Reply From The FDA

[mooreted]

"Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products."

However, we know for sure what's in the drugs that are approved by the FDA which kill thousands of people every year.

 

[CaminoDiablo]

FDA Fails to Protect Americans from Dangerous Drugs and Unsafe Foods

Read this FDA Fails to Protect Americans from Dangerous Drugs and Unsafe Foods ~ Newsroom ~ News from CSPI ~ Center for Science in the Public Interest I feel safe with these guys around thats for sure

 

[DragonflyVaper]

Reply to DragonflyVapers post.

Don't get me started on the tca toirtap. lol

Please do.... what is tca toirtap?

 

[DragonflyVaper]

Sorry but this cracks me up...".Make no mistake, the Obama Administration shares your concern" HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHA he's also gonna pay for my house and give me free health care that I have to pay for anyway sorry but I hope people got what they wanted from him, didn't like him and his ideas to start with. BTW this is my opinion and if I offended anyone I just spoke how I feel, sorry if you where offended.

It's your right to dislike the current administration but it's obvious NO ONE including Obama actually read our petition. I believe this canned response would have been sent even if another administration was in office. It's the government that hasn't been working in our interest for a very, very long time and we are just now waking up to this mess. Shame on us.

 

[MajorRocker]

Personally, I feel the govt doesn't want people to quit smoking. It's big business. Without people suffering from the negative effects of smoking, pharmaceutical companies would be out a lot of money. Sickness is a big money maker for them and they'll do whatever they can to ensure money making illnesses are always around.
I'm convinced that many of today's illnesses could be cured and even possibly be wiped from existence, but these breakthroughs in science will never see the light of day because pharmaceutical companies rely on sick, dying people to keep them rich.

 

[denali_41]

E-cigarettes may contain ingredients that are known to be toxic to humans or otherwise harm public health

human nature at it's finest !!! we don't understand it so lets KILL IT !!!!!!!!!!!!!!!!!!!

 

[Cool_Breeze]

Why doesn't the FDA do a real study? Your tax dollars at work!?!?

I think it better that the ecig industry do studies. Those who fund the studies control the data and get to be the interpreters.

 

[CaminoDiablo]

It's your right to dislike the current administration but it's obvious NO ONE including Obama actually read our petition. I believe this canned response would have been sent even if another administration was in office. It's the government that hasn't been working in our interest for a very, very long time and we are just now waking up to this mess. Shame on us.

I concur DragonflyVaper , your very correct

 

[denali_41]

double post

 

[Poeia]

Personally, I feel the govt doesn't want people to quit smoking. It's big business. Without people suffering from the negative effects of smoking, pharmaceutical companies would be out a lot of money. Sickness is a big money maker for them and they'll do whatever they can to ensure money making illnesses are always around.
I'm convinced that many of today's illnesses could be cured and even possibly be wiped from existence, but these breakthroughs in science will never see the light of day because pharmaceutical companies rely on sick, dying people to keep them rich.

Forget drugs to treat emphysema and cancers that are linked to smoking. If everyone quit smoking tomorrow, they'd still have a decade or more of people getting sick from having smoked. So that money is somewhere in the future for them.

In the meantime, they are making billions a year now "helping" you quit. The patch, nicotine gum, Wellbutrin and Chantix are hugh business for them today. And, if they can convince people to try to quit using those methods, a large percent will fail, allowing them to sell them another round of "quit smoking" drugs now and a decade from now they'll still need the drugs to treat those other diseases. As far as the FDA, Pfizer, Glaxo et al are concerned, that's a win-win.

 

[Vocalek]

I think it better that the ecig industry do studies. Those who fund the studies control the data and get to be the interpreters.

If you are talking about chemical content of the liquid, many vendors do conduct regular testing of their products and post test results on their web sites. Except for the FDA's "study", all of the studies that were reviewed in the Cahn & Siegel analysis were funded by e-cigarette companies.

If you are talking about the "dose" of nicotine users get, that's a non-issue. Smokers don't know how much nicotine is in their brand of tobacco cigarettes either. Furthermore, smokers tend to self-regulate their nicotine, so they might be getting different amounts of nicotine from the same brand during different smoking sessions.

It would be nice to have the percent of nicotine accurately measured and documented on the product label.

If we are talking about clinical trials to prove e-cigs help people quit, that's nice, but not a necessity. We know that snus is effective as a substitute for smoking because we have population studies that show many of the snus users are former smokers. Likewise, we have survey data that shows us that at least SOME consumers are using them to quit.

It is certainly not a necessity to prove e-cigs help smokers quit if e-cigs are to be regulated as a tobacco product.

It's obvious that even though it is the Tobacco Program director talking, he has his head wrapped around the idea that e-cigarettes are a medical treatment.

I would have been MUCH more impressed if Deyton had talked about reasonable regulations (batch testing, labeling, packaging) that FDA would be considering when they regulate e-cigs as tobacco products. Instead, I get a very strong feeling that if the FDA does regulate e-cigs, it will be with the end-goal of getting most products removed from the market, leaving only the least effective ones available.

When I say "effective" I mean "acceptable as a substitute for smoking," not as a cure for nicotine addiction.

