Wednesday, July 23, 2014

Second Call to Prepare for FDA Proposed Regulations - Prepare/Refine Draft Comment

On Thursday, May 8th, 2014, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  
As noted in CASAA's Action plan, this is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are attacking this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness, and extending beyond comments to the FDA docket.

  • On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA's Action Plan.  
  • On May 21st, 2014, CASAA released the second Call to Action.  
  • On June 13, 2014,  CASAA released the third Call to Action.
  • On July 17, 2014, CASAA released the first Call to Prepare.
This is the second Call to Prepare in CASAA's Action Plan.  


In the first Call to Prepare, you created some comments that addressed several substantive points. This second Call to Prepare is your opportunity to add to that content. Instructions on actually filing your comment to the FDA will be contained in the Fourth Call to Action that will be issued tomorrow, July 24, 2014.  


These guidelines are written for people who have used e-cigarettes for tobacco harm reduction. Obviously, we encourage comments from other CASAA members or other consumers, but much of this (it is obvious which parts) will not apply, and you will need to write more in third-person than first-person.



FIRST, prepare your opening paragraph(s). We believe that all consumers should make it clear that you -- people who are using these products and who are experiencing dramatic improvements in their health and general well being -- are the primary and most important stakeholders in this process, and our interests are being ignored. Below are some key points to include as well as a sample that YOU SHOULD NOT COPY AND PASTE.  (The sample is intended give you some idea of the points that would be good to make, in your own words, in your first paragraph(s).)  Remember that you have already written your personal story of e-cigarette use, which will appear later, so this bit should not repeat that.


Key points:

  • I, along with millions like me, am a consumer, and, as such, I am the primary stakeholder here.
  • FDA Regulations are supposed to benefit me.  
  • As written, these regulations would hurt me, and other consumers like me, both from a public health standpoint as well as financially, and provide no apparent benefit.
  • The impact on consumers seems to not be considered in these regulations.
  • Why is the FDA more concerned with the interests of industry than the welfare of the public?

Sample paragraphs (again, please do not copy and paste these; use your own words):

“As a consumer, I am one of the real stakeholders here. Thousands of people have opinions about what I should be prevented from doing, but I am one of the consumers who FDA regulations is supposed to benefit. And yet what you are proposing to do will hurt me badly.  

“I am concerned that despite the fact that consumers are the primary stakeholders and despite the fact that these proposed regulations will have devastating consequences to consumers, there appears to be no consideration whatsoever given to the impact these proposed regulations will have on consumers. The impact statement considers only the effects on industry, and the effects on consumers is ignored by the FDA as well as the so-called “public health” community. This is completely unacceptable and a perversion of the FDA’s mission to benefit consumers.”


SECOND, prepare your closing paragraph.  We think it is appropriate and helpful to let the FDA know that you believe this entire issue -- an issue which impacts your life directly and fundamentally -- has become a political game and the legitimate needs and desires of the most important stakeholders, consumers, has largely been ignored or dismissed. Here are some key points as well as a sample closing paragraph that, again, you should NOT copy and paste. Rather, it should give you some idea of the points that would be good to make in your final paragraph.


Key points:

  • One of my most intimate health-related decisions has become part of a political game.
  • As consumers, we are being treated like pawns subject to the whim of unresponsive bureaucracies, out-of-touch politicians, and uncaring activists.
  • The aforementioned entities are acting on an agenda that bears little resemblance to honest public health concerns.
  • What the FDA is proposing to do will cause harm to millions of people, all for the sake of making rules that do no apparent good. (This is also a point from the introduction -- it is worth repeating.)
  • If implemented, the proposed regulations will increase the disdain for the FDA, the politicians who have supported this, and the U.S. government in general.


Sample paragraph (again, please do not copy and paste this; use your own words):

“I realize that a very important aspect of my life has become part of a huge political game. I know that I, and consumers like me, have become a pawn and will likely be the victim of large, unresponsive bureaucracies, out-of-touch politicians, and uncaring activists with an agenda that bears little resemblance to honest public health concerns. What the FDA is proposing to do will cause harm to millions of people, all for the sake of making rules that do no apparent good. If implemented, the only apparent benefits of the proposed regulations will be to big companies. These regulations will increase the disdain for the FDA, the politicians who have supported this, and the U.S. government in general.”
 
