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Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

May 10, 2014

Two weeks ago the 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 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 two 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).

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

FDA, which took more than three years to issue these enormous documents, has given us a mere 75 days to comment. While responding in that timeframe is challenging in the base case, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is, at best, inadequate.  

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.

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. 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 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 Facebook, 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.

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.

*Blog post reposted from the CASAA website

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