Can we stop the FDA? Mabye - link inside

[tpboles]

I know this is reffering to a different product, but it sounds really similar to what we are dealing with (correct me if I am wrong). Let me know what you guys think. I could be way off base.

American Pharmacy Solutions - Compounding Pharmacy

 

[Oliver]

Hmmn, so by claiming that e-liquid is a "compounded medication" you may circumscribe a ban?

Maybe, but you'd have to have it on prescription, right?

 

[Sun Vaporer]

I know this is reffering to a different product, but it sounds really similar to what we are dealing with (correct me if I am wrong). Let me know what you guys think. I could be way off base.

American Pharmacy Solutions - Compounding Pharmacy

Tpboles--I like your thought process and can see the argument. The problem is that smoking and vaping have huge vested interests at stake (1) corpoarte profits; (2)taxation issues; (3)safety concerns; (4)political issues; and (5) public preception problems. Oddly enough, the e-cigs demise may very well be that it "was too good a solution" to a possible safer alternative to smoking tobacco which is a known killler IMO---Sun

 

[dEFinitionofEPIC]

I don't know man.... seems like it would be a stretch. And like Smokey Joe said you would need a prescription. I don't see how that whole required prescription thing would work for suppliers buying from overseas... Plus... Would the internet suppliers require you to fax over a prescription to cover their own asses before they would ship your product? It would just be too complicated.... at least you're scraping for stuff.....

 

[tpboles]

I was actually just looking at the fact that a judge told the FDA to backoff. It was clearly a product that the FDA was wanting to "control" and the judge ruled that is was not under the jurisdiction of the Food and Drug Administration (FDA). The FDA had argued that compounded medications are "new unapproved drugs" (very similar to what they are saying about e-cigs). Very interesting that the FDA had deemed those products "illegal" and a judge said nope. I more or less found it to be an interesting read.

Does anyone with legal knowledge (I have zero) know how we may bring this to trial? Or could we legally fight if the FDA does ban these? Would it be better to do this before the ban hammer comes down? I am game for anything.

 

[pwholmes]

Yah, I think we have enough people on this forum that if somebody contracted with an appropriate law firm thousands of dollars would pour in, even if in 5, 10, or 20 dollar increments. I've thought about this recently with all the commotion over the Senator from New Jersey and I think this would be the next logical step if indeed ecigs were banned.

Paul

 

[tpboles]

I agree PW - I would gladly sink some money into it. I'm sure we could get quite a few on here to pony up. I have signed the petition, and emailed all my state reps (who will the petition get sent to SJ?). Hate to set here and do nothing. Surely we can put up a decent fight, I'm just not sure how?

 

[radiokaos]

Hmmn, so by claiming that e-liquid is a "compounded medication" you may circumscribe a ban?

Maybe, but you'd have to have it on prescription, right?

I have a side business in which I'm part owner of a Pharmacy here in the US. We do compounds for chronic pain customers. The only organization we have to report to is the DEA. Mainly because our meds are compounded with controlled substances (i.e. opiates). I like the OP's thoughts but I'm not sure if I would want the DEA to regulate nicotine.

 

[ratfink]

I don't know man.... seems like it would be a stretch. And like Smokey Joe said you would need a prescription. I don't see how that whole required prescription thing would work for suppliers buying from overseas... Plus... Would the internet suppliers require you to fax over a prescription to cover their own asses before they would ship your product? It would just be too complicated.... at least you're scraping for stuff.....

Basically the suppliers would have to become mail order pharmacies and everyone would have to find a doctor to prescribe them which may be the harder part since many wouldn't want the liability of prescribing people a delivery method for nicotine that is relatively untested.

 

[TropicalBob]

I really like the thought process. After all, nicotine is a legal drug, sold over-the-counter in products like Nicorette gum, etc. Propylene glycol is legal. Glycerine is legal. Everything in e-liquid is just a new mix of legal ingredients. There is no "new drug" in the mix. Just the mix itself is a "new drug" per the FDA. Is it?

