FDA Good comments being submitted to FDA

[Jman8]

A bit questionable in first few paragraphs, but rest of it is making good points.

I am a "vaper" who quit smoking over 16 months ago, with almost no problems. That was the second time I quit, and the first time required medical intervention. (I used Welbutrin and the nicotine patch in combination.) It was very expensive, difficult, caused several unpleasant side-effects, and unfortunately never had the effect of making me not WANT to smoke. It just made it possible for me to say no. Switching to "vaping", I did not have any of those problems. Even though my first device was terrible compared to the devices I use now, as soon as I picked it up I knew I could switch and I knew it would be easier. And it was.

Although I signed the petition, I do not necessarily believe it should be completely outside the control of the FDA. Rather, I would like to see it managed as any other age-restricted food product. For example, while alcohol sales are much more strongly restricted than cigarettes, local craft breweries are not required to submit a costly application months in advance simply to produce a new beer or sell a new cocktail. This is true regardless of whether they are bottling for retail sale or selling in the restaurant.

Those small businesses would not exist if they had to function under the proposed rules. Imagine if your local restaurant had to get it's daily specials approved by the Federal government each day, through an expensive and slow process.

The vaping industry is largely a cottage industry right now. The proposed rules are very much driven by the larger tobacco companies, and will exempt most of those companies from regulation due to the cutoff dates. These rules will cause undue strain on new businesses while reinforcing the near-monopoly of the large tobacco companies.

The scientific questions are largely answered already, for well-made liquids and parts. The effects of propylene glycol are thoroughly known, including approval use in those with compromised lung function. The inhaled nicotine 'mist' has been approved already as an NRT, in a device that is effectively identical to the ones used by many "vapers".

Regulations in a "perfect world" would allow me to buy refill fluid from a variety of vendors, both large and small. The vendors would offer (by default) childproof containers, reasonable prices and I would not have to wonder whether it was contaminated, made in unsanitary conditions or had the wrong levels of nicotine. Today, the majority of trustworthy vendors already follow those ideals. Nicotine base comes with independent batch testing results, flavoring ingredients are limited to those known to be safe, spot checks are done every few batches to verify contents, etc.

Under these proposed rules, I fear that my choices would be limited to those that are approved by the same large companies that ensnared me to begin with. I started smoking before the tobacco settlement, but it did nothing to reduce the cost of cessation aides or to pay for my mother's lung cancer treatments. Their goal is not and has never been cessation, and their electronic cigarette products are no different. There is no technical reason they do not sell the same quality of refills that other vendors do, or even better. They sell what they do because it is an additional revenue source, not because it can help reduce the harm of smoking.

Please be very careful of the effects of these regulations. Don't let the tobacco industry force hundreds of thousands of former smokers back to smoking. Take the steps necessary to do what the tobacco settlement couldn't: protect the health of the citizens from those who would put profit over human decency.

Thank you.

 

[Bobbilly]

This is an excellent example of a comment that will be summarily ignored by the FDA. The FDA has the law on its side (i.e., the Family Smoking Prevention and Tobacco Control Act):


https://www.govtrack.us/congress/bills/111/hr1256/text

I bolded the phrase that allows the FDA to declare that liquid which contains nicotine meets the definition of a "tobacco product."

The pharmaceutical grade nicotine used in e-cigarette liquid is derived from tobacco. There is no pharmaceutical grade nicotine that comes from any other source.

It may be ignored but not because of law. I quickly read the outcome of the FDAs attempt to make it a drug delivery device and there was there were arguments that it was a stretch to include nicotine was a tobacco product. I'll need to read more on it. Nicotine is just that nicotine

 

[Jman8]

Nice personal story that touches on key points. Includes one attachment:

• Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers

I am an over the road trucker, and I started using electronic cigarettes in February of 2009. I wasn't trying to quit smoking, I just wanted to stop smoking in the truck while I was driving. This was where I did most of my smoking and it caused the truck and my clothes to smell badly. I also felt it would help me be healthier. As time passed and the technology and available liquid flavors got better, I quit smoking completely in May of 2012. I have been smoke free since then. I myself only use tobacco flavors, but my girlfriend quit smoking as well shortly after I did, and she also did so with the help of electronic cigarettes. She uses mostly fruit flavors.

