We need to beat the FDA to the gate!

[RandallFlagg]

Why can't we ask for our own studies to be done?
There are a great many of us here. Someone here knows people in the field who's job is to test things for chemicals and such. Why can't we have our vapor tested? Get a bunch of documented, defensive evidence to throw back at the FDA if they want to ban ecigs.

I work in a major brewery, and will ask around about this.

Brainstorm, friends. It couldn't hurt.

 

[Surf Monkey]

Testing costs money. You offering to pay?

 

[radiokaos]

Testing costs money. You offering to pay?

Lets not forget it takes time for studies. Not months but years to assess the efficacy of E Cig's.

 

[RandallFlagg]

Testing costs money. You offering to pay?

Yes.
If we don't, we will later by force.

 

[John Kin]

It would taker a decade and over millions of dollars to do this....

Three and a half million dollars.

That, according to Open Secrets, is what Philip Morris has spent lobbying this year.

It's just over three times what the second biggest company company spent.It's also more than half of all the money spent on tobacco lobbying in the US.

And what's it spending the money on?

Here's a good guess - the tobacco Bill due to enter the senate next week.

The Tobacco Bill will lead to a defacto ban on safe alternatives to cigarettes like the electronic cigarette. That means smokers will have no choice but to smoke on regular cigarettes.

The Tobacco Bill will reduce advertising. That means smokers will only remember the most popular brands of cigarettes - which belongs to Philip Morris.

The Tobacco Bill will introduce new restrictions on cigarettes. Can you guess which is the only company to be ready for these restrictions?

 

[TheIllustratedMan]

I was thinking about this very thing today at work, and was going to start a thread, but seems you beat me to it by a few days... so be it.

As a disclaimer before all this: I have yet to even try a PV. I don't know that I'm even going to like it. However, I fully support the idea, and am encouraged by all the positive stories that I'm reading. Also, this became a terribly long post, and I apologize for that. That said...

There are numerous benefits to having our own testing done. In no particular order:

- If we wait for the FDA to do it, it won't happen. They can use the "untested" excuse indefinitely.
- Having test results in hand makes our case that much stronger. We aren't just spouting anecdotal evidence (the BEST kind, according to Dogbert).
- If the funding is done by a multitude of individuals, and we make full disclosure of who those individuals are, the testing becomes a lot harder to claim as biased. This is made even stronger if we can get those who love us and want us to be using a safer alternative to smoking to provide funds. If part of the funding comes from non-supplier non-users, bias is even harder to claim.

The first thing that we need to decide is how to "market" the PV. Is it Nicotine Replacement Therapy, a recreational nicotine delivery device, or some other category that I haven't thought of? If we claim that it's an NRT, there is at least one additional test that needs to be performed: effectiveness.

Ideally, we would have identical concurrent testing occurring at at least two different labs. There are two-three areas of testing that need to happen.

The Device
Is the device itself safe to use? Is there possibility of malfunction causing harm to the user? If so, how likely is this scenario?
What kind of contaminants are found on/in the device? How do these contaminants compare to those found in the typical tobacco pipe (or other comparable device)? Are the contaminants transferred to the vapor produced? If so, in what quantities? Again, compare to comparable device.

The Liquid
What compounds are found in the liquid? There need to be individual tests on each compound to determine potential harm and side-effects. How much of each compound is found in the vapor? How much of each compound remains after being filtered by the lungs? How much of the remaining compounds could be transferred to another person, and at what distance? How does the potential harm caused by transferrance compare to potential harm caused by transferrance of other compounds from accepted devices (ie. cars, factories)?

Effectiveness as an NRT (if branded as such)
What is the success rate of replacing tobacco products with the personal nicotine vaporizer? Are subjects able to step down nicotine levels to none? How long does this take? What is the relapse rate after a week, a month, several months, a year?


These are the things that I think they're going to look for. Personally, I think that the most important is how much vapor is transferred to other people, what that vapor actually consists of, and if it could be harmful to others. Everything else can have a warning label slapped on it and adults can make the choice whether or not to use it.

Thoughts?

 

[TropicalBob]

Sorry, but nothing proposed here is practical or realistic. Remember that it is not up to the FDA to test these and/or prove them unsafe. It is up to the companies intending to sell and market them to prove safety and efficacy.

At present, e-smoking has no legs to stand on, from a scientific consideration. We have belief .. and that doesn't cut it with any regulatory agency.

 

[Surf Monkey]

Sorry, but nothing proposed here is practical or realistic. Remember that it is not up to the FDA to test these and/or prove them unsafe. It is up to the companies intending to sell and market them to prove safety and efficacy.

That's correct. According to the legislation, it's up to companies that manufacture, market and/or sell reduced risk products to provide research evidence supporting their claims. But that actually makes this thread a little more relevant than if the FDA was tasked with doing that research. After all, we have the ear of the retailers of these devices. I agree that it's pointless for end users to fund this kind of thing if the goal is to convince the FDA to approve them.

 

[Mua]

What do you think of the tobacco companies doing the research ? I may be wrong about this, since I am so VERY new to this, but they could get in on this...... couldn't they extract the nicotine from their tobacco, and market the juice, and in turn market the devices ?