Why shouldn't the logic in this court ruling apply to e-liquid -- but without a prescription, since all ingredients are non-prescription?

This is tact that might be worth a try if the FDA comes down too hard. Regulation, we are going to get. A ban, we cannot tolerate.

And we need legal liquid. I could care less about having a vaporizing metal tube if I can't get nicotine liquid to use in it! Just me.

 

[ratfink]

After all, nicotine is a legal drug, sold over-the-counter in products like Nicorette gum, etc.

I do believe that these are exceptions to the rule and have gone though a special approval process to get that status. Some things like Nicotrol Inhalers do require a prescription so I don't think this is an across the board thing.

 

[TropicalBob]

There are both over-the-counter and prescription nicotine replacement products. But Big Pharma argued that low-strength nicotine is safe for general sales, in order to obtain non-prescription status for its products, which began as prescription drugs. Big Pharma knew it can sell far more that way than depending on a doctor to prescribe something.

The FDA obviously agreed that the majority of NRT products do not pose a public hazard sufficient to incur a prescription-only status. How is an e-cig different really? We need to push for sensible regulation, to avoid an all-out ban. That's the point I was making.

I readily concede Big Pharma did its testing and filed its approval papers -- which our Chinese makers neatly avoided doing while selling a few million of these. So I'm not expecting the FDA to say, "Hey, why don't you just keep selling these things, just like they are right now." That's laughable.

 

[Duckies]

Hi TropicalBob,

I think the difference is in the control. While in theory, someone can slap a dozen patches on themselves, there is a mechanism in place to instruct on proper usage.

With empty carts and refill-at-will, we run into issues.

The only way I see this happening is with sealed prefilled carts -- potentially attached to atomizers and sold as a sealed/weighed/regulated/taxed unit.

Tell the FDA that we all want to self-regulate nicotine via juice recipes without 'official' guidance using fish tank filters (or couch stuffing) for cart filler, vaping red #40 tinged flavorings, cleaning parts with Everclear and/or ice machine acids and you will be able to feel the heartburn from K Street all the way to Florida.

Every single thing in 0 nic juice is legal. What we need to do is seperate out the nicotine use from the device and make them 2 different topics. 0 Nic juice + Device = no issue. Make the liquid nicotine a seperate topic.

 

[Vaporpuff]

It's is an uphill battle for now because until we can find a manufacturer of the liquid who can meet the FDA regulations with consistency we will continue to deplete our resources. I personally wouldn't have a problem with that but with the FDA being so clueless and corrupt it can take them ten years before we see an approval. If you can go online now and order medication without a prescription, why can't you order nicotine? The bad part about it is that it is a fairly new market and there are so few suppliers that it wouldn't be that hard to find the leak. The largest risk for suppliers is in essence not the FDA but customs. Imagine if we could only have a manufacturer of the liquids on our soil by next week...I was actually going to put an order in for $10,000 worth of products from china to become a supplier but now I regret to say that I have to come up with a new strategy between my manufacturer and partner. Lets just say that there is a light at the end of the tunnel but at the end you'll still be stuck with the bill. When I figure something out that works, I will most certainly pass it down to other suppliers.

Viva la Vapor!

 

[TropicalBob]

Just as in Canada, there is likely to be a total ban on any liquid from China. Period. But the United States has Johnson Creek making liquids in a facility that the FDA could monitor for standards. So we do have a U.S. liquid maker (undoubtedly using ingredients from everywhere, but it's the final liquid that counts and would be tested!).

And I agree that the easiest solution to allowing e-cigs is to mandate a single-unit, non-refillable, non-rechargeable e-cig of known, specific nicotine strength. Right now, the Ruyan Jazz, Njoy Weekender and one from Gamucci, I believe, are on the market. To me, they clearly have the advantage of being easily regulated.

 

[Cymri]

VERY interesting. This is an example that could gain traction. It is total bull that the FDA has been allowed to make a distinction between plant vs extracted forms of substances. Using tobacco IS using nicotine. Therefore, if that nicotine is legal to use, then any form of it has to be as well. They can't have it both ways.