Comments Please on AAPHP Petitions to FDA

[AJMoore]

I made a comment, let's see if it ever appears!


Success! Your Comment Has Been Submitted
Comment Tracking Number: 80ad5fc8
Thank you for submitting a comment on the following OTHER

 

[thorn]

Success! Your Comment Has Been Submitted

Comment Tracking Number: 80ad6769
Thank you for submitting a comment on the following OTHER
Document ID: FDA-2010-P-0095-0001: American Association of Public Health Physicians, tobacco Control Task Force (AAPHP) - Citizen Petition

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I left my comment, add yours! In the "View By Relevence" boxClick, on the right side under "Actions", click on "Submit a Comment" in blue. Link: Regulations.gov

 

[LuckyCharm]

Success! Your Comment Has Been Submitted
Comment Tracking Number: 80ad63c7
Thank you for submitting a comment on the following OTHER

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

I have been a confirmed cigarette smoker for over 30 years, with no intention of quitting, until I obtained my first e-cigarette. Literally, I quit "by accident," without even meaning to! The e-cig allows me to enjoy my nicotine with the added pleasure of inhaling a vapor (which patches or gum wouldn't provide) without all the harmful chemicals and carcinogens associated with traditional cigarettes. My health is much improved with the e-cig -- no more coughing fits, better stamina with physical exertion, etc. -- and I no longer have ugly butts to dispose of, the fire hazard associated with lighters and hot ashes, or a tarry film coating the surfaces around me. Since nicotine is quickly absorbed into the body, the vapor I exhale is harmless, and I can now "smoke" around my parents (who are very sensitive to airborne contaminants) and my dog.

I oppose any effort to classify the e-cig as a drug delivery device because unlike the patches or gum, the e-cig is not used to treat a condition (smoking cessation), but is rather a recreational novelty that is often used with no nicotine at all. Most e-cig users are not attempting to quit the habit altogether, just to pursue it in a safer way.

For the same reason, I oppose any effort to classify them as tobacco products, because that would impact people who do use them without nicotine.

In short, I oppose any regulation that would place undue restrictions on adults' ability to obtain and use these products at their own discretion. Many physicians have spoken out loudly in support of their use, having seen real health improvements in patients who use them.

Thank you for considering my comments.

 

[LuckyCharm]

Success! Your Comment Has Been Submitted
Comment Tracking Number: 80ad63ca
Thank you for submitting a comment on the following OTHER

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

(Same exact text as above post)

 

[Mister]

My comment was submitted on 2010/3/13 and I was given tracking number 80abd06f. My comment has not appeared on the docket.

 

[rothenbj]

Below is my resubmission to the FDA, foolish was I not to key it into a word document first then submit it as I did this time. Who would have thought that the FDA would misplace comments........

Success! Your Comment Has Been Submitted
Comment Tracking Number: 80ad69ee
Thank you for submitting a comment on the following OTHER
Document ID: FDA-2010-P-0095-0001: American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition

I am writing to request that the FDA not put the electronic cigarette in the Drug Device category and allow the product to remain on the market as has been stipulated in the Citizen’s Petition. To take this product off the market and to force it into the ethical drug approval process is equivalent to the FDA issuing the death sentence to 400,000 smokers each year that it remains off the market. There have now been years of use globally and a few years of use in the US without any serious health issues identified. The product removes the most harmful aspects of smoking and enables smokers to have a product that actually works. Not allowing this product to remain on the market would be the most significant setback in our country's attempt to get people to stop smoking real cigarettes since the bad science the tobacco industry furnished. Don’t allow the “bad science” of the anti-smoking zealots lead to this mistake.

I was a 43 year smoker, quitting after my habit had reached a 2 to 3 pack a day habit. I have not had a cigarette in two months and had reduced my intake to less than half a pack soon after finding the e cigarette about 8 months ago. I tried ever FDA approved method of quitting as well as a few herbal remedies and hypnotism. I did not try Chantix because of the bad adverse reactions I read about and the suicides reported. I wanted to quit so I didn’t die from them, not die trying to quit.

None of the FDA approved methods worked as has been proven by the dismal one year record of all the products, they just don’t work. The e cig works, open your eyes. I had started coughing a lot on cigarettes. I’d go to sleep coughing and I’d wake up in the middle of the night coughing. I developed a wheeze. I can honestly say that both those symptoms are now gone. I am one of thousands that have had similar benefit from these products- DON”T TAKE THEM OFF THE MARKET!

 

[CES]

Although I resubmitted my comments, I'm curious about what happened to the first ones. I don't want to assume conspiracy, though incompetence isn't a whole lot better. So, I sent an email with one of the tracking numbers for the first comments to the help regulations.gov help desk. I'll let you know if i get anything back....

