FDA Good comments being submitted to FDA

[Jman8]

After ECF moderator has given me the okay to do this, I am creating this thread to highlight comments made to the FDA that are good comments.

Anyone can add comments (from FDA site) here but this is the requested format for this thread:
- 1 comment per post
- if comment cites legitimate scientific studies, that are pro-vaping, those ought to be given more weight (more reason to post them here on this thread)
- if reasoning is sound in the comments, those ought to be given more weight
- no need to include names of people that posted, unless it is mentioned in their comment (many comments are submitted anonymously anyway)

My interest here is to retain those that are helpful to the cause (pro vaping) and that are well written, citing scientific data, and serve as 'good' example of well written comment. I'm thinking the more the merrier. Also thinking that down the road, when final rule comes out, it would serve as immediate repository of data that helps consumers see what actually was sent to FDA (plus number of comments that said similar thing) in comparison to what ended up in final ruling.

I will note that on date I started this thread, I went thru about 75 comments (out of around 500 that are public) and only found 5 that I consider worthy of adding to this thread. Most of those 75 were pro vaping, maybe 3 were anti-vaping/pro regulations and maybe 5 were on premium cigars. The premium cigar ones that I read weren't exactly well written.

Also just want to note that comments that are rants or spoken only from personal experience are not the type of ones I'd like to see in this thread, but some of those are interesting comments and helpful to the cause, to some degree.

 

[Jman8]

Adding this one because I find it to be sound reasoning

These are consumer comments about any additional FDA regulation of ecigs or flavored ejuice used in ecigs.

Ejuice is not a tobacco product and vaping is not smoking - it may be nicotine replacement or it may just be vaping without nicotine.
Nicotine is a 'by choice' additive in ejuice and not found in all ejuice.
Nicotine is not exclusive to tobacco products, it is found in vegetables.
Nicotine juice can be purchased and added to anything.
The 'habit forming' factor of using an ecig- - ANYTHING can be habit forming.
The 'addiction' and health risk - ANYTHING can be addicting at some level and excess consumption or use of most everything causes health risks.
FDA currently oversees the ingredients in quality ejuice - it is made with food grade ingredients and if someone isn't buying food grade ejuice, FDA oversight is not going to change what they are buying or mixing on their own.
Everything that comes in a 'flavor' is not directed to children - doesn't everyone, at any age, have a favorite flavor? *likely the candy flavor marketed when you were a child and sold today in candy or ice cream being marketed to kids and adults without warning labels and the FDA has the same oversight of these ingredients just like they already have with ejuice ingredients*
Candy and ice cream (flavors) causing obesity is marketed to children and adults - are there FDA warnings on candy or ice cream and age limits to purchase them or only the oversight for the ingredients just like ejuice today?

The ingredients in ejuice are not new.

If child behavior with ecigs is an issue, that truly should not fall under FDA responsibility.

As a former smoker, I can say without a doubt that my health has improved since I began using ecigs over a year ago. I do not miss nicotine and I like flavors. I can breath better which leads to more activity and better health, I do not have sinus / allergy symptoms, no more snoring and more restful sleep. These changes have resulted in reduced medical expenses and improved mental functions-not to mention feeling better truly makes people nicer and more productive.

Step up everyone, whether you vape or not - no more laws or regulations are needed for ecigs or ejuice (among other things).

 

[Jman8]

Written by someone that signed there name as "Dr." - sound reasoning, bonus points for brevity

E Cigarettes do not contain tobacco, thus there is no authority to regulate.

 

[Jman8]

Sound and thorough reasoning

1. The proposed regulation of non-combustible tobacco products, particularly including e-cigarettes, does almost nothing to address any real problems.

With the exception of ingredient labeling requirements, which benefit consumers, and bans on sales to minors, which we also support, this appears to be a classic case of a solution in search of a problem. FDA presents only speculative claims of harms or risks from smoke-free products. To the extent that they identify potential problems, there is no reason to believe that the proposed regulations will address them.