There is a lot of misinformation about electronic cigarettes, and I was happy to see that these proposed regulations steered away from some of it. I constantly hear people referring to fruit flavors as "marketing to children" yet nicotine gum is also available in fruit flavors and, at least with the children I know, gum is much more appealing to them than cigarettes are.

That having been said it is important to me that any regulations protect the availability of this product to consumers. I can't give you a scientific study showing you that e-cigarettes are healthier. I can only tell you how much easier I breathe since making the change. I find it easier to exercise as my muscles no longer stiffen up during a brisk walk like they did when I was smoking. I assume this is due to higher oxygen levels in the blood. I feel better, I sleep better, and I have much more energy and vigor.

I have won my battle with cigarettes. I have found a healthier alternative. It is important to me to protect this alternative so that others like myself can live a healthier lifestyle when they find themselves ready to make the switch.

 

[Jman8]

Reasonable response touching on 2 key points

Those of us in the vaping community welcome regulation to ensure that we are recieving a safe product with safety and production standards. I would like to point out two of the issues with the proposed regulation. First is the industry is primarily ran by small business's and the cost of the application for new products will drive prices sky high and run these individuals out of business. We as a community don't want big tobacco company's to take over and run us out of business but they are the only ones that can afford the application process.. Second is the timeline to grandfather devices in. The industry has advanced so much since 2007 that it is unfair to use an ancient standard to base new products on . The product I bought in January 2014 is far safer than the product that I purchased five years ago.
A little back ground on me, I'm a 45 year old male that started smoking traditional cigarettes when I was 13. Many time I had tried to quit smoking during my adult life. I've used groups, chantix, patches, gum, cold turkey. None worked, three days with a personal vaporizer and I have not smoked in three and a half years. I run without losing my breath, sleep on my back and generally just feel better about myself. We ask as a group to look closely at the feedback that you are receiving and evaluate the help as well as the harm. Nothing that we take into our bodies that is not natural is not good but the lesser danger is the best choice.

 

[Jman8]

Very thorough and specific to proposed regulations.

