Hypothetically, would you commit to this? (heading toward FDA approval)

[tannerk]

I see what you're saying, but the ultimate goal here would be to get the FDA to come to some agreement where the approval process is expedited (seeing as how there's already an industry developing), and sales would be allowed to continue provided certain benchmarks are met in that process. This isn't my idea, many others have posted those sentiments. I have no idea if it's a realistic proposal. Assuming it is, the industry needs to give the FDA reason to think that it will make those benchmarks, and this could be a good step in the right direction. Not to mention that some of the requisite tests would already be done for both approval processes.

Sure, but there is a clear distinction between the "industry" and "company". As such, industry and FDA should not be used in the same sentence, it holds no merit. Same goes for "approval" and "manufacturing".

Look at it this way:

Step1. Who are you and what you are doing
Step2. Provide supporting data
Step3. Validate via Pier-Review
Step4. Conduct the trial

After those steps are complete, you get into manufacturing, QC standards, labeling, taxes, audits and such. While your ideas are absolutely spot-on, they address manufacturing and completely bypass 1-4.

EDIT TO CLARIFY

This only applies if FDA maintains it's current position, without allowing sales. In case that changes, you will certainly have to take the steps you proposed while simultaneously conducting 1-4. Perhaps that's exactly the strategy of JC.

 

[TheIllustratedMan]

Absolutely they by-pass 1-4, because the industry (used as a catch-all for all companies who wish to gain FDA approval) has by-passed them. The companies (if that's more to your liking) need to go back to step 1 while still providing us with product. This is my idea for how that might possibly have a chance at happening.

 

[tannerk]

Absolutely they by-pass 1-4, because the industry (used as a catch-all for all companies who wish to gain FDA approval) has by-passed them. The companies (if that's more to your liking) need to go back to step 1 while still providing us with product. This is my idea for how that might possibly have a chance at happening.

Yes, in that case you are absolutely spot-on.

 

[TheIllustratedMan]

Whew! Only took me 3 pages to get my point across...
Thanks for the discussion though, puts some more seeds in the old noggin.

-Nate

 

[tannerk]

Whew! Only took me 3 pages to get my point across...
Thanks for the discussion though, puts some more seeds in the old noggin.

-Nate

PM me in case you need help or to bounce some other ideas.

 

[Taylor]

A good start on hardware would be to apply for UL listing, I believe many of them already have CE approval. Don't know of equivalent voluntary independent labs for the liquid, I'm sure there's something.

 

[Vaponator]

At this point I would not commit.

The main reason being is that most likely I see the prices of the juice skyrocketing.

FDA approved companies and products means a increase in cost, then you factor in another governing body. Possibly the ATF since they regulate Alcohol and tobacco already, hell maybe even a name change to ATVF. The additional letter alone will cost billions! Then you figure it's now a regulated or controled substance and with any addictive LEGAL drug come.. Yup thats right.. additional taxes on top of sales tax.

Sounds like a good idea to have it regulated and legal but I would think the governmental revenue whores will jump on that bandwagon and it would cost us equal to if not more than analogs.

With a little good comes alot of bad in my opinion and from the investigating I have done so-far, the industry is policing itself fairly well with lab reports etc..

 

[KreeL]

I voted no because I'm very happy with my juice as it is.

 

[Sun Vaporer]

I see what you're saying, but the ultimate goal here would be to get the FDA to come to some agreement where the approval process is expedited (seeing as how there's already an industry developing), and sales would be allowed to continue provided certain benchmarks are met in that process. This isn't my idea, many others have posted those sentiments. I have no idea if it's a realistic proposal. Assuming it is, the industry needs to give the FDA reason to think that it will make those benchmarks, and this could be a good step in the right direction. Not to mention that some of the requisite tests would already be done for both approval processes.

Very well stated my Friend. I have been suggesting for quite a while that SE and NJOY should settle their case with the FDA based on an expidited approval process if in fact the studies show that the e-cig is "reasonably safe" for indefinate use. This is a very viable option that SE and NJOY should not turn their back on. I would welcome reasonable regulations and approval of Manufactures and their Suppliers based on reasonable protocal. It really is time for NJOY et al to get on the ball and negotiate with the FDA instead of trying to circumvent the system.


Sun

 

[Janetda]

Yes, Yes, Yes! Thank you, this is all I've been saying. So where do we go from here? Who do we talk to? Seems like this is something that the ECA should be doing.

 

[Kent C]

No. I don't trust gov't with my health. There should be private testing companies that would handle the job and their standards would become known by how correct their science is, rather than how policitally correct the junk science of gov't would be. The companies that were good at doing the job would survive. The ones that put people at risk would not.

I'm not willing to put my health in the hands of some group of lobbyists who offer the highest bribe to some group of corrupt politicians in order to be "US(F)DA approved".

 

[Taylor]

OK after reading a few of the last comments I feel the need to add a qualifier to my 'yes'.

I would support independent voluntary standardization and quality control akin to UL listing. Government approval is not what I'm advocating.

 

[Technocrat]

People are so paranoid about the FDA (with good reason) that this thread has devolved off topic. Anyway, these steps are so simple that there doesn't seem to be a real need for somebody to certify them.

1. Ingredients list. (for ALL flavours)
2. Independent testing. (for contaminants)
3. Lot numbers for tracking batches.

There are literally hundreds of companies that test for impurities in foods and pharmaceuticals, and it would not cost very much to have random lots tested for impurities. I don't see a need make a bureaucracy to do the obvious. A vendor need just have the ingredients listed and the results of the independent testing available (or online).

---

The biggest problem is that Chinese manufactures in general are notoriously corrupt. Even when regulatory agencies are (supposedly) watching them they will still cut corners whenever possible. Check the internet and you will find literally hundreds of incidents of manufactures selling inferior/adulterated/substituted ingredients/products. I'm sure that some Chinese manufacturers are legit, but the sheer number of incidents is hard to dismiss. Even some respected manufacturers have been burned by Chinese suppliers because it's just 'understood' (everywhere but China) that when you buy 99.99999% pure 'Chemical X', that is indeed what it is.

The companies supplying the juice ingredients probably think that people are making foodstuffs/cosmetics/pharmaceuticals which will be occasionally tested. If they knew they were supplying for an unregulated product like e-cig juice, half of us would probably be dead already.

Anyone who has ever dealt with Chinese suppliers already knows all this, and knows that you have to watch your suppliers like a hawk and run quality tests that would be considered paranoid for North American / European suppliers.