For example, there are vague assertions that regulation will address problems of unsanitary manufacturing processes or contamination. Addressing these would benefit consumers. But the regulations, which primarily involve busy-work information filings and applications, would do nothing to address such problems. Another example is the repeated claims about fixing consumer misperceptions. There is no evidence that consumers are misinformed. But even if they are misinformed, there is no apparent way the proposed restrictions would change that. Indeed, we believe the proposed regulations would increase confusion.

2. There is no recognition of consumer interests.

The consumers are the primary stakeholders in this process, yet FDA displays an utter disregard for their interests. Discussions of the cost of the proposed regulations focus entirely on the compliance costs for manufacturers. There is no apparent awareness of the costs imposed on consumers.

FDA consistently insists that e-cigarettes and other smoke-free products cannot be considered smoking cessation aids and asserts (contrary to overwhelming evidence) that they are not effective as such. Yet this regulation says that the only reason for allowing a new (which means post-2007) product onto the market is that it is useful for smoking cessation.

3. The rules would eliminate the small businesses that provide the high-quality e-cigarette products that experienced vapers prefer.

The filing requirements that would be imposed on manufacturers would put small-sized, and probably medium-sized, companies out of business. Only a half dozen large manufacturers (particularly including the major traditional tobacco companies and their suppliers) would be able to meet these requirements. Moreover, any smaller manufacturer that was able to complete the filings would face the prospect of being instantly put out of business by the FDA’s ruling as soon as the grace period (24 months) expires and FDA gets through the backlog and rules on their applications. Thus, these regulations appear to eliminate the vast majority of e-cigarette manufacturers approximately two years after they take effect.

FDA repeatedly asks for comments on how the requirements could be made non-fatal for small manufacturers. But this appears to be disingenuous; there is simply no way to reconcile the burdens imposed by proposed requirements with the resources of small and medium specialty businesses that make higher quality e-cigarette components.

4. The scientific claims made by FDA are flawed and biased.

We are very concerned with FDA’s apparently tenuous grasp of the relevant science. They ignore the bulk of what is known, repeatedly misinterpret studies, and accept as fact politically-motivated assertions of authors. They have some out-and-out factual errors in their review of the science, but far worse is the spin and innuendo. They cherry-pick single sources with particular conclusions about topics that are far more uncertain when all the evidence is considered. In almost every case, the uncritical acceptance of bad information tends to justify restrictions and deny the harms they will inflict on the public with these restrictions. This bodes ill for what they will accept as new evidence in response to their requested comments.

By contrast, they downplay overwhelmingly obvious facts about the benefits of e-cigarettes. For example, they present the statement that e-cigarettes reduce exposures to toxicants compared to smoking, something that is true beyond a doubt, with the caveats “some researchers have stated” and “may.” They similarly downplay the evidence about e-cigarettes’ effectiveness in aiding smoking cessation.

In short, it is quite obvious that these regulations are going to be used to protect the profits of large tobacco companies and everyone else who stands to lose money due to decreased health care costs for e-cigarette users compare to tobacco users. Also, everything needed to create an e-cigarette is available at Home Depot, and everything needed to make the liquid is available for purchase from pharmaceutical companies.

 

[Jman8]

In addition to this comment, 5 items were attached to this submission:

• Technical Report re Peering Through the Mist Systematic Review of What the Chemistry of Contaminants in Electronic Cigarettes... (Attachment)
• Burstyn Peering Through the Mist Systematic Review of What the Chemistry of Contaminants in Electronic Cigarettes Tells us About... (Restricted Attachment)
• Clive Bates Regulation When Less is More
• Wagener et al Electronic Cigarettes Achieving a Balanced Perspective (Restricted Attachment)
• Judge Richard Leon Memorandum Opinion re FDA vs Ecigarettes (Attachment)
  

