FDA Who will survive the FDA Regs?
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Not true. As far as I know, there are absolutely no laws or regulations regarding the purchase of nicotine base. ECF does not permit the discussion of those strengths due to the safety factors involved.
@retired1 Thanks. I think the source of my confusion came from articles such
as this. ( and other sources) Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China « The counterfactual
Regards
Mike
as this. ( and other sources) Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China « The counterfactual
Regards
Mike
The TCA does not permit the FDA to ban tobacco products, nor ban nicotine per se (as far as I can tell). The law specifically says:
(3) Limitation on power granted to the food and drug administration.--Because of the importance of a decision of the Secretary to issue a regulation--
``(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than
little cigars, all pipe tobacco, or all roll-your-own tobacco products; or
``(B) requiring the reduction of nicotine yields of a tobacco product to zero,
the Secretary is prohibited from taking such actions under this Act.
Hence, per the TCA, the FDA cannot force e-cigarettes to zero nicotine, nor can they just "ban" them de jure.
They can ban them de facto by over-regulating them out of existence, which is clearly what will happen to 99% of the products unless something changes.
I still contend that the FDA will approve several (if not all) of the cig-a-likes created by BT (Vuse, Blu, etc) and trumpet their "effective regulation". Half the battle of dealing with regulatory bodies is having staff on-hand that specialize in this area. That's all these folks do, and they do it well. BT already has these people, as they are already dealing with the FDA regularly, while your local juice mixer does not.
(3) Limitation on power granted to the food and drug administration.--Because of the importance of a decision of the Secretary to issue a regulation--
``(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than
little cigars, all pipe tobacco, or all roll-your-own tobacco products; or
``(B) requiring the reduction of nicotine yields of a tobacco product to zero,
the Secretary is prohibited from taking such actions under this Act.
Hence, per the TCA, the FDA cannot force e-cigarettes to zero nicotine, nor can they just "ban" them de jure.
They can ban them de facto by over-regulating them out of existence, which is clearly what will happen to 99% of the products unless something changes.
I still contend that the FDA will approve several (if not all) of the cig-a-likes created by BT (Vuse, Blu, etc) and trumpet their "effective regulation". Half the battle of dealing with regulatory bodies is having staff on-hand that specialize in this area. That's all these folks do, and they do it well. BT already has these people, as they are already dealing with the FDA regularly, while your local juice mixer does not.
Even if I could buy 99% pure nicotine, there is NO WAY I'm dealing with that stuff. It is VERY dangerous to handle, and I'm a complete klutz to begin with....you should see me with a grease gun, I end up with grease in my hair, all over my clothes....
I think the iQOS will be the telling product as to whether the FDA is going to play ball or not.
iQos Expands in Japan
If the FDA kills the iQOS in the US, then it's pretty much a given that every single PMTA they receive for e-cigarettes and associated products will be denied as well. Your e-cigarette business isn't going to have 400 engineers, scientists and technicians to put together that kind of paperwork for FDA approval.
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the iQOS seems like such a step backwards.
I've seen 500mg nic for sell at at one online vape store, with the caveat, "DO NOT purchase this product unless you have been approved to do so."
I love requirements like that. You can approve yourself and no other official body exists to grant the approval. It's like service animals. If someone is presenting a certificat it's most likely bogus. Everyone who needs a service animal knows no official certification is required or even exists. You only need to state, I have a disability and my dog is trained to perform [insert specific task].
Wow, there is a lot of mistrust and hyperbole out here. From having talked with many of them several times, the FDA is caught in the cultural and institutional vise. Politically they don't believe they can do anything other than what Big Public Health (ACS, ALA, CDC, NIH) and Congress want them to do. The fact that it helps Big Tobacco drives them bananas!
That said, Big Tobacco is lobbying hard in Congress to change the date and allow everything introduced before 8/8/16 to stay on market with no application. They are not our enemy in this fight!
Those are the facts on the ground right now. There will be one chance to change the date and allow all vapor products to stay on market this year. The decision on that will be made in Congress in early December.
So what the hell is everyone waiting for. Insist that the predicate date be changed in the year end spending deal! Please??????
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That said, Big Tobacco is lobbying hard in Congress to change the date and allow everything introduced before 8/8/16 to stay on market with no application. They are not our enemy in this fight!
Those are the facts on the ground right now. There will be one chance to change the date and allow all vapor products to stay on market this year. The decision on that will be made in Congress in early December.
So what the hell is everyone waiting for. Insist that the predicate date be changed in the year end spending deal! Please??????
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While true, it still seems like a step backwards on a development continuum. Rephrased, the ecig seems much further separated from the analog than the iqos is.
There will certainly be e cigs available on the black market, because everything else is on the black market. I have personally used black markets for purposes that I'll be flagged for if I mention, and I can tell you that I would have 0 safety concerns about using BM's for e cigs. BM's are just like anything else on the Internet. It's a highly competitive world and sellers live and die by their reputations. Customers comment, review, and rate the sellers. So, as far as devices go I have very little concern. When it comes to juice, most sellers will probably be selling reputable brands from over seas, and the people selling their own juice will be found out if they are using poor quality ingredients.
If push comes to shove, juice makers who get pushed out of business should simply fly a big ole bird to the Feds and BT and post their recipes online. I know if it were me and my business was going under due to the regs, I'd rent space in an overseas server and do everything I could to help people continue to vape.
Who will survive the deeming regs? Me, that's who!
Regardless of whether vaping is banned, restricted, promoted, left alone, whatever... I'll still be here. Should I want to vape I've no doubt the equipment and juice will be readily available. Just ask the DEA how effective banning, criminalization, etc are. I mean what can't you buy these days. Hillary will ensure the Chinese continue to market their products to the US and if customs gets anzy well there are whole countries full of Canadians and Mexicans who will be more than glad to assist. Look at the bright side, there is a certain camaraderie that exists when you are all breaking the law together.
Regardless of whether vaping is banned, restricted, promoted, left alone, whatever... I'll still be here. Should I want to vape I've no doubt the equipment and juice will be readily available. Just ask the DEA how effective banning, criminalization, etc are. I mean what can't you buy these days. Hillary will ensure the Chinese continue to market their products to the US and if customs gets anzy well there are whole countries full of Canadians and Mexicans who will be more than glad to assist. Look at the bright side, there is a certain camaraderie that exists when you are all breaking the law together.
Contrary to popular belief, the amount of booze that found its way from Canada to the US during prohibition was negligible compared to what was being made in the US at the time. Stolen and redistilled industrial alcohol was the primary source of booze at that time.
The only thing I see being different with this product versus the vapor products we use is that this one seems to contain real tobacco instead of "nicotine derived from tobacco". I can see where the FDA might view it a little differently, although your point is valid that a company the size of Philip Morris / Altira with "400 scientists" developing a single product has a pretty high degree of being able to navigate a PMTA approval.
By the way, these products already exist in the market, usually used for vaporizing "other" products, but also marketed to vaporize tobacco (and I'd imagine it would work quite well for tobacco).
However, with the other uses not under the thumb of the FDA at all, I'd bet money that the vendors who make these type of systems no longer mention tobacco use so they don't run into the FDA tobacco control dreadnought. There is plenty of market on the other side... and more each election cycle.
The truth is, the FDA has approved ONE SINGLE product using the PMTA pathway since 2009. That is very telling.
That's the spirit. Nobody should be making this easy for the feds. For instance, I hate when I see reviewers who have stopped doing giveaways until they know what the rules are. Tucking your tail between your legs and cowering in the corner only strengthens their position.
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