Aaphp Has Submitted Two Citizens Petitions To The Fda

[BirdDog]

NOTICE: This post as been updated and edit by the Admin. This is a direct copy from ECF created by Executive Director Smokefree Pennsylvania. Please take a moment to read it - Christopher

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Alert: Urge FDA to protect health of smokers and vapers, not cigarettes

Dockets now available to submit comments urging FDA to protect the health of smokers, not cigarettes

The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products (instead of trying to ban the products by classifying them as drugs or devices) is at Regulations.gov

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Suggested talking points:

- since e-cigarettes (nicotine vaporizers) are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products",

- by choosing to classify e-cigarettes as "drugs" or "devices", the FDA was/is attempting to ban the products,

- hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes,

- by reclassifying e-cigarettes as tobacco products, the FDA would ban their sale to minors, can establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste,

- in SE vs FDA, federal Judge Richard Leon has ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices",

- sales and use of e-cigarettes have continued to sharply increase despite the FDA's ongoing attempt to ban the products,

- banning e-cigarettes would primarily protect cigarette markets at the expense of consumer and public health,

- if applicable, describe your personal experience using e-cigarettes.

- - - -

The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to clarify/correct inaccurate and misleading claims about electronic cigarettes (nicotine vaporizers) made at the FDA's July 22, 2009 press conference, and to truthfully inform the public of existing evidence about the products is now available at Regulations.gov

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Suggested talking points:

- the FDA Electronic Cigarettes grossly mispresented its own laboratory test findings on two brands of e-cigarettes http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf

- in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user or nonuser, and there is no evidence that e-cigarettes are marketed to youth,

- the FDA failed to acknowledge any evidence (sent to the agency) that e-cigarettes are far less hazardous alternatives to tobacco cigarettes, and that thousands of e-cigarette users informed the agency they had quit smoking by switching to the products,

- cigarette smokers have a human right to truthful information about, and legal access to, less hazardous alternatives,

- FDA officials have an ethical duty to protect consumer health and to provide truthful health risk information,

- if applicable, describe your personal experience using e-cigarettes.

- - - -

More than TWO YEARS have passed since NY State Health Commissioner Richard Daines submitted a Citizens Petition to the FDA at Regulations.gov to (1) allow FDA approved Over The Counter NRT products (i.e. nicotine gums, patches and lozenges) to be sold in all stores that sell cigarettes; (2) allow NRT products to be sold in less expensive daily dose units; and (3) change labels on NRT products to inform consumers of the health benefits of NRT compared to cigarettes, to eliminate unsubstantiated health warnings, and to encourage use of NRT if tobacco use continues.

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Please note that another petition very similar to Richard Daines' petition was recently submitted by SRNT and ATTUD, which is now awaiting docketing by the FDA.

Suggested talking points:

- many more smokers would try using NRT products if they are sold in $5-$10 packages instead of just in $35+ packages,

- more smokers would try using NRT products if they are sold at more retail stores alongside cigarettes,

- current warning labels on NRT products mislead many consumers to believe they pose far greater health/safety risks than is the case,

- NRT products are far less hazardous than cigarettes, and are often used as temporary and/or long term substitutes for cigarettes,

- smokers can reduce their health risks by concurrently using NRT products and cigarettes, with risk reduction proportionate to cigarette reduction,

- many/most NRT products are consumed by people who have used the products longer than the twelve weeks currently approved by the FDA, and

- although clinical trials find that just 7% of NRT users remain smokefree after six months, many NRT users consider them acceptable alternatives to cigarettes.

Bill Godshall

Executive Director

Smokefree Pennsylvania

1926 Monongahela Avenue

Pittsburgh, PA 15218

412-351-5880

smokefree@compuserve.com

[StevenP]

Definitely going to support this!! On my way to the links now!

[Mark]

Nice find Birddog. +1 for you!!

[BirdDog]

Thanks for making it look better.

