FDA IF you were the FDA, what would your proposal be?

[SensesFailed]

Then maybe you'd care to explain why this is an area in which you think government intervention (at the federal level, no less) is warranted, especially when 1) the vast majority of vendors have already chosen not to sell to minors, and 2) most of the states already prohibit it anyway? Seriously, how shocked can you be about people opposing a federal policy that's essentially symbolic and superfluous, and will do nothing to materially benefit anyone?

[Edit] One more question: You do realize, I assume, that there's no federal age restriction on tobacco and/or smoking? So, Washington is content to let the states decide for themselves who can buy real cigarettes (which actually kill people), but they feel it necessary to establish a federal-level age restriction for e-cigs? Frankly, if you can't understand why this is complete stark raving insanity that makes no sense whatsoever, then I'm the one who's shocked here.

Yes I realize there is no federal age restriction laws and that it's up to the states, but I feel there should be. Disagree me and be shocked all you want, but I honestly have no problem with an age restriction on buying cigarettes. While I will never consider e-cigs tobacco products because, obviously, they don't contain tobacco, I also am in favor of limiting the sales to minors, it is what it is, we'll have to agree to disagree on that.

We have different views on nicotine use by minors so it is what it is.

 

[SensesFailed]

Any prohibition is demonstrably ineffective and harmful. Do you find it acceptable that kids today can get easier and cheaper access to illegal or prescription drugs than they would to ecigs?

No I don't find it acceptable and I feel something should be done about it. No idea where you pulled that from.

 

[Nate760]

We have different views on nicotine use by minors so it is what it is.

Well, this begs another pertinent question: Do you disagree with the FDA's policy of 1) approving over-the-counter sales of nicotine gum with no age restrictions, and 2) approving the long-term use of nicotine patches and inhalers by people as young as 12?

The crux of the issue is not whether there should be policies regarding nicotine use by minors. There are perfectly good arguments to be made either way. The point is that the policies which currently exist are inconsistent and nonsensical, and take wildly different approaches to the use of the same substance according to the aesthetic appearance of the delivery system being used.

 

[Elizabeth Baldwin]

The problem is any regulations from the FDA gives them precedence over the industry. Once they've deemed ecigs/vaping as a tobacco product we are in for a rough ride.

 

[SensesFailed]

Well, this begs another pertinent question: Do you disagree with the FDA's policy of 1) approving over-the-counter sales of nicotine gum with no age restrictions, and 2) approving the long-term use of nicotine patches and inhalers by people as young as 12?

The crux of the issue is not whether there should be policies regarding nicotine use by minors. There are perfectly good arguments to be made either way. The point is that the policies which currently exist are inconsistent and nonsensical, and take wildly different approaches to the use of the same substance according to the aesthetic appearance of the delivery system being used.

No I don't agree with it. I think the FDA is hypocritical in the way it handles certain things and handles others. It's pretty evident by the way it's handling these regulations. They pick and choose what to attack or defend based on several factors including, but not limited to:

1. Biased Information
2. Congressmen influence/Big Company influence
3. Personal bias
4. Personal vested interest

I am not the biggest fan of the FDA, as I feel they, at this point, aren't doing the job they are supposed to do, but instead, are doing a job they get bought out to do.

Of course this could lead up to another can of worms when it comes to money in politics which pretty much would end up with a 1000 word rant from me on how stupid it is. Seriously, it's such a pain to find out every dollar sent to politicians.

 

[aikanae1]

What I see as the root is that the deeming regulations are disproportional when applied to ecigarettes. No other tobacco category has no SE equivalent. That increases costs substantially. This is the only category where benefits of filling or not filling applications can't be estimated. This is the only category where there's projected "exits" that result in the consequence of the public loosing significant choices (per the economic report). It's discriminatory and in that sense, interferes with the market which (to my understanding - which has been wrong in the past) regulatory agencies are not supposed to do.

At this point in time, I believe BT thinks they can get cigalikes approved, but the reality is they could be playing with fire too. I don't think that's written in stone yet either.

I tend to view this as a war between BT and BP and we are caught in the middle. BT wants a piece of BP's NRT market and I'm pretty sure that BP doesn't want to just give that away. "We" (the vaping industry) are more like the fly on their windsheild.

