Our Member, Frubbish to give ABC TV News Interview on E-Cigs Tomorrow - Let’s Wish Frubbish Luck!!

[RjG]

Well, here's your FDA laws, for your evening reading...

Section 510
and SEC. 513. [21 USC 360c ] Classification of devices intended for human use.
FD&C Act Chapter V, Sections 513-523
are good reading, if you intend on keeping the "e-cigarette" as a nicotine delivery device, or as a NRT device

new drugs is here: FDA > CDRH > CFR Title 21 Database Search

All of this stuff is 100% dependent on the device being used for nicotine, because nicotine IS a drug.

like a broken record - market our P.V.'s as a "herb vaporizer" device with a herb and water cart in the box, and none of the above applies.


And yes Kate, as long as it is marketed as an e-cigarette, then it is still is a nicotine drug delivery device whether the cart has nicotine in it or not.

 

[bizzyb0t]

Well, here's your FDA laws, for your evening reading...

Section 510
and SEC. 513. [21 USC 360c ] Classification of devices intended for human use.
FD&C Act Chapter V, Sections 513-523
are good reading, if you intend on keeping the "e-cigarette" as a nicotine delivery device, or as a NRT device

new drugs is here: FDA > CDRH > CFR Title 21 Database Search

All of this stuff is 100% dependent on the device being used for nicotine, because nicotine IS a drug.

like a broken record - market our P.V.'s as a "herb vaporizer" device with a herb and water cart in the box, and none of the above applies.

Exactly... but good luck getting the Chinese and the distributors to change their marketing, wording on the site, and literature. Some sites will have to abandon their domain name entirely...

 

[Kate]

So the only way for traders to sell devices legally is to not sell them as cigarettes or with nicotine.

Eliquid presumably is illegal to sell at all. I wonder where that stands for personal possession and use.

 

[RjG]

Quote:
The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

Well this makes sense, in a twisted way.... I've read the form letter before, but didn't quite get why a device was being labelled "new drug", that's odd.

BUT - if you read this part of that section:
FDA > CDRH > CFR Title 21 Database Search

you will see it is referencing NRT's as a device containing nicotine, under "new drug". So now the quote makes sense. The above quote from the FDA specifically targets the manufacturers throwing around the "quit smoking" phrase. ( Which was stupid to begin with, we can all agree.)

none of which changes - label/promote/document it differently, same device, no legal issues.

 

[Kate]

What do you think is the status of eliquid RjG, have you found much about how that will be regulated or enforced?

 

[RjG]

So the only way for traders to sell devices legally is to not sell them as cigarettes or with nicotine.

Eliquid presumably is illegal to sell at all. I wonder where that stands for personal possession and use.

I would have thought illegal on all counts, it is a drug AND an extremely potent poison after all.... but our law is based on the Queen's, and you lucky U.K. folk appear to have gotten away with adding warning labels, and childproof containers So I am hopeful Canada wil follow that...

 

[Kate]

We've been lucky in the UK. Eliquid slipped through the requirements for poisons law and is being ignored by medical/health product regulators. All they've said is to take down the NRT and health claims.

Fingers crossed for Canada.

 

[DisMan]

Jesus Christ people....we have TB coming in with "the FDA says it's illegal so it's illegal", then the news report says "Because they contain nicotine, the FDA says they are illegal". So we have all this confusion...WHY ARE THEY ILLEGAL? In the end, the FDA is calling it a new drug...if nicotine is why these are illegal, where the "new" part of "new drug" coming into play?

The FDA then quotes a section of law in official statements. Let's look at that section of the law, shall we?

(p) The term ``new drug'' means--
(1) Any drug (except a new animal drug or an animal feed bearing
or containing a new animal drug) the composition of which is such
that such drug is not generally recognized, among experts qualified
by scientific training and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof, except that such a drug not so recognized shall not be
deemed to be a ``new drug'' if at any time prior to June 25, 1938,
it was subject to the Food and Drugs Act of June 30, 1906, as
amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing
or containing a new animal drug) the composition of which is such
that such drug, as a result of investigations to determine its
safety and effectiveness for use under such conditions, has become
so recognized, but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.

So, my argument is simple...where is the statement and investigations required to call these items "new drugs"? I haven't seen them yet. Anybody else seen them? Who are the experts? Where is their report? If the FDA is making such a statement, then I (as a citizen of the USA) would like to see the published findings.