THIRD, if you choose to directly address some of the scientific claims being made by the FDA, we encourage you to first read CASAA’s analysis in the AntiTHRLies blog, which starts and is indexed here.  


FDA does not expect individual consumers to analyze the science.  But if you believe you understand it well enough to do so, it is an option.  However, reciting sciencey claims that are incomplete or inaccurate might tend to diminish the effectiveness of what you know best: your own story and what this will do to you.  If you do decide to include scientific claims, make it clear that you are focused on the big-picture issues (the proven low-risk of smoke-free alternatives; the lack of harmful levels of any contaminants in e-cigarettes) and not specific details that do not really make that point (e.g., study X showed that vapers’ cardiac function was Y); doing the latter may tend to reinforce FDA’s bias that consumers are being misled about e-cigarettes.


FOURTH, as you put the finishing touches on your paragraphs from above and from the first Call to Prepare, please keep in mind that this is YOUR opportunity to share YOUR views in a respectful and intelligent manner.  You want to tell your personal story and why this is so important to you.  Use your own words and don’t be afraid to make a personal appeal from the heart.  

The Fourth Call to Action for FDA Proposed Regulations will be issued Thursday, July 24th, 2014 and will contain detailed instructions on how to submit your comments.

11 comments:

Anonymous said...

I realize that a very important aspect of my life has become the sole part of a huge political game. I know that I, and consumers like me, have become a pawn and will likely be the victim of large, unresponsive bureaucracies, out-of-touch politicians, and uncaring activists with an agenda that bears little resemblance to honest public health concerns. What the FDA is proposing to do will cause harm to millions of people, all for the sake of making rules that do no apparent good. If implemented, the only apparent benefits of the proposed regulations will be to big companies. These regulations will increase the disdain for the FDA, the politicians who have supported this, and the U.S. government in general.I wish the government would keep there noses and hands off the products I use. I consume what I feel is MUCH better than a cigarette. Tobacco and cigarettes need to be regulated more before you regulate electronic cigarettes. Do some research before you start your bans.

Anonymous said...

you are exactly right . worst part is we may not be out numbered but our funded and so it goes money talks bullshit walks . the us government could careless about its people its all a money game the tobacco giants have already bought NYC ... LA and Chicago will be next . Its so sad that the fda and the feds wouls rather worry about whet grown adults out in their body ( no really its the loss of cig tax ) but its ok for our schools to feed gross disgusting crap to our kids , they take food away from our kids and could careless that the FDA APPROVED Garbage will undoubtedly kill us all

Anonymous said...

Isn't the FDA primarily concerned with the law they are using, and not what the Congress decided when it created that law. Shouldn't the comments focus on the aspects of the 99 questions which you have collected, that the FDA has movement on. The FDA can not just drop the law, certain Senators and Congressman won't let them skip the law.

Anonymous said...

I do not dispute putting age restrictions; children should not have access to these and certain other sensible regulations on e cigarettes but as for the FDA’s findings they continually publish on electronic cigarettes containing harmful chemicals, including diethylene glycol, a key ingredient of antifreeze, I depute there claims.

currently I purchase my own e cigarette chemicals and make my own e-juice (as do many, many Americans) and I know precisely what is in them, beside the Nicotine all the rest are ingredients found in every day foods such as propylene glycol witch is found in most foods and medications and has been labeled as safe by the FDA, vegetable glycerin also labeled as safe by the FDA and food flavorings.

The only way they would find toxic ingredients is from companies who use substandard ingredients they purchased from foreign companies to save a few dollars (I am aware of these types of e-cigarettes and juices most come from overseas or out of the US), With a little research I found the proper companies to purchase from, there are many E-cigarette and E-Juice companies out there that state in bold letters all there ingredients in there e-cigarettes and juices (the same ingredients I just mentioned above)

My concern is the loss of a truly great product, and companies who use the proper ingredients, over the years I have tried every methods to quit smoking cigarettes from patches to pills to hypnosis to no avail, my breathing was very bad and I had a constant cough, I have also lost family to cancer from smoking, I have tried it all But happily after 32 years I found the e-cigarette and am no longer plague by breathing problems or constant coughing in fact my breathing is better today then 5 years ago and the many flavors, tank and battery options help to keep me away from regular cigarettes with a loss of the current products available I would most likely return to smoking.

