FDA Good comments being submitted to FDA

[EddardinWinter]

I just found this thread, and it is a good idea, Jman.

Even if it is solely to provide good examples of sound arguments as a resource, and I think it could be more than that. It is important for us to act as part of a group with CASAA and as individuals. CASAA cannot fight this alone, so we all must use our individual talents to attack this issue on multiple fronts.

 

[Papajohns]

Hey, someone posted my comment

 

[kevinj6121]

I went to the actual FDA website, guess what, all e-juice ingredients are already approved by them. So whats the dam problem here?

 

[Jman8]

A person who isn't exactly pro-vaper making simple sound point on why vaping must be kept available.

As a college professor on this subject for many years, I have also conducted post-graduate research in many semesters on causes of smoking & tobacco use.
It is with some irony that I am in favor of allowing e-cigarettes as the "lesser of evils" approach toward tobacco use reduction. Clearly there are less harmful ingredients in e-cigarettes than in the smoke of cigarettes, cigars, and pipe tobacco.
I teach that the best way to beat the tobacco habit is via getting more active, and promoting the use of sugarless gum as often as needed.
In a perfect world, everyone would be educated before age 9 that tobacco has a myriad of hazards, but overcoming the myths and mi-information / mis-beliefs about this plant and the effects of medicine to thwart tobacco with world-wide problem solving remains an uphill battle.
THANKS for considering this !
Prof P J Gammarano, M.A., J.D.Health Educator

 

[Jman8]

Comment seeking reasonable regulations based on sound reasoning.

Hello

I would like to make a few comments and suggestions in regards to the proposed Electronic Cigarette regulations.

While I am in full support of age restriction sales I do oppose many of the proposed regulations.

The Biggest issue I see is product registration. New Products arrive on the market( Mostly Hardware and Accessories not containing or derived from Tobacco) monthly. By the time a product would go through the Pricey and lengthy registration process it will become obsolete or will have had a revision . Mods , Devices ,Batteries ,Cartridges should not be subject to any FDA Regulation as they are not derived from Tobacco Products. Regulating Hardware I feel would be discriminating against the Electronic Cigarette Industry as the products ,If not identical, are similar to flashlight and battery chargers. Cartridges , atomizers , tanks also should not be included in the regulations as they are made of plastic and metal parts and can be used for Non nicotine products. I don't understand how the regulations can be enforced for Hardware and strongly encourage them to be removed from regulations.

For E liquids Containing nicotine I feel that Product registration will be a lengthy and costly process and may force most, if not all, many Small to Medium sized Companies to go out of business and make thousands of Hard Working Americans unemployed.Simply registering products does not ensure all end products will have the same quality as the samples provided to the FDA for the registration process.

Product registration is not the Answer to electronic Cigarette regulations.

I do feel that the Ecig industry should be subject to Good Manufacturing Practices and should be held to high Standards in regards Manufacturing Of E liquids in order to assure that the products are of high quality and do not pose any risk to the consumer or public. All Eliquid Manufacturers should be required to register their facilities and should be subject to frequent inspections.

 

[Jman8]

Note: This comment was submitted entirely as PDF that was 3 pages long, from CEO of Firebrand (eLiquid manufacturer). I am not including the person's name, nor about 2/3rds of what was on PDF as it would be ridiculously long post.

You absolutely have to grandfather in products that have been on the market after 2007. You have no proof these products are harmful and in fact – plenty of data to prove the opposite. You will destroy this budding industry and the lifeblood of thousands of small and mid-sized businesses with this move, as it is simply too costly to scale.

The FDA must act in good faith to correct these oversights and propose regulations that are reasonable and sustainable.
My suggestions are the following specifically for e-liquid manufacturers.

