Thursday, May 8, 2014

Overview of CASAA's Action Plan Regarding Proposed FDA Regulations




NOTE: To keep up on CASAA Calls to Action and other posts regarding the FDA, please click and bookmark this link: FDA Alerts and Calls to Action

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In April 2014, FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.


Early on, we asked CASAA members to be patient and to refrain from making formal comments (you are allowed to submit more than one comment) about the proposed regulations until CASAA leadership  had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that  makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.

The last few weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the Tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.


This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack 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.


The Action Plan will include, among other things, Calls to Action with specific requests directed towards members of Congress. To support this massive undertaking, we have subscribed to CQ Roll Call, a program which will help connect our members easily and in a targeted fashion with their state and federal legislators on specifically crafted campaigns we design.   This tool will be valuable as we move forward to the next stage of our battle, and it will also help us in our continuing efforts at state-level advocacy.


The CQ Roll Call program represents a significant commitment of financial resources, but we have been careful with the money our membership has donated over the years, practicing sound fiscal management to ensure that the money will be available when the time is right. That time is now. We are working with the company to get the program rolled out as quickly as possible, and we have been told that we should have it functional enough within the next two weeks, in time for our second Call to Action (which will be the first of several directed at Congress).


We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait. There is absolutely no benefit to making substantive comments now, and, in fact, it can undercut the very reasonable and truthful position that we have taken that the comment period must be extended. Early comments will lack the useful information that we will be able to assemble over the coming months. While FDA is required to read all comments, it would not be surprising or unreasonable if they were to gloss over those that are submitted early as being completely uninformative (as, indeed, many are, based on our spot review of what has been submitted and posted  to the web). Moreover, organized interests who support the regulations, or who want to suggest that they become even more prohibitionist, will undoubtedly wait until near the deadline to submit; they will take advantage of what they can learn about our arguments by reviewing the early submissions.  

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline (currently August 8th, 2014.) Submitting comments earlier than that has no benefit and might have substantial costs.


In the meanwhile, there are still many things you can do to prepare:


  • Submit your story to the CASAA Testimonials Project
  • Prepare a one- or two-paragraph summary of your personal story for use with various Calls to Action that will be issued.
  • Continue to encourage others to join CASAA.  Membership is free, and more members will increase our influence and reach. CASAA members are more informed on the issues, and having the proper information  will result in more effective advocacy.
  • Ask vendors to provide information on CASAA to their customers:
    • CASAA has a "We Support CASAA" Graphic for use on commercial sites.
    • CASAA offers vendor kits at cost which is designed to let customers know about CASAA.
    • Informational flyers and brochures are also available on our website for download to print and hand out at vape meets and stores or even for employers and medical professionals.
  • Let people (including your favorite vendors) know about CASAA’s social networks and encourage them to join our forum on ECF, follow us on Twitter, subscribe to our blog and/or join us on our Facebook page and Facebook discussion group, so they do not miss important information.
  • Share CASAA’s blog posts and emails about the FDA rules and our plan, so they also know what we are doing and what to expect.
  • If you have a blog, video or radio show about vaping, share CASAA's plan, tell your audience about the Calls to Action (including non-FDA actions) and encourage them to participate.
  • If you know someone with a vaping website, blog, video or radio show, ask them to share CASAA's plan, tell your audience about the Calls to Action (including non-FDA actions) and encourage them to participate.

Also, while the proposed FDA regulations are by far the biggest issue we are dealing with, we continue to address other matters, including state and local Calls to Action. (And we encourage our members to continuing paying attention to state and local legislation!) We also just released our White Paper on civil disobedience.

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CASAA's FDA Actions Regarding Proposed Regulation:


15 comments:

  1. So hurry up and wait ... great ..

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  2. As it stands I think we all know that Big Tobacco(now selling their own brands of ecigs) as well as the large pharmacetical interests have a great influence at times! One of the things CASAA has going for it however is the CASAA funded independent study conducted at The Drexel Medical University with the science to back up the CASAA position. http://publichealth.drexel.edu/~/media/files/publichealth/ms08.pdf