The regulations as proposed are reasonable with considerations. In the matter of liquid testing procedure, approval and markings should be no more different than any other substance that is intended for ingestion. That is, a listing of ingredients that is sufficient to identify substances for which individuals may have sensitivities. It is important that ingredients be protected as per formula in a manner like coca Cola. The livelihood of the manufacturers depend on this. It is important that the type of glycerine be identified. Pharmaceutical grade is safest then food grade and the unsafe technical grade. Safety is paramount. As long as the ingredients are fully disclosed and are not on a standard FDA listing of known toxins the approval process should take no longer than any other ingested substance. The eLiquid should include notice that it contains nicotine and that it is addictive. There are no studies showing that nicotine itself has effects on the body that are negative other than temporary on neurotransmitters. It would not be appropriate to use cigarette warnings. The product should be childproof though the burden of safety is on parents. A simple qualification for being cjoldproof won't delay approval. Since the product is similar in intended consumer to alcohol it seems that testing and approval be analogous to beer. It should also be noted that since it is a product similar in Intent and use to alcohol that flavors are appropriate as they are intended to provide variety and enjoyment for adults. The same as holds true for different flavors of liquor, wine and beer. Warning lables should also be similar to those on beer or Wine, stating that nicotine is toxic and should be used and stored with caution. No special characteristics require altering the general aesthetics of the bottles in any manner more significant than beer. (small discrete and simple.) Users of these products are well aware of the effects and precautions as evidenced by discussions of groups, both physical and on electronic media. As for the to technical aspect the APV units (variable and refulated) they currently have notice of certification from FCC, FDA and the European standards organizations. Those tests seem reasonable as the test for safety in interference with radio signal, shock Hazzard and appropriateness for the delivery of a substance into the human body. No more restriction or rigor would fairly be imposed than any other material item that is ingrsted. A battery operated beverage heater for example. It runs in battery and delivers an ingested substance. The mechanical mods (as they are known are similar in firm and function as the devices from which they originally derived... Flashlights. Batteries operating with mechanical or semi mechanical switches passing electricity through a filament. There is no substantial difference in form or function. They should have the same safety testing and requirements. The batteries that are used are safe chemistry batteries that are no different from those that are contained inside a standard laptop battery unit... Verifiable by either opening one or contacting a manufacturer. 18650 size safe chemistry Hybrid or IMR. Protected batteries do not have the proper high drain configuration. They are every bit as safe as a laptop computer. The APV units have protective circuitry built in and the mechanical units can easily have a small fuse inserted by the users and hence are just as safe. (since they are not resetable it is impossible to require them to be built in.) A simple Instruction sheet indicating these facts is sufficient warning. The language is simple and this information is common knowledge amongst users. The majority of units are comprised entirely of metal on the outer surface and have no cords to attach warning labels. A sheet inside of the packaging would suffice as they are never in the possession of minors or the inexperienced. It has never been the case in my experience that complete instruction was not included in Internet purchasing or by staff at retail locations. Labling the actual unit is problematic due to the materials. A small label on the inside would be visible and easily applied. If applied outside a simple clear and unobtrusive label on the base indicating the use for the known toxin nicotine is sufficient. No user would be under the impression that nicotine is safe without proper handling. Such information would be unnecessary and burdensome in design to the manufacturer. While it has been suggested that indications be made that a statement of it not being proven to be safer than cigarettes is not needed. A simple absence of such a statement is sufficient. At this point there are preliminary test results that they are as safe as smoking cessation products.. Including APA journal of internal medicine. Since the matter is not settled the absence of any statement other than about nicotine being present would be premature.

 

[Jman8]

Good personal response that speaks to key points

Electronic Cigarettes have saved my health and life. I am 1 year 1 month tobacco free. My health has improved immensely. Most ecig user's understand you want to keep them away from children. We for the most part agree with standards on eliquids. Please do not burden us with unnecessary and costly regulations that benefit a handful of Big Tobacco companies. I have met with 100's of ecig user's through my journey with ecigs. Not one use a cigalike to stop smoking. If you make choices hard and expensive more people will stay with smoking. My wife who is a non smoker is over joyed with my decision to use vape instead of cigarettes. If you are truly trying to help the American public you will make honest and helpful changes. Giving this market to Big Tobacco will only stifle the industry and stagnate it. The vaping community is the first to find flaws and issues that cause concern and vocalize it. This industry needs guidance and common sense rules from FDA and not nanny-ism. Most of us would love to see some good rules and regulations implemented but future plans that you have seem to go against this. Again, If you truly want a safer alternative to smoking and something that could end smoking completely than do so. Thanks for your time.

 

[Jman8]

Fairly thorough and well reasoned.

I find these new regulations proposed on the subject of e-cigarettes and vaping extremely worrying. Firstly, classifying e-cigarettes as "tobacco products" is inane and completely incorrect. There is NO tobacco in e-cigs or personal vaporizers, and putting them in this category is a perfect example of the federal government's eagerness to step in and regulate our every day lives, without backing it up with any sort of peer-reviewed and unbiased evidence to the contrary. These devices save lives, helping people quit smoking and get involved with a vast community of very helpful, friendly people who have been brought together due to their communal love of vaping.

Secondly, I would like to address section #2 in which the subject of youth appeal is brought up. Saying that these devices and flavors encourage underage citizens to begin smoking is simply FALSE. In my year of vaping, I have never been able to buy e-liquid or e-cigarette parts (either online or in a physical store) without providing some sort of age verification or identification. Calling vaping devices a gateway to smoking real cigarettes is the most counter-intuitive argument I have ever heard. E-cigarettes are targeted for the exact opposite: To help people quit smoking and save lives.

