FDA demands review of newer tobacco products- Front Page MSNBC

[kristin]

So it looks like the PV's themselves are ok. It is about the juice.

Further more it goes on to explain that such blending alternatives are acceptable as in changes of blends are ok and it states that the a new manufacturer only needs to show it is equivalent to something already marketed in the US by 2007, which I am POSITIVE there were e-cigs marketed in the US by 2007 and hence e-liquid.

Ken

If they're including rolling papers, you can bet the electronics of an e-cigarette would be included. But they have to rule them tobacco first.

 

[Aaeli]

Don't know why I am so focused on the heating source part but this is from the pdf ...

6. Description of Heating Source
The 905(j) report should provide a description of the heating source (e.g., burning
coal, electric, chemical reaction, carbon tip) used in the consumption of the
finished tobacco product. If the heating source of the new tobacco product differs
from that of the predicate tobacco product and, if applicable, from the
grandfathered tobacco product, this description should be in enough detail to
demonstrate that the change in heating source does not raise different questions of
public health.

I can see why you are coming back to that. This sounds like it is specifically talking about PV design changes since 07, meaning they would not be automatically grandfathered if there was a change. That's what I was trying to allude to, I'm just too tired to think straight...

 

[mauzey]

I don't think the principle and process of the PV system has not changed since 2007, the e-juice is the big variable in this scenario.

 

[devilock76]

If they're including rolling papers, you can bet the electronics of an e-cigarette would be included. But they have to rule them tobacco first.

Look at the quote I posted from the doc, they specifically list devices as an exclusion. I mean count on government to wax semantical but it would be hard pressed to call an ecig a device:

de·vice (dĭ-vīsˈ)
noun

1. A contrivance or an invention serving a particular purpose, especially a machine used to perform one or more relatively simple tasks.

I would relate rolling paper more to the cartridge filling material as I would a rolling machine to an e-cig. My opinion of course and has history has proven my opinion and the governments are often grossly different.

Ken

 

[devilock76]

I can see why you are coming back to that. This sounds like it is specifically talking about PV design changes since 07, meaning they would not be automatically grandfathered if there was a change. That's what I was trying to allude to, I'm just too tired to think straight...

See I read that as the heating source being the curing method, but maybe I am trying to be too optimistic.

Ken

 

[jagstang]

See I read that as the heating source being the curing method, but maybe I am trying to be too optimistic.

Ken

It is not the curing method.

The 905(j) report should provide a description of the heating source (e.g., burning
coal, electric, chemical reaction, carbon tip) used in the consumption of the
finished tobacco product.

 

[jagstang]

the e-juice is the big variable in this scenario.

I think in one of the predictions thread for 2011 I posted that I thought 2011 would be the year one of the BT companies bought or licensed one of the popular e-juice makers. An example might be Phillip Morris Applewood. They would have the money to pay for FDA approval.

 

[StormFinch]

I did some hunting around and the bulk juice should be fine I think; American eLiquid Store.com Review - E CIGARETTES in Wauwatosa, WI - BBB Reliability Report - BBB serving Wisconsin
Check out their business start date: 06/22/2006, and their products and services description: "This company manufactures and sells American made e-liquid with and without nicotine, and distributes a full line of e-cigarettes and accessories."

My one question is, do businesses have to prove to the BBB the date they start? Accreditation rating is somewhat based on the length of time a business has been operating, so it makes me wonder if the BBB would just take a business' word for it or not.

 

[rachelcoffe]

Is it just me or is the FDA basically trying to take on the role of legislator? I don't think they have the authority to ban products just because they don't meet with a brand-new dinky internal rule of theirs that does not have a basis in law! I don't remember Congress ever passing legislation saying that tobacco products can never progress - that all tobacco products must be "substantially equivalent" to ones commercially available before Feb. 15, 2007. Do you?

Just saying, it seems to me the FDA's new tack here is seriously of dubious legality (i.e. enforcing some sort of prohibition on e-cigs/e-juice, which is clearly the intent). They clearly know their appeal of their earlier appeal re the FDA vs Sonterra case will fail. They've lost twice now over the last 2 years, and going for strike three as we speak. So they're rather underhandedly trying to make up new rules & treat them as laws, in order to get away with the exact same thing that the judges decided was not OK.