1. Facility registration. All e-liquid facilities must be registered and inspected by the FDA. I'm certain a fair fee can be proposed of $5,000 to $10,000 – or perhaps even discounted for businesses making less than $1 Million per year.
2. Facility standards. All nicotine must be titrated to 10% of the label and documentation must be kept on periodic batch reviews to prove the facility is submitting the products to third party laboratories analysis for nicotine accuracy. Secondly, you must act to ban diacetyl & acetyl propinol in e-liquid. Put the burden of proof on the manufacturer and hold them to a similar record keeping and batch testing as proposed for nicotine titration.
3. Grandfathering. All products on the market before the day your laws go into effect are grandfathered in and allowed to stay on the market, but must be registered with The FDA. All applications for e-liquid must be approved unless there are public health complaints surrounding the products, and as long as they come with documented proof of batch testing nicotine accuracy and certificates of analysis proving the products are diacetyl and acetyl propionyl free. We all know that ecigs were not on anybody's radar when The Tobacco Act went into effect, so to act now and cram them into tobacco products because you can is poor and sloppy policy that reeks of protectionism. There is no tobacco in e-liquid – it is a tobacco derivatives product if anything.
4. Future products. The pre-market applications are too burdensome on businesses – specifically small to mid-sized businesses - and must be abandoned. We all ready know that e-liquid is completely safe in comparison to combustible cigarettes – especially when said e-liquid is created in an AEMSA certified facility such as Firebrand's. My suggestion for future products is they should be registered with the FDA along with documents proving nicotine accuracy and diacetyl/acetyl propionyl free. The burden of proof for safety is then on The FDA and you can command to pull products that don't live up to quality control standards at will.
5. Classification. E-liquid cannot be classified as a tobacco product. There is no tobacco in it. E- liquid is a nicotine product. E-liquid is no more a tobacco product than Coca-Cola is a coffee bean product. You must innovate and change this classification to either a “tobacco derivatives product” or simply “a nicotine product”. Currently, the only legislative might you have over e- cigs is that the L-nicotine in our product is derived from tobacco plants. What happens when we figure out how to pull our nicotine from eggplants or tomatoes? Then it truly has nothing to do with tobacco. You must address this now and classify e-liquid accordingly.
6. Hardware. The FDA must surrender its authority over electronic cigarette hardware. You have as much authority over the hardware as you do a pipe for tobacco. These are metal casings and batteries – it's even possible to purchase adapters and turn them into laser pointers. You must abandon this initiative and focus on what you're really after – e-liquid containing nicotine – which is what consumers inhale into their lungs.

If you take the right steps and work with those of us in the industry who are experts in e-liquid manufacturing, you have the potential to change public health for the better forever.

What would be great is to do the right thing and separate e-liquid into it's own classification and then start a special task force that handles the enforcement of FDA standards in regards to e-liquid. This is the right thing to do. Not try and cram a square peg into a round hole which is what your current proposal is doing.

I implore you to take my points into consideration and act upon them. Specifically on substantial equivalence and pre-market applications. If you move forward on that, you will be mired down in litigation for years to come and you will hand this industry to big tobacco if you happen to succeed – and we all know their track record. I would hope that you would rather work with independent entrepreneurs like myself who are earnest in wanting to do the right thing.

 

[Jman8]

Another vendor submitted comment citing sound reasoning.

I am writing about proposed regulations on ecigarettes. I own a small vapor shop where we deal in ecigarettes, eliquid and the like. I support most parts of the proposed rule to include being 18 to purchase any product and some regulation of those who are manufacturing the liquids. When I opened my shop I decided long ago that I was not going to manufacture our own eliquid in house for many reasons, and instead source reliable and established brands to purchase from to resell in store. We carry four brands which we know have been around for years, made in the USA, proper labeling with warnings, lot numbers, ingredients, child safety caps, etc.

In reality I find most shop owners already required persons to be 18, so this is not anything that should be surprising to anyone and is a good thing. You'll find most your owners were responsible enough to use common sense in requiring this from themselves as a business owner.

I understand the rules being proposed for manufacturers, but the question is do they go to far? I'm not an expert by any means, but I've read the cost involved in even applying for and getting approved would put most your small businesses out of business. There is many good small eliquid manufacturers out there that do a great job of 'policing' themselves and put out a safe, properly labeled product. Should we destroy the majority to penalize the few that give the industry a bad name? My personal opinion is that of 'NO".

