FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

[Jman8]

I was also fairly stunned about the reply to SJ.

Oh, dear heavens.

I mean, you were?

 

[aubergine]

Nothing very deep. I changed my mind and deleted my OP because it was just more of the same. Round and round the mulberry bush...



Really? Hmm... Are you sure? I just saw one of them lecturing the owner and founder of this forum. He probably has no idea whom he's talking to. SJ has spent the past 7 years in the trenches.



Thanks. At this point, only the njoy lobbyist knows what is going on with the bill...

Re "lecturing the owner and founder" - yeah. Gads.
On a similar note, it seems to me that it might be a good idea to have a couple of comment-less stickies up in ECF where our several enormously knowledgeable and long-time politically active Venerables could simply keep us updated and clarify issues. One Ven. per thread, like wee blogs? It might be helpful for members who have no idea who's legitimately credible, and would save the rest of us the effort of scouring every thread in this section for the blessed moment when they pop up and clear away ever-accumulating heaps of misconception.
It would also prevent Aubs here, arguably venerable (say what? I ain't DEEF!), but far from authoritative, from launching divers irritable tangents, by way of passing time - surely a blessing.

 

[zelda]

The cheapest way to manufacture nicotine in the long term would be to use a plant with as much nicotine in as the tobacco plant: Duboisia Hopwoodii, aka the Australian pituri plant.

But this approach is flawed because the legislators would quickly adjust the law to include all sources of nicotine (including synthetic). The purpose of the regulations is not to control ecigs and/or e-liquid or protect health, it is to prevent low-risk, difficult to tax alternatives to cigarettes eliminating smoking and the profitable diseases it causes. It's best to forget about such details in regulations, and concentrate on what they want to achieve.

They'll do what they need to do in order to achieve their goal, which is putting in place the most restrictions that can be achieved without a successful legal challenge.

The details are not really relevant until further down the road. If they can get away with what they hope for, then we will just have sealed disposables or minis with prefilled cartos, no refills, no web sales, no advertising, no flavors, no anything except a Blucig etc. All that will take a long time to implement and a lot of it will get challenged. Forget about cunning ways to evade the regulations, they will have all that covered once they get their ducks in a row. The black market will take over until such time as there are enough tens of millions of vapers to make a difference. The sooner the better.

I was fortunate enough to start vaping almost 5 years ago. I will always consider it a rare privilege that I witnessed the evolution of the ecigarette industry in the open market free(for the most part) from regulations and rules. I commend the responsibility and ingenuity of the ecigarette vendors and manufacturers throughout the years. It's been impressive.

I can never thank ECF administration, moderators and members enough for all their knowledge and support. No matter what the regulations bring - and I personally agree with your scenario Roly- what occurred in the vaping industry has been remarkable.

 

[Gato del Jugo]

The FDA is sometimes right--GMOs are safe to eat. Everything we eat today is genetically modified. Our dogs and cats are genetically modified--by centuries of selective breeding.

I don't want to side-track this thread with something off-topic, but considering the FDA isn't exactly the "objective, science-based" organization which they & others claim it to be, and the FDA's intentions & motivations are certainly & rightfully questioned re: the e-cig proposal...


But when you take some of the DNA of something (e.g., a bacterium), and manually insert it into the DNA of something else (e.g., a soybean plant), that is not traditional & natural selective breeding..

We're not even talking about different species, here.. and in taxonomical terms, not even different families, orders, classes & phylums, either -- but different kingdoms!


And neither should GMO fall under the FDA's substantial equivalence rule.. And yet, oddly enough, it does...

Hey, eat all the GMO you want, nobody is stopping you.. Doesn't mean that others should unknowingly or unwillingly be forced to, just because the lines are extremely blurred between the FDA & a certain industry (who stands to benefit) wherein both say it's perfectly "safe"...


And even though something like this is an example of how the FDA operates, I shall now give myself a

 

[Kent C]

I don't want to side-track this thread with something off-topic, but considering the FDA isn't exactly the "objective, science-based" organization which they & others claim it to be, and the FDA's intentions & motivations are certainly & rightfully questioned re: the e-cig proposal...


But when you take some of the DNA of something (e.g., a bacterium), and manually insert it into the DNA of something else (e.g., a soybean plant), that is not traditional & natural selective breeding..

We're not even talking about different species, here.. and in taxonomical terms, not even different families, orders, classes & phylums, either -- but different kingdoms!


And neither should GMO fall under the FDA's substantial equivalence rule.. And yet, oddly enough, it does...

Hey, eat all the GMO you want, nobody is stopping you.. Doesn't mean that others should unknowingly or unwillingly be forced to, just because the lines are extremely blurred between the FDA & a certain industry (who stands to benefit) wherein both say it's perfectly "safe"...


