Contact the FDA - Before December 28th!!

[Belowme]

That felt good, to insult the FDA. Screw recommending what they should do, the only recommendation they hear is the ca-ching of a cash register opening.

Buncha numbnuts wearing Rolex's at the FDA: "Lets approve fentanyl patches, fentanyl is only the most horrific opiate to withdraw from, its also the most dangerous because of its highly selective mu1 receptor agonism and the inherent respiratory depression that results from that. Futhermore, lets allow the patches to contain enough lethal dosages of the drug to kill an entire family, and lets let the patient slap this loaded-revolver of chemical weaponry onto their skins surface and hope that the pharma company didint make an incredibly tiny mistake that could cause the entire dosage to leech out at once and cause a massive overdose that robs children of their parents and parents of their children.... good idea? This briefcase full of lobbyist cash says so!".

Thats just one of the almost endless streams of xxxxed up xxxx the FDA does. Dont even get me started on Zyban, I had to be hospitalized for attempted suicide from taking that ....-wannabe xxxx, it gave me severe bipolar episodes, and I mean SEVERE. Good call FDA!! Thanks.

Damn Dude, your scaring the hell outta me man! I just started on 75mcg Mylan Patches 2 months ag, is that WHY I KEEP Sweating and feeling weird all the time?

 

[WebNetIncome]

My comment I've posted several days ago is not listed on that site
Regulations.gov
Can you find yours?

" Given certain regulations may have thousands of comments, processing may take several weeks before it can be viewed online."

 

[WebNetIncome]

just added my comment:

My personal story is one of a 30 year smoker at two packs a day. I was able to quit using what you are referring to as an "electronic cigarette or e-cig". Those of use who have been able to switch over from analog cigarettes call it a "PV or personal vaporizer".


I attempted to quit analog cigarettes for many years using various methods, none of which worked until I tried the personal vaporizer. I have been a non-smoker now for over two months.


I consider anything which will aid someone to quit analog cigarettes a near miracle.


I personally don't even think the FDA has any business at all even in regulation of this product. I feel strongly that the government should sponsor public messages to get the message out concerning the benefits of the personal vaporizer.


While there is nicotine in the liquid (what I consider trace amounts compared to a cigarette) it is small enough in content that any serious side effects would be minimal. Using a personal vaporizer compared to the ingredients in a cigarette is a tremendous step forward for those wishing to have an alternative to cigarettes.


Should something happen that I was not able to use my personal vaporizer or even make it harder to obtain, I feel that I would resort again to analog cigarettes.


Please use careful consideration in your decision making process as to any road blocks placed in the way of someone being able to purchase and use a personal vaporizer. The decision you make could very well save many lives.

Thank you for your consideration of my opinion.

 

[GarrettW]

love how you use the term "analog cigarettes" like everybody has heard it before.

 

[chc]

done, submitted my 2 cents

 

[JamieJ]

done and 5 other friends done!

 

[paise]

Damn Dude, your scaring the hell outta me man! I just started on 75mcg Mylan Patches 2 months ag, is that WHY I KEEP Sweating and feeling weird all the time?

Harry: It will take your body time to adjust to the effects of the Fentanyl patch. I've been using the patch for approximately 8-9 years now and I hate it. Sure, it helps keep the pain from lupus tolerable; however, it also requires me to a) take breakthrough pain medication in the form of opiate medication like Loracet when the patch isn't enough especially when I am experiencing a lupus flare; b) the Oxycontin would be a better choice for pain relief because at least then I could have some control over what I was taken and how much not to mention the fact that should a patch fall off from sweating, showering, or even swimming, it darn near takes an act of congress and divine intervention to get the patch that came off replaced.

The Duragestic company used to supply its patients with covers (bioclusive and/or tegaderm) like the ones that are used to cover an IV tube when one is on IV fluids and medications; however, this has stopped for some reason and the other companies like Mylan and the other (I forget the name but there are like 2 generic fentanyl patches and then the Duragesic brand name).

I have hydrotherapy spa that seats about 5 to 8 people including having a lounger in it. It is one of the few ways I have to relieve the pain in all my joints especially in the winter months when I have gone out only to be chilled to the inner parts of my bones making it almost impossible for me to dress or undress myself let alone walk. without the adhesive covers, which Medicare doesn't pay for & neither does Medicaid, any time spent in the spa is time I could have the patch come off then leave me fighting with medical tape, surgical tape, and even large band-aids for large wound so the patch will remain on but usually doesn't.

