AAPHP to the FDA - Talking points discussion for comments submissions

[Bill Godshall]

[edit by SJ - this thread is for discussions for comments submissions to the AAPHP only, if you wish to discuss the general issues surrounding this action, please do it on this thread: http://www.e-cigarette-forum.com/fo...lease-aaphp-petitions-fda-10.html#post1136417 All off topic posts on this thread will be moved there. Thanks]

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/ScienceResearch/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

 

[Bill77094]

On the comment submission forms, you are given a submitter category, with numerous choices (for example, "Other Government - G0022"). Which ones do we select for the specific petitions? The submitter Category is a mandatory field, so it cannot be left blank.

 

[DC2]

For the first petition...

I am strongly in favor of NOT regulating electronic cigarettes as drug devices. If that were to happen, I would be sent back to smoking Camel Lights until electronic cigarettes are once again approved. This, in spite of the fact that I have been free from cigarettes for over eight months now. And when they are finally approved it is most likely they would be have been rendered completely useless, just like all other smoking cessation products. The end result therefore being that I will never be able to quit smoking again.

And for the second...

It is hard to understand the misleading conclusions draw from the FDA testing in question. And it is disturbing beyond words the way those conclusions were presented to the media for mass consumption. There are millions of lives as stake, and countless numbers of those lives can and will be saved if a press conference were held to correct the obvious misrepresentations of the test results, and the erroneous conclusions being drawn by both the media and the public at large.

 

[Kobudo]

On the comment submission forms, you are given a submitter category, with numerous choices (for example, "Other Government - G0022"). Which ones do we select for the specific petitions? The submitter Category is a mandatory field, so it cannot be left blank.

There is an option for "Independent Consumer," if that is what you are. That's what I chose.

 

[yvilla]

On the comment submission forms, you are given a submitter category, with numerous choices (for example, "Other Government - G0022"). Which ones do we select for the specific petitions? The submitter Category is a mandatory field, so it cannot be left blank.

If you are submitting simply as an individual consumer, then the most appropriate category would be "Individual Consumer". If you are a supplier, then you might want to use "Private Industry" instead.

There are also categories for "Consumer Group", "Health Professional", "Media", "Academia", etc. We should all pick whichever category is the most appropriate to our individual situation.

 

[GregH]

Signed them both.

 

[override]

Signed the first for now....Below is what I wrote.

I have been using Electronic Cigarette devices for something of about 8 months now. I was a smoker of 7 years and although I had many desires to quit smoking. I never could find a way to put the cancer sticks down until I heard about electronic smoking devices.

Since picking up my first Intellicig Evolution E-Cig I have not smoked a single cigarette. After the first month of smoking I already noticed a HUGE difference in the way I felt. I noticed I was able to get a better nights sleep and breathe easier. I stopped getting daily headaches and didn't reak like an ashtray. My blood pressure has dropped to a normal rate aswell since "vapeing". The biggest improvement in my personal opinion is that my chest no longer feels like I have a 50 pound weight on it all day.

Electronic Smoking devices or what have you need to be accepted and approved as a nicotine delivery device. Although Im saying that these devices should be legalized, I am not saying that just anyone should be able to purchase them. I do feel that an age restriction of atleast 18 should be in place. I also feel that companies should package and secure there products in a "child safe manner" and should inform the purchasers of the potential hazards of using nicotine products, while also informing users of the proper usage and handeling of elctronic smoking devices.

Please allow electronic cigarettes to stay a legal and active form for use as an alternative to smoking. For the sake of myself and others who have successfully quit smoking and have made themselves a healthier people by choice. For the futures of others that have yet to discover the wonders of electronc smoking devices.

Thanks for your time,
Robert Pfeil

 

[nugod777]

Signed both petitions using my own story as well as trying to hit on all suggested talking points. I hope it helps!

 

[pitzerdog2]

Thank you for keeping me informed. This is exactly what I hoped for by registering to this forum, an oppourtunity to voice my opinion on the benefits of vaping before some government agency takes this practice away from the people. I am working on the petitions this evening. Many thanks... happy vaping to all!

 

[thefuminati]

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


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.

- - - -

If the FDA reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products wouldn't they be able to add tobacco tax to them? If so we could see the price of them skyrocket higher than regular tobacco products due to the longer lasting and reusable nature of the product. Since they get to tax every aspect of regular tobacco products wouldn't it seem they would raise tax on e-liquid since the other parts of the PV's are reusable and therefor not purchased as often.

 

[Vocalek]

The FDA does not levy or collect taxes on consumer products.

 

[kristin]

If the FDA reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products wouldn't they be able to add tobacco tax to them? If so we could see the price of them skyrocket higher than regular tobacco products due to the longer lasting and reusable nature of the product. Since they get to tax every aspect of regular tobacco products wouldn't it seem they would raise tax on e-liquid since the other parts of the PV's are reusable and therefor not purchased as often.

If they get classified as drug delivery devices, the pharmeceutical companies will charge an arm and a leg for them. Government taxes will seem like a deal by comparision. Just look at what they charge for Nicotrol and nicotine gum compared to a heavily taxed pack of cigarettes.

Besides, as a tobacco product, we can lobby the legislators to NOT put the sin tax on this particular "tobacco product" because it is a reduced harm product. If Big Pharma gets their hands on them, we'll have no way to lobby to keep them affordable.

 

[miss MiA]

...I figure I may well have missed something pretty obvious somewhere , but... what the heck are the due dates/cutoff dates for comments on these matters?? In the FAQs at the Regulations.gov site I see:

Where can I find the due dates for comments?

