e cig NJ workplace Ban...whats the big deal?

[PlanetScribbles]

As a member here for almost two years, I fully understand the frustrations being expressed here. But this is a bottom-line fact:

There is only one agency in the United States that has the authority to classify our e-cigs and e-liquids. That is the FDA. It has said, repeatedly and clearly, that the e-cig is an unapproved "drug delivery device" and e-liquid is an unapproved and/or misbranded drug.

The only way those classifications can be changed is by a court judgment saying the FDA was and is wrong.

Such a case is awaiting publication of a decision now. It should come shortly. Either way it goes, the FDA regulates e-cigs and e-liquid in the future. That is not pleasant to contemplate, but at this point it is quite correct to say e-cigs are illegal drug delivery devices -- because the only agency that can define them has done so.

Anyone's opinion here to the contrary matters not one whit.

No, I'm not a troll. Just a veteran e-smoker with stashes of stuff I use daily, one who keeps a close eye on legal and health matters, and knows how to connect dots that others refuse to acknowledge even exist.

I agree with every word you said TBob
Doesn't make it any easier to swallow though. Every human on the planet, smokers, non-smokers and vapers alike, exhale a dangerous substance ... CO2. In concentration it's a killer. PG has been approved as safe by the same FDA that wants to outlaw a product that uses ... yep, PG.
Damn. It annoys me when all logic gets lost in a mist of idealism

 

[NJDrew]

Is there any maximum safety level for ingestion?
Propylene glycol is used professionally by manufacturers of consumer and industrial products, but it is not available to consumers as pure substance. Under normal conditions it is therefore impossible to ingest propylene glycol in large amounts, and consumer exposure to propylene glycol via products is extremely low. In addition, studies have shown that propylene glycol has a very low degree of toxicity. Actually, from a toxicological point of view, alcohol is more toxic than propylene glycol. European legislation limits the presence of propylene glycol as food additive to 1-3 g/kg in the final foodstuff (0.1-0.3%). A full acceptable daily intake (ADI) of 0 – 25 mg/kg bodyweight has been assigned for propylene glycol by the European Commission´s Scientific Committee on Food.
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Can propylene glycol have negative health effects when consuming it over a long period/time in small amounts?
Propylene glycol has been used safely for more than 50 years in a large variety of applications. Studies have shown that propylene glycol has a very low degree of toxicity. No negative health effects from exposure to small amounts of propylene glycol have ever been observed. The authorities have approved the use of propylene glycol in sensitive applications such as in pharmaceuticals, food and cosmetics, and thus confirm its safety.

I think everyone and their mother knows that the absorption rate of chemicals is different between inhalation, skin and digestion. Not to mention, that states under "normal conditions". What do they define as "normal". I know what point you are trying to prove, but that quote wont do it.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I don’t know where you are going with this... it doesn't say the FDA is responsible for proving a product unsafe. By banning a product they think might possibly be unsafe, they are protecting the publics health. Now, before you say "by forcing them back to cigarettes" or something to that effect, use of nicotine in any form maybe an addiction, but its still a choice. If the FDA bans Ecigs, you don’t have to go back to smoking. That is a choice.

Can we please stop using quotes out of context? Bolding certain words in a quote wont change the meaning of the quote. You can bold all you like, it still won’t say what you want it to say.

 

[Darmeen]

I don’t know where you are going with this... it doesn't say the FDA is responsible for proving a product unsafe. By banning a product they think might possible be unsafe, they are protecting the publics health. Now, before you say "by pushing them back to cigarettes" or something to that effect, use of nicotine in any form maybe an addiction, but its still a choice. If the FDA bans Ecigs, you don’t have to go back to smoking. That is a choice.

Can we please stop using quotes out of context? Bolding certain words in a quote wont change the meaning of the quote. You can bold all you like, it still won’t say what you want it to say.

I didn't take it out of context...that is their entire mission statement on THEIR website...

http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

and what they are doing with the e-cig is quite contrary to

helping the public get the accurate, science-based information they need.

Again, with your own words...it shouldn't be what they 'think'...it should be what they know! I am not interested in their opinions, they should be basing their actions on scientific fact, not their own speculation. Hell, by their own report, they have proven that the e-cig is magnitudes better than an analog, not even in the same sport much less ballpark as analogs.

Here is what I KNOW...the FDA did ZERO research into the actual vapor that we inhale...and only tested a minute sample, which contained errant data that could not be reproduced in the other samples, that errant data is their basis for their ban. that is NOT accurate, or science based!

 

[NJDrew]

I didn't take it out of context...that is their entire mission statement on THEIR website...

What We Do

and what they are doing with the e-cig is quite contrary to

Again, with your own words...it shouldn't be what they 'think'...it should be what they know! I am not interested in their opinions, they should be basing their actions on scientific fact, not their own speculation. Hell, by their own report, they have proven that the e-cig is magnitudes better than an analog, not even in the same sport much less ballpark as analogs.

Here is what I KNOW...the FDA did ZERO research into the actual vapor that we inhale...and only tested a minute sample, which contained errant data that could not be reproduced in the other samples, that errant data is their basis for their ban. that is NOT accurate, or science based!