The pharmacy near me began selling the covers in packs of 10 for $22 plus taxes. I am on 2 patches because my dosage is up to 150 mcg. The fentanyl patches, as you are likely aware, only go as high as 100 mcg in one patch before one has to switch to 2 patches. I wear one 100 mcg patch and then another 50 mcg patch. If I spent time in my spa while wearing the patch x3 days I'd have to spend $44 a month for the patch covers to ensure the patches remained in place and adhesed against my skin.

If these pharmaceutical companies are going to make products in patch form then the least they can do is to supply free of charge enough covers for each patch be it the lowest dose of fentanyl or the highest.

BTW, all total, because of lupus (SLE) and Sjogren's disease, I get to take some 28+/- different medications nearly every day to control various problems resulting from lupus/Sjogren's or problems that have become a problem due to them.

I have low blood pressure, hypoglycemia, terrible bone density levels, osteoporosis, and complications within my retinas caused by a retinal eye disease complicated by the drug that slows the progress of lupus (an anti-malarial drug; docs don't know how or why but it slows the progress) yet in order to be effective, one has to take such a high dose that it damages the retinas. In my case, the doctors can't figure out which causes what part of the damage, the retinal disease or the medication for slowing lupus, or lupus itself making it a catch-22. It doesn't help that most of my meds make me sick to my stomach with eating, without eating, or with Soy (or almond milk) being I am lactose intolerant.

At least the e-cigs have cleared my croupy smokers cough and all the wheezing not to mention the snap, crackle, & pops. The FDA doesn't seem to realize there are times when they should not get involved at all such as with e-cigs.

That's just my opinion... I'm stepping off the soapbox before I fall off of it.

 

[WebNetIncome]

love how you use the term "analog cigarettes" like everybody has heard it before.

Ooops, i meant to define "analog cigarettes" as regular cigarettes, but apparently didn't catch my own proof-reading skills.

hopefully they will be smart enough to figure that one out as written.

 

[Worutaa]

I fail to see mention of e-cigs in FDA
Docket No. FDA-2009-N-0294

How is this relevant to our cause?

EDIT: I fail to see any mention of e-cigarettes as a tobacco product. Can someone point me to a bill or motion that e-cigs be considered a tobacco product, whether by loose wording or directly?

EDIT2: FDA vs. SE http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM173193.pdf

 

[Gottabefree]

Big Bro - Big Pharma - Big Tobacco - can all Kiss mine - time for revolution if we had enough balls..... maybe one day....

 

[Less is more]

Done.

Are they extending the comment time frame? Some of the wording on the link for submission looks like they might be.

 

[Vocalek]

The statement refers to the fact that the comment period already was extended. Comments originally closed on 9/29/2009, but they extended them through today 12/28/2009.

 

[Dane]

Done, even I am from Denmark, where e-cigs with nicotine are banned.

 

[jimster33]

Done, submitted my comment.
-Jim

 

[fanofwalt]

Done, and got several others to post as well (including non-smokers who are thrilled that I quit smoking via PVs). Here's what I sent to FDA, as well as to Congress critters to ask their support in the matter; note that I highlight the term PV over "e-cigarette" in order to make more distinction and difference from analogs:

---

One of the actions the agency should strongly consider initially to increase the likelihood of reducing the incidence and prevalence of tobacco product use and protecting the public health would be to champion the easy availability of the Personal Vaporizer (aka PV; previously known as "e-cigarette" or "e-cig").

The World Health Organization has observed, "If a tobacco user can only abstain from smoking through the use of a therapeutic dose of ‘clean’ nicotine, this should be an option. Such products should be made available, and not placed at a marketing disadvantage compared with tobacco products." [Ref. Sweanor (2000) Is it the nicotine or the tobacco? Bulletin of the World Health Organization, vol.78 no.7, Print version ISSN 0042-9686.]
SciELO - Health Public

For almost 20 years, I smoked a pack a day, and would have continued, except I discovered and tried the PV. As a direct result of that trial, I gave up ingesting tobacco completely -- a course of action I would not have otherwise taken. Due to repeated unsuccessful attempts at quitting (via nicotine replacement therapy [NRT] gum), I viewed the PV not as a method of quitting, but as a way to replace *some* of my cigarette smoking. I didn't know I'd prefer the PV so much that I'd drop cigarettes altogether!