This confirmation number is about my email to the help desk- it's not the confirmation for the actual comment.
Success! Your Question or Suggestion Has Been Submitted
Help Desk Tracking Number: 6510
Thank you for Submitting a question or suggestion to the Regulations.gov Help Desk

 

[m201]

I think we may have to join regulations.gov

Click on the Exchange tab at the top

It reads "Browse the Exchange to view our latest proposals and log in to share your opinions."

Anyway, I did, and received this:

"m201,

Thank you for registering at Regulations.gov Exchange. Your application for an account is currently pending approval. Once it has been approved, you will receive another e-mail containing information about how to log in, set your password, and other details.


-- Regulations.gov Exchange team"

I will resubmit my comments on

the petition to reclassify FDA-2010-P-0095-0001 and the petition regarding the press conference FDA-2010-P-0093-0001

as soon as my membership is confirmed -- and see if the comments show up sooner ...

It is strange though, because I am sure that when I submitted my comments on April 01, 2010 and received Comment Tracking Number: 80ace4f8 and Comment Tracking Number: 80ace937

there were comments from EC and ECF, etc. When I looked at all 64 today, they are all under the agency of FDA ????

Will let you know what develops with joining the "Exchange" ...

 

[rothenbj]

I didn't submit a response to the second Petition the first time I went to the FDA site since I really thought there would be little chance that the FDA would ever publicly admit that what they published and addressed was hogwash. However, after having to again address the first part, I decided that even if they did nothing on the second, they should hear how a citizen feels.

Success! Your Comment Has Been Submitted
Comment Tracking Number: 80ad6b6e
Thank you for submitting a comment on the following OTHER
Document ID: FDA-2010-P-0093-0001: American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition






I am not a scientific person, but I was able to review the report that the FDA used as the basis for their July 22nd show. Other than the one cartridge that supposedly had DEG in it, the numbers I saw matched up with the numbers for approved FDA NRT drugs.

E cigs are not NRT drugs, their users do not expect to have a completely safe product, they just want something that is safer than the cigarettes they’re smoking. As a senior citizen that has done my part for this “free” country, I should be allowed to make decisions on my own health. I certainly prefer to inhale something that may not be totally safe compared to something I know is definitely not, the cigarette.

For the sake of the millions that should be looking at alternatives to cigarettes, we should be able to trust our government to make us aware of products that may not be totally safe, but certainly much saver than a product that is on the market today- that would include things like e cigarettes and Swedish snus.

Gives us the comparison with the cigarette rather than “we don’t know what’s in the e cig“, for the good of the country.

 

[rothenbj]

My comment was submitted on 2010/3/13 and I was given tracking number 80abd06f. My comment has not appeared on the docket.

I wonder how many thousands of responses "felll through the cracks". This is beginning to look watergatish (not a word, but sure is appropriate).

 

[Vocalek]

Notification of Request Change
The following changes have been made to this Request: Changed Status to Closed from Open, Appended a Additional Comments., Added Assignee : Helpdesk.

[FONT=Verdana, Arial, Helvetica, sans-serif]Project: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]New Regulations.gov July 2009 [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Request: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Comment not posted [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Request Number: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]6495 [/FONT]
[FONT=Verdana, Arial, Helvetica, sans-serif]Status: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Closed [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Date: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]04/12/2010 [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Time: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]19:17:54 [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Creation Date: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]04/12/2010 [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Creation Time: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]17:13:07 [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]Created By: [/FONT][FONT=Verdana, Arial, Helvetica, sans-serif]RegsUser [/FONT]
Click here to view Request in Browser
Additional Comments:
Entered on 04/12/2010 at 19:17:54 by Patrick M:
The Regulations.gov Help Desk is unable to help you with this request. The
Regulations.gov Web site was created as a way for the public to review and comment on
proposed federal rules and regulations. We are unable to answer questions about
current federal rules and regulations.

Please contact the FDA Division of Dockets Management at 301-827-6860 to inquire
about the status of your comment.

If you need any help using the Regulations.gov Web site to review or comment on
proposed federal rules or regulations, please contact us again.

Thank you,
Regulations.gov Help Desk
Entered on 04/12/2010 at 17:13:07 by RegsUser:
On March 3, 2010, I left a comment on Document ID: FDA-2010-P-0093-0001: American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition. I received the tracking #80ab3df9 . It is now over one month later, and this comment does not appear. Can you explain this? Current Assignees: Helpdesk

So tomorrow I will be phoning the number to inquire about the status of my comment.