Lastly, my biggest concern is classifying and ecigarette as a tobacco product will open up Pandora's Box in a sense. I see it as a way for it to be ridiculously taxed and further regulated as to defeat the whole purpose of the product - to give tobacco users a way out of smoking tar and thousands of chemicals. We hear story after story each day in our store of customers using these products and feeling much better, breathing better, not coughing, being able to chase after their kids without feeling like their having an asthma attack, the list goes on.

Let's just sit back and weigh it all out before jumping to conclusions. Let's not turn a potentially great alternative into a negative that puts people back on tobacco cigarettes that will ultimately kill them and reduce their standard of living.

 

[Jman8]

Very thorough reasoning and 9 linked studies to help support that reasoning

I would like to share my experience with electronic cigarettes. First I this calling them cigarettes is a mistake. the only thing they have in common with cigarettes is nicotine.

I have been smoking since I was 14, I am now 45 years old. I have tried countless times over the 30 years to quit smoking with little success. I have tried nearly every smoking cessation product available. With little or no success. Until I discovered electronic cigarettes. This is the first thing that has worked for me. As an adult I enjoy the variety flavors available to me instead of the nasty flavor and smell of analog cigarettes. The flavors may be attractive to children, but so are the strawberry wine coolers that they should not have access to but seem to find a way drink. Don't deny adults flavoring to save few kids. Many kids buy and smoke analog cigarettes now. Theses same kids will buy tobacco flavors in the electronic for also.

The one things about this regulation I don't understand is. In the same breaths I hear politicians say ' We dont know enough about this product, we need to study it" But are quick to recommend regulations. If you dont understand the product how could you make smart regulations? My guess is they see it as a new tax base and the tobacco companies and Nicorette's of the world's stand to lose millions from this innovative product.

Labeling these as tobacco products is a huge mistake. The only thing e-cigs has in common with tobacco is nicotine. No burning, not tar, modified chemistry to make nicotine enter the body faster and who knows what else the tobacco companies have added. the FDA does not consider Nicotine replacement a tobacco product. Why would you label this as a tobacco product

I agree concentrated nicotine is dangers but we dont use it concentrated.. Me personally I use a concentration of 1.8% not very dangerous to me. maybe to little children but so is Bleach and 100 other household Items.

I also agree Nicotine is addictive and the tobacco companies have taken full advantage of this by engineering their product to be more addictive. In the for we use it I liken it to energy dicks or caffeine. By choosing this form of nicotine, I know exactly what ingredients are in them. I can mix my own if I choose to. I can go to the store and have it mixed right in front of me.

By labeling this as a tobacco product you will only hurt real people and fatten the wallets of the tobacco and pharmaceutical companies by reducing the competition and driving prices up with new regulations and taxes. All the benefits of this new found technology will be under minded.

I for one believe some people have high addiction levels to nicotine than others, that make it nearly impossible to quit. I am one of those people. I will smoke or vape. if you take away vaping by making it too difficult or cost too much I will just return to analog cigarettes. I am sure there are thousands out there with the same feeling. We dont always need the government to protect us, but when we do such as the case with the tobacco companies, the government tends to side where the money is.

Benefits of e-cigs as I see it. I cannot provide scientific proof but the FDa cannot either at this time.

I don't produce second hand smoke.
I don't annoy people with he smell.
I choose the ingredients and level of nicotine.
My costs went from $195 per month to under $30.
I feel healthier than I have in years and I can breath better.
With the flavors of my choice I don't have taste the nasty burning tobacco.