Also, I can agree on a few points, such as enforcing more rules to stop the sale of e-cigarette products to minors. That, I feel, is a sensible and necessary step in furthering the responsibility of our industry. Having companies list ingredients on bottles or their website is also a good point, since almost everything that comes in a box, bottle, or can these days has that anyway. But forcing these e-liquid and vaping companies (the vast majority of which are small businesses run by family or just a few people) to apply for permits to sell their products, which costs thousands of dollars, will not only force them out of business but give the opportunity for big tobacco companies to buy them out and further their own profits.

One common argument is that "We don't know what's in these things." Really? I can make my own e-liquid using nothing more than the following:

-Vegetable glycerin (One of the most widely used compounds in the food industry and USP certified, available at any drug store)
-Flavoring (Often used in candy and other food products, similar in structure to something like snowcone flavoring.)
-Sweetener (Same thing used in soft drinks, cake mixes, candy, etc)

Passing this legislation limiting the use and access of e-cigarettes and vaping devices will cripple small businesses and severely impact the ability of people to quit smoking, the leading cause of preventable death in the United States. I understand that one comment will most likely not change anyone's mind, but I feel very strongly about this issue and encourage the FDA to re-think these haphazard, knee-jerk reaction legislation.

Thank you

 

[Jman8]

Reasonable response touching on several key points.

Keeping nicotine products out of the hands of minors is an excellent idea. And limitations on advertising to minors is acceptable.

And a system of quality controls and standards is obviously a good idea as well.

However:

1) The repeated statements that the "sweet" flavors are directed at children are pure nonsense. For me, and many others, the sweet flavors sharply contrasted with the bitter odor of traditional cigarettes and THIS WAS KEY to switching my habituation from combustion of tobacco to the vapor. Now, the scent of cigarettes is offensive to me -- because I've come to associate satiating my nicotine craving with the "sweet" flavors that are being so maligned.

Do not regulate the flavors (beyond safety). (Smirnoff has dozens of flavored vodkas, this "for the children" argument it patently absurd. And the notion that a sweet flavored ecig would be a gateway to a real cigarette is just beyond comprehension. The sweet flavors make cigarettes gross.)

2) The approval process for these products MUST be kept affordable to small businesses. This historically has not been the case and while you say it's not a "ban", it is a de facto ban on all products made by small businesses and a monopoly for the big tobacco companies. Only big tobacco can afford such approvals. And I must emphasize the incredibly poor quality of the products made by the large tobacco companies. They taste terrible, have unreliable batteries and almost guaranteeing failure for smokers trying to quit.

Do not make product approval expensive nor lengthy (and this will simply drive nicotine addicts back into the jaws of Big Tobacco)

3) Quality control standards need not be overly expensive either. Testing purity and concentrations can be done in most any bench-top lab.

Do not regulate the small companies out of existence. Big tobacco and pharmaceutical companies have no interest in make ecigs effective at helping people to quit smoking -- regulating and taxes the small companies out of existence will send millions of people back to combustion cigarettes (and all the health effects that entails).

4) I request an international *independent* study be done on the efficacy of ecigs for people trying to quit smoking. From my own experience and literally thousands of testimonies that I have read, I simply do not *believe* the published studies' "results". I do not believe these studies were done by impartial researchers. In my experience, ecigs have been much more effective than any other cessation method.

I smoked for 17 years, tried the gum, tried the patch, tried cold turkey, tried switching to a pipe, tired dip, tried prayer and occult ceremonies (okay, not really on that one) -- and NOTHING worked. I could never last more than 2 days before reverting back to the cigarettes.

Today I haven't had a cigarette in 15 months. The initial transition was still very difficult -- because I was using the Blu brand (and as I've already said, that category of products are terrible for people honestly trying to quit). Once I upgraded to my refillable style, it was almost automatic.

I only vape 3 or 4 times a week now, at 12mg. But without that mild nicotine supplement? What would I do? Just shrug and forget the addition entirely... the addition I couldn't escape through any other means for 17 years? Or would I resign myself back into the jaws of Big Tobacco?