 

[ladyraj]

Thank you for all you do VocaleK! This is what I posted to the comment section:

The smoking alternative, referred to as an e-cigarette, has an inherent value of reducing the number of cigarettes smoked by individuals who use tobacco products. This benefit alone would justify the smoking alternative as a product that is in keeping with tobacco harm reduction strategies and tobacco control policy. Adding restrictions or putting in obstacles to a tool that many use to prevent tobacco usage seems unethical and dangerous to a population that one professes to want to protect. Please allow this valuable alternative to remain on the market as a viable replacement option to users of tobacco products. Thank You

80ad6cc7

 

[rothenbj]

Thank you for all you do VocaleK! This is what I posted to the comment section:

The smoking alternative, referred to as an e-cigarette, has an inherent value of reducing the number of cigarettes smoked by individuals who use tobacco products. This benefit alone would justify the smoking alternative as a product that is in keeping with tobacco harm reduction strategies and tobacco control policy. Adding restrictions or putting in obstacles to a tool that many use to prevent tobacco usage seems unethical and dangerous to a population that one professes to want to protect. Please allow this valuable alternative to remain on the market as a viable replacement option to users of tobacco products. Thank You

80ad6cc7

Good luck on seeing it show up on the site. I'm dying to find out what Elaine finds out today. I'd guess the thousands of responses to the petition ended up in digital la la land.

 

[rothenbj]

I decided not to wait around for someone to explain why our comments were not reaching the web site. I emailed both Pennsylvania Senators and my congressman and did a little selling on the electronic cigarette, explained the issues with comment not getting the the government web site and asking them to check into what the problem might be.

This has me more than a little upset. Time for a vape out in front of the FDA building.

 

[renderwerks]

Comment Tracking Number: 80ad798a



Wouldn't the media be interested if it turns out we're being censored?

 

[Vocalek]

I have just gone through this entire thread, found 11 tracking numbers and searched the FDA site. None was found. I did find the two comments left by Ladyraj and a comment from Territoo.

I just got off the phone with the FDA. I was told that my comment was probably not posted to protect my privacy. She mentioned something about addresses and phone numbers and I told her that I did not include my address and phone number and did want my comments published on the Web.

Please contact the FDA Division of Dockets Management at 301-827-6860 to inquire
about the status of your comment and let them know that you want yours to be published.

Document numbers are FDA-2010-P-0095 and FDA-2010-P-0093

If you have your comment tracking number, that makes it easier, but they can search by your first name / last name.

NOTE: Ladyraj selected "Health Professional" as her "Submitter Category". Maybe that is why hers and Territoo's comments did make it onto the Web. In the future, I will find a category other than "Individual Consumer". Maybe "Media - C002" would work.

 

[rothenbj]

I have just gone through this entire thread, found 11 tracking numbers and searched the FDA site. None was found. I did find the two comments left by Ladyraj and a comment from Territoo.

I just got off the phone with the FDA. I was told that my comment was probably not posted to protect my privacy. She mentioned something about addresses and phone numbers and I told her that I did not include my address and phone number and did want my comments published on the Web.

Please contact the FDA Division of Dockets Management at 301-827-6860 to inquire
about the status of your comment and let them know that you want yours to be published.

Document numbers are FDA-2010-P-0095 and FDA-2010-P-0093

If you have your comment tracking number, that makes it easier, but they can search by your first name / last name.

NOTE: Ladyraj selected "Health Professional" as her "Submitter Category". Maybe that is why hers and Territoo's comments did make it onto the Web. In the future, I will find a category other than "Individual Consumer". Maybe "Media - C002" would work.

I'm trying Drug Industry this time around since I retired from Big Pharma.

 

[Mister]

Very nice work Vocalek! You've discovered why a lot of comments aren't visible.

I suspect that this is deliberate obfustication by the FDA disguised as stupidity. The regulations.gov site (which states that it services nearly 300 federal agencies, not just the FDA) includes in its Privacy Notice the following:
"The comments you provide to a Federal Department or Agency through Regulations.gov are collected voluntarily and may be publicly disclosed in a rulemaking docket or on the Internet."

I think that some people were reluctant to post a comment on the petition because the site repeatedly and strongly suggests that the information a person posts will be made publicy available. And so it should generally, it is a place for public comments.

So what does the FDA do? They hide publicly made comments supposedly to protect privacy which people didn't expect to have. Call me cynical but I think this isn't just stupidity, that it is deliberate to keep the petition looking less strongly supported than it is. I wonder how many other layers of defense there are, all probably disguised as stupidity which can be explained away if discovered.

Oh well, the good news is that you've caught what they are up to on this one. As a result we don't know how many comments have been submitted nor their content. It is a fair guess that many times the number which are visible have been submitted. We can only hope that when (if?) the comments are reviewed internally at the FDA someone doesn't "forget" to print the hidden ones.

And the people here who are determined enough to have continued to follow this thread can now phone the number you've posted and request their comment to be made public.

