Sunday, August 10, 2014

Call to Action: FDA Comments Survey


NOTE: If you tried to do the survey and were kicked back to the begining (or out) without being able to get to the end, please try again. There was a glitch late Sunday night that may have interrupted your progress with the survey!



On August 8, 2014, the FDA comment period closed. As stated in our Calls to Action, 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.

Because the FDA comment site may not post all of your comments and they are particularly difficult to track, we are also doing a survey of the vaping community to collect and officially record the comments made to the FDA. Depending upon participation, this should give CASAA a way to report the true involvement of the community to the media and Congress, along with a way to share your comments directly with them, without the comments submitted by the opposition and the cigar supporters. It will also give CASAA statistics on ways to better reach the vaping community for future actions. This will be compelling information that will help us continue our fight.

This very short survey will be asking just a few, simple questions and for you to copy and paste your confirmation number and your saved submission to the FDA into the survey. Don't worry if you don't have those things saved, just answering the remaining questions will be a great help to us.

When you are done with the survey, please be sure to share a link to the survey with your vaping circles: Facebook groups, Twitter, Google+, vaping forums, Reddit, YouTube videos, and vendors. Please ask any video reviewers and bloggers you know to also share the link.

NOTE: Results of this survey will be shared online, so please remove any personal information from your comment before submitting it to us.

Thank you for your assistance!

Click HERE to submit your comment to the CASAA survey.


You can see the results of the survey and read the comments HERE.

Friday, August 8, 2014

CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

Last night, CASAA submitted its comment on behalf of consumers in connection with the FDA's proposed deeming regulation.  Following are a few highlights from the 53-page comment:

  • The proposed regulation is a de facto ban of more than 99% of the e-cigarette products currently on the market (something in the order of 100,000), creating an enormous cost to consumers.  In fact, the proposed regulation comes remarkably close to being all costs--very substantial ones--with no benefits.
    • The paperwork burdens are not about actual health, safety, or quality control issues and really provide no benefit to consumers.
    • The only products that will be able to successfully navigate the approval process will likely be the cigalike devices produced by the largest manufacturers.
  • The proposed regulation and accompanying publications by FDA are misleading, arbitrary and capricious for numerous reasons, and thus are not a legitimate basis for rulemaking.
    • The stated scientific background and impact analysis are fraught with omissions, bias, and errors.
    • The proposed regulation does not meet FDA’s own standards for showing that there will be a net public health benefit, and, in fact, there is overwhelming reason to believe the net public health effects will be negative.
  • For decades, it has been considered an ethical and political mandate for stakeholders to have a seat at the table in FDA rulemaking.  Yet consumers have been excluded from such a seat in the process.  
    • The slot on the TPSAC committee supposedly reserved for a consumer representative has been occupied by advocates who are not only not consumers of the products or representatives therefore, but whose political goals include eliminating consumption of the products, the diametric opposite of representing consumer interests.
    • Part of the explanation for FDA's apparent lack of understanding about the role e-cigarettes and other tobacco products play in consumers lives, as well as what will actually happen if these regulations are implemented, is the lack of consumer involvement in the process.
  • Consumers are better served by the current marketplace than they would be by the marketplace that would be created by the proposed deeming regulation.
  • If FDA wishes to do what is best for consumers, the primary stakeholders, it needs to either remove e-cigarettes from the proposed deeming or completely withdraw the proposed deeming regulation. FDA should then ask Congress to provide enabling legislation that would allow for genuinely beneficial regulation of e-cigarettes.
  • If FDA insists on moving forward with this type of devastating legislation, it is morally and legally obligated to:
    • Revise its scientific analysis so that it is complete, accurate, and unbiased;
    • Revise its impact analysis so that it actually assesses all of the impacts;
    • Assess and report the predictable real effects of the regulation (e.g., black markets);
    • Complete and report an analysis of the full public health effects of the regulation;
    • Include consumer representatives in the rulemaking process; and
    • Eliminate the unequal treatment of different social classes by giving "premium e-cigarettes" the same consideration granted to premium cigars.
While commenting on the proposed regulation is, of course, an important step in our fight against the deeming regulation, it is by no means our last.  We will be issuing a CQ Roll Call campaign in the next week directed at members of Congress as we continue with CASAA's Action Plan.