In conclusion, we in the vaping community do support common sense regulation to prevent minors from becoming addicted to nicotine. None of us want the next generation to have to go through thye same struggles we've had to face.

Hundreds of thousands of former smokers are now smoke free thanks to these products. The proposed regulations establish a great danger of producing a federally enforced monopoly for the Big Tobacco companies by requiring fees beyond the means of their smaller competitors. And it's those competitors who have been making the quality products -- the ones that really help people quit smoking (and the flavors that resensitize our pallets to how awful smoke really tastes).

Assorted musings:
By what authority do you believe you are authorized to regulate batteries, plastic tubes, wires and wicks? Police can't keep ....s out of head shops, so how would one establish the "intent" of a battery?

Is some industrious producer recignized the market and developed a cost-effective process for harvesting nicotine from non-tobacco sources... How on Earth could you these be considered "tobacco products"?

So is that "Category" menu at the bottom there so you can just automate the "Ignoring-The-Will-of-the-People-In-Favor-of-Wealthy-Corporation" process? By clicking that I'm just a regular person, am I guaranteeing my voice will never be heard? Seems to be the modus operandi of the USA lately. Maybe always.

 

[Jman8]

Very well reasoned, and thorough response.
Note: I altered wording of part of response as it alluded to "other stuff" that is not allowed on ECF
Also note: link to scientific study in this comment is for Burstyn's "Peering through the mist: What does the chemistry of contaminants in electronic cigarettes tell us about health risks?"

As a pharmacology and biochemistry major in University who is applying for medical school, I would like to give my perspective. Electronic cigarettes provide the vaporization of propylene glycol, vegetable glycerine, and nicotine. In theory, if you vaporize those three things and inhale there are no health effects other than the direct mechanism of action in nicotine. Of course we haven't studied the vaporization of PG/VG in a laboratory setting as much as we should have, it is very clear this is far superior to tradition cigarettes. How could anyone even put the two in a similar category? That would be like comparing smoked [*other stuff] to vaporized [*other stuff]. The health benefits of electronic cigarettes (indirectly from the cessation of tobacco cigarettes) are immeasurable, and the idea behind an electronic cigarette is one that has been patented, FDA regulated, and been on the market for years: A nicotine inhaler. There is literally no difference between the two other than propylene glycol which the federal government of the United States is a strong advocate for.

These proposed bills would destroy or radically alter the electronic cigarette market. Purchasing a high quality electronic cigarette is hard enough as is, with government regulation it could potentially pave the way for highly marketable but far less cost efficient brands such as Vuse and Blu. This is a major problem because for once in hundreds of years people have had access to relatively fair priced nicotine products, and we seek to end that. Why? I understand regulation for health reasons, and taxation because it is a "vice" product, however there are ways of doing this that would not have these consequences, such as the regulation of nicotine juice.

Nicotine as an isolated compound is not an intoxicant. It is not very addictive either. Tobacco contains over a hundred alkaloids that produce the effects of traditional cigarettes, these alkaloids include MAOI's, dopamine agonists, and other serious drugs and chemicals. Nicotine by itself is similar to caffeine in that it produces a mild cognitive stimulation and is not intoxicating. Allowing people to have direct access to pure nicotine is a huge leap in public health, and although there have been nicotine products on the market for many years their price make them very unfeasible and do not allow for long term or conscious use. Some people want to keep using nicotine for the rest of their lives, just as some people want to continue using caffeine (a totally unregulated drug) for the rest of their lives. Please, electronic cigarettes may have well saved my mother and brother's life, seeing as 4 of my close relatives died of lung cancer which has hereditary factors.

I understand the effects should be further investigated in a laboratory setting, however almost all controlled experiments thus far have proven them to be significantly less harmful than tobacco, almost harmless.

https://www.google.com/url?sa=t&rct...=ENugkfYnGALhfQBo4H_7LQ&bvm=bv.65397613,d.aWc

Here is a clear scientific study backing my claim. It is clear that electronic cigarettes are safer by far, there is no comparison when you are comparing anything to tobacco combustion inhalation. Anything is better than tar and polonium breathed into the lungs. Do not destroy the entire market for a product that has been proven by so many scholars to be extremely beneficial to public health.