[Compenstine]

I only see one problem with this, if I may without dodging bricks If they are labeled as "tobacco products" then they fall under the no smoking bans and are no longer allowed anywhere smoking is not. For example, MI just passed a law that bans all "Tobacco Products" from public places. This includes anywhere the public is gathered. Bars, Outdoor events, and 35 feet from any public place including the sidewalks. By the wording of this law it would include the e-cig if it were labeled a "tobacco product" would it not?

[Christopher]

Compenstine you bring up a very valid point here. I suppose it's sort of a catch 22 here. Anyone else's thoughts on this?

[Jeffb]

It seems that because of the FDA battle, we have pushed to have e-cigs classified as a tobacco product so the FDA wouldn't regulate them. We obviously don't want them classified as a drug delivery device. Maybe e-cigs need their own classification?

[CNubel]

I only see one problem with this, if I may without dodging bricks If they are labeled as "tobacco products" then they fall under the no smoking bans and are no longer allowed anywhere smoking is not. For example, MI just passed a law that bans all "Tobacco Products" from public places. This includes anywhere the public is gathered. Bars, Outdoor events, and 35 feet from any public place including the sidewalks. By the wording of this law it would include the e-cig if it were labeled a "tobacco product" would it not?

While I agree with the spirit of the plan of the AAPHP, I can't get behind the letter of it. It is not a tobacco product, there is no tobbaco in it. Calling e-cigs a tobacco product because it contains nicotine is like calling Coke-A-Cola a fruit because it contains sugar. Thats a can of worms I don't think we can afford right now.

Edited March 10, 2010 by CNubel

[markarich159]

I only see one problem with this, if I may without dodging bricks If they are labeled as "tobacco products" then they fall under the no smoking bans and are no longer allowed anywhere smoking is not. For example, MI just passed a law that bans all "Tobacco Products" from public places. This includes anywhere the public is gathered. Bars, Outdoor events, and 35 feet from any public place including the sidewalks. By the wording of this law it would include the e-cig if it were labeled a "tobacco product" would it not?

I agree totally. The best possible outcome would be to have e-cigs and e-liquid classified seperately as a non-tobacco, recreational nicotine delivery system. Besides the various public tobacco bans that would immediately apply to e-cigs, the relevant Federal, and State tobacco taxes would also immdiately be assesed. Although I'd definitely not want to see e-cigs regulated as drugs, I don't see this as a viable solution either. But if it comes down to it, I guess this(tobacco regulation) would be good enough for the time being.

[FTJoe]

I agree totally. The best possible outcome would be to have e-cigs and e-liquid classified seperately as a non-tobacco, recreational nicotine delivery system. Besides the various public tobacco bans that would immediately apply to e-cigs, the relevant Federal, and State tobacco taxes would also immdiately be assesed. Although I'd definitely not want to see e-cigs regulated as drugs, I don't see this as a viable solution either. But if it comes down to it, I guess this(tobacco regulation) would be good enough for the time being.

Recreational? Ouch, there comes the specter of kids vaping, but I get the point. No matter what these are an NRT, no NRT has to be defined as something that has to be stopped, though that is the goal. I know at least two people that quit and continue popping nic gum all day long. I would go further and say PVs can be used as a quit device for not only smoking but nicotine, in fact the best one available.

[markarich159]

Recreational? Ouch, there comes the specter of kids vaping, but I get the point.

I hear ya. How about, non-tobacco, non-therapeutic, nicotine delivery devices.(NNNDD's)

[cmdryker]

Or just a non-burning (no flame) tobacco product, If they word it that way it solve the problem

[VapOrDie]

Or just a non-burning (no flame) tobacco product, If they word it that way it solve the problem

But "Big Tobbaco" wants us to buy their new "Snus" if we want nicotine where smoking is prohibited. Vaping is just in their way of a bigger bottom line.... Plain and simple.

