Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[PhiHalcyon]

Phi--I agree that trouble is on the horizon--regulation could be as broad as a shut down till approval or as narrow as some quick paperwork--but I think we are going to have some serious issues with supplies soon and those that could not stock up if that happens are going to pay a step price.

There is something seriously wrong with a ruling on a request for a Preliminary Injunction taking half a year---I have never witnessed it.

I'm not sure what to think about the delay. It could be a sign that the FDA is assisting SE and/or Njoy to do what is necessary to be in compliance (as modified risk tobacco product applicants); or a sign that the powers that be have not quite figured everything out yet (as possibly evidenced by the FDA's extension of the period for public comment on the implementation of the FSPTCA); or, worse of all, a sign that the FDA is planning full-scale enforcement action, and just needs some time to prepare. All I know is that none of these possible explanations bring me much comfort.

[PhiHalcyon]

What I want to see is an article like this: Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First ... But for an ecig/e-liquid manufacturer.

[Sinless1]

Ph--that distinction goes to the heart of the case--If Judge Leon finds that the e-cig is a drug and medical device combination, then the approval process will knock the e-cig off the market for years if not for good. If Judge Leon holds that it is not a drug, rather a tobacco like product, then the current legislation will foreclose the FDA from banning the e-cig. So it goes to the amount of regulation and if it will give rise to what constitutes a de-facto ban.
Sun

i think the delay may be due to it's definitely not a tobacco product because it doesn't contain tobacco. and the other side of "drug delivery device" won't work either because it creates a future endless "intended use" argument.

I think we could all be in for a surprise and see something like it's neither a drug delivery device no more than a soda can is for caffeine nor is it a tobacco product due to the absence of tobacco.

It is a electrical device similar to a theatrical fog machine and subject to electrical components guidelines.

if he finds for the fda the judge will in fact be creating a legal president in support of a few "opinions of the FDA" and this will be grossly against the will of the people!!

I think he is being lobbied behind the scenes by big tobacco, big pharma and the anti smoking groups!

[Sinless1]

Phi--either these Manufactures are just a bunch if greedy idiots or geniuses. I once thought they where just greedy and threw it on the market, but after thinking it out, they may have purposely avoided regulation to get enough people using the e-cig and thereby putting political pressure into the equation.

Maybe I am giving them too much credit now--but either way, having a base of users does not hurt the cause by any means.

Sun

Everyone is scarred to say the truth here!
The truth here is that the electronic cigarette works better for smoking cessation than anything ever invented and that even if you aren't trying to quit it gives freedom to smoke back to the smoker!

Big tobacco stands to loose from competition, big pharma stands to loose money on all there NRT products. and all the emotional anti-smokers can't handle the fact they fought for 50 years to cage the smokers only for them to have the freedom to smoke again!

[sherid]

Everyone is scarred to say the truth here!
The truth here is that the electronic cigarette works better for smoking cessation than anything ever invented and that even if you aren't trying to quit it gives freedom to smoke back to the smoker!

Big tobacco stands to loose from competition, big pharma stands to loose money on all there NRT products. and all the emotional anti-smokers can't handle the fact they fought for 50 years to cage the smokers only for them to have the freedom to smoke again!

I think you have it exactly right except for the BT thing. We already know BT will buy anything that continues to enrich them, including smokeless products, natural tobacco companies, and e cigs. Since they are now engaged in talks with Ruyan, it seems silly to believe that BT does not want a piece or perhaps all of the e cig business.

[PhiHalcyon]

Since they are now engaged in talks with Ruyan, it seems silly to believe that BT does not want a piece or perhaps all of the e cig business.

If one assumes that an ecig-like market will be permitted to thrive within the modified risk tobacco product classification, then device patent ownership will be the key to market-share development and protection. For, making a device that does not infringe on the patent rights of others is more difficult than making a tasty and satisfying e-liquid.

It therefore makes perfect sense that PMI would be interested in Ruyan. Not to continue making the ecig as we know it today, but to kill it; while providing an expanded range of patent-protection for its own commercially-viable version.

If I had the money to do so, then I would refine, patent, and manufacture my own ecig-capable/ecig-similar device that does not even require an FDA approval.

[ritalin]

It therefore makes perfect sense that PMI would be interested in Ruyan. Not to continue making the ecig as we know it today, but to kill it; while providing an expanded range of patent-protection for its own commercially-viable version.

If I had the money to do so, then I would refine, patent, and manufacture my own ecig-capable/ecig-similar device that does not even require an FDA approval.

While I understand this logic, I do not think it is correct. BT, as stated here often, has already dipped their toes in this market before with several products that failed miserably. It would make more since to buy out Ruyan and continue selling the product as is. After BT has their refined, new product, based on previous Ruyan patents ready to sell, they would then close the door on the previous products.

I still say that it will be hard for ANY company to lock down the market based on patents alone though. There are just to many ways to accomplish the act of vaporizing a liquid. That new product Ploom is a perfect example of this.

[PhiHalcyon]

While I understand this logic, I do not think it is correct. BT, as stated here often, has already dipped their toes in this market before with several products that failed miserably. It would make more since to buy out Ruyan and continue selling the product as is. After BT has their refined, new product, based on previous Ruyan patents ready to sell, they would then close the door on the previous products.

I still say that it will be hard for ANY company to lock down the market based on patents alone though. There are just to many ways to accomplish the act of vaporizing a liquid. That new product Ploom is a perfect example of this.

BT was also hampered by the disposition of the FDA. A problem that has been rectified by the broader definition of tobacco products in the FSPTCA. As for continuing to sell the current ecig products, this would not be possible in the U.S. at this time; and why go through the process of gaining a modified risk tobacco product approval for a product you don't intend on selling for very long?

As for the market-share capturing value of device patents, I didn't say they would be market lock down capable; just better at market-share protection and development than e-liquid products would be.

[Exceller1]

A Modified risk tobacco product.Yes,That is a Fair estimate of what the equivalent(Balanced) Desciption the E Cigarette is.

[Webby]

If I had the money to do so, then I would refine, patent, and manufacture my own ecig-capable/ecig-similar device that does not even require an FDA approval.

I know most of the mods rely on established attys or parts from available e-cigarette models. Has anyone produced a PV from "Radio Shack" components? It would only make sense that there are engineers who have plans for a variety of gadgets waiting in the wings. All of which would circumvent any Ruyan patent.

The proverbial cat is out of the bag folks. Any legal restrictions will affect sellers and the US business of selling e-cigs. Liquid will be manufactured like bathtub gin and homemade device plans will sprout up all over the internet.