IJERPH | Free Full-Text | Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey (Downloadable PDF of the Impact of Flavour Variability)

An Error Occurred Setting Your User Cookie (Downloadable PDF - Toxicology study on vapor proves electronic cigarettes are much better than tobacco)

IJERPH | Free Full-Text | Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers (Downloadable PDF - Switching from cigarettes to e-cigarettes has significant health benefits, according to a survey of more than 19,000 users)

Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices : Scientific Reports : Nature Publishing Group (Downloadable PDF - Nicotine Abosprtion from Electronic Cigarette use between "First generation" (pre 2007) and Third Generation Devices)

http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.ashx (Downloadable PDF - Chemicals generally found in E-Cigarettes pose no health concerns)

http://......................./wp-c...tion-When-Less-is-More-E-Cigarette-Summit.pdf (Downloadable PDF - Dangers of over-regulating E-Cigarettes)

BMC Public Health | Abstract | Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks (Downloadable PDF - No Concern for Bystanders of Second Hand Vapor)

http://www.biomedcentral.com/content/pdf/1471-2458-11-786.pdf (Downloadable PDF - Effect of E-Cigarettes on smoking reduction and cessation)

http://goo.gl/LhEDoK (Downloadable PDF - Study that found of more than 2000 former smokers in this survey, 96% reported that the e-cigarette helped them to stop smoking.)

 

[aubergine]

I kinda liked "Dear FDA, Please keep your dirty hands out of my humidor."

 

[Jman8]

Comment sticking to points raised in proposal and not citing personal experience. Deals with reasonable regulations.

There is a distinction between tobacco products and nicotine products.

For instance, I know for fact both New York and Florida promote programs where nicotine delivery systems, such as patches and gums, manufactured for-profit by private companies, are given away by government-subsidized programs - in the interest of public health.

Studies by trusted and independent groups have concluded there is no substantial threat to public health in the vapor exhaled by those using an e-cigarette. If there is a shred of human decency left, you will not allow special interest groups like pharmaceutical companies, to pay for and misinform biased studies with reports which ...... truth.

Please, let's stick to facts.

Certainly, some standards should be in place. I can find no reason why those standards should be any different than the myriad diet and protein shakes available: a list of ingredients, expiration date, and assurance of a clean facility in which they are made.

 

[Jman8]

Vape vendor with thorough reasoning and noting pertinent points.

I am an owner of a brick and mortar vape shop in Greensburg Indiana and we also do online sales. I believe these regulations will devastate the vaping community. First of all it took close to 2 yrs. for these regulations to be written. I think we deserve more than 75 days for the public to respond to them. Second the FDA needs to look at what vaping products were available for it's equivalency standards. Nothing is to be allowed on the market now that wasn't on the market before 2007. There were your basic cig-likes and about 3 different companies that make e juice. The products on the market now are far superior than what was on the market at that time. Smokers have a much better success at quitting smoking with products that feel or mimic the habit and the products that were on the market at this time do not satisfy that need as well as what is available now. I also feel that the FDA has an agenda and is in bed with big tobacco. Notice that all of the types of ecigs that are going to be allowed on the market are the ecigs that are most similar to the ones being marketed and sold by Blue and the other big tobacco companies. They are the only companies at this time with enough resources to sue the FDA and probably win. But because the FDA have deemed only these will be allowed on the market they are safe from being sued from these companies. This along with the reported 10 million dollar application fee for new products is the reason all small to medium sized vape companies will be put out of business. There also is another way to look at this. The FDA is suppose to be a responsible party for the safety and welfare of the American people but if this regulation passes there will be a black market for this product. Consumers won't be able to get the juice and supplies they need from reputable companies like ours and will go out on the internet to search out places to buy what they need. This means they will be mixing their own juices. Without knowledge of how to do this and the inferior supplies they will be getting, there will be mistakes and people will overdose themselves on the nicotine. This could become a crisis in and of itself. The FDA spokesman has cited instances where batteries have blown up on people. If they are making their own e cigs and getting them from less than honest companies abroad this will inevitably happen more often possibly resulting in fatalities.

Then you also have to look at this from a personal perspective. My husband and I were former smokers ourselves. The 4 other people who we employ were also smokers. I can personally attest that quitting smoking has changed our lives. My husband and I smoked for over 20 yrs. I suffered from constant sinus infections and I am also a diabetic. Since I have switched to vaping I no longer suffer from sinus problems and by blood sugar is under control. My husband no longer wakes up in the mornings coughing and unable to breathe. Our house doesn't stink anymore. Our children don't smell like smoke anymore. Even though we didn't smoke in the house my son's asthma is no longer such a big problem. We have 1 employee who has a blood clotting disorder who has been helped greatly by not smoking anymore. Another employee has COPD and has been greatly helped by not smoking anymore.