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  3. I totally agree and have said this in other groups. By commenting early, since all the ANTZ can also see the comments, we are giving them the opportunity to use our own comments against us. People need to learn to take a deep breath AND THINK. This isn't the time to be impatient and act like a bunch of hot headed fools. It's not as though a comment submitted today is more valuable than one submitted the last day. In fact, an emotional outburst, that's not well written, not fact based and attacking the proposal point by point isn't only useless, it's harmful. People submitting comments filled with foul language, erroneous information, insulting the FDA with no constructive criticism or alternative proposal WILL be used against us by the ANTZ, and whoever else has an opposing interest. "Hurry up and wait" Is a good idea in this instance. It gives us the opportunity to band together as a cohesive unit, to take the time to THOUGHTFULLY, PRODUCTIVELY AND CONSTRUCTIVELY compose our responses. Just attacking the proposed regs does nothing. We need to address them point by point AND offer an alternative proposition. This is the proposal, This is why it's flawed, and this would be a better way to address this issue. People seem to just want to blast the fda proposal without offering an alternative. The FDA WILL REGULATE this and what we want is for it to be regulated in a reasonable manner.....we need to tell them what we believe those reasonable measures would be, not just tell then how wrong they are. Then of course we also have to support our arguments. It really bothers me to see so many impatient, hot headed, angry people that just attack everything with no alternate suggestions. Worse the comments to the FDA that have been posted to social media that are clearly written by people who haven't read the proposal and are talking about issues that aren't in the proposal and have nothing to do with the fda, such as taxation. You can't very well address the issues, much less offer an alternative if you haven't even read the proposal and don't even know what the hell you're dealing with. I really wonder how many people that are complaining about waiting have even read the 241 pages. Everyone needs to calm down.....there IS NO HURRY to comment. Your comment carries no more weight if it's submitted on day 1 versus day 75. If you take that time to be as informed and educated as possible, compose a great, well written response, addressing the points of the proposal and suggesting reasonable solutions you'll likely have a much more impactful, intelligent and persuasive comment than just firing off a premature comment just because you are in a hurry to comment. We need to behave like the intelligent and well informed consumers we claim to be. Being passionate is great, it can provide the motivation and drive to accomplish great things.....BUT ONLY if that passion and energy is channeled and directed in a productive way. Having a passion you allow to just run wild, where you're impatient, angry and lashing out isn't just useless, it usually produces the opposite result of what you wanted to achieve. As a group, what each of us does has the potential to impact every other member.....we HAVE TO remember we are working TOGETHER for a common goal. We all want to be able to continue to have access to the devices, hardware and liquid we have come to love, that keeps us from smoking. I wish everyone would just be patient, wait for direction so that we will produce the best possible comments. We only get ONE CHANCE to submit a comment, we can't afford to squander it by being impatient.

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    1. I too, thought we could only comment once but while listening to a panel discussion about the FDA deeming regs I heard we can comment as many times as we like on different aspects of the regs.
      I would like to get confirmation about this so I know for certain it's true. I don't want to be giving out incorrect info.

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    2. Please just wait for CASAA to tell us when, how and what we should say. PLEASE WAIT!!! Read the above LONG comment and it will explain ALL the reasons as to 'why we are waiting'. Long story short, CASAA is compiling what we should say that will give us the most bang for our comments.
      ONLY reply when CASAA says to, and use what they tell us to say, PLEASE!!!

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  4. Where are we supposed to submit our testimonial? Everything has sad to wait and not to comment yet? So I am confused about the testimonial

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    1. The testimonial is on the CASAA website.

      http://www.casaa.org/E-cig_User_Testimonials.html

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  5. Your detailed testimony should go to the casaa testimony project if it hasn't already.

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  6. Going to go ahead and submit my testimony. Also going to share with friends with blogs and websites to see if they can help as well. kind of late to the party but better late than never right?

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    1. 1 month later, and CASAA has not given an update, or shared what they want anyone to do, except to wait and wait. I think a lot of people who waited, will not participate after waiting this long.

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    2. CASAA has been encouraging members to prepare their personal story to add to the final comment. If their comment is prepared, adding the CASAA guidance comments and submitting should only take a matter of a few minutes. Since June 14th, CASAA has issued a Second Request for an extension and two "Calls to Prepare." The final comment Call to Action is coming in a matter of days now.

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  7. Lets try this then. Lets just make it a law in all states that children under the age of 18 can not buy or use ecigs. Then if that don't work lets just stand up like real Americans and fire our GOV. We have that power and instead of using it we just let the madness spread like wildfire. This over reach for profit is not new and its funny how when it finally effects you that your willing to cry about it and do nothing else. YOU MADE YOUR BED!!! This GOV is not ran like it was intended to. Wake up..... Its not just ecigs. None of this will matter when the people just bend over in the end anyways and this is already done unless something is done to drastically change the system. Be honest, you know its true, and if not then get your head out of the sand. Its murder for profit and the slaves cant take a cut to better the situation no matter how much better ecigs make it. In the end your still a slave.

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  8. I have been in federal government relations for 25 years. FDA WILL NOT approve a second extension of the comment period. There is no reason to wait to comment, you are losing people every day who would comment, but lose interest when not allowed. Go to Free to Vape and comment away!

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    1. No one is "not allowed" to submit a comment. The only people who are waiting are those CASAA members who wish to have guidance for their comments from CASAA. If you do not wish to wait, you can submit your comment at any time.

      As far as the request for a second extension, there are more reasons for doing that other than just getting the extension (which we already knew was unlikely.) CASAA is looking at what actions will be needed beyond the comment period.

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  9. Visit this link if these Calls to Action is confusing or to time consuming. This was very easy and fast to do and your "comments" and other info gets submitted to the correct people and places. Hope this helps some of you, all our voices need to be heard regarding this. FreeToVape.org will send your entry to the FDA, your Congressional Representative, and your two Congressional Senators. For the FDA, we will be printing out your entry onto paper and hand delivering them directly to their offices. For your Congressman/Senators/the Committee Members - we will directly fax your entry to them in real time. Here is your opportunity to take action!

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