 

[Surf Monkey]

Can and probably will. They haven't stayed in the business of killing their own customers for generations without being savvy. It's practically guaranteed that the main tobacco producers already have their own versions of the e-cigarette just waiting in the wings for the right moment to be released.

 

[TheIllustratedMan]

All right. So we hang out, do nothing, and hope for the best. Sounds like an excellent strategy.

*sigh*

About FDA Product Approval
The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers.
Some products — such as new drugs and complex medical devices — must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products — such as x-ray machines and microwave ovens -- must measure up to performance standards. And some products — such as cosmetics and dietary supplements — can generally be marketed with no prior approval.
At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs.
FDA has streamlined its review process for medical products in recent years to help speed important new treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.

Doesn't tell me anything about who has to do the testing. It says that the FDA reviews the test results. It ALSO says that some products don't need to actually be approved. How is us getting our data together and attempting to present it to the FDA in defense of e-cigs and e-liquid going to hurt? Sitting around and doing nothing definitely will.

 

[RandallFlagg]

All right. So we hang out, do nothing, and hope for the best. Sounds like an excellent strategy.

*sigh*



Doesn't tell me anything about who has to do the testing. It says that the FDA reviews the test results. It ALSO says that some products don't need to actually be approved. How is us getting our data together and attempting to present it to the FDA in defense of e-cigs and e-liquid going to hurt? Sitting around and doing nothing definitely will.

Agreed.
As will just hoping for the best without being proactive about it.
Smokers hoped for the best when they were told to stay in the smoking areas of the airplanes once long ago.
Look what their, "Hope," got them. They're the lepers of society. Shunned, hated, and discriminated against at every turn. Back of the bus for you, smoker.

I really don't want to go through that again.

 

[Surf Monkey]

Read section 9.11 (ironic!) of the new tobacco legislation. That's the section that details regulation of "reduced risk products" including the e-cigarette. It also details what testing is required for approval and who's responsible for the testing.

 

[happily]

We need to get some universities on board. They can request grants to study the devices and publish their findings. There are several companies in my city that do clinical trials, but how do we get to that stage.

 

[happily]

Read section 9.11 (ironic!) of the new tobacco legislation. That's the section that details regulation of "reduced risk products" including the e-cigarette. It also details what testing is required for approval and who's responsible for the testing.

link?.......

 

[Surf Monkey]

link?.......

There are several floating around the board, but the best way to view the complete text is to search at thomas.loc.gov for HR 1256.

Thomas is set up as a database, so sometimes direct linkage doesn't work. I'll try pasting this one in, but if it fails, just go to the main site and search for the bill number.

Search Results - THOMAS (Library of Congress)

 

[TheIllustratedMan]

Check out HR1256 9.11(g)(4). These are the criteria that need to be reviewed.

`(4) BENEFIT TO HEALTH OF INDIVIDUALS AND OF POPULATION AS A WHOLE- In making the determinations under paragraphs (1) and (2), the Secretary shall take into account--
`(A) the relative health risks to individuals of the tobacco product that is the subject of the application;
`(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;
`(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;
`(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under chapter V to treat nicotine dependence; and
`(E) comments, data, and information submitted by interested persons.

I think that we would fall under 9.11(g)(4)(E). Paragraph (2) shows how a product could be marketed and sold without scientific data, contingent on scientific data being provided at a point in the future. I guess they just go by anecdotal evidence on that accord?

I don't know, SM, it seems like we should be able to at least make a decent case for the overall idea, and then just have specific manufacturers submit their own apps and data. It's awfully ambiguous as to whether the law applies to new technology or new products (to me, anyway). I still say that we band together and get some testing done. At the very least we'll be better informed about what is going into our bodies, and that's NEVER a bad thing.

 

[RandallFlagg]

I don't know, SM, it seems like we should be able to at least make a decent case for the overall idea, and then just have specific manufacturers submit their own apps and data.

Here's a case:
They don't know if these devices are hazardous.
But they are absolutely positive that smoking tobacco is deadly.
If they are banned, people will die.
And THEY will be to blame for it.

I think the local news folks might pick up on it.

 

[vaportiger]

For people that have some age on them my remember back in the late 70's Jimmy Carter recommended that someone invent a safe cigarette. I of the tobacco companies came out with a smokeless one that lasted around a few months that tasted bad and was hard to find. I am writing a letter to X pres Carter and inform him that what he recommended is here and try to get his support. He may be a jack ... but he still has some pull in government. I recommended that everyone do the same. When I find the correct address I will post it.

 

[RandallFlagg]

For people that have some age on them my remember back in the late 70's Jimmy Carter recommended that someone invent a safe cigarette. I of the tobacco companies came out with a smokeless one that lasted around a few months that tasted bad and was hard to find. I am writing a letter to X pres Carter and inform him that what he recommended is here and try to get his support. He may be a jack ... but he still has some pull in government. I recommended that everyone do the same. When I find the correct address I will post it.

AHH! Favor cigarettes.
They were okay, but no smoke emitted. It was the last thing close to a cigarette commercial I remember.