My husband and I worked in factories for 17 yrs. Barely making ends meet and trying to do the best we could. Starting this business has been the best thing we could have done. Not only are we helping people but it has created jobs for 7 poeple in the community. Also the building we are in stood vacant for 5+ yrs. before we opened our store and rehabbed the building. If the rug is kicked out from under us there will be more unemployed people in a county where businesses are closing and there are no jobs. Not to mention all the people that will go back to smoking because there will be no other suitable alternative. They have already tried the other ecigs that are going to remain on the market and they didn't work. I don't think you realize the feeling you get when someone tells you that their doctor told them they are going to die if they don't quit smoking and our products are the only thing that worked for them. They are crediting companies like us for saving their lives. We know we are doing the right thing but do you feel by basically outlawing the products that are really making a difference in peoples lives is doing the right thing? If these regulations go into effect people will die from them. I'm not trying to overly dramatic. Whether they go back to smoking or they are mixing their own juice or using faulty equipment there are going to be people that die. FDA DO THE RIGHT THING!!!!

 

[Jman8]

Vape vendor noting business impact and other pertinent points.

Thank you for this opportunity to comment on the FDA proposed rule. First off i would like to thank the administration for their initial proposal to regulate electronic cigarettes. What concerns me is that the language and the stipulations of the rule. They have not been well thought out and the effects not only on the millions of people around the US but also the thousands of small business owners, tax payers, will be devastating. I strongly urge you to open this to the public for more information and open testing of eliquids by some of the manufacturers here in the USA. I am a small business owner that found this industry through chance. It helped me quit smoking as well as more than 3 dozen of my friends and family. It has been a heaven sent. The newer technology of electronic cigarettes prove to be more effective and safer than any in 2007. My company, Vapor Craze LLC, only mixes eliquids that contain contents from already FDA approved ingredients from major pharmaceutical companies like Glaxosmithkline and we mix in an FDA standard food prep facility.
This rule would not only ruin the help that we have given to thousands of people across the US in their struggle against nicotine addiction but rather promote the alternative, Tobacco cigarettes.
Please take this into consideration and find that we the people are voicing our 1st Amendment right not to be tread upon but to be heard and at least taken into account. This is not a wise or healthy choice for a ruling and should not be pursued with the current language. I speak not only for myself but for every person that has struggled with nicotine addiction (tobacco products) and found electronic cigarettes, specifically those manufactured in more recent times, to be helpful in our goal to quit smoking altogether.

 

[Jman8]

Important personal story that did include an attachment of scientific study: Peering Through the Mist Systematic Review of What the Chemistry of Contaminants in Electronic Cigarettes tell us about health risks?

Hello,

I would like to start by saying I am a cancer survivor I was diagnosed with stag 2 Hodkins Lymphoma 3 years ago, I was a smoker for over 20 years I tried everything: Patches, Gum, Lozenges, and even Chantix with no success. I needed to quit and fast. I picked up my first e-cig at a gas station for 20 bucks it was awful to be honest but at least now I knew about them and when I got home I did a ton of searching and reading about e-cigs online. Once I knew more I ordered one from a website, the day I received it in the mail I knew I had finally found it, found what you ask? Well I found my way out of smoking I was so effective that from day one I had quit smoking analog cigarettes(the ones you light.). From that point on I have been smoke free going on 3 years now. Also I have made friends and met people because of this industry that I would have never have had the chance to meet any other way. Since making the switch to an e-cig I also have noticed I hate the taste of tobacco, thanks to flavorings I don't have to go that route, now had I not had the opportunity to try different flavors I don't know that it would have been as effective at as it was. I do believe with all my heart that this industry has saved my life and even added years to it. Thank you for taking the time to read my story, please don't regulate this product to the point that a: It will be to expensive or B: Take away from the way we use these products such as flavorings. Again thank you for reading my story.