In short I and many Americans like me believe you and the other senators should do a little more researcher before making your final decision and not rely solely on the FDA for there information, the FDA has a way of Coloring things to there advantage but it is not always the Truth

Thank you for your time and consideration
Roy Pelletier

Uttam Kumar said...

The electronic cigarette has been in existence for almost Eight years and is a clever device aimed at providing smokers with a healthier option. Apparently also useful in helping to reduce and indeed quit smoking altogether. Please visit more information Vaporizer

Tom Wright said...

I am a consumer Of these products what you are deeming to do is wrong it is just another way for you to try to control our lives and put us back on things and products that just don't work and are a joke you have no right to tell me what I can and cant do. I know that it is all about the money. you have to control everything we use like food, oil, alcohol and so on this is so perverse and stupid there are many things out there that are worse going on in this country main because of our corrupt government which allows company like pharmaceutical, Tobacco companys to rob and mutilate and even kill millions of people a year. but still allow it be cause of some back room deals. We all know that there is know money in a cure for some illness only in the cure that is why everything is worse no than before watch TV commercials on drugs that are prescribed or all these lawsuits I have arthritis but all the things to take for it will possibly do more harm and cause other more severe things or possibly death but yet the fda still allows it to be sold. Same goes for smoking and dipping how many people will die this year from that?

David Enderson said...

we are all adults,mind your own business and stop supporting big tobacco

Aj said...

When will I be sending this to the F.D.A. ?

WWW.GR8EVAPE.COM said...

I would like to start off by telling a little about my story I was a heavy smoker for 17+ years 2-3 packs a day. In 2012 I was introduced to ecigs and have not looked back. I believe in ecig/vaping industry so much that I opened a vape shop to help others make the change from analog cigarettes to vaping.

We also produce our own e-liquid and EVERY one of the ingredients are made with FDA approved ingredients, I only mention this so that there is no reason for anyone to say all e-liquids are toxic, that's just not the case. I also would like to mention I did an experiment, I used to have to take 2- blood pressure meds a day I didn't take them for 2 weeks and monitored my blood pressure daily and at the end of the 2 weeks my physician and I decided I no longer need them due to quitting smoking, and vaping doesn't affect my blood pressure at all.

I have converted many people into non smokers through vaping, I can only attest to the people I see daily or often. 5 the number of people in my family I have vaping instead of smoking is 5, I know your thinking 5 is not very many people but I believe having 1 person quit smoking is a victory.

I believe the vaping industry is doing just fine as is, I do however strongly agree that you MUST be 18 years old or older to use vaping products. I would in no way compare them to tobacco products, vaping has 3-4 ingredients that are used in everyday life by most people on the planet, where as tobacco products have something along the the lines of 3,000-4,000 poisons and other extremely dangerous chemicals, so I do NOT see the commonality in these 2 products, forgive my ignorance.

In short I opened a vaping business because of how strongly I believe in vaping as a smoking alternative, I will do whatever I can to keep my RIGHT of choice to VAPE and save my health and my fellow VAPERS health.
any questions or comments my contact information is below. VAPE ON!
Thank You, Timothy Healy, www.gr8evape.com

John Dillard said...

I have been vaping for a year now. I feel a lot better. I don't hack and cough in the morning anymore. I feel like vaping has defiantly added years to my life.

Rolando Figueroa said...

In any case, children will get there's hands on ecigs regardless of regulations. Hell, if there able to get weed or cigarettes through various ways, what's makes you think regulations on ecigs will work? Are you willing to make a bet that will surely not work out? Come one man, stuff like this needs to be sorted out with parents. Parental responsibility is a key factor. I'm no parent, and those who want there children to have healthy lives, should just be more observative toward there child. I'm not trying to there people what to do, this is just a option. But in the end, don't scapegoat your failures. That's what it always comes down to is just scapegoats.