First let me say I am a Dossier Specialist (aka Submissions Publisher) for one of the top 5 Parma’s in the world. It is my job to know or find the FDA regulations for submitting applications (NDAs, Supplements, Amendments, etc) to the FDA. So on this topic I have a lot of experience.

Nicotine is classified as a drug, thus Ecigs are drug delivery devices. Any drug delivery device that has not been submitted to the FDA for approval can not be marketed in this country. It is not the responsibility of the FDA to do the research for the manufacturer. The fact that they even bothered to test samples of eJuice/Carts, is the "helping the public get the accurate, science-based information" part of that statement. Understand that the FDA is not banning this product, because they feel that it is completely unsafe. They are banning the product, because a. it has not been submitted to them for approval, b. the product could be unsafe, but they can’t know that without an application and c. under the current law they have every right to do so.

Knowing the FDA as well as I think I do included in the quote is my interpritation of key words in the quote:

The FDA is responsible for protecting the public health by assuring (reviewing applications and doing limited testing/research) the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations (aka fast tracking applications) that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information (taken from the applications themselves or limited testing/research) they need to use medicines and foods to improve their health.

 

[Darmeen]

First let me say I am a Dossier Specialist (aka Submissions Publisher) for one of the top 5 Parma’s in the world. It is my job to know or find the FDA regulations for submitting applications (NDAs, Supplements, Amendments, etc) to the FDA. So on this topic I have a lot of experience.

Nicotine is classified as a drug, thus Ecigs are drug delivery devices. Any drug delivery device that has not been submitted to the FDA for approval can not be marketed in this country. It is not the responsibility of the FDA to do the research for the manufacturer. The fact that they even bothered to test samples of eJuice/Carts, is the "helping the public get the accurate, science-based information" part of that statement. Understand that the FDA is not banning this product, because they feel that it is completely unsafe. They are banning the product, because a. it has not been submitted to them for approval, b. the product could be unsafe, but they can’t know that without an application and c. under the current law they have every right to do so.

Knowing the FDA as well as I think I do included in the quote is my interpritation of key words in the quote:

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All you had to say was that you worked for big Pharma and that would have been enough. I gotcha.

The FDA isn't fast tracking anything that has been submitted regarding the e-cig...that much has been talked about already in this forum...and just like the FDA I am not going to do the research for you. The fact is that Big Pharma and Big Tobacco would be hurt by the e-cig, and those generate so much income for the government, their interests will be protected...the FDA approves drugs like CHANTIX, with all of its potential side effects...kinda makes me distrustful of Big Pharma and the FDA.

 

[smonomo]

Where there's vapor there's fire I'm afraid, if we were sucking the flavor out of a pen minus the vapor we wouldn't be having this conversation.

I recently showed my penstyle to a friend, she was curious, as I started to take a draw, the blue light came on,.. she said oh!.....she continued to watch with a concentrated gaze as I took a five second draw, on letting the vapor go, her head shot back, and with a startled look and a half smile on her face she said ...WHOAH!!!!!! ..where does the smoke come from?

I'll say it again, they're an amazing invention, and incredibly realistic.

I think it's the bad manners and irresponsibility of some smokers in the past that has in part led to this problem with e-cigs, I think the best we can hope for is for control to be a little less stringent than it is with tobacco - For instance.. ELECTRONIC CIGARETTES ARE PERMITTED IN THIS AREA - TOBACCO SMOKING IS PROHIBITED

I might be in the minority with this, but if ecigs were allowed inside I would still go outside with the smokers, they're my type, they seem to be more well rounded, we've been through some hard times... I hate to see people pushed around, I'll proudly stand shoulder to shoulder with them....in fact, fcuk it!..you know what! I'm gonna buy a pack of ultra lights and join them.

Damn it!..I gotta change my user name, smonomo sounds like an anti.

 

[NJDrew]

All you had to say was that you worked for big Pharma and that would have been enough. I gotcha.

The FDA isn't fast tracking anything that has been submitted regarding the e-cig...that much has been talked about already in this forum...and just like the FDA I am not going to do the research for you. The fact is that Big Pharma and Big Tobacco would be hurt by the e-cig, and those generate so much income for the government, their interests will be protected...the FDA approves drugs like CHANTIX, with all of its potential side effects...kinda makes me distrustful of Big Pharma and the FDA.

Did you just called me a troll lol. I am not "big pharma". I am a person. I have a full time job. My job is at a pharmaceutical company. I don’t represent any side of this discussion. I’m merely giving you my opinion based on my knowledge of both Pharma and the FDA.

I know everyone likes to think that there is some great dark conspiracy to kill the people and get rich doing it. The fact is respectable Pharmas want to help you and get even richer doing it. ...... is a perfect example of this. Given it may not be medically necessary, but it has helped people and as a product it is an absolute cash cow for Pfizer (although I don’t think they where the ones who developed it?) It doesn't pay to kill off your consumer base.