 

[Jman8]

Vape vendor making note of pertinent points, including public health concern

I am writing about proposed regulations on ecigarettes. I own a small vapor shop where we deal in ecigarettes, eliquid and the like. I support most parts of the proposed rule to include being 18 to purchase any product and some regulation of those who are manufacturing the liquids. When I opened my shop I decided long ago that I was not going to manufacture our own eliquid in house for many reasons, and instead source reliable and established brands to purchase from to resell in store. We carry four brands which we know have been around for years, made in the USA, proper labeling with warnings, lot numbers, ingredients, child safety caps, etc.

In reality I find most shop owners already required persons to be 18, so this is not anything that should be surprising to anyone and is a good thing. You'll find most your owners were responsible enough to use common sense in requiring this from themselves as a business owner.

I understand the rules being proposed for manufacturers, but the question is do they go to far? I'm not an expert by any means, but I've read the cost involved in even applying for and getting approved would put most your small businesses out of business. There is many good small eliquid manufacturers out there that do a great job of 'policing' themselves and put out a safe, properly labeled product. Should we destroy the majority to penalize the few that give the industry a bad name? My personal opinion is that of 'NO".

Lastly, my biggest concern is classifying and ecigarette as a tobacco product will open up Pandora's Box in a sense. I see it as a way for it to be ridiculously taxed and further regulated as to defeat the whole purpose of the product - to give tobacco users a way out of smoking tar and thousands of chemicals. We hear story after story each day in our store of customers using these products and feeling much better, breathing better, not coughing, being able to chase after their kids without feeling like their having an asthma attack, the list goes on.

Let's just sit back and weigh it all out before jumping to conclusions. Let's not turn a potentially great alternative into a negative that puts people back on tobacco cigarettes that will ultimately kill them and reduce their standard of living.

 

[Jman8]

Comment that notes personal story which includes research done by commenter.
In addition to this comment, 7 items were attached to this submission:

• Peering through the mist: What does the chemistry of contaminants in electronic cigarettes tell us about health risks?
• Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey
• Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers
• Clive-Bates-Regulation-When-Less-is-More-E-Cigarette-Summit
• Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation:
  a prospective 6-month pilot study
• Electronic cigarettes achieving a balanced perspective
• The Ultimate List of E-Cig Studies Are E-Cigs Actually Safe Updated 2 16 14 » onVaping

Hello,

I am a 48 year old male who had been smoking traditional analog cigarettes since I was 18 years old. Before I found electronic vaporizers (e-cigarettes) I was smoking 2 packs of cigarettes daily. I am not overweight but 6 years ago, while still smoking regular tobacco cigarettes, I was diagnosed with high blood pressure and after a pulmonary test at the doctor, it was revealed to me that my lung capacity had been affected significantly and was at 70%. While it was not a diagnosis of emphysema, it still was an eye opener! I decided to research alternatives and started using 40 mg nicotine patches which helped curve the cravings but never helped me with the oral fixation of smoking. The doctor told me to try holding cinnamon sticks in my mouth when I had a craving, but that didn't help much either. I started researching e-cigarettes and their use of nicotine and food grade propylene glycol along with the various flavorings and I though I may give that a shot.

Before I purchased a kit I continued researching more info and found that the forums were a great place to find out what these vaporizers were all about. I found a plethora of information which helped me with my decision to make my first purchase.

Much of the information I found has been updated after further research during the last few years and I have uploaded a few of the files/reports.

I have been using electronic cigarettes exclusively now for 4 years now. As of my last doctors appointment last November, I no longer need to take atenolol for my blood pressure and my pulmonary test has my lung capacity at 90%. I can actually take a deep breath without coughing or weezing, my clothes do not smell anymore, I don't feel dirty now that I don't need to throw throw butts out on the ground anymore or snuff them in an ash tray. I have saved money significantly while using e-cigarettes because I do not need to purchase 2 packs of analogs daily. Both my job and relationships have all improved after starting the journey into electronic cigarettes and for me it has been a great experience.

Sincerely