Remember:

Judge Leon's decision was based on a Supreme Court case decided in 2000 called FDA v. Brown & Williamson Tobacco Corp. In that case, the court decided that allowing cigarettes and smokeless tobacco products to be marketed as drugs or devices would result in their being banned from the market.
(Source: Nasdaq.com)

The point being - the courts clearly agree that the FDA should use regulation to regulate, not as a tool to arbitrarily ban things just because they don't like them. They recognized that the FDA was trying to do exactly that before...and the courts said "no, you can't do that. Regulation exists to regulate, not as a pretext for unfounded bannings."

MOST IMPORTANTLY...
In any event...I am certain that electronic cigarettes (regardless of brand name) have been commercially available in the U.S. since well before February 2007. Not on the same scale as today (demand has increased, obviously, and therefore so has distribution). But available? Yes. Ditto e-juice (with nic & without).

E-cig technology & e-juice are all similar enough to what was commercially available before February 2007 that there is no way modern e-cigs & e-juice could possibly be construed as anything other than "substantially equivalent" to pre-February 2007 e-cigs & e-juice.

So good try, FDA - but (if you'll pardon the expression), no cigar. Even on this ridiculous ploy of dubious legality, which reeks of desperation I might add - you lose. We win. Yay!

By the way, thanks FDA for continuing to exhaust every possible recourse at your disposal. Yes I'm thanking you!

The sooner you do, the sooner this ridiculous farce can be over with, and the sooner e-cigs & e-juice can be marketed properly in the States, leading to millions of happy vapers!

 

[trying]

From archive.org, the earliest listing for Njoy I could find, june 2007.
http://www.archive.org/web/200706111705351/http://njoy.com/about_us.php


link not working but the page is there.........

 

[trying]

While Njoy.com dates back to 1998, as of February 2007 there was no reference to it being related to an E-cigarette company or device.

 

[yvilla]

Is it just me or is the FDA basically trying to take on the role of legislator? I don't think they have the authority to ban products just because they don't meet with a brand-new dinky internal rule of theirs that does not have a basis in law! I don't remember Congress ever passing legislation saying that tobacco products can never progress - that all tobacco products must be "substantially equivalent" to ones commercially available before Feb. 15, 2007. Do you?

Just saying, it seems to me the FDA's new tack here is seriously of dubious legality (i.e. enforcing some sort of prohibition on e-cigs/e-juice, which is clearly the intent). They clearly know their appeal of their earlier appeal re the FDA vs Sonterra case will fail. They've lost twice now over the last 2 years, and going for strike three as we speak. So they're rather underhandedly trying to make up new rules & treat them as laws, in order to get away with the exact same thing that the judges decided was not OK.

Nice try, but in fact the tobacco legislation passed in June 2009 does have that grandfathering provison in it. The FDA is not making this up.

In fact, discussion about this, and worry about when ecigs were first marketed in the US, was extensively being discussed here back in 2009, well before the legislation was even passed.

 

[yvilla]

While Njoy.com dates back to 1998, as of February 2007 there was no reference to it being related to an E-cigarette company or device.

I personally researched this issue back when the legislation was being considered. And I saw official US Customs import letters on Njoy products from as early as August, 2006. That does not necessarily mean they were being "marketed" in the US within the meaning of the statute at that time however.

People are trying to get reliable information on this right now, as it's very hard to believe that players like Njoy and its attorneys have not been aware of this all along, as they were spending hundreds of thousands of dollars on litigation against the FDA over the past two years. My hope is that of course they have been aware of this issue, and have had a strategy in place on how to deal with it since the beginning (since the legislation was passed at least).

 

[FreakyStylie]

I just have a little question.

Why can't we have a public debate on this? I seriously don't understand why there hasn't been a legitimate news story bringing the attention to what is going on. I would like to see a nice investigative piece. The light needs to be shown on the corruption because, dammit!, the FDA is murdering people and causing great suffering in order to provide income for fat pigs.

This is no longer America. I am ashamed.

 

[trying]

The june 2007 njoy.com site, stated that they were test marketing with sales expected to begin in Fall 2007.