And even though something like this is an example of how the FDA operates, I shall now give myself a

A few comments - any replies should go to PM. You're right, you should have a choice. GMO is a short cut to evolution or 'selective breeding/hybrids in plants that have gone on ever since the Native Americans discovered maize. The long route was years of hybridizing to get a better product. Science found a way to short cut that process to come up with virtually the same result. The fear mongering that goes on with GMO, imo, is the same 'nicotine is poison' argument. I don't buy either and have read extensively on both and 'both sides' not just what is force fed, where any dissent is equal to holocaust denying.

 

[Roger_Lafayette]

[...]
On a similar note, it seems to me that it might be a good idea to have a couple of comment-less stickies up in ECF where our several enormously knowledgeable and long-time politically active Venerables could simply keep us updated and clarify issues. One Ven. per thread, like wee blogs? It might be helpful for members who have no idea who's legitimately credible, and would save the rest of us the effort of scouring every thread in this section for the blessed moment when they pop up and clear away ever-accumulating heaps of misconception.
It would also prevent Aubs here, arguably venerable (say what? I ain't DEEF!), but far from authoritative, from launching divers irritable tangents, by way of passing time - surely a blessing.

Kinda off-topic for this forrum, but since you mentioned it, I agree

One forum for people like SJ, Roly, Bill G., Kirsten, Jule W., C.V. and (who else am I missing? Additional access, maybe for actual or potenial occasional posters such as Clive Bates, D!ck Puddlecote and a few others like Dr. F. and so forth, perhaps).

Just for announcements. If organizing for a legislative fight was going on or some other activity for whch pubilc posting participation was helpful, then they could drop in a link to a thread in some forum with open posting.

The yellow banner that someone suggested in a CASAA conference call a few weeks ago (someone I know well ;-) is helpful, but perhaps more could be done for those of us who want to keep tabs on things like the coming FDA fight or biggies such as AB 1500 or critical devel.s in the EU as the TPD gets implemented by member states (etc.).

 

[Stosh]

Definitely off topic Roger, but a great idea for a post to Site Feedback and Help, (copy & paste? .) where it stands a better chance of adoption.

 

[Roger_Lafayette]

Aubergine, this was your idea. Please be my guest

Definitely off topic Roger, but a great idea for a post to Site Feedback and Help, (copy & paste? .) where it stands a better chance of adoption.

 

[aubergine]

Hm, don't think it'll really be noticed there. And sorry to be OT - it really has been that sort of a week. Sigh.

 

[MikeNice81]

I was fortunate enough to start vaping almost 5 years ago. I will always consider it a rare privilege that I witnessed the evolution of the ecigarette industry in the open market free(for the most part) from regulations and rules. I commend the responsibility and ingenuity of the ecigarette vendors and manufacturers throughout the years. It's been impressive.

I can never thank ECF administration, moderators and members enough for all their knowledge and support. No matter what the regulations bring - and I personally agree with your scenario Roly- what occurred in the vaping industry has been remarkable.

Vaping is a great example of how well the free market can work. The industry has come a long way since using tea bags to make usable cartos. Just look how fast Kanger has evolved the MT3 into the Evod 2 glass. Then Aspire too prebuilt dual coil heads to a whole new level and Smok developed a different way for heads to seal on the post and brought out ceramic cups to stop leaking.

This is how free markets and capitalism really work. Now the government steps into regulate and we're hoping we don't get knocked back half a decade or more. Honestly, we're hoping we don't get wiped out.

 

[Roger_Lafayette]

Done. It's right here.

http://www.e-cigarette-forum.com/fo...all-legislative-regulatory-critical-news.html

Likes and follow-ups from those who agree w/ the idea might be helpful ;-)

Definitely off topic Roger, but a great idea for a post to Site Feedback and Help, (copy & paste? .) where it stands a better chance of adoption.

 

[sqirl1]

Now I haven't read responses from all 20 pages of this thread but I still say our best bet is trying to fight them in court when they make their move. Of course we need to be vocal about stopping this from going through in the first place but as far as money goes CASAA should be mostly investing in a legal team. Yes it would be difficult to file a preemptive court case against them but if and when they start handing out cease and desist letters to vendors I still say we have a good chance of having section 901 in general come under investigation at the very least. I say that because the FDA has acted on 4 of the 3000+ apps they got for cigarettes in the last 5 years, so unless they seriously step their game up there's no way they could POSSIBLY keep up with all e-cig products. If we can convince the judge that the FDA is biting off more than they can chew, we might seriously have a good chance. Not to mention the fact that one part of FSPTCA has already bitten the dust to the courts with the whole warning label thing. I'm not saying We're 100% going to win in a legal battle but we have a case and once they start handing out C&D letters to vendors we need to keep this in mind.