hello I am a disabled veteran who had smoke for 13 years. I have a lot of issue's that live. With these issue's it was impossible for me to quit smoking. The only thing that had gotten me off of traditional tobacco cigarettes is vaping. I will not call them e cigs because they have nothing in common with traditional cigarettes. while I understand the concern for safety and some need for regulation, the proposals you have presented will do much more harm then good. Vaping saved me from tobacco, what more needs to be said. The whole point in the campaign against tobacco was harm reduction. in my first upload I am presenting FACTS that the current vaping products show none of the concern that tobacco has. Another viable point in the campaign against tobacco was that innocent bystanders also received harm from that product. Again there is zero concern for this, in my second upload I will show another study to show this. So why the over regulation. Again you are going to destroy thousands of small business's in this country. 3rd upload and last is a survey show they do help get of traditional cigarettes. What you are doing to a product that Is much healthier and safer then tobacco cigarettes is unmoral and irresponsible. The fda is supposed to help people, not to run based off of financial influence" Pharma Payments".
“The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulations, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths.”
Donald W. Light of the School of Public Health, University of Medicine & Dentistry of NJ
Risky Drugs: Why The FDA Cannot Be Trusted

A government program that has been influenced by outside sources losses credibility and trustworthiness. Your contributors are loosing money due to a product the is very unsuccessful aiding those who with to stop smoking. Hence the illegal ban.
"ORDER, For the reasons set forth in the Memorandum Opinion, it is this 14th day of January, 2010,

hereby ORDERED that Plaintiff Motion for Temporary Restraining Order and/or Injunctive relief , which the Court has converted to a Motion for Preliminary Injunction (Minute Order dated May 1, 2009), and Plaintiff’s Motion for Preliminary Injunction are GRANTED; it is further ORDERED that FDA shall not detain or refuse admission into the United States of Plaintiff’s electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. 301 et seq;

It is further ORDERED that FDA shall not detain or refuse admission into the United States of Plaintiff’s electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations under the FDCA, absent a proffer of evidence, consistent with the Court's Memorandum Opinion, that Plaintiff’s products are intended to have a therapeutic effect; it is further ORDERED that the Combined Motion for Leave to Submit a Brief Amicus Curiae and Brief Amicus Curiae in Support of Defendant FDA by Action on Smoking and Health and Alliance of Electronic Smokers' Motion for Leave to Participate and File Brief as Amicus Curiae are GRANTED; and it is further ORDERED that the Motion of Intervenor-Plaintiff Sottera, Inc. d/b/a PLANTIFF for leave to File Reply to Defendants' September 17th Response to Proposed Amicus and Plaintiff Motion for Leave to File Instanter a Status Report Concerning Recent Events Which May Impact Plaintiff's Continued Existence are DENIED.

SO ORDERED. Signed by Judge Richard J. Leon on 1/14/10. (kc) (see order.) (Entered: 01/14/2010)

So are e cigs as you call them a drug or "tobacco" as your now calling it. The fda should make up its mind. The fda is clearly reaching here. YOU are doing more harm them good in this matter.

A simple regulatory issue is all that is needed. proof has been offered to the safety of these devices.
18 or older to purchase
child safety caps
warning labels about nicotine safety

this is all that needs to be addressed.
thank you for your time

 

[Jman8]

In addition to the comment, the submission included 1 item:

• Impact of Flavour Variability on Electronic Cigarette Use Experience (Attachment)

I am here to let you know about my experience with using electronic cigarettes. I was able to stop smoking over three years ago with the use of these devices. I found that I tend to like flavors other than tobacco ones, as I think the tobacco taste is now the nastiest taste in the world! I would like to see the various flavorings still be available to us adults, especially since many do not like the tobacco flavors, anymore. Also, alcohol has many different flavors that could be appealing to youth, but I do not see these being taken off of the market. Thank you for hearing me out.

 

[aubergine]

To anyone coming across this thread who hasn't read http://www.e-cigarette-forum.com/fo...ponding-fda-deeming-proposal-please-wait.html I do urge you to do so.

And very importantly, this: http://blog.casaa.org/2014/05/overview-of-casaas-action-plan.html

We have the enormous benefit of very experienced advocates working hard to make our voices heard in the most effective possible way. It's difficult to be patient, but a strong, well-coordinated effort is what's wanted here, IMHO.

 

[DC2]

Just FYI for those itching to comment...
CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

Which brings us to the first Call to Action, which will be issued in the next day or two.

The first Call to Action will be for all consumers to request an extension of the comment period. Such an extension is needed for anyone who is going to attempt to compile the information required to answer FDA’s substantive questions. The Call to Action will provide details on how to do that. We expect that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers. The cigar interests are doing the same.