Until then, I don't see where the FDA has any jurisdiction at this time.

 

[Nuck]

That report was excellent. The net result will be a lot of new smokers wanting to get their hands on an ecig. Good job guys.

 

[RjG]

Disman - go read the relevant sections, I posted them just a few posts back.

FDA is attempting to call an E-CIG an NRT device, classified as a "drug-device combination". And under that premise, everything posted there applies, since the e-cig is part of the whole NRT.

remove the nicotine part, and the literature and markings related to nicotine, and that whole premise is toast. OK??

 

[DisMan]

Disman - go read the relevant sections, I posted them just a few posts back.

FDA is attempting to call an E-CIG an NRT device, classified as a "drug-device combination". And under that premise, everything posted there applies, since the e-cig is part of the whole NRT.

remove the nicotine part, and the literature and markings related to nicotine, and that whole premise is toast. OK??

No sh*t. That's what I was saying. It's only a new drug because it contains nicotine. That's the bottom line. So, sell zero nicotine cartridges with the device and the problem is solved.

 

[fjames]

Lacey, they have turned back shipments of vaping goods because they don't have new drug approval. That sounds like a clear ban to me, what more proof do you need? Nobody here is likely to be able to cite the legislation that gives the FDA permission to police vaping specifically. They have classed electronic cigarettes and eliquid as new drugs so it's their jurisdiction.

You could challenge the classification I suppose. Personally, as far as eliquid is concerned I think you are fighting a losing battle, it's already banned.

Enforcement is another matter.

I've just been poking around the FDA site, mostly to find out info on Rita, who so seems to scare everyone here. Couldn't find anything, so I'm going with my instinct and saying she's just another PR person, which whether corporate of government, means basically nothing. She's a mouthpiece with no authority and people should stop quoting her IMNSHO.

What I did find was a listing of stopped e-cig shipments. Commonalties of all were they seemed to be labeled as e-cigs or e-cig parts, and the shipper in all cases was either UPS or Fed-Ex. On the same list were deodorant, skin cream and other apparently irrelevant stuff.

The US government is process oriented, not performance oriented. It's all about filling out the right forms in the right way. This leads to massive corruption (our Medicare system is forever being ripped off by doctors in poor areas with phony patients because they've figured out all they have to do is fill out some forms to get a bunch of gov. money,) huge expenditures that achieve nothing, or even worse have a negative impact (pollution laws that don't define the levels of allowable pollution but instead simply define a "process" for the company to follow and assume all is well as long as, wait for it ... the forms are properly done) and all sorts of modern evils of our industrialized world.

It's just the US gov. doing its thing, while we and our suppliers do ours. May the best dog win.

 

[taukimada]

TB- Took your advice and googled for Rita and well... here is a great article from CNN... FDA hazy on e-cigarettes' safety - CNN.com

And an even better video from Dr. Sanjay Gupta... FDA hazy on e-cigarettes' safety - CNN.com

Now these are pretty balanced reports.

From this CNN article: "The idea that that e-cigs may be a good tobacco smoke alternative in the future could hold true, the FDA and WHO acknowledged, but proof of the product's safety must come first."

As a supplier, I do not disagree that safety must come to the forefront, but to outright ban something that keeps people off of a product that has been proven as unsafe, and that is a tobacco cigarette, is simply ridiculous and I just don't think they will be able to get away with it. They don't have any law that gives them the right to ban them that I can find. Can you send me a link to a law? I keep asking for it around here and I just can't seem to get anyone to send it to me. It is so weird that my request continues to go unanswered.

just as a note... i have no intention of doing more research on this.. i'm quite sure you know how to google and can conclude on your own

i really don't care what the FDA says unless they ACT on it... personally i think they are doing alot of foot stomping but something/someone is tying their hands... but this little ditty may explain the foot stomping in the first place...

source is Court and Congress to Press FDA to Regulate Nicotine,

Court and Congress to Press FDA to Regulate Nicotine,

Agency Given 60-Day Formal Legal Notice of Law Suit

At a press conference to announce the filing of a bill to require the Food and Drug Administration (FDA) to regulate the nicotine in cigarettes, it was announced that the agency was also being put under legal pressure by the judicial system to act.Action on Smoking and Health (ASH), the organization whose legal actions triggered the ban on cigarette commercials, smoke-free domestic flights, and a pending proposal by the Occupational Safety and Health Administration (OSHA) to ban all smoking, also announced that it has given the FDA a 60-day notice to regulate nicotine or face possible legal action.