Let me ask you of all those side effects for CHANTIX, what is the percentage that you would get swelling of the lips or nausea?........................ You don’t know, no one knows. It’s a best guess. Even the clinical trial information provided to you in the PI, package insert, can’t tell you if you will have a side effect. It can only tell you the percentages of the people who had side effects in the trials. The entire pharmaceutical industry revolves around risk vs benefit. If a pharma & the FDA believe that a product can help people, because there is a need for it and its benefits out weight the risk, it is marketed.

 

[roxinal]

The point is these are non tobacco products. Iowa is a state they prohibit smoking cigatettes outside in the parks beaches etc, Is this going to happen next with ecigs it is taking away our rights I understand respecting peoples rights and if it is offensive to others then go outside the bathroom or whatver, If you give them an inch they will take a mile., The bottom line is the money the states are going to loose by not buying analogs and the big pharma guys back the FDA of course by us smoking cigarettes they make money even if it is to stop try their gum, patches, inhalers, lozengers, chantrix and if we continue to smoke well hey you got chemo, radation, albuteral inhalers, morphine and ll of that and we all know the big tobacco industeries back a lot of our senators, and up the line. It is all about money, and they are nitpicking everything, One person posted that eventually the tobacco company will eventually sell these and tax these and get their peice of the pie and I agree some day that will happen. I for one think these people make me sick

 

[rothenbj]

O

First let me say I am a Dossier Specialist (aka Submissions Publisher) for one of the top 5 Parma’s in the world. It is my job to know or find the FDA regulations for submitting applications (NDAs, Supplements, Amendments, etc) to the FDA. So on this topic I have a lot....

Okay Drew, you are the man to answer these questions.
From your experience, how long on average does it take a drug company to move a new drug through the NDA process? What's the quickest and longest that it could take?

Not being offered up by a Pharma company, how do you feel an organization would deal with this process? Also, not being presented by a Pharma company, what would you feel the chances are that there would be a fast track allowed. If so, average time to get to market.

I also worked in the industry, but on the business side in IT.

Ive tried to elaborate on how FDA approval will narrow the field on approved devices and liquid content, but you are much closer to the process.

 

[NJDrew]

O

Okay Drew, you are the man to answer these questions.
From your experience, how long on average does it take a drug company to move a new drug through the NDA process? What's the quickest and longest that it could take?

Not being offered up by a Pharma company, how do you feel an organization would deal with this process? Also, not being presented by a Pharma company, what would you feel the chances are that there would be a fast track allowed. If so, average time to get to market.

I also worked in the industry, but on the business side in IT.

Ive tried to elaborate on how FDA approval will narrow the field on approved devices and liquid content, but you are much closer to the process.

I apologize for not answering you sooner; we are hitting the end of the year rush to get stuff out the door.

The NDA process takes years and costs millions of dollars. How many years and dollars depend on the product. e-Cigs are not a drug and not a medical device in the traditional sense. I must admit I not that familiar with medical devices as they are neither INDs nor NDAs, however looking threw some of the guidance’s, this might fit:

Devices Appropriate for Expedited Review ​

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FDA considers a device, or combination product containing a device,​

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[/FONT][FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]7 [/FONT][/FONT][FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]appropriate for expedited review[/FONT][/FONT][FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]8 [/FONT][/FONT][FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]if the device or combination product: ​

2. addresses an unmet medical need, as demonstrated by one of the following:

d. The availability of the device is in the best interest of patients. [FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]That is, the device provides a specific public health benefit, or meets the need of a well-defined patient population. This may also apply to a device that was designed or modified to address an unanticipated serious failure occurring in a critical component of an approved device for which there are no alternatives, or for which alternative treatment would entail substantial risk of morbidity for the patient.
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Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices

 

[Pack-A-Day]

The only suggestion I can make here is to STOP CALLING THEM E-CIGS. If you don't want laws that put them in the same category as cigarettes (cigs) then don't name them cigs.

Also, Don't go the extra mile to make them look exactly like a cig with the little end that lights up, etc.

If lawmakers equate them with tobacco products, these things may have contributed to the problem.

Also, if any of you have a chance to participate in any laws being voted on in your states by contacting lawmakers, you might consider reminding them that these are not necessarily a nicotine delivery system. Many of us use zero nicotine e-juice. How can they ban that?

 

[NJDrew]

The only suggestion I can make here is to STOP CALLING THEM E-CIGS. If you don't want laws that put them in the same category as cigarettes (cigs) then don't name them cigs.

Also, Don't go the extra mile to make them look exactly like a cig with the little end that lights up, etc.

If lawmakers equate them with tobacco products, these things may have contributed to the problem.

Also, if any of you have a chance to participate in any laws being voted on in your states by contacting lawmakers, you might consider reminding them that these are not necessarily a nicotine delivery system. Many of us use zero nicotine e-juice. How can they ban that?

To quote one of my favorite movies "I'm afraid that time has come and gone, my friend...." They will be forever known as e-cigs. Even if every distributor started calling them PVs, the headline would read Personal vaporizers aka electronic cigarettes....