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

 

[Jman8]

Fairly sound reasoning and one of better presentations of frequent rant noted in other submissions

First off, liquid nicotine is the ONLY part of an electronic vapor device for which you have any authority whatsoever to regulate under the Tobacco Control Act. The hardware used in for vaporizing does not contain any tobacco at all.

Second off, I would like the FDA to consider the hard science on these facts and hear and consider the scientific opinions on both sides of this issue. The regulations, as proposed would stifle innovation in this important product which is already actively saving former smoker's lives via harm reduction. The previous studies conducted by the FDA resulted in a lot of disinformation being spread.

Third, the regulations seem to favor large companies such as those already established in what is commonly referred to as Big Tobacco and Big Pharmaceuticals. These corporations are not interested in public safety but only in profit. Your agency is set up to protect the public, not to be a cash conduit from former smokers to these mega corporations.

 

[Jman8]

Sound and thorough reasoning

Hi,

For smoking cessation I believe electronic cigarettes far exceeds all methods. BAR NONE!!! I was a 32 year on and off smoker. After discovering E-cigarettes I quit within a week and I have been cigarette free for over a year. I feel great! For the first time since I was diagnosed with Type II at 40 (I am 48) I got an excellent report from my doctor on my overall health and he reduced my Metformin and took me off of heart medication. My fitness is wonderful I usually walk a few miles daily and I enjoy electronic cigarettes everyday. I have been saving huge amounts of money. My girl and I switched at the same time and we just got back from a trip to Myrtle Beach with savings from cigarettes. I have lowered my nicotine level from a Marlboro (around 24 mgs ish) to 6 mg now. I for see myself lowering my nic level to zero soon (but I do like the throat hit of a little nic in my juices). If I felt like it now I know I could easily stop e cigarette useage but for now I still enjoy the smoking sensation.

I have heard that electronic cigs were originally pioneered in the 60's. A commercial version was released commercially around 2003 by a Chinese inventor. There are multi millions of users now and soon billions.

I am sure the Government pending is being strongly influenced primarilly by the tobacco companies (That are already cashing in on e cigarettes) and Uncle Sam's strong desire to put a sin tax and other taxes on e cigarette products.

I have spent some time researching and I have found little of people having ANY ill effects aside from throat irritation and heart rate increase. Both of these are from the nicotine and in my experience the throat irritation is from high PG concentrations. A lot of people who start vaping experience this. (Reducing the PG eliviates this for me)

I use primarily a Organic Vegetable Glycerin mix with concentrated flavorings I prepare myself. ( At great saving and customization) The Propylene Glycol that detractors are demonstravising (-10 spelling ) is negligible as it is only contained in the flavor concentrates in the e juices I create for myself.

I believe that the propylene glycol in ejuices is actually. Critics misstate that it is antifreeze it is not. It is an ingredient that is used in food flavorings, asthma inhalors and other consumable products since the dawn of manufactured foods and medicines.

I am hearing the pending regulations seek curtail the offering of fruit and sweet flavors as the are attractive to minors. The flavor concentrates are readily available from many sources as food and candy flavorings. As governmental controls are set forth people with get smart and do as I did and produce their own e liquids. The PG, VG and Flavorings are legal and are not and should be controlled. The nicotine probably should be regulated, but minors will always find a way to get what they should not have and always did. I no longer go to any e cigarette vendors, but I know they post they only sell to 18 and older.

What do I know about minors usage of electronic cigarettes? I have 6 kids ranging for 8 to 24. My 17 year old son uses e cigarettes and so does some of his friends. Some friends were smokers and switched or quit after ecigs. My son does not use tobacco and does not use drugs. He has always been an honor student, an eagle scout and has a full paid athletic scholarship to the areas finest college. It was not a good choice for him to start using e cigs, but it is far better than him or any other minors smoking cigarettes or {OTHER STUFF}. Just like alcohol or tobacco and drugs minors who choose vices will procure them or get them on the black market.