So the question becomes does test marketing count ?

 

[jagstang]

The june 2007 njoy.com site, stated that they were test marketing with sales expected to begin in Fall 2007.

So the question becomes does test marketing count ?

From what I read, I do not think test marketing counts.

 

[yvilla]

No, test marketing is specifically excluded. But again, we still don't know the earliest date some ecig company may be able to prove they were marketing in the US.

 

[jagstang]

From what I read, I do not think test marketing counts.

It does not look like it can be used to grandfather it in.

E. Predicate Tobacco Product
A tobacco product manufacturer must show that a new tobacco product is “substantially
equivalent, within the meaning of section 910, to a tobacco product commercially
marketed (other than for test marketing) in the United States as of February 15, 2007, or
to a tobacco product that the Secretary has previously determined, pursuant to subsection
(a)(3) of section 910, is substantially equivalent and that is in compliance with the
requirements of this Act.” (Section 905(j)(1)(A)(i) of the Act.) The comparison product
chosen by the tobacco product manufacturer is referred to by FDA as the predicate
tobacco product.
For the purposes of this guidance document, FDA refers to predicate tobacco products
that were commercially marketed (other than for test marketing) in the United States as of
February 15, 2007 as “grandfathered tobacco products.”

 

[rachelcoffe]

Nice try, but in fact the tobacco legislation passed in June 2009 does have that grandfathering provison in it. The FDA is not making this up.

In fact, discussion about this, and worry about when ecigs were first marketed in the US, was extensively being discussed here back in 2009, well before the legislation was even passed.

Fair enough, yvilla. That part wasn't entirely clear to me.

But in any event...I am certain that electronic cigarettes (regardless of brand name) have been commercially available in the U.S. since well before February 2007. Not on the same scale as today (demand has increased, obviously, and therefore so has distribution). But available? Yes. Ditto e-juice (with nic & without).

E-cig technology & e-juice are all similar enough to what was commercially available before February 2007, that there is no way modern e-cigs & e-juice could possibly be construed as anything other than "substantially equivalent" to pre-February 2007 e-cigs & e-juice.

It may take a little extra digging...but I'm sure there are vapers out there with credit card records, receipts, emails...vendor websites...and more...that can prove that e-cigs & e-juice "substantially equivalent" to those available today, were in fact commercially available in the U.S. pre-February 2007.

BUT...even if they somehow find e-cigs & e-juice to be "new tobacco products"...how on earth does that translate to an ultimate ban (like post-FDA testing)? Testing would not show vaping to be harmful. Or rather, it would not show vaping to be anywhere remotely near as harmful as tobacco cigarettes, or even NRT...which are both legally marketed.

The FDA is basically saying this isn't about the health or safety of vaping so much as it's now all about some arbitrary date on a calendar. Are they seriously reduced to arguing red tape & arbitrary calendar dates as the reason why smokers should keep smoking proven-deadly tobacco, or keep using 90 to 95% ineffective NRT...but not be allowed to vape safely?

Two courts have already said "no, you cannot ban these products while you attempt to convince us that they should be viewed as a new drug." And now the FDA...surprise surprise, wants to ban these products while they "conduct testing" - !!

It doesn't get more ridiculous or sneaky than this! Could this be construed as a violation of the current injunction that allows e-cigs & e-juice to be imported into the States? Could it be construed as contempt of court? We'll be interested to see what the courts have to say re: this. No doubt Sonterra (& possibly other manafacturers) will go to court if need be, requesting a new injunction.

So I repeat, good try FDA - but (if you'll pardon the expression again), no cigar. Even on this ridiculous ploy, which reeks of desperation I might add - you will ultimately lose. We will ultimately win. Yay!

But thanks FDA for continuing to exhaust every possible recourse at your disposal. Yes I'm thanking you!

The sooner you do, the sooner this ridiculous farce can be over with, and the sooner e-cigs & e-juice can be marketed properly in the States, leading to millions of happy vapers!

 

[DonDaBoomVape]

Damn! This reads like something out of Atlas Shrugged: Directive 10-289. I don't know whether it will impact vaping or not; I still don't like it!