FDA to regulate e-cig as tobacco

[Our House]

It's painfully obvious that if the FDA had been able to find any other potentially toxic chemicals (than what they announced) they would have included them in the press statement, even if they weren't at harmful levels either. So, that strongly indicates that what they reported in the press statement was the worst they could find (and those weren't even at harmful levels.)

This is very true...for us at least. But we can't count on the general public reading that far into the test results in order to make the same connection about the innocuousness of ecigs.

 

[kristin]

Which is why we keep pointing it out to them until they finally get it!

 

[CJsKee]

I think what CJ meant was that the FDA testing failed to find harmful levels of ANY chemicals or carcinogens (which was actually GOOD news,) yet the press release made it sound like they did, not that HOW they tested was "fine."

It's painfully obvious that if the FDA had been able to find any other potentially toxic chemicals (than what they announced) they would have included them in the press statement, even if they weren't at harmful levels either. So, that strongly indicates that what they reported in the press statement was the worst they could find (and those weren't even at harmful levels.)

Thanks, Kristin...I just saw this and, yes, that's what I meant (just didn't take it quite far enough, I guess). The FDA found nothing harmful, but told the world they did.

 

[sjrily]

So basically it's okay to say, "Vitamin C boosts the immune system." not "Vitamin C prevents scurvy"

Basically, yeah. That's considered a "disease claim," and is not permitted.

 

[sjrily]

So in your opinion, the FDA should consider this njoy:

...and this njoy:

...to be the functional equivalent of this njoy:

?

I agree, yes, it would be the same.

 

[GMoney]

I agree, yes, it would be the same.

I believe you are correct. Although, I am unaware of the guidelines the FDA uses and I am unaware of any cases involving determination of equivalence by the FDA(I haven't checked), for purposes of determining "equivalency" in patent cases the courts will generally apply the "triple identity" test:

Something would be considered "equivalent" if:

1. It performs substantially the same function
2. In substantially the same way
3. To yield substantially the same result

 

[StormFinch]

So in your opinion, the FDA should consider this NJOY:

...and this NJOY:

...to be the functional equivalent of this NJOY:

?

The short answer; yes. Not identical but same functionality and general principle. The FDA is not sure if there are cartridges, attys, or juice cause any unintended byproducts during vaporization. Since atty/cart, and atty/carto are virtually identical (heating coil, filler, juice.

I'd love for the FDA to test the bejeesus out of these products from the major brands like greencig, njoy, blu and volcano, all the way down to generic joye and riva, and every mod and wetbox in between. I'm no scientist, but I do like to know the facts and if legit testing is done on EVERYTHING (which it probably will be, given the huge timeframe it takes for the FDA to get anything done.)

I agree, yes, it would be the same.

I believe you are correct. Although, I am unaware of the guidelines the FDA uses and I am unaware of any cases involving determination of equivalence by the FDA(I haven't checked), for purposes of determining "equivalency" in patent cases the courts will generally apply the "triple identity" test:

Something would be considered "equivalent" if:

1. It performs substantially the same function
2. In substantially the same way
3. To yield substantially the same result

What they said!

Truthfully though, it performs exactly the same function, the only difference is where the filler is located.

 

[Katya]

The biggest impact of Monday's FDA announcement on e-cigarette companies and consumers are likely to include:
- Sales/consumption of e-cigarette products will continue to skyrocket,
- More companies (including tobacco companies) are likely to begin manufacturing and marketing e-cigarette products,
- More retailers (including more convenience stores and big box stores) will begin selling e-cigarette products,
- The price of e-cigarette products will go down,

All that, and Osama Bin Laden is dead.

Life is good.

Happy vaping, folks!

 

[Our House]

Thank you for the responses guys.

Although, I am unaware of the guidelines the FDA uses and I am unaware of any cases involving determination of equivalence by the FDA

This is the worrisome part; the unknown. We saw what the FDA did with the ecig NDAs (New Drug Applications) last year. FDA instructed ecig companies to apply for NDA to be considered "legal" by their terms. Some suppliers from this forum did apply -- all were ignored and the FDA continued parroting "we have received no electronic cigarette applications" well after.

FDA can deny any applications it feels like denying. For smaller suppliers, this is a nightmare. Once you get denied by the FDA, you're done! Because of the FDA's unethical tactics, most suppliers will be afraid to make application with the FDA and put themselves on the FDA's radar.

 

[Who_Wants_To_Know]

Our biggest challenge is going to be changing the knee jerk reaction to e-cigs. That is all most people are going to go by. They don't want to have to think about things on levels, balance good vs bad. They want instant answer and most people will not think past what the first image that pops into their head. At this point most people see e-cigs and cigs as the same. They don't want to be bothered to learn what the truth is.

We have to get as much out there into the news, on the web and any other place were people gather their information.

If you have a face book page link to information on it. If You do you tube talk make a video about them. Just anything you can do to get the word out.

These are politicians we are dealing with, they do what popular opinion tells them to no matter what the facts are. If they can't control it they follow it.

This will go a long way in keeping things good for us. Not the only effort by far, but politicians will have to weigh their options if they know that people know the truth about e-cigs.