 

[TropicalBob]

I finally wrote up my comment; I'm a kind of Mr. Dissolvable, having used the Stonewall product regularly since its introduction. I have a tracking number and will see if mine is posted in the next few days. I attached the full comment, since I can't even clear my throat in 2,000 characters!

Many of the responses to this topic will come from those with convictions about tobacco usage -- those who either want to prohibit it entirely or restrict alternative nicotine delivery sources. Their objections are a matter of principle.

I bring a different perspective. I have been a daily user of Star Scientific's Stonewall dissolvable hard snuff since it came on the market in 2004. In 2007, I turned to Stonewall and Swedish snus to kick a 50-year cigarette addiction. I had smoked 30 cigarettes a day until July 17, 2007. I have not had one since that date.

In January 2008, I purchased my first electronic smoking device and have since that date used e-pipes, e-cigars and e-cigarettes to satisfy the habit part of a smoker's practice.

At age 68, my health, by every medical measure, has improved substantially since quitting smoking. Every six months, I undergo blood tests, plus physical examinations. Smoking had taken me to the brink of stroke and surgery unclogged a 95% closed carotid artery. That became my impetus to quit smoking.

But I was and remain a nicotine addict. Truth is, I enjoyed smoking. I relished the alertness and relaxation that nicotine -- much like caffeine -- provides me. At the time I stopped cigarettes, I had no desire to quit nicotine, only to stop the harmful practice of inhaling combusted tobacco smoke into my lungs. Nicotine, after all, has known benefits. I have no reason to stop using it. I never intend to.

Many times in my life, I had tried to quit cigarettes. I have used, as directed, every one of the FDA-approved NRT products, with their abysmal success/failure ratios. None helped for long. I tried stepping down. I used the Quest nicotine-free cigarettes. I underwent hypnosis. I had a chemical concoction injected into my head -- at a cost of $400 -- that failed to help defeat the cravings for nicotine. I even went through horrible side effects while using Chantix.

They all fail for one reason: They provide nicotine but not the entire spectrum of alkaloids found in tobacco. That is a critical difference for smokers. Providing just nicotine results in a success rate not much better than a placebo. If nicotine were all a smoker needed, the NRT products would enjoy great success. They do not. Exactly the opposite happens. Smokers fail -- and pledge to never go through such agony again.

Dissolvable tobacco products provide nicotine and more. My Stonewalls have 4mg of nicotine per piece, much like the pharmaceutical lozenge. But Stonewall is a natural product, made from tobacco specially cured to create the lowest nitrosamine levels of any tobacco product. Being 100% tobacco, they provide me the full spectrum of tobacco alkaloids. I am satisfied in a way no NRT product can match.

I get the same satisfaction from Swedish snus, for the same reason.

I recently taped a YouTube video comparing the new Camel Orbs, Strips and Sticks to the older, more established Star Scientific products. The Camel products are inferior by all measures, but the one thing that struck me most was how childproof all of these dissolvable products are. Stonewalls are blister-sealed and difficult to reach. The Camel Orbs dispense one at a time -- but the plastic dispensing pack fails to yield one on many attempts. All of the packaging, for all dissolvable products, will frustrate an adult. Clearly, attempts have been made to keep these pieces from children. Also clearly, children are not the intended users -- and sales of all tobacco products should be limited to adults. No further laws on sales are needed. Enforcement is the problem.

These pellets do NOT look like candy, either. My Stonewalls look like what they are: compressed tobacco that creates a hard snuff pellet.

If the overriding goal of the FDA is to improve the health of this country's citizens, as it should be, then widely available, inexpensive, non-prescription, and far healthier alternatives must be available when a decision to quit smoking is made. Dissolvable tobacco is one such alternative.

I would encourage the FDA to fast-track alternative sources of nicotine. Every smoker who stops inhaling tobacco smoke surely adds quality time to his or her life and decreases the costs of smoking to society. Former smokers can use dissolvable tobacco products without endangering others with second-hand smoke, fire hazards or environmental litter. Those who understand harm reduction and nicotine addiction would call this a win-win situation.

Dissolvables are the most personal of nicotine products. Place one in the mouth, between cheek and gum, and absorption of nicotine and the other alkaloids begins. No bystander knows it is in use. No nuisance is created. No waste needs disposal after use.

And I can only laugh at the idea that children will desire these. No, they will still turn to the most dangerous two tobacco products -- cigarettes and chew tobacco. Focus your attention on keeping those products out of young mouths. Let adults choose far safer alternatives like dissolvables, snus, and e-cigarettes.

 

[Janetda]

I resubmitted my comments and took note of the confirmation numbers this time.

I was kind of disappointed though was I read through the comments left by other people. A lot of folks didn't comment on the issues at hand. I think it's important that when you make your comments that you address the issues of the particular petitions.