We feed genetically modified meats and grains along with synthesized sweeteners and the FDA has no issue, yet now they are taking a stand? This couldn't have anything to do with the tax revenue and lobbying from tobacco companies? I don't care personally, as I said before I'm going to be a pharmacologist and I look forward to working for a major pharmaceutical company in the future. This is not the solution to the e-cigarette issue, and people who already use these products will continue regardless of FDA regulation, it will just become much more expensive and put money into the pockets of criminals. Think about the 18th and 21st Amendment to the United States Constitution, because that really worked out well for the mafia and organized crime.

 

[Jman8]

Well reasoned and bonus points for using FDA as cited reference for safety of one of eCigs key ingredients

In so much as Electronic Cigarettes contain no tobacco, they should not be regulated as though they do. While they do contain nicotine, tobacco is not the only naturally occurring source of nicotine (tomatoes). I do support banning the sale to minors and advertising in a manner that relates to minors. This is where my support ends. The additional requirements for new tobacco products and the monetary burden this would impose is unacceptable.

The FDA has already deemed the ingredients used in American made e-liquids as generally regarded as safe (GRAS), indicating that this regulation has nothing to do with safety. This includes propylene glycol, vegetable glycerin and the flavorings used. Nicotine by itself is also considered far less dangerous than tobacco cigarettes.

Electronic cigarettes have become a viable alternative to traditional cigarettes for a growing number of people who want nothing more than a safer option. This is inline with the governments desire for people to quit smoking. Regulating e-cigarettes in the same manner, is essentially telling people you would rather they smoke traditional cigarettes.

The loss of profits to the tobacco companies and thereby loss of funds to the FDA seems a larger reason for the desired regulations, as they would require small businesses to apply for every new product at a very high cost. This also stifles innovation and the economic growth provided by new small business ventures. In the long run, it puts the power and ability back in the hands of the big tobacco companies.

I will close simply by saying, this goes beyond the intended scope of the FDA and anything past preventing minors from acquiring electronic cigarettes should be a choice left to the adults to make on their own. Freedom of choice.

Below, I have copied data directly from the FDA site, showing the FDA's approval of use of propylene glycol.

Database of Select Committee on GRAS Substances (SCOGS) Reviews
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FDA Home
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Propylene Glycol

Return to Listing

Report No.:27

Type of Conclusion:1

ID Code:57-55-6

Year:1973

CFR Section:184.1666

SCOGS Opinionropylene glycol is metabolized by animals and can be used as a carbohydrate source. Propylene glycol can be ingested over long periods of time and in substantial quantities (up to 5 percent of the total food intake) without causing frank toxic effects. Propylene glycol monostearate is readily hydrolysed in vivo and the propylene glycol and fatty acid moieties enter their respective metabolic pathways. At lethal or near lethal doses (6 g per kg or more), however, it has been reported to cause kidney damage in several species and toe deformities in chicks. These doses contrast with the few mg per kg per day estimated in Section III of this report to be the human daily dietary intake of propylene glycol. The Select Committee has weighed the available information and concludes that: There is no evidence in the available information on propylene glycol and propylene glycol monostearate that demonstrates, or suggests reason to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future.