To summarize I believe prior to the FDA attempting any control of the electronic cigarette industry they need to do the homework. It is time for real studies on the use and effects of these products. Without the e cigarette alternative I probably would be smoking and having serious detrimental effects to my well being. I feel better than I have in 20 years and I have e cigs to thank for that and I know if I want I can stop this. As for stopping Minors. Good Luck with that unless you can wipe e cigarettes off the face of the earth. They will get anything they want and always did and will just like we did.

I have some characters left. I know I am long winded. I apologize for spelling and typos. I know this regulation may or will control or oversee vaping hardware due to mishaps like I recently viewed. (*ie. "e cig lith battery blows up when overcharged by Ipod in bar" and e cig blows up in Florida mans mouth" etc.) If you regulate/ do away with e cig devices there will be far more accidents when people start making their own devices easily out of flashlights etc.

Please find another battle! Support Art, Music and Education and get rid of Professional Sports. Lets get industry going again and open steel plants and put people to work again and be able to defend ourselves.

 

[Jman8]

I liked post #3 in this thread for its brevity. But this may be the best one ever.

No

2 letters (for the entire comment) that say it all.

 

[Jman8]

Another short one, making a highly relevant point, with a little humor. What's not to like?

I would just like to say, I vape 0 nic juice. So because the industry typically uses nicotine, I once again have to have more regulations put on me? No tobacco leaves were harmed while I vaped, and wrote this.

 

[Jman8]

This one from a manufacturer (in my neck of the woods) that speaks to highly relevant issues.

Hello, my name is PJ Allen. I run a small E-Liquid manufacturing facility in Milwaukee Wisconsin. We create hand crafted E-Liquid for people to purchase. Our small company is constantly growing every month. I support my family with this business and also have a passion for vaping and the e-liquid I put on the market. I agree with the regulations but have one concern. If the cost to register product is in the thousands all of the small companies like myself will be forced to close doors. The general public likes to have choices in what they vape. If the cost is in the thousands the only companies able to afford that will be big tobacco companies and that will limit the choices everyone has. There are literally thousands of small compaines like me making the liquid. We are not only helping the community but we are creating jobs and also supporting families. If the big tobacco companies are the only ones able to afford this and supply the juice everything will go over seas and we will lose money and jobs. Put it this was if there was onyl miller light and bug light people would not like beer. it is the smaller comapnies and all the craft beer that make the market. Agasin i agree with all regulations i just suggest you take into consideration the little people here and realize we want the same thing as you but if the costs become too high thousands of business will go under and big tobacco wins. Thanks for your time and i look forward to hearing the results.

 

[Jman8]

This one from a vendor with some sound reasoning.

I believe an open ended policy is going to do nothing but ruin many small businesses. I myself work for a small business in central Illinois selling and servicing these devices. I am a firm believer in these products and that when used properly, they work. I do agree that they should not be sold to minors and the shop I work for does not, nor do any other shops I know of, sell to minors even before it was state law in Illinois. I believe the responsibility should rest on parents shoulders to teach their children about the hazards of smoking and tobacco use, and not rely on laws and regulations alone to keep these out of the hands of minors.

Having used the "Electronic Cigarette" to quit smoking my self and helping many others quit smoking using these products, I find the writing of these policies to be very troublesome. Smoking kills many Americans every day and does an insane amount of damage to the human body. We know far more about what goes on in the Electronic Cigarette than we ever knew about traditional tobacco cigarettes. The combustion process releases tar and an untold number of known and unknown toxins into the human body.

I am very tired of the "Fear Mongering" that is being feed to local news and media outlets about how dangerous these devices are. For example, the episode of Dr. OZ that recently aired about "Nicotine Liquid" and how dangerous it was. I was appalled how the juice used in these devices was compared to straight Nicotine. Yes, there is Nicotine in the "Juice" HOWEVER, the juice being used in electronic cigarettes is an extremely diluted mixture with in most cases less than 3% Nicotine. The majority of the juice sold in our shop goes between 1.2% and 2.4%. Not only that but in a 10mL bottle of juice with 2.4% Nicotine there is less Nicotine than a single pack of Marlboro cigarettes. The 10mL bottle we sell is designed to last most users between a week and 2 weeks and it usually does. Most users who use these devices as a hobby use juice with far less nicotine yet. We sell juice all the way down to 0% (ie) NO Nicotine.