The Comment Due Date is located below the titles in the Search Results.
To find all documents with comment periods closing in the near future, click the tab on the homepage that reads, "Regulations with Comment Periods Closing Soon."

Note: The comment due date is based on Eastern Standard Time. For example, if the Comment Due Date is 05/05/2009, it means that the comment is due on 05/05/2009 11:59:59PM ET.


...but no matter how I bring up any filing or list of filings on the site, I'm still not seeing anything like exact future dates anywhere around them, only dates of previous activity of various kinds...

 

[basic_atheist]

Done!......

 

[trailblazer6]

Me too. I just hope it is effective

 

[(So) Jersey Girl]

Here's mine:

American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition (FDA-2010-P-0095-0001)

COMMENT

I urge the FDA to classify electronic cigarettes/nicotine vaporizers as tobacco products for the reasons detailed in this petition. I smoked for over 35 years. I tried to quit many times using FDA-approved products, starting back in the late 80's, and cold turkey without success. Quitting smoking was the worst thing I ever did. I became a depressed, suicidal mess. Never once did any doctor connect my suicidal depression to nicotine abstinence. I had to figure this out for myself. I eventually decided that it would be better to die from a smoking related illness than from putting a bullet through my brain. (I am sitting here in tears as I type this from the memories of those horrible times. I assure you, the above is NOT an exaggeration.) I would pray to God at night for something/anything that could deliver the nicotine I needed without all the harmful effects of smoking. I found the answer to my prayers on January 22, 2010 when I bought my first PV (personal vaporizer). I had no intention of quitting smoking when I bought this device. I bought it solely as a substitute for regular cigarettes. The fact that I haven't smoked a single cigarette for over 3 weeks is a happy accident. I find it unconscionable that I could soon be forced to smoke tobacco again because of the FDA. Yes, nicotine is a drug, but it is a drug that I can legally consume through smoking. I should have the same right to consume it in a non-hazardous tobacco product like an electronic cigarette. I have done my own research into these devices and have concluded that these are safe for me. I support reasonable regulation to ensure that the nicotine liquid I use meets established manufacturing standards as to content, labeling and any necessary hazard warnings. Thank you for this opportunity to share my story. For me, this issue is a matter of life or death.

 

[(So) Jersey Girl]

Here's the other one:

American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition (FDA-2010-P-0093-0001)

COMMENT

I concur with the views expressed by the AAPHP. Last summer, while I outside in the "smoking section" I first heard of electronic cigarettes. Many of my co-smokers were discussing the benefits of using a product that would allow them to continue to smoke without the negative health consequences. Then came the FDA press release. All talk about e-cigs ended because the all knowing FDA said it was worse than smoking tobacco. I was totally floored when I read for myself the actual FDA report and learned that the FDA had seriously misrepresented the results of their own findings to the public. It is crucial to the mission of the FDA that the American public have confidence in the agency. To continue to mislead the public into believing that electronic cigarettes are as dangerous as or more dangerous than tobacco cigarettes will only serve to further erode that confidence. The FDA needs to remove itself from the influence of special interest groups that provide false and alarmist information in the name of saving children and to focus on improving the health of millions of nicotine addicted adults who would eagerly switch to e-cigs if the FDA told the truth. BTW, none of the other folks who were discussing e-cigs that day last summer have switched. Whenever they see my with my PV, they remind about how bad the FDA says they are for me. I just tell them the FDA lied.

 

[ChipCurtis]

Basically we are locked into a culture-war stalemate on the issue of e-cigs. If we take one position to try to protect it (say, tobacco classification), the anti's will take the other position (drug-delivery device). If we switch positions in order to gain an upper hand halfway through this legal battle (let's say, okay, go back to drug delivery device), the anti's will again shift gear and switch back to their original position (tobacco product) to gain the upper hand on us.

It's just at this point a legal circus game of cat and mouse; whoever has the most clever lawyers and the most cash, as well as ability to manipulate public opinion, will prevail. And the anti's have the public perception thing (based on 20 years of anti-smoking hysteria) in the bag.

 

[debareb]

My name is Debbie and I have had two heart attacks and I have a difibrillator implant in my chest. I tried the gum and the patches and wellbutrin. I kept going back to cigarettes. On the 2nd attack I told the cardiologist that nicotine was harder to kick than ........ He left to research came back later and said I was right and he was sorry.
I picked up an e-cig 1/15/10 and never touched another cigarette. I had COPD as well and two weeks after quiting cigs I saw my pulmonologist to get my regular tests. My lung function had quite improved!! I know this is long winded but my story is REAL and I feel like e-cigs have saved my life. Blood pressure is good and heart rate is level. I can work down to zero nic and still blow vape that I love. Please keep it legal! Thanks

 

[(So) Jersey Girl]

It's just at this point a legal circus game of cat and mouse; whoever has the most clever lawyers and the most cash, as well as ability to manipulate public opinion, will prevail. And the anti's have the public perception thing (based on 20 years of anti-smoking hysteria) in the bag.

I don't necessarily agree that the anti-smoking movement has a lock on public opinion. Sure, they've been beating us over the head with how bad smoking is for years but now there's an option that provides the nicotine without all the harmful effects of smoking. The public will see the benefits of this unless the anti's are successful in convincing them that e-cigs are as bad as, or are worse, than tobacco cigarettes. That's why it's critical that the FDA publicly retracts their previous erroneous statements. The public hates self serving fanatical zealots no matter what their ideology.