You may download and read CASAA's comment to the FDA here: http://casaa.org/uploads/CASAA-FDA-Comment-8-7-14.pdf



Wednesday, August 6, 2014

Podcast: CASAA Director Jan Johnson on "How and Why YOU Should Submit A Comment to the FDA"





CASAA has been producing and posting FDA Alerts and Calls to Action since before the proposed regulations were released. For a full background on this issue, please go here:

For instructions on how to submit your comment to the FDA, please go here:

Friday, August 1, 2014

Call to Action Baltimore, MD - Indoor Use Ban

UPDATE 8/13/14:  14-0371 Electronic Smoking Devices: A hearing is scheduled for Tuesday, October 7, 2014 before Judiciary and Legislative Investigations at 9:30 AM. The location is Du Burns Council Chamber, 4th floor, City Hall.

This legislation would prohibit the indoor use of “electronic smoking devices” (aka e-cigarettes, despite the fact that they emit no smoke) in any area where actual smoking is prohibited.  The bill could also regulate the placement of e-cigarettes in retail establishments that sell e-cigarettes with exemptions.  The proposed legislation also restricts the sale of e-cigarettes to minors and imposes civil citations for any violations.

Councilman James Kraft introduced this legislation (legislative file number 14-0371) and the bill is currently assigned to the Judiciary and Legislative Investigations Committee.  The committee requested reports from the City Solicitor, the Department of Health, the Environmental Control Board, and the Department of Finance.  These reports are due June 4, 2014.  But, the Committee could schedule a hearing before June 1, 2014 if all reports are received by the Committee.  To date, the Council has not scheduled a hearing. 

            You can submit written comments either in person at the hearing, or by fax or email prior to the hearing.  The staffer in the Office of Council Services for the Judicial and Legislation Investigations Committee is Marguerite Murray (see legislative contact list) informed us that you can submit your written comments to her via email.

CASAA strongly encourages vapers to call and email the members of the City Council.

Wednesday, July 30, 2014

Call to Action! Massachusetts E-Cigarette Usage Ban -- HB 3726 (formerly HB 3639) (UPDATED 7/30/14)

Massachusetts: Bill Would Ban E-Cigarette Sales to Minors, But Also Add E-Cigarettes to State's "Smoking" Ban -- HB 3639 HB 3726


 

URGENT UPDATE 7/30/14:  HB 3726 is still in play.  Having received a favorable recommendation from the House Committee on Health Care Financing on 7/28/14, HB 3726 is now in the House Ways and Means Committee.  

CASAA has created a CQ Roll Call Campaign for Massachusetts residents to help you express opposition to HB 3726:


The first and last sentences of the email are not editable, but the body is completely editable by you.  In fact, we STRONGLY encourage you to make changes to the email to reflect your views and to share your story.  Personalized communications to legislators are far, far more persuasive than form letters.

If you plan to substantially edit the email, you may wish to copy the text into a word processing program and make the edits there, then copy and paste back into the CQ Roll Call email.  We have had some reports that CQ Roll Call might "reset" when you keep the window open for a long time or when you open a separate browser window, causing you to lose any unique text you've added (and reverting back to the original).   

In addition to sending an email through the CQ Roll Call system, we're also asking Massachusetts residents to take a moment to make two phone calls to
Robert DeLeo (Speaker of the House): 617-722-2500 and Brian Dempsey (Chair House Ways & Means Committee) 617-722-2990.
Let them know
  • You are calling with comments about HB 3726. 
  • You support banning e-cigarette and vapor product sales to youth.
  • You oppose defining low-risk e-cigarettes as “tobacco products” for state law purposes because they shouldn't be treated the same as traditional combusible cigarettes.
  • You strongly oppose banning the use of e-cigarettes where smoking is prohibited. There is no sound science to support such a ban and prohibiting e-cigarette use in public actually works against the interests of genuine public health. Property owners should be free to decide whether or not to allow e-cigarette use on their premises.

Saturday, July 26, 2014

STREAMLINED VERSION of Fourth Call to to Action for FDA