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.
- 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.
- 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.