Most bottles of juice already have warning labels on them. Most juice bottles already have some kind of safety cap. It is impossible to pass laws or regulations that will guarantee 100% exclusion from minor use. Some of the responsibility has to fall onto parents and the end user. Even with all the labels, signs, locks, etc... someone somewhere is going to do something stooped with it and that is out of even your control. Please understand as we grow as an industry, we are willing to adapt and use tools to prevent what we can and help who we can. I believe the electronic cigarette is far safer than smoking and probably cleaner than most of the air we breath in major cities. This policy needs a more forgiving approach that will help more people actually quit smoking rather than remove a working alternative.

 

[Vocalek]

Written by someone that signed there name as "Dr." - sound reasoning, bonus points for brevity

E Cigarettes do not contain tobacco, thus there is no authority to regulate.

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):

SEC 101. Amendment of Federal Food, Drug, and Cosmetic Act

(a)Definition of Tobacco Products
Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

(rr)
(1)The term tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

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.

 

[Dave_in_OK]

Sorry deleted as not what the OP was asking for.

 

[Jman8]

Please keep posts on this thread aligned to what OP is asking for. Thanks!

 

[Jman8]

A bit of a rant for this submitted comment, but last 3 paragraphs raise some very good points.

Hello,

I have been smoking electronic cigarettes of various kinds for 4 years. I started with "cigalikes", which seem from the FDA suggestion to be where the electronic cigarette market is being consolidated to. "Cigalikes" never helped me at all, I only used them when I didn't feel like going outside. They were terrible and unsatisfying.

With that being said, I haven't picked up a tobacco cigarette in over two years, strictly due to my personal nicotine vaporizer I currently use. It is a mechanical mod, with two pins that contact a battery and channel a current to a coil inside an atomizer, which vaporizes nicotine contained in a piece of organic cotton. I learned all the relevant mathematical electric laws, and feel no danger doing this. I could build another one from some pipes and scrap metal if I needed to replace it for whatever reason.

As for the nicotine, the only thing the FDA could potentially regulate here, it is not nearly as dangerous as the media has presented. It is heavily diluted, and the nicotine is not concentrated. If outlawing these "dangerous flavors of nicotine juice" is what comes to pass, I'll be forced to buy a big vat of heavily concentrated nicotine and craft my own juice. I do not want to do this, this would be dangerous. Others will either do the same, which is very dangerous and should be left to people with specialized equipment, or switch back to tobacco, which is very dangerous and should not be used.

Banning nicotine "e-juice" will be the public health hazard, you will see a high escalation in nicotine poisoning. If I get my "e-juice" on my hand, diluted, there is no effect. If I proceed to distill my own liquid and get a concentrate on my hand, I may die. I will risk that over the assured death of cigarettes though.

Thank you for you time. I really hope the research is done properly before any hasty decisions are made. These devices are literally saving lives. If anything, think of the health care savings that will (obviously not fully) supplement the lost revenue of big name tobacco taxes. Banning this revolution would be a clear indicator to a significant chunk of the population that money overrides public health.

 

[Jman8]

Polite, nicely written, thorough reasoning.

Thank you for your attention.

I would like to offer my opinion on the proposed e-cigarette regulations - specifically the registration, application and approval process for e-liquids. I believe they are unduly onerous, destructive and ultimately harmful to vapers who have quit smoking, current smokers who wish to quit and the economy as a whole. They will result in the demise of hundreds of small businesses and a consolidation of the industry into the hands of tobacco companies.

I am a 55 year old former smoker who was only able to quit a 40+ year, 3 pack a day cigarette habit because I discovered vaping last year. I have not touched tobacco for 6 months and for the first time in my life I consider myself an ex-smoker. I fully realize that I have only replaced one habit with another but it's a much healthier habit and my overall health is vastly improved - I breathe better, I sleep better, I am less stressed and I have more energy - and I could not have done it without vaping. If not for vaping, I am certain I would be smoking today and I'm convinced it will add many healthy years to my life.