 

[Jman8]

Thorough reasoning addressing several key points

the regulation of e-cigarettes is premature. per your own Email i have recieved "Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don't know enough to make that call." I don't believe this, I know this for a fact. I am one of the success stories. first cigarette at age 9, pack a day smoker by 11. I had my last cigarette 18 months ago. The flavors i enjoy are fruity and dessert flavors. I will not buy from a shop that will sell to anyone under 18. below are my issues with this premature restriction on electronic cigarettes:

1. public health: while we have no proof one way or the other about second hand vapor we do have a long line of medical studies showing how dangerous allergens are to the general public. Anaphylaxis is a serious danger to myself and millions of americans. I am allergic to one of the chemicals found in most modern perfumes. I break out in hives, my throat swells and my eye water when I am exposed to small amounts of this chemical. This issue has been known for at least 30 years as my mother suffered from it as well. At no time has the FDA limited my exposure to this chemical via restrictions on its use in perfume, deodorant, soap, or cosmetics. You have on the other hand decided to limit my future exposure to possibly dangerous chemical that I choose to expose myself to.

2. claims of helping quit smoking: when last I checked the FDA did allow testimonials for products. If it helped me quit smoking and I tell someone else that it did am I advertising that it helps people quit smoking. If i take money for telling my story am I advertising. if the caveat " your experience may differ" is appended will that make a difference.

3. dates involved: you have basically decided to backdate 7 years of innovation on a product. If you came out and said that any insulin delivery device not on the market prior to February 15, 2007 will require proof that there product was better, safer than there current product or pay $15,000 to manufacture and sell their product how do you think the manufacturers would respond.

4.restraint of trade: by setting up the laws the way you have you will destroy 99% of the new businesses in the vapor industry. Manufacturers will not longer be allowed to innovate. shops will no longer be able to make "house juice". by setting these laws you will be strangling a new industry in the US. The last one that crush this industry it may take grew at this rate was the internet. Is not free trade one of the basic principals our country was based on. supply and demand. not supply and demand as long as you have 2 million dollars for R&D and bribes to the right officials.

5. flavoring: it is claimed that by having fruit, dessert, or drink flavors the vaping industry is pandering to children. from my own experience this is just not true. once you stop smoking your taste buds start to come back and you find "tobacco" flavors to be harsh and bitter. you want something pleasant to the palate. just like most ex-smokers chew gum for the flavor after quitting we chose pleasant flavors that allow us to keep going on the journey of quitting.

In closing I have been vaping for 3 years now. I have been 100% cigarette free for 2 years. I am what the American cancer society would call a success story if I had used the patch, nicorette, or the nicotine inhaler. but because I did it my own way with products I knew were safe(I made my own coils to heat the fluid, I washed and disenfected my own cotton, and watch my juice being made by hand with FDA approved chemicals) I am considered a failure.

please stop and rethink this miscarriage of your powers

 

[Jman8]

Brings up several points with decent reasoning and bonus points for using Zeller's words to justify why nicotine in eCigs is not something to be overly concerned about

I believe the FDA should remove the regulation of e-cigarette hardware and accessories from the proposal as choices in these items are almost purely cosmetic and do not fundamentally change the effects of e-cigarette liquid; neither in the way that it is consumed by the end user nor in the effects it has on the body.

I believe the FDA should remove the regulation of e-cigarette liquid from the proposal until further information on larger samples than 4,444 college studies on the long term (5 year plus) effects of e-cigarette use has been observed, studied, peer reviewed, scientific and health communities accepted and published.

I believe the FDA should only look to regulate e-cigarette products should substantial evidence is collected that shows that e-cigarette products pose a GREATER risk to public and private health than standard tobacco products (ie cigarettes, cigars, chewing tobacco).

I believe that should the FDA not find significant information showing that without a doubt that e-cigarette products are more harmful to public health than standard tobacco products (ie cigarettes, cigars, chewing tobacco) that the FDA make no move to regulate the sale and consumption of e-cigarette products except to make them unavailable to users under age in their community.

I believe that the FDA should also examine the economics effects of stifling a burgeoning industry in its infancy. I also believe that the FDA should take steps to recognize the difference between nicotine products and tobacco products, and change the language they use to describe either. I believe that not making that distinction is harmful in both policy making and education efforts. I believe that the FDA cannot do due diligence in this matter without acknowledging the difference in levels of harm between smoked tobacco and vaporized and inhaled nicotine. Should the FDA not have access studies providing this information I believe that the FDA can only do due diligence in this issue by acquiring said information- either from studies already done or from performing their own.