 

[Cool_Breeze]

Vocalek -

Dr. Deyton makes references to 'clinical studies' and '(lack of) validated scientific data.' It seems to me that action for the FDA either relies upon having supporting information along the lines of 'relative safety' or 'harm reduction' in this light, or in absence of such, falling back upon the known horrors (pardon me) associated with nicotine and nicotine related activities. In short, in lack of formal data, the FDA must pursue the matter along the lines of what is already known and (assumably) proven, (though perhaps not in the context of vaporing).

I don't know that any amount of reasoned, but perhaps (scientifically) unsupported words can change this approach for the FDA. You and I may 'know' some of the truth of this matter, but without supporting data, it won't change FDA's outlook. They have nothing but largely anecdotal information and that won't allow for the FDA to "conclude that electronic cigarettes are an effective alternative to smoking."

It does seem clear that in absence of 'clinical studies' and 'validated scientific data,' the outlook of the FDA is not likely to change. I don't suspect the FDA will be attempting to prove our case in the near-term future. Therefore, the onus for producing studies supporting the relative benefit of vaporing lay somewhere else than with the FDA.

By using the terminology 'clinical studies' and 'validated scientific data,' is Dr. Deyton not saying, 'My hands are tied..."?

Vocalek - Are you an attorney or otherwise have training in law?

 

[Vocalek]

Vocalek - Are you an attorney or otherwise have training in law?

I'll take that as a compliment. The closest I came to being in the law field was working as a legal secretary during the years I went to college. It's why I understand phrases such as "subpoena duces tecum" (show up at the appointed place and time and bring the specified list of documents with you.)

E-cigarettes don't really fit the pattern for a drug-delivery device because they do not treat a disease. They don't contain tobacco and they were not among the products specifically named in the Family Smoking Prevention and Tobacco Control Act.

Unfortunately, Judge Leon's bright idea of stretching the meaning of the definition, "made of or derived from tobacco," to encompass e-cigarettes under the Tobacco Act gave the FDA the bright idea of expanding their authority to encompass every tobacco product as well.

Perhaps the petition should have asked the president to assign the Consumer Products Safety Commission to regulate electronic cigarettes. As I understand the situation in the UK, the agency that regulates e-cigs is involved with trade, rather than medicine.

 

[Bill Godshall]

cool breeze wrote:

Dr. Deyton makes references to 'clinical studies' and '(lack of) validated scientific data.' It seems to me that action for the FDA either relies upon having supporting information along the lines of 'relative safety' or 'harm reduction' in this light, or in absence of such, falling back upon the known horrors (pardon me) associated with nicotine and nicotine related activities. In short, in lack of formal data, the FDA must pursue the matter along the lines of what is already known and (assumably) proven, (though perhaps not in the context of vaporing).

Deyton is fully aware of the scientific evidence on e-cigarettes because I've sent him all of the existing studies and lab reports.

Deyton is also fully aware that clinical studies are only required for FDA approval of drugs and drug devices (and not for any tobacco products, which e-cigarettes are now legally classified as).

And Deyton's reply included the weblink for the false and misleading claims made by FDA in July, 2009 (which Judge Leon overruled).

 

[Cool_Breeze]

Okay... It seems it's being pointed out that I am in error and perhaps my insight, or lack thereof is not appreciated.

The word-dance here is great, but I haven't the energy to dance so vigorously!

I'll remove myself from participation in this discussion.

Have a nice day!

 

[rolygate]

@CB
The FDA's agenda is to kill off e-cigs. That is what they have been told to do by the people who pay the bills. It wouldn't matter if evidence was produced that using an e-cig makes you live to 200, it's irrelevant.

They were blocked from doing it the fast way, so now they will investigate other ways.

 

[Cool_Breeze]

@CB
The FDA's agenda is to kill off e-cigs. ...

And the plans for the e-cig industry to deal with what you say is the situation are...?

 

[Poeia]

@CB
The FDA's agenda is to kill off e-cigs. That is what they have been told to do by the people who pay the bills. It wouldn't matter if evidence was produced that using an e-cig makes you live to 200, it's irrelevant.

They were blocked from doing it the fast way, so now they will investigate other ways.

If such evidence were produced, people would encourage their children and grandchildren to vape which would give the FDA what they need to make PVs illegal.

 

[Poeia]

And the plans for the e-cig industry to deal with what you say is the situation are...?

CASAA (which Vocalek) and Bill Godshall's organization (Smokefree Pennsylvania) are doing a lot. But those types of scientific studies take a lot of money. For small businesses like the ones that make up the bulk of the e-cigarette marketplace, it's a LOT of money, for Philip Morris/Altria and Pfizer it's a drop in the bucket.

And, of course, once you submit that type of evidence to the FDA, you immediately get classified as a drug. That gives them almost limitless power over you. Vaping is an alternative method for people who do not want to smoke tobacco cigarettes to get their nicotine. While some people may choose to use it as one step on the way to getting off nicotine, that is not what it was designed to do.

 

[Cool_Breeze]

It seems it seems the consensus is that I have nothing to offer that isn't already figured out so as to be of no value.

Are there singular statements of concrete efforts being made by SmokeFree Pennsylvania and CASAA? ...links?

I have offered a plausible plan to raise funds for e-cig promotion. I don't know that the powers that be gave it any consideration. If they have, no mention has been made to me.

Without a plan that I might understand and with the potential obstacles being determined as fatal, I am dismayed. Perhaps I should enjoy my ignorant bliss.