[Mark]

Or just a non-burning (no flame) tobacco product, If they word it that way it solve the problem

But pvs are not tobacco products--nicotine products maybe (some can be 0 nic), but not tobacco products--

[Compenstine]

I think the strongest point that can be made is there are flavors out that have no nicotine and no tobacco flavoring at all in them. How can something be a tobacco product and not contain tobacco? This is where they should be separated from "Tobacco Products". The device it's self is not a pipe or any other smoking paraphernalia. It is a vaporizer. A device that vaporizes PG and "simulates" smoke. The fluid on the other hand could be a tobacco product if it indeed has nicotine extracted from tobacco and the same with the some flavors. But those alone do not cause cancer or any known ill effects to the surrounding public. Patches and gum have nicotine but they are not under fire because they do not emit vapor or smoke. They have nicotine and in the case of gum, flavor... so wouldn't they have to ban those in public places as well? They would be a "Tobacco Product" as well with the way they want to regulate PV's.

[haft2doit]

I think the strongest point that can be made is there are flavors out that have no nicotine and no tobacco flavoring at all in them. How can something be a tobacco product and not contain tobacco? This is where they should be separated from "Tobacco Products". The device it's self is not a pipe or any other smoking paraphernalia. It is a vaporizer. A device that vaporizes PG and "simulates" smoke. The fluid on the other hand could be a tobacco product if it indeed has nicotine extracted from tobacco and the same with the some flavors. But those alone do not cause cancer or any known ill effects to the surrounding public. Patches and gum have nicotine but they are not under fire because they do not emit vapor or smoke. They have nicotine and in the case of gum, flavor... so wouldn't they have to ban those in public places as well? They would be a "Tobacco Product" as well with the way they want to regulate PV's.

Maybe what needs to be done is change the way pv's and juice are marketed. The device does not require nicotine. The nicotine juice is the same as gum, or patch. If you were to ingest the juice without vaping, say by putting a drop on your tongue, There would be no problem. So market them as two different products. The pv just to be used with usp or pg, and the juice as a way to ingest nicotine. There are problems of course but just a thought.

[Compenstine]

Compenstine you bring up a very valid point here. I suppose it's sort of a catch 22 here. Anyone else's thoughts on this?

Yes it is a catch 22. I think the regulations are going to come down to the fluid and what is contains. This is going to raise cost for the people making it. I would expect in time fluid will go up in price as the regulations are set up. I wish the FDA would get off it's high horse and work with those like AAPHP, Heath Insectors, Department of Agriculture (Regulates licensing for handling Nicotine), and others to come up with a workable solution. We were talking in our shop about doing fluid and standards that should be in place. We are taking our own steps to clarify these things now for our store.

[BirdDog]

You all have made very valid points about classifying the e-cig as a tobacco product. I do agree this is a catch 22.

If you can not get behind the petition for the classification, it is completely understandable. I still have not made up my mind about this subject either.

Please don't forget there is a second petition asking the FDA to clarify/correct inaccurate and misleading claims about electronic cigarettes. I think we can at least all agree on this one that the FDA needs to fix this error.

[Compenstine]

You all have made very valid points about classifying the e-cig as a tobacco product. I do agree this is a catch 22.

If you can not get behind the petition for the classification, it is completely understandable. I still have not made up my mind about this subject either.

Please don't forget there is a second petition asking the FDA to clarify/correct inaccurate and misleading claims about electronic cigarettes. I think we can at least all agree on this one that the FDA needs to fix this error.

It's not that I agree or disagree so much I see this as a work in progress. The more we talk about it the more clear we can be when discussing it in letters we write and things we do to get this gray areas cleared. This is a very good topic to make and get talk flowing about these issues.

[Uma]

While I agree with the spirit of the plan of the AAPHP, I can't get behind the letter of it. It is not a tobacco product, there is no tobbaco in it. Calling e-cigs a tobacco product because it contains nicotine is like calling Coke-A-Cola a fruit because it contains sugar. Thats a can of worms I don't think we can afford right now.

I agree completely with this poster and the others who've voiced a concern. I won't sign it as is either.

I agree with the renaming of the products, changing the offical names and terms used for them.