I believe that it would behoove the FDA to not regulate e-cigarettes solely as a smoking cessation product and acknowledge them as a safer alternative to tobacco, should they acquire the information to support that claim while doing due diligence in the other areas of e-cigarette study.

Mitch Zeller is quoted as saying
"I'm not saying nicotine is benign, but when compared to the risk associated with regular tobacco, it pales,"
(E-cig industry on tenterhooks ahead of U.S. regulation | Reuters)

I believe that the FDA should also reexamine their timeline for legislation to allow for themselves to acquire more information to better serve not only the public health interest but the interest of users that prefer e-cigarette use to tobacco products.

Thank you for your time.

 

[wv2win]

I plan to follow CASAA's advice and wait to submit a comment to the FDA. That being said, I really appreciate Jman taking the time to provide a sampling of comments already submitted as they provide us all examples of some excellent points and arguments.

 

[aikanae1]

I enjoyed reading these comments and realize it must have taken a lot of time to find them.

As far as commenting, I think CASAA has issued a CTA requesting people send in comments for an extension. Their blog has more details.

It appears that some members in Congress are putting pressure on the FDA to not make any extension and finalize these rules asap. Congress is more than likely, reacting to pressure from various ANTZ groups. IMO that's where pushback is needed (Congress) and quoting science probably wouldn't do harm either since "evidence based decision-making" seems to be the current theme.

 

[2coils]

Really Really good thread Jman! I personally do not have the time to gather or read these stories on my own (from the site). I value your effort involved to do this! Additionally, though I am waiting for CASAA, posting some good talking points has value IMO, for those who are not patient enough to wait for such direction. Additionally, to be honest, not everyone will agree with CASAA's direction, though that may prove to be a mistake!! I can't think of any other group that represents our interests better!!!

 

[DC2]

I must be an idiot, because I can't figure out how to get at the comments.
I'd like to read my comment regarding request for extension again (1jy-8c1s-6yfy) but I'll be damn if I can figure out how to find it.

For whatever it's worth, this is where I'm trying to look...
https://www.federalregister.gov/art...-food-drug-and-cosmetic-act-as-amended-by-the

 

[Dave_in_OK]

Try this link Regulations.gov

You can sort by ID #

 

[pamdis]

Not sure you can see even your own comment until FDA posts it. Of the 7327 comments submitted so far, only 525 have been posted for viewing. My fear is that FDA will not even get to our requests for extension until the comment period is long over. I emailed regulations.gov to ask if there was any other place to submit extension requests, and they said, no, just the comments.

So I think we should also be sending our requests directly to the agency contact listed on the proposed rule:

Agency Contact
Gerie Voss
Senior Regulatory Counsel
FDA
HHS
CTPRegulations@fda.hhs.gov
(877) 287-1373
9200 Corporate Blvd.
Rockville, MD 20850-3229

and/or the instructions in the rule:

Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name, Docket No. FDA-2014-N-0189, and RIN 0910-AG38 for this rulemaking. All comments received may be posted without change to Regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of theSUPPLEMENTARY INFORMATIONsection.

Of the two posted extension requests, both were written letters, one to each of the above options, which appear to have been scanned and then posted. (Although, the one sent directly to FDA was addressed to Mitch Zeller, not Gerie Voss, but same address)

This is what I'm going to do - print my letter out, send it by mail, and also send a follow up email to the agency contact with the letter as a PDF attachment.

 

[lamarrk]

Folks, please stay on topic with the OP's original request for pertinent 'quotes' from the FDA's website.
Totally off topic postings will be deleted at the OP's request.
-Lamarr

 

[Jman8]

As an FYI, here is the link to the Docket Browser where I am getting comments from. OP of this thread explains criteria I look for as 'good comment' but as anyone can contribute, then feel free to use own criteria, just as long as it isn't overtly for regulating eCigs (out of existence).

I would also note that I'm about halfway thru the 500 or so public comments, and am using the tracking info to reference which ones I've already posted.