Other smoking cessation methods didn't work for me, and tobacco flavored "cig-a-likes" were unsatisfying. It was only after I found 2nd and 3rd generation vaping gear along with - and I emphasize this - fruit, candy and bakery flavored e-liquids was I able to kick tobacco.

I have no financial interest in this other than as a consumer. If my understanding of the proposed regulations are correct, they appear to be designed to eliminate the wide variety of flavors by reducing manufacturers The reason this industry has grown so large so quickly is because they offer an effective and much healthier alternative to smoking and because it was free to innovate, offering lots of variety and being able to bring new products to market quickly, something tobacco corporations have little incentive to do. This is because most of the e-liquids available today come from hundreds of small businesses. The proposed changes will force most of those small businesses to close up shop - in effect eliminating Big Tobacco's competition using taxpayer dollars. If that happens, it would be criminally negligent.

It means that virtually all of the flavors I enjoy today would disappear. I do not like tobacco or menthol flavors. Currently my rotation includes strawberry, blueberry, peanut butter and cinnamon rolls and I am constantly trying new and more complex flavors. My current favorite is a mixture of caramel, peanut butter, banana and vanilla This flavor would not exist if it had to go through the proposed approval process. The ingredients used are already FDA approved, so why do we need an additional approval process simply for mixing them in a different way?

Most of the proposed regulations are very reasonable - sanitary manufacturing standards, ingredient standards, product labeling, age restrictions, etc. - all of these are welcome and useful changes and not particularly intrusive. But requiring multiple FDA applications and approvals for every combination of ingredient, flavor and nicotine level is not just excessive, it's punitive and vindictive. The only explanation is that it's purpose is to limit flavors by limiting manufacturers.

I think it's important to note that the e-liquid industry to-date has a nearly spotless record - to my knowledge, there have been no serious poisonings and one has been seriously injured using e-cigarettes as intended or directed. With millions of consumers nationwide, the industry has done a remarkably good job of self-regulating. Why punish them for that?

In summary, I urge you to reconsider and relax the approval process. It is too extensive and expensive for the vast majority of businesses it affects and the result will be to keep current smokers smoking, push vapers back to smoking, put a lot of people out of work and hand deliver the industry to tobacco corporations.

I understand the long term effects of vaping are not well known, but the long term effects of smoking are extremely well known and devastating. This is the most promising smoking harm-reduction activity ever, and these regulations will set it back years if not decades by making vaping even harder and less attractive than smoking. If that happens, I believe it would be the biggest public health tragedy of this century or the last. It would be a mistake of epic proportions.

If they remain as proposed, it will crush a very vibrant and growing industry in it's infancy and hand over it to the big tobacco corporations - an industry that not only provides plenty of jobs and happy consumers, but offers a less dangerous path to a more healthy life for millions of Americans who have been unable to quit smoking any other way.

Thank you for your kind attention.

 

[Jman8]

Sound reasoning, touches upon key points.

1. Electronic cigarettes are not tobacco products, The nicotine of the juice is, so the juice is the only thing that the FDA should have a legal right to regulate. The FDA regulates pipe tobacco, but not the pipes themselves. Ecigarettes are like pipe, the ejuice is like the tobacco.

2. When did we start regulating things until we know they are safe? Shouldn't it work the other way around?

3. The 2007 grandfather date is too long ago for a budding industry and will completely stifle innovation.

4. The nicotine itself should be regulated, not the final juice. This allows small businesses to produce custom flavors without re-submission to the FDA for approval. It would also take into account 0 nicotine ejuice, where the FDA should have no jurisdiction.

5. Flavors are an important element in the efficacy of ecigarettes to help ween people off of traditional tobacco products.

6. These regulations will not "expand the amount of information available to the FDA and the public". The entire statement is ridiculous. Also, the studies done to this point have shown the potential for an enormous health impact, a positive one, by allowing the ecigarette industry to thrive and actually promote their adoption by current smokers.

I suggest a few regulations, namely sale prohibited to people 18 years of age and over, and safety regulations on the raw nicotine used in the manufacture of ejuice. Anything else will do more harm to public health than good.

Regarfs,
An ex smoker, a current vaper, and a tax payer