Law professor John Banzhaf, ASH's Executive Director, explained that the FDA's tentative decision was based upon a legal principle ASH had established in an earlier court suit.

Based upon that principle, and the growing evidence that cigarette manufacturers deliberately manipulate the levels of nicotine in cigarettes in order to satisfy the drug addictions of consumers, ASH petitioned the FDA to assert jurisdiction over nicotine in cigarettes, as it now asserts jurisdiction over nicotine in chewing gum, patches, and other devices.

The FDA's failure to act on that petition for more than one year now gives ASH the legal basis to sue the agency to act without further "unreasonable delay." It was similar pressure on OSHA to respond to a court filing which prompted the agency to issue a notice of proposed rulemaking which would virtually ban smoking in all workplaces.

Banzhaf says that he hopes the combination of pressure from the courts and from Congress will finally move the agency to correct a mistake it made more than 50 years ago when there was little evidence about the drug- and addictive nature of nicotine.

Although the bill introduced today -- The Freedom From Nicotine Act -- would explicitly give the FDA jurisdiction over nicotine -- a prior decision in a case brought by ASH held that the agency could assert jurisdiction without any new legislation; a position the current FDA Commissioner has also taken.

FOR IMMEDIATE RELEASE:Thursday, June 15, 1995

 

[TropicalBob]

I think this issue was resolved by the Supreme Court, which said the FDA could not regulate tobacco products without a new law from Congress. That new law is in the works, but not completed. Note the 1995 date on your ASH comments. Lord help us if ASH ever gets it way on anything!

 

[LaceyUnderall]

As always, I thank everyone for their efforts for more links to help me prepare a pretty strong argument for the electronic cigarette, a style of personal vaporizer.

For those who agree with my stance, you confirm that I am not reading something that is not there and for those in my opposition, you help me see what lies ahead before I actually hit that bump, helping me prepare an even stronger argument for all of us.

Either way, back on topic of this thread... this was a fairly done report, our boys did well... and we can only hope for more reports that are fair and objective. These reports will create more users and more voices and in the end, that's what we really need - happy and satisfied users who are willing to stand up for their alternative smoking devices.

 

[taukimada]

I think this issue was resolved by the Supreme Court, which said the FDA could not regulate tobacco products without a new law from Congress. That new law is in the works, but not completed. Note the 1995 date on your ASH comments. Lord help us if ASH ever gets it way on anything!

sadly ASH did get it's way on that item... which is why we don't have nicotine lollipops and lip balm.. when i found that link i also spotted the more recent nicotine water but chose that one because it was a legal mandate given to the FDA to DO something about a nicotine product instead of SAY.. the point basically being.. they had been legally mandated to take action.. and had chosen to not act.. thus the courts were decided they were in violation.. ie see previous "foot stamping" statement

 

[ruggz]

I was just watching the news and they are advertising a story on e-cigs for monday night @ 10pm channel 5 kstp.

 

[taukimada]

i just reminded myself of something...

i honestly have no clue of people's opinions of my statements... and in a way.. i don't care.. with one small exception.. i dont want anybody getting the idea that i THINK im overly knowledgable about ANY of these issues...

i really am just another idiot american consumer hoping for the best and realizing that my hopes are most likely to be dashed upon the rocks of bureaucracy yet again...

i do my research sporadically.. but i don't STUDY anything.. if i happen to see something i'm curious about i tend to run a google and browse points... so feel free to correct me if you see an actual mistake... as long as you point it out simply i have no problem verifying one way or the other.. or choosing to be lazy and not..

thank you for your time... and yet again... good job Frub and Bizz

 

[TheEmperorOfIceCream]

Great job guys, I think you came over very well. And I don't think we've seen as balanced a piece of reporting as this before now (certainly not a video piece). Props all round, to our guys and the reporters.

Emp

 

[NicoNut]

Frubbish and Bizzy...thanks so much for stepping up for us all, you both did a stand up job! I thought the clip was fair, one of the best ones I've seen so far, and a good advertisement for e-cigs.

Still confused as to why anyone was jumping on the reporter or Kate? Hopefully everyone calmed down after the actual clip came out...hey, we're all on the same side!