I vote we open a brainstorming thread. Some great ideas have already been tossed in the basket.

[ThornsofTime]

Another interesting point to make...

When you boil it down to its basic basic basic concept: vaporizers are just a delivery method. Less invasive then a shot, faster acting than pills.

Who is the FDA to tell me how I can or cant introduce nicotine to my system. Its not as if were going the opposite way... were not standing in dark alleys thumping our veins holding a rusty needle trying to get our fix. Our desired method has MANY benefits BEYOND our personal health. THINK ENVIRONMENTAL juice bottles are reusable, cigarette butts are not. Smoke is deteriorating our ozone, vapor is not. Cigarettes can start fires, vaporizers cant. Do I need to continue??

The way I see it:A) we have a right to nicotine, just as we have the right to alcohol (we pay for that right through HEAVY taxation). vaporizing is a medically acceptable delivery method for any "drug", it is less invasive than a shot (useful for hemophiliacs) and no worries of stomach ulcers as with pills. WHY IS THE FDA SO OPPOSED TO COMBINING THE TWO?!?!?!?!

As and end-note- If e-cigs contained ONLY VITAMIN C, why do I have the suspension that the FDA would praise it as a new and innovative way for parents to get there kids to take care of their immune systems.

[CNubel]

Recreational? Ouch, there comes the specter of kids vaping, but I get the point. No matter what these are an NRT, no NRT has to be defined as something that has to be stopped, though that is the goal. I know at least two people that quit and continue popping nic gum all day long. I would go further and say PVs can be used as a quit device for not only smoking but nicotine, in fact the best one available.

I'm leary of calling them NRT's. The FDA will jump all over that and call them drug delivery systems. Many people use them as NRT's, but there are a lot of people out there that vape 0mg nic juice. They will be impacted by that label to a great degree if the FDA puts PV's under the classification of a drug deliver system. If there is no nic in gum, its just a piece of gum. If there is no nic in the juice, a PV will still be a drug delivery device if the FDA gets their way.

[CNubel]

Maybe what needs to be done is change the way pv's and juice are marketed. The device does not require nicotine. The nicotine juice is the same as gum, or patch. If you were to ingest the juice without vaping, say by putting a drop on your tongue, There would be no problem. So market them as two different products. The pv just to be used with usp or pg, and the juice as a way to ingest nicotine. There are problems of course but just a thought.

Excellent idea. I've never liked the ways PV's are marketed. I personally think we should divorce ourselves from any relationship with cigarettes. Stop calling them e-cigs and start calling them PV's. Don't make them look like cigarettes either. Make them look like anything other than a cigarette. Most mods don't resemble cigarettes at all, but many of the stuff sold in malls and on the radio do. We need to move away from that line of thinking.

Edited March 11, 2010 by CNubel

[FTJoe]

I'm leary of calling them NRT's. The FDA will jump all over that and call them drug delivery systems. Many people use them as NRT's, but there are a lot of people out there that vape 0mg nic juice. They will be impacted by that label to a great degree if the FDA puts PV's under the classification of a drug deliver system. If there is no nic in gum, its just a piece of gum. If there is no nic in the juice, a PV will still be a drug delivery device if the FDA gets their way.

Yeah - as noted earlier (by you?), could make it two separate items, a PV which in and of itself is nothing, and juice with nicotine. I would hazard a s.w.a.g that 98% of the people using them do so with nicotine. So what we want to call them is irrelevant, they are ultimately NRTs. Now I used it to get to 0, and in doing so, I lost the urge to vape as well, so I quit everything. But I still insist using them with nicotine is better than smoking. As an FYI I'm now vaping as much as I can as I think quitting vaping brought on some weight gain...

Edited March 12, 2010 by FTJoe

[crossbar]

I have a hard time with them regulating e-cigs as a tobacco product because then they would be classified AS a tobacco product; therefore, they would be subject to the same tabacco taxtation laws for each state. The price of juice would go through the roof!