 

[MTFogger]

If FDA is really about public safety.
Deem it as a non tobacco substitute, thereby creating a whole new field.
Require certified mixers. Creating a new job position and classes, teachers etc.
Require a clean semi lab type area for mixing and storing. Clean area standards like food prep not open to public intrusion.
Require health inspections. random testing on liquids if making, storing, selling liquids.
Max limit on nicotine strength. IE 2.4%.
Label all ingredients and nicotine strength and mix ratio. Include nicotine warning.
Limit non nicotine ingredients to FDA approved VG,PG and non oil base food flavorings. Mix ratios not regulated.
Max size limit on retail bottling. IE 50mg.
Requested optional child proof caps.
Require non leeching materials on device tanks.
Max power limits on devices. IE 15watts.
Max tank capacities. IE 10mg.
Require battery and short protection on all devices. Include a possible max size battery.
Age verification, no sales to minors under 18 years of age.
Further testing on E-cigs in general.

 

[mynewtoy]

If FDA is really about public safety.
Deem it as a non tobacco substitute, thereby creating a whole new field.
Require certified mixers. Creating a new job position and classes, teachers etc.
Require a clean semi lab type area for mixing and storing. Clean area standards like food prep not open to public intrusion.
Require health inspections. random testing on liquids if making, storing, selling liquids.
Max limit on nicotine strength. IE 2.4%.
Label all ingredients and nicotine strength and mix ratio. Include nicotine warning.
Limit non nicotine ingredients to FDA approved VG,PG and non oil base food flavorings. Mix ratios not regulated.
Max size limit on retail bottling. IE 50mg.
Requested optional child proof caps.
Require non leeching materials on device tanks.
Max power limits on devices. IE 15watts.
Max tank capacities. IE 10mg.
Require battery and short protection on all devices. Include a possible max size battery.
Age verification, no sales to minors under 18 years of age.
Further testing on E-cigs in general.

all of this ^^^^^

great list

matter of fact this is going in my response to the fda

 

[Dave_in_OK]

Wrong thread

 

[mynewtoy]

If the FDA wanted to deem a product a non-tobacco substitute could they?

or would that require a law by congress giving them authority over non-tobacco substitutes

 

[Nate760]

If the FDA wanted to deem a product a non-tobacco substitute could they?

Sure, but that would mean official classification as a smoking cessation device, which would mean everything gets pulled off the market immediately and we have to wait for 7-10 years of clinical trials, after which e-cigs would be available only by prescription.

 

[mynewtoy]

Sure, but that would mean official classification as a smoking cessation device, which would mean everything gets pulled off the market immediately and we have to wait for 7-10 years of clinical trials, after which e-cigs would be available only by prescription.

but a judge already ruled to 2009 e-cigs where not medical devices and the FDA could not pull them off the market. i'm talking about a whole new class of products. which is what e-cigs are

 

[MTFogger]

I'm not sure classifying it as a substitute automatically puts it as a cessation product but I may be wrong. You can call it what you want, but to me its not a tobacco product, but they want to deem that way.

 

[mynewtoy]

ok non-tobacco nicotine product then. that sounds better

 

[pamdis]

I seriously can't believe people are actually against regulation of sale to minors, holy crap

Seriously, on what basis should they be denied to minors?

The only argument I have heard for it is that it is a compromise that will 'get them off our backs, make them happy, then we can be left alone.'

I have not ever heard one rational argument that justifies why a minor should not have one. Especially those who already smoke.

To me, it just smacks of 'throw them under the bus to save ourselves' logic. An emotional decision, not a scientific one.

 

[Nate760]

Seriously, on what basis should they be denied to minors?

The only argument I have heard for it is that it is a compromise that will 'get them off our backs, make them happy, then we can be left alone.'

I have not ever heard one rational argument that justifies why a minor should not have one. Especially those who already smoke.

To me, it just smacks of 'throw them under the bus to save ourselves' logic. An emotional decision, not a scientific one.

This is a great example of the extent to which ANTZ propaganda is so pervasive and so unquestioned that certain aspects of it are even widely accepted within the vaping community. It is by now a statistically well-attested fact that as e-cigs proliferate, tobacco use goes down. It's just as true for people under 18 as it is for people over 18. If our goal is truly to reduce the number of people who smoke cigarettes, and to do so as quickly as possible, prohibiting young people from buying and using e-cigs does nothing to accomplish it.

The "we don't want kids to get addicted to nicotine" argument is a scientific non-starter, because all the available data say it's impossible to become dependent on nicotine except by using tobacco. Moreover, no one (including the FDA) seems to have a problem with teenagers using nicotine gum, patches, inhalers, or lozenges.

The "kids shouldn't be allowed to buy habit-forming stimulants" argument is an exercise in hypocrisy, since no one seems to care about the fact that millions of kids spend their days strung out on coffee, energy drinks, and caffeine pills, all of which arguably pose greater health risks than nominal doses of nicotine.

