IMPORTANT - email from FDA to a supplier.

[jbbishop]

Sadly the FDA is not going to tell anyone how to exploit any loopholes to circumnavigate their intentions. I see no point in playing 20 questions with them. Again, consult an expert.

I'm sure there is a way around it. Unfortunately I expect it involves a number of undesirable sacrifices. First the device and the liquid are sold separately. There is no reference for the devices of any intended uses whatsoever and no reference to smoking alternatives or electronic cigarette, it is simply called a personal vaporizer. The liquid is sold with no statements of intended use for this purpose, and likely requiring a statement of some other credible intended use and a disclaimer that it is not intended for internal consumption and that the inhalation of vapors may be harmful.

Unfortunately, the playing field is going to change in a few months when new laws are introduced. I don't believe the industry can adapt in that time frame.

The other alternative is to get the system approved as a drug delivery device and good luck! In 10 years we all might have one brand available to us with no flavors and reduced tamper proof nicotine delivery. It won't be coming out of China and it won't try to look like a cigarette. It will be owned by big pharma. It will be expensive and disposable, sold only in pharmacies. It will be marketed specifically with the intention of quitting with gradual reduction of nicotine levels, just like the patches.

 

[syntaxevasion]

This is the same letter, word for word, that I received four or five months ago...

Ben

 

[TropicalBob]

Did you post this most important information and we missed it?????

 

[chicagobrad01]

Wow, straight from the horse's mouth.

In Chicago, the health dept./consumer affairs will not let gas stations sell 'glass roses' because they are used for drugs, but in all the Chicago suburbs all the gas stations have them. Seems like selective enforcement

I just overheard someone asking for "A Rose and Brillo" at a gas station in my neighborhood (in Chicago) a while back & then the cashier bagged in under the counter. I couldn't figure out what that was
all bout until now. The Rose was throwing me off, but GLASS Rose makes more sense.

 

[jukeboxsabotage]

I LOVE your avatar chicagobrad

 

[Duckies]

I just overheard someone asking for "A Rose and Brillo" at a gas station in my neighborhood (in Chicago) a while back & then the cashier bagged in under the counter. I couldn't figure out what that was
all bout until now. The Rose was throwing me off, but GLASS Rose makes more sense.

That flew right over my head. In case anyone else is confused, I found this: A Fake Rose in a Glass Tube Gives Root to Illegal Activity

Amazing the lengths people have to go to. Scary to think that this could be us in a short time.

 

[Cymri]

Writing to the FDA all but ensures a rapid ban on these devices. The FDA is spread very thin trying to regulate all the areas they have managed to wrest under their control. Writing to them just makes them focus more on vaping than they are inclined to. I don't think it's a productive strategy. They have an agenda to wipe out nicotine use and no argument is going to change that.

 

[strayling]

Writing to the FDA all but ensures a rapid ban on these devices. The FDA is spread very thin trying to regulate all the areas they have managed to wrest under their control. Writing to them just makes them focus more on vaping than they are inclined to. I don't think it's a productive strategy. They have an agenda to wipe out nicotine use and no argument is going to change that.

I don't think hiding and hoping they don't notice us is a viable option at this point. We've been noticed and need to present our case calmly and rationally.

Besides, if they're understaffed then writing letters will keep them busy reading instead of busybodying. Think of the letters as a type of DoS^* strategy if that helps.

^* DoS = Denial of Subservience in this case

 

[piezooo]

so... the FDA. BUMMER They are doing this so they can "regulate" money into their pockets. Like others, they will make it to where you have to have a prescription to get the refills.

 

[Vapor Pete]

What about the intended use of 'water pipes'? Everyone knows what those are being used for. Everyone. Somehow those people managed to redefine their product and are now safely off the radar. You can buy a 'water pipe' at a convenience store!

I completely see your point here about the intended use of water pipes. A rather strong argument, if you were trying to fight a ban on them. But the hole in your thinking is the fact that water pipes are not sold with the ability to vaporize THC. Also, just to correct you with all do respect, "those people" never had to "redefine" their product... they were immediatly marketed as "Tobacco Water Pipes" right out of the gate. So they are no different than your grandpa's old tobacco pipe, other than looks/design. And dont forget the stand by rolling papers! I know what I used to roll up in my ZigZags! Tobacco of course
My best,
-VP

 

[TropicalBob]

Isn't the entire point of the letter that these are already banned? None have been approved by the FDA and it is illegal to sell or market them.

They've been noticed. In Australia. In Canada. By the FDA.

What we need to concentrate on now is working with the authorities, if that's possible, to get a product or products approved.

TOP PRIORITY: GET PRODUCTION OUT OF CHINA AND INTO THE U.S.