 

[rolygate]

One of the biggest factors that will work in our favor is that many journalists and others in the media are smokers. By the nature of things, a proportion will switch to e-cigs, and therefore eventually we will see positive reporting on e-cigs balancing out the pharma/antis' propaganda. In fact that seems to be happening already.

In the end it's all a matter of image, and the media control that. We need people on the inside and sooner or later we'll have them.

 

[GIMike]

We have to get as much out there into the news, on the web and any other place were people gather their information.

We should have tried to use the FDA announcement as leverage to get ourselves on talk shows or anywhere else they would have us. I guess colbert and leno and letterman would be out of our reach? Probably too late on all that since it's now "last week's news" Riding on the back of the FDA's media attention would have been a good time for it though. If we can't get enough attention on our own, maybe something else will happen soon to allow us to get the news out there. I think it's time for a protest where a group of people smoking e-cigs will chain themselves to a tree in a "non-smoking" public park lol

 

[6pointprime]

Last night I interviewed Jacob Sullum, senior editor of Reason Magazine about these new developments. You can catch the replay here, he comes on at around the 14 minute mark.

Video by VapeTVLive: Live Recording - 05/02/2011 01:03

-Russ

 

[Maxwell_Edison]

Last night I interviewed Jacob Sullum, senior editor of Reason Magazine about these new developments. You can catch the replay here, he comes on at around the 14 minute mark.

Video by VapeTVLive: Live Recording - 05/02/2011 01:03

-Russ

The video starts and 2 seconds later the page goes blank white. I'm logged in, but can't watch it.

 

[kristin]

Same thing happens to me - tried it several times.

The video starts and 2 seconds later the page goes blank white. I'm logged in, but can't watch it.

 

[rolygate]

Works fine for me. Try using a proxy, maybe it's blocked to your region.

 

[Bill Godshall]

Several threads ago, Jacinda wrote

"Thanks for all the info Bill! Although I was wondering if you could clear something up for me? From this statement made by the FDA:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

I get the idea that they are going to try to amend the FD&C Act so that the pre-market requirements will apply to e-cigs and other tobacco products. Am I misunderstanding this? Do you think that they won't be able to change it, or are you just saying that currently it doesn't apply to e-cigs? I'm sorry if I'm missing something..."


The FDA stated it "intends to propose a regulation" to extend the many different Chapter IX provisions
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf to ALL currently unregulated tobacco products, which includes cigars, pipe tobacco, e-cigarettes, e-liquid, nicotine gums, lozenges, patches, nasal spray, skin cream, water and at least several dissolvables.

But the regulatory promulgation process could take several years, and the Secretary of HHS must determine that any new regulation "would be appropriate for the protection of the public health."

Since there is no evidence that any of these unregulated tobacco porducts (except for cigars and pipe tobacco) have harmed any users, there is really no public health justification for imposing any Chapter IX regulations to e-cigarettes. More importantly, applying some Chapter IX provisions to e-cigarettes and other smokefree alternatives would actually harm public health.

We need to carefully review all of the Chapter IX provisions, and expose/oppose those that could/would actually harm public health if the are applied to e-cigarettes and/or other smokefree alternatives (e.g. the Feb 15, 2007 grandfathering date in Sec. 910, and the Modified Risk clause that prohibits e-cig companies from truthfully claiming they are less hazardous than cigarettes in Sec. 911), as well as exposing other Chapter IX provisions that wouldn't benefit public health.

We should assume that CTFK/ACS/AHA/ALA/ALF/AMA and other e-cigarette prohitionists will aggressively urge the FDA to apply ALL Chapter IX provisions to all unregulated tobacco products.

Meanwhile, tobacco harm reduction advocates and the makers and users of currently unregulated smokefree tobacco products will be exposing and opposing the counterproductive and unnecessary regulations in Chapter IX (if they are applied to various unregulated tobacco products).

Since cigars and pipe tobacco are unregulated tobacco products, cigar companies (including Philip Morris and Swedish Match) and pipe tobacco companies also will be exposing and opposing counterproductive and unnecessary Chapter IX regulations (as they apply to cigars and pipe tobacco products).

If PM and Reynolds are planning to market e-cigarettes, they'll also be joinin us in opposing counterproduct and unnecessary provisions in Chapter IX (if applied to e-cigarettes and any other products they are planning to market).

The more vested PM and Reynolds are in e-cigarettes, the more aggressively they will oppose the FDA's forthcoming proposed regs (as they apply to e-cigarettes).

 

[6pointprime]

Same thing happens to me - tried it several times.

Stickam can be fussy sometimes...I'd actually recommend that you NOT be logged in before you click the link. Also, it definitely helps to have the latest version of Flash. Either way just let it sit for a few seconds after you click the link. They serve up an advertisement and after that my video so it takes a while to load - thanks for trying to watch!!

Video by VapeTVLive: Live Recording - 05/02/2011 01:03

 

[Jacinda222]

For anyone interested in a discussion of this subject, there will be a special edition of VP Live on Thursday night: VP Live Special Edition: So we're a tobacco product. Now what?

 

[6pointprime]

For anyone interested in a discussion of this subject, there will be a special edition of VP Live on Thursday night: VP Live Special Edition: So we're a tobacco product. Now what?

It was a good show - thanks so much to Kev for asking me co-host with him!