 

[DrMA]

If FDA is really about public safety.
Deem it as a non tobacco substitute, thereby creating a whole new field.
Require certified mixers. Creating a new job position and classes, teachers etc.
Require a clean semi lab type area for mixing and storing. Clean area standards like food prep not open to public intrusion.
Require health inspections. random testing on liquids if making, storing, selling liquids.
Max limit on nicotine strength. IE 2.4%.
Label all ingredients and nicotine strength and mix ratio. Include nicotine warning.
Limit non nicotine ingredients to FDA approved VG,PG and non oil base food flavorings. Mix ratios not regulated.
Max size limit on retail bottling. IE 50mg.
Requested optional child proof caps.
Require non leeching materials on device tanks.
Max power limits on devices. IE 15watts.
Max tank capacities. IE 10mg.
Require battery and short protection on all devices. Include a possible max size battery.
Age verification, no sales to minors under 18 years of age.
Further testing on E-cigs in general.

Some of those go too far. I wouldn't want FDA to limit bottle or tank size, or device power output and battery capacity. Oh, and also no limit on nic strength. Seriously what's with that?

I like to purchase my juice by the gallon in 100mg strength and use 6600mAh batteries on 120W capable devices with the biggest tank I can get my hands on. By all means, regulate the quality standards, but don't tell me how much juice I can buy or how strong my device can be. What? Is your name Bloomberg or something?

 

[Myrany]

Yes I realize there is no federal age restriction laws and that it's up to the states, but I feel there should be. Disagree me and be shocked all you want, but I honestly have no problem with an age restriction on buying cigarettes. While I will never consider e-cigs tobacco products because, obviously, they don't contain tobacco, I also am in favor of limiting the sales to minors, it is what it is, we'll have to agree to disagree on that.

We have different views on nicotine use by minors so it is what it is.

I do not have a big problem with a ban on sales to minors (we can debate its necessity at the fed level as I thinks states should handle it). I DO have a problem with a ban on USE by minors. I firmly believe in a parents right to get their kid off regular cigs and onto vaping.

 

[Stosh]

If FDA is really about public safety.
Deem it as a non tobacco substitute, thereby creating a whole new field.

So far so good...

Require certified mixers. Creating a new job position and classes, teachers etc.

Devastate the DIY mixers, subject vapers to only flavors mixed by "experts"

Require a clean semi lab type area for mixing and storing. Clean area standards like food prep not open to public intrusion.
Require health inspections. random testing on liquids if making, storing, selling liquids.

A food prep standard, acceptable but a full pharmaceutical standard...not so much.

Max limit on nicotine strength. IE 2.4%.

So vapers that need 3.0% - 4.8% to beat smoking can either quit or die. I vaped 3.6% for over a year to be able to lay down the smokes.

Label all ingredients and nicotine strength and mix ratio. Include nicotine warning.
Limit non nicotine ingredients to FDA approved VG,PG and non oil base food flavorings. Mix ratios not regulated.

You realize that some oil based flavor is safer than some non-oil soluble. And a FDA food flavoring is not necessarily safe for vaping.

Max size limit on retail bottling. IE 50mg.

Will you be tearing down Costco also, they sell all sorts of things in very big packages.

Requested optional child proof caps.
Require non leeching materials on device tanks.

Leaching to what degree, how many parts per billion? Any trace of anything whatsoever, or a FDA standard that allows a certain amount of bug parts in cereals?

Max power limits on devices. IE 15watts.

To what end, saving electricity?

Max tank capacities. IE 10mg.

You realize a 510 cig-a-like with an atomizer and cartridge holds 0.5 mL and leaks much more than a much larger better built tank.

Require battery and short protection on all devices. Include a possible max size battery.

You realize larger batteries are safer than small under-powered ones. Engineers also design figuring in a "human numbskull factor", yet people still seem to be able to win "Darwin Awards"

Age verification, no sales to minors under 18 years of age.

They should definitely experience 5-10 years for destroying their health before they are allowed to vape.

Further testing on E-cigs in general.

Agreed, if they disclose all the data, how the subjects were selected, what vaping equipment was used, what nicotine level was used, etc...no bogus slanted studies need apply.

 

[SensesFailed]

I do not have a big problem with a ban on sales to minors (we can debate its necessity at the fed level as I thinks states should handle it). I DO have a problem with a ban on USE by minors. I firmly believe in a parents right to get their kid off regular cigs and onto vaping.

I don't think a ban on use by minors is honestly doable, nor would I agree to something like that. I would never take something that far. I shake my head whenever I see kids my son's sage with a cigarette in their hand, but I would never call for an outright ban or even trying to "criminalize"(for lack of a better term) it. What does that accomplish? Jack and crap except push a burden of paying a fine on them... and by them.. I mean most likely the parents.