Use the car model: Toyota, Honda, BMW and others "make" cars in America. They have plants and dedicated workers taking home paychecks. They assemble cars, to be more accurate. So open a U.S. plant that obtains all parts from China and then assembles the product under the watchful eye of FDA inspectors.

Get Johnson Creek liquid, in the U.S., approved and inspected.

Made in America means more money spent in America and, frankly, better quality assurances. That's win-win. A new Chinese gizmo sold over the Internet or from pop-up mall kiosks is lose-lose in this stagnating economy.

The problem is that the present system has no oversight and no way to implement it. And it does need oversight and safety assurances. Focus on those to avoid sending a promising product to a premature death. The FDA has a job to do. Let's have suggestions to help it do it. Before long -- tobacco or alternative nicotine delivery system -- the FDA will have to approve all products like ours.

 

[Steph2323]

Frank Lautenberg truly desires to reduce smoking, but he's been misinformed about e-cigarettes.

The ACS, AHA, ALA also need to hear from e-cigarette users (who also should let them know they won't receive any more contributions until they change their position), as a top priority of those organizations is fund raising. I used to work at the ACS, which is very concerned about public criticism (of their organization) and negative press coverage.

Good info here Mr Godshall. I have only written once, but I think we all need to keep writing and sharing our stories. Lots of calls and letters to get their attention. (so far, I have only rec'd a reply from the ALA, who said that no studies have been completed on these devices, and I forwarded them the testing that has been completed. No word back on that yet).
Stephanie

 

[wanderlust]

So many drug delivery devices and paraphernalia are being sold legally as "novelty devices" within this country that it seems defeatist to single out personal vaporizers that have many legitimate uses. Write your Representatives. The beast is afoot!

 

[sherid]

This is my first posting on this site. I think it helpful for e-cigarette users to contact Senator Lautenberg (Phone: (202) 224-3224, Fax: (202) 228-4054), as well as the DC offices of American Cancer Society, American Lung Association and American Heart Association (which issued a joint press release calling for the FDA to ban e-cigarettes), and let them know how these products helped users quit smoking and/or reduce cigarette consumption.

The folks calling for a ban on e-cigarettes really need to hear from users of the products.

The sensible policy solution for e-cigarettes (and other smokefree nicotine products that aren't sold as smoking cessation aids) is for the US Senate to amend Waxman's FDA tobacco bill with some of the responsible harm reduction provisions in Senator Burr's legislation (including regulating e-cigarettes as tobacco products).

I've been collaborating with Joel Nitzkin in dealing with these issues

Bill Godshall
Executive Director
Smokefree Pennsylvania
PO Box 81570
Pittsburgh, PA 15217
412-351-5880
Fax 351-5881
smokefree@compuserve.com

I'm glad you came to the forum and posted this information, Bill. I post on Dr. Siegel's blog also.

 

[TropicalBob]

So the FDA is going to read our letters and petition and say, "Wow, we sure were in error about the electronic cigarette. We see how great they really are and we now approve and allow sale and importation of these products. We're sorry our rules got in the way."? Does that seem realistic?

E-cigs are banned. What e-smoking needs now is one manufacturer -- it almost certainly has to be Ruyan -- to step forward and submit a proper application for FDA approval as a medical device using nicotine liquid. In the process, everyone will learn exactly what information is needed and demanded.

Without it, pleas will fall on ears closed to all but scientific proof.

 

[strayling]

TOP PRIORITY: GET PRODUCTION OUT OF CHINA AND INTO THE U.S.

...

Get Johnson Creek liquid, in the U.S., approved and inspected.

Seconded. In fact I agree with everything you said in that message, which proposed a very productive and realistic way forward IMO.

 

[Duckies]

TB, I may be mistaken, but didn't Ruyan try but get nowhere because of the "new drug" status on delivery devices and no "rules" laid out on testing?

All, A refresher on where mfg is on this would be helpful - preferrably a new thread if anyone is privy.

 

[puff-puff-pass]

Sorry to hear that the ban has hit the U.S. Does anyone KNOW how long it will take for trials and approvals? (please...no guessing at the length of time. I could do that myself)

 

[TropicalBob]

Hmmm. Both the FDA and Health Canada seem to me to be saying the rules are in place and known. E-liquid is a new drug. It requires approval to put on the marketplace. And only Ruyan has testing to back up safety and efficacy of the liquid, carts and e-cig.

If Ruyan tried and failed, throw in the towel on getting any kind of reasonably quick approval. We would be facing a looooong delay -- until Philip Morris qualifies the Aria and Big Pharma perfects prescription-only e-liquid for use in the Aria.

I don't want to wait that long ...

 

[Duckies]

There is no question that unregulated liquid nicotine was on the short list for "no".

I am just curious as to where manufacturers are in this process, assuming that information has been made public.