 

[Roger_Lafayette]

Well, the FDA can keep up with vendors if they want to, by sending out those C&D letters and asking the Justice Dep't to prosecute vendors who don't comply. I think in the short term, the strategy might be more focused on trying to force them to respond to the science and other considerations raised in the comments section. Pressure can also be applied through Congress. We'll have to see what CASAA's strategy will be. Like you, I wouldn't be surprised if parts of this end up in the courts.

Now I haven't read responses from all 20 pages of this thread but I still say our best bet is trying to fight them in court when they make their move. Of course we need to be vocal about stopping this from going through in the first place but as far as money goes CASAA should be mostly investing in a legal team. Yes it would be difficult to file a preemptive court case against them but if and when they start handing out cease and desist letters to vendors I still say we have a good chance of having section 901 in general come under investigation at the very least. I say that because the FDA has acted on 4 of the 3000+ apps they got for cigarettes in the last 5 years, so unless they seriously step their game up there's no way they could POSSIBLY keep up with all e-cig products. If we can convince the judge that the FDA is biting off more than they can chew, we might seriously have a good chance. Not to mention the fact that one part of FSPTCA has already bitten the dust to the courts with the whole warning label thing. I'm not saying We're 100% going to win in a legal battle but we have a case and once they start handing out C&D letters to vendors we need to keep this in mind.

 

[DC2]

Hm, don't think it'll really be noticed there. And sorry to be OT - it really has been that sort of a week. Sigh.

They notice things at the Site Feedback and Help subforum.

Go for it.

 

[Roger_Lafayette]

Done. It's right here.

http://www.e-cigarette-forum.com/fo...all-legislative-regulatory-critical-news.html

Likes and follow-ups from those who agree w/ the idea might be helpful ;-)

Currently being discussed. Anyone who wants to participate, use the link quoted above.

 

[sqirl1]

Here's another thing I'm curious about: I know the FDA has regulatory jurisdiction of "components" of tobacco products and hardware would obviously be treated as such no way around it. What I'm wondering is do companies who currently ONLY make the components for cigarettes have to file SE apps for the components themselves? IE do companies like Tops and Zig-Zag have to file apps for all their papers and filters? If not I don't see how hardware would be any different.

 

[Roger_Lafayette]

Here's another thing I'm curious about: I know the FDA has regulatory jurisdiction of "components" of tobacco products and hardware would obviously be treated as such no way around it. What I'm wondering is do companies who currently ONLY make the components for cigarettes have to file SE apps for the components themselves? IE do companies like Tops and Zig-Zag have to file apps for all their papers and filters? If not I don't see how hardware would be any different.

I bet those older rolling papers are all grandparented. Although they might still have to register and file ingredient disclosures under the new proposed rule (?).

According to Professor Google: https://www.google.com/search?q=fda...la:en-US:official&client=firefox-a&channel=sb

I got this for starters (I have no idea how credible they are):
HBI® International News, Wholesale Tobacco Products USA, Worldwide

If the above is correct then cigarette rolling papers are also effectively "frozen in place" by FSPTCA, i.e. new ones require premarket approval. Which is basically saying that there won't be any, since the FDA never seems to approve premarket applications for new products. Or SE applications either.

 

[sqirl1]

I bet those older rolling papers are all grandparented. Although they might still have to register and file ingredient disclosures under the new proposed rule (?).

According to Professor Google: https://www.google.com/search?q=fda...la:en-US:official&client=firefox-a&channel=sb

I got this for starters (I have no idea how credible they are):
HBI® International News, Wholesale Tobacco Products USA, Worldwide

If the above is correct then cigarette rolling papers are also effectively "frozen in place" by FSPTCA, i.e. new ones require premarket approval. Which is basically saying that there won't be any, since the FDA never seems to approve premarket applications for new products. Or SE applications either.

Kind of ridiculous that a 10 centimeter peice of paper requires premarket approval isn't it? Who other than big tobacco ever thought this was a good idea?

 

[Stosh]

Kind of ridiculous that a 10 centimeter peice of paper requires premarket approval isn't it? Who other than big tobacco ever thought this was a good idea?

But they can submit a substantial equivalence application and wait 2 /12 years for approval, just be sure the differences are minimal....

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM370074.pdf

KEY DIFFERENCES BETWEEN NEW AND PREDICATE TOBACCO PRODUCTS


The new tobacco product has the following key differences compared to the
predicate tobacco product:
x Increase in tube length (from 84 to 100 mm)
x Increase in filter length (from 15 to 25 mm)


The chemical compositions of the new and predicate tobacco products are nearly identical.

 

[Roger_Lafayette]

The funny thing is that they still leave tobacco pipes alone as far as I know. I think cigarette papers are perhaps suspect because of their other uses (and the fact that there's no alternate product, like a toilet paper roll ;-)

Kind of ridiculous that a 10 centimeter peice of paper requires premarket approval isn't it? Who other than big tobacco ever thought this was a good idea?