We ex-smokers welcome the presence of the PV and applaud the ingenuity of the device. With no second-hand smoke (or first-hand smoke, for that matter), no tobacco, no combustion, and no disagreeable smell, a growing, widespread use of PVs in place of traditional "analog" cigarettes would be most desirable for all concerned. Just as NRT gums have been offered in various flavors to enhance usage, a wide palate of available e-juice flavors supports the success of the PV option. PV users exhort the FDA to recognize the Personal Vaporizer for what it is: a sane alternative intended for adult usage, that is far superior to tobacco products.

--

They may not read every word of everyone's submissions, but they'll surely count the number of submissions, if nothing else. The deadline is TODAY, so rally your troops via Twitter, Facebook, blogs, old-fashioned-telephone-calls or whatever it takes. Remember to rope in all the non-smokers who were so happy to discover you either decreased or completely stopped your tobacco consumption due to PVs!!

 

[UpInVapor]

Done, Lets hope this gets through to someone!

 

[V-Dub318]

fanofwalt, you make a great point. i definitely agree with you. i sent them a very similar message encouraging the use/availability of e-cigs as a better, healthier alternative to the consumption of tobacco products by those who want to use or are addicted to nicotine. told them my story of smoking for 8 years and going from a pack and a half of analogs a day to zero in 24 hours....e-cigs would make our world a healthier place for everyone. I feel like it's our responsibility as human beings to point out this healthier alternative to tobacco to the powers that be and to fellow humans who are harming themselves with analogs or other tobacco products. Even if they dont read every one of the posts on there, if enough of us suggest e-cigs as a viable alternative to tobacco, it's going to get through to someone!

 

[spyhoppingcom]

For what it's worth, here is the comment I submitted. I hope others who have experienced the benefits of "vaping" will take a few moments to submit their own comments so that others can also be given the opportunity to benefit.

To Whom It May Concern,

I have been a smoker for over 20 years. I've tried many times, using a variety of methods, to quit; I failed each time. Last year I underwent surgery to remove a Carcinoid Tumor (lung cancer). After my surgery I tried once again to quit, this last attempt failed after one week. For the past five years or so I have been suffering from a range of medical ailments (COPD, Emphysema and recurring pneumothorax) which has worsened with my continued smoking.

Last week, I purchased an electronic cigarette. It arrived at 3:00 PST on Wednesday. I am happy to inform you that, since it's arrival, I have not smoked a SINGLE cigarette. I am writing this on a Monday; I'm still smoke free.

While I understand the need to regulate and control substances such as tobacco products, I urge you to consider people like myself whom have tried and failed other alternatives and therapy's. I truly believe that my conversion from analog cigarettes to electronic cigarettes has saved my life; and with more promotion and approval, it could save countless others.

I don't know much about the process in which you work, but I do know that cancer equates to death. Cigarette related deaths are avoidable, and E-cigarettes could play an important role if regulated properly and approved as a smoking cessation device.

You have a unique opportunity to change the lives of millions of people each year, it's an opportunity that you should not let pass by. Please don't allow this important opportunity to get caught up in the bureaucracy and red tape that plaques the legislative process. Don't allow this to become a political issue where greed and motives rule, this is a public health issue, and I urge you to do the right thing.

Thanks for taking the time to consider this comment.

 

[Territoo]

Done. Here's my post.

The goal of the Family Smoking Prevention and Tobacco Control Act is to prevent nonsmokers, particularly children, from forming the habit of tobacco use. In implementation of this goal, the FDA must recognize those who are currently addicted to nicotine and take care not to ignore their rights and needs. The Tobacco Act does not permit the FDA to completely ban tobacco, so the "drug of choice" will always be readily available to the current smoker, thus smoking cessation will be as difficult as before the enactment of the Act. Most smokers wish to quit smoking but cannot do so. Nicotine is one of the most addictive recreational drugs known, and current methods of treating nicotine addiction do not show a history of long term success. Therefore, the FDA must make liberal use of the provision in the Tobacco Act concerning reduced harm, and the most promising reduced harm product is the electronic cigarette.
The FDA did a study earlier in the year using 18 cartridges from two electronic cigarette companies, Smoking Everywhere and Njoy. This study revealed that the liquid in the cartidges contained trace amounts of tobacco-specifc nitrosamines (TSNA's), known carcinogens found in tobacco. Based on this study the FDA reported that electronic cigarettes could not be deemed safe. However, the FDA report did not look at electronic cigarettes in the light of being a reduced harm product. The levels of TSNA's were at or below the levels found in the FDA approved Nicotrol inhaler, and the presences of TSNA's do indicate that electronic cigarettes are a tobacco product as the nicotine in the liquid is derived from tobacco, which is why TSNA's can be found in the liquid. Based on the FDA study, electronic cigarettes are safer than smoking tobacco cigarettes because, in addition to the much reduced levels of TSNA's, there is an absence of many of the other compounds found in cigarette smoke, such as tar, formaldehyde, heavy metals, and hundreds of other known carcinogens.
The FDA's report of polyethelyne glycol in one out of the 18 cartridges tested and the wide variation of nicotine levels in cartridges can be corrected by proper quality control methods. Currently, there is no accountability for the companies, mostly from China, who import the liquid and many will cut corners to save money by adding less nicotine than indicated and cutting the propylene glycol w/ polyethelyne glycol. There is no labeling of ingredients and no assurances of childproof packaging. A ban of the electronic cigarette will not eliminate the possible risks associated with their use as there is no way that all shipments can be stopped and a ban will just expose users to impure and improperly labeled products.
A ban on the electronic cigarette will, however, prevent current smokers who currently have not tried an electronic cigarette from being able to obtain a product which can replace their harmful smoking with something that is less harmful, even though it is not guaranteed harmless. The idea that smokers will take up use of electronic cigarettes as an alternative to quitting altogether is not valid. Most smokers cannot quit despite multiple attempts, and the current "quit or die" mentality will lead them to death. Another alternative, reduced harm products, should be available.
One concern about having the FDA control and regulate the electronic cigarette industry is the current availability of nicotine liquid in levels as high as 100mg/ml in which users dilute to a usable strength and fill their own cartridges. This level of nicotine is dangerous and the maximum strength needs to be regulated. However, as is done in current nicotine replacement products, overregulation can be detrimental to the success of the reduced harm policy. If the maximum strength of nicotine liquid is too low, then smokers will not find electronic cigarettes as an effective means of nicotine delivery and will switch back to the deadly tobacco cigarettes. Most users find that 24mg/ml is the maximum necessary to alleviate nicotine withdrawal symptoms, and anything greater than that would be to dangerous to use.
With the electronic cigarettes currently on the market, the use of refillable cartridges is necessary however. Many electronic cigarette companies market their cartridges as being equivalent to a carton of tobacco cigarettes. This would perhaps be true if the cartridge were efficient enough that nearly all of the liquid were usable. The cartridge, as currently desgined, however, is very inefficient and most of the liquid is never adsorbed by the atomizer. Thus a cartridge is more like only one or two cigarettes in practical usage. At a current pre-tax cost of about $3 a cartridge, using a cartridge and disposing of it is too cost prohibitive, preventing many from ever switching from tobacco cigarettes in the first place. By using a bottle of liquid to "top off" the cartridge when no more liquid can be adsorbed, the cost actually matches what the companies claim. This problem will need to be eliminated by proper design of the cartridge before do-it-yourself liquids can be eliminated.
In summary, the FDA must make use of the reduced harm provision of the Family Smoking Prevention and Tobacco Control Act by promoting reduced harm products, such as the electronic cigarette. The concept of reduced harm must be presented as an alternative to the "quit or die" mentality currently given smokers. The FDA must not ban the electronic cigarette, but use its regulating authority to ensure purity and quality control. The nicotine content in the liquid must be regulated to safe levels, but not overregulated to ineffective levels. Until cartridge design becomes acceptably efficient to be cost effective, nicotine liquid used for refilling of cartridges must remain available. Above all, electronic cigarettes must remain available as a ban would be detrimental for current users of electronic cigarettes and current smokers.

 

[Kamanjah]

Whew, done!