine how good this product is or could be. If anyone, includes vapers, is unable to accept vaping in that way, then I think the market will appear to be broken and a lot of assumptions will be made to fix it, so it can conform to the worldview that vaping is best positioned as a smoking reduction/cessation tool.

But to have it both ways (or more than one way) is the issue that is being addressed through this clarification of the regulation. Can vaping be a great recreational product that even non-smokers enjoy? And can it still be a product that smokers use to reduce/eliminate their cravings? I'd say yes to both, and think both deserve fair consideration. Yet, one of these includes everyone and the other excludes a large segment of the population and arguably excludes some smokers (i.e. those who don't have problem with their smoking habit). Yet, to ensure the latter gets its fair shot, I think the best approach going forward is to rely on word of mouth marketing rather than something industry should be allowed to do regardless of who might have problems with that approach.

Want to say more on all this, but wish to wrap this up by saying we have done this to ourselves, are somewhat still fighting to do this to ourselves (thus exacerbating the perceived problem), and were somewhat doing this to ourselves before vaping was even conceived of. IOW, smoking is a recreational activity / product that really ought to remain that way, but because some, perhaps most, have abused that activity, it has become a perceived problem in search of a viable solution. Vaping is not the first solution, and is arguably not the best solution (cold turkey being a strong viable competitor). That anyone thinks vaping still needs to be considered a viable solution to the smoking problem, and ought market itself that way by industry when consumers have that covered, is the naive portion.

Based on the zealous assumption that smoking, in and of itself, is a problem that is in need of a solution (and not a recreational product for people to enjoy).

Won't be too much longer that same zealous mentality paints vaping in similar fashion. An activity that is inherent problem (look at all the abusers) and is in need of a solution, to stop people from their addiction and out of control behavior with vaping. Thus, not really a recreational activity.

 

[DC2]

Too hot in San Diego?

Yeah, I doubt someone in San Bernardino is feeling any sympathy for me.

 

[DrMA]

Analysis of proposed rule by Dr. Seigel. Interesting read:
http://tobaccoanalysis.blogspot.com/2015/09/fdas-proposed-rule-on-allowable-e.html

 

[zoiDman]

Analysis of proposed rule by Dr. Seigel. Interesting read:
http://tobaccoanalysis.blogspot.com/2015/09/fdas-proposed-rule-on-allowable-e.html

Thank you for Posting this.

It Is an Interesting Read.

 

[tj99959]

OMG...........what ever will we do..........

Thought this was about FDA not ATF

Doesn't the "T" stand for tobacco?
I keep wondering why the whole cigarette mess got shifted over to the FDA in the first place.
Thinkin' the guys at ATF must feel a lil ....-hurt.

 

[LaraC]

also, I think this rule is a response to the Cole bill specifically.

For anyone not familiar with "the Cole bill", here is a thread posted back in May 2015 about it:

https://www.e-cigarette-forum.com/f...007-to-2015-for-newly-deemed-products.670731/

The Cole bill, if passed, would be a good thing, in that it would mitigate some ( but not, by any means, all) of the disastrous consequences to vaping the FDA's proposed deeming regulations would cause.

And for those not familiar at all with FDA's proposal to deem electronic cigarettes as "tobacco products", here ya go for a starter:
http://blog.casaa.org/2014/05/casaas-basic-background-for.html?spref=tw

The proposed deeming regulation itself is here:
http://casaa.org/uploads/FDA_Ecig_Rules_2014.pdf

 

[DC2]

For anyone who already knows about vaping, marketing doesn't really matter, for those who are still on the fence about trying it, it can mean a lot.

I think it helps to realize there are lots of people who don't give a crap about anyone but themselves.
Keeping that in mind really does help one to understand some of the viewpoints expressed here.

 

[Oliver]

Thanks Lara.

Also, what Siegel said (albeit, I have no idea whether his reading of caselaw or the constitution is correct).

 

[Oliver]

One thing I don't see Michael addressing is the notion that "replacing cigarettes with e-cigarettes" IS altering the structure or function of the physiology of the smoker.

 

[skoony]

One thing I don't see Michael has addressing is the notion that "replacing cigarettes with e-cigarettes" IS altering the structure or function of the physiology of the smoker.

I am having a hard time digesting this. Does this mean since my health has improved by using
e-cigs instead of smoking that my physiology has changed and that could be a bad thing?

Regards
Mike

 

[zoiDman]

Thanks Lara.

Also, what Siegel said (albeit, I have no idea whether his reading of caselaw or the constitution is correct).

I think one thing is a Given.

And that is Unless the FDA does Nothing regarding "Intended Use" and "Marketing Claims", there will be Litigation to Determine the Legality of the FDA's Actions.

 

[DC2]

No offense to THR, but how long have they been working at it, and how far has it gotten?

But they have really started gaining some ground throughout the world in the last few years.
And it's mainly due to electronic cigarettes, and the passion of the users of electronic cigarettes.

Do you think e-liquid vendors should be compelled to add "WARNING: Not a safe alternative to smoking" to their labels?

They won't require that because it also states an unproven claim.

They already require if for snus, even though it's more than an unproven claim.
It's a freaking lie that they mandate by law must be told to consumers.

I still fail to understand why anyone with a brain lives in these fascist progressive utopias.

But, you live in California!


Hey, I live there too..
So I can say that.

I'm much more comfortable buying any product from companies which can follow guidelines and adhere to regulations, than from companies who feel they are above regulations. This is why vaping will be regulated and why those who give vaping a bad name will be regulated out of business...

I know you think Halo is going to survive the deeming regulations.
But I also know we don't see anywhere near eye-to-eye on the impact those regulations will have.

Either way, I do hope that you're right, but I have my doubts.