From CNN.com Today/Eissenberg study with feedback

[Vocalek]

Exactly. It's one thing to declare something is safe and another thing to define what safe means. As a result the FDA continues to lose credibility and public confidence.

The reason I want to know how the FDA defines safe is because I recently had conversations with a couple of smokers who, upon seeing my PV, stated they had considered switching to e-cigs but changed their minds when they learned they are not FDA approved as safe and effective. They couldn't explain what this means and so far neither can I. It got me thinking about how this terminology is being tossed around, especially by opponents of e-cigs.

My response to the "FDA doesn't say they are safe and effective" argument goes like this.

Chantix was supposed to be "safe and effective", based on clinical trials required for FDA approval. But when Chantix began to be used by the types of people who were excluded from clinical trials, such as those with depression, we began to see cases of severe depression, suicidal thoughts and completed suicides, as well as physical problems (e.g. seizures), and quite a few deaths. The point is the clinical trials are limited in scope and we never know the full safety profile until after the drug is in general use. Electronic cigarettes have already been in general use in China for over 6 years, the UK for over 2 years, and the US for over a year with no serious adverse events and no deaths.

 

[kristin]

I was really tired when I read that last night! Doesn't take much to confuse me!

Still, it would help to have some idea what the FDA means by "safe," even if it is a simplistic explanation like the one for "effective" (given their track record).

I don't think there is ONE answer to that question - it depends on the intended use of the drug.

Chemotherapy drugs are deadly, yet they can be effective in treating a deadly disease. So "safe" is relative.

I believe that a rule of thumb would be that "safe" means they do not cause any side effects worse than the disease they are intended to treat, they contain approved levels or less of known toxins and that side effects have actually been determined, so they can be disclosed. As we all know, plenty of drugs on the market have possible dangerous side effects, but they are supposedly tested extensively to be able to warn consumers to make an informed choice.

So "safe" would mean:

1. No side effects worse than the disease the drug is intending to treat
2. Approved levels or less of toxins
2. Side effects are disclosable

Right now, although anecdotal evidence shows that ecigs would probably pass with flying colors (if they did have deadly toxins or horrible side effects, someone would have died or become ill by now and most side effects have already been documented on the forum threads), no one has done testing in the U.S. to prove it to the government.

If researchers test ecigs for safety the same way they tested for effecacy, we should be ok. The test subjects won't be able to even vape properly, so adverse side effects will be unlikely.

 

[Mister]

The reason I want to know how the FDA defines safe is because I recently had conversations with a couple of smokers who, upon seeing my PV, stated they had considered switching to e-cigs but changed their minds when they learned they are not FDA approved as safe and effective. They couldn't explain what this means and so far neither can I. It got me thinking about how this terminology is being tossed around, especially by opponents of e-cigs.

My response to the "FDA doesn't say they are safe and effective" argument goes like this, since a couple of smokers are posing it:

Huh? Are you under the impression that the FDA says smoking is "safe and effective"? These things replace cigarette smoking. Why should they be "safe and effective"? What I care about is that they're hugely less harmful. Read about them, try them if you like, and make up your own mind, because the FDA isn't going to help you to understand whatever risks they have any more than they helped you as a smoker.

 

[Kilroy]

All of this flies in the face of government taxation, big pharma and big tobacco. There won't be any testing. They know what the results would be. They'll just keep on with the thug strategy until the vendors give up. Just my 2 cents.

 

[anim8r]

nevermind. Comments were off when I visited the page. Looks like they're back

 

[Bill Godshall]

(SO) Jersey Girl wrote:
The reason I want to know how the FDA defines safe is because I recently had conversations with a couple of smokers who, upon seeing my PV, stated they had considered switching to e-cigs but changed their minds when they learned they are not FDA approved as safe and effective.

To better understand what the FDA considers "safe" for an Over The Counter NRT product, read the warning labels on the products (which are scarier than warnings on cigarettes).

That's also why SRNT petitioned the FDA to make NRT products more user friendly, as Jonathan Foulds describes at the link below.

Citizens' Petition to FDA on Regulation of Tobacco Treatment Medicines
Citizens? Petition To FDA on Regulation of Tobacco Treatment Medicines.

All of the petition's proposed changes for NRT products (which I strongly agree with) would eliminate or reduce "safety" concerns that FDA still has with NRT products.

 

[Bill Godshall]

Per previous post, I guess yellow isn't a good color to use. But its quoting the same inquiry about what the FDA considers "safety" for drugs.

 

[(So) Jersey Girl]

Thanks, all, for your input. I'll just keep doing what I always do: reading, learning and asking questions.

 

[Vocalek]

I love this quote from Dr. Foulds: "...every additional year that hundreds of billions of cigarettes are smoked in this country results in hundreds of thousands of premature deaths and millions of cases of avoidable illness."

 

[Belletrist]

...That's why Judge Leon's decision is important: If the FDA is allowed to regulate e-cigs as a drug, they can drag their feet on every step of the process basically as long as they want. If, however, they regulate e-cigs as a reduced harm tobacco product, they would not be able to ban them unless and until they fail safety standards.

exactly, exactly.

& bill godshall--nice link on the srnt/nrt petition; good stuff.

 

[Pinko Panther]

I just did a heart rate test on myself. I counted my pulse for a minute and hour after i woke up, not having consumed any nicotine for 10 hours. My BPM was 67.

I took 20 puffs of my vapor king, waited a couple minutes and took my pulse again. My BPM was 88 this time

So, what magic placebic substance caused this change?

 

[cyb0rg]

HAHAHAHA wow, "E-cigs do not deliver nicotine". That's a joke. I smoked analogs for 23 years, and since I started vaping 4 months ago I have only lit up maybe one or two analogs and they didn't do anything for me (but taste like ...). They must have been using the BLU's for their test. Somebody send them a 510 to show them what REAL VAPORITES USE.

Since when did the Cracker Jack company start doing lab testing for the FDA anyway?

 

[miss MiA]

Somebody send them a 510 to show them what REAL VAPORITES USE.

On his own Dr. E already obtained and tried a KR8 manual with Cowboy cartos (don't recall the nic level) and tested for/found nic in his system afterward. But it was a casual, informal follow-up he did on his own, not to be appended to any of his findings that I've heard of. You can find discussion of that experiment if you want to page back far enough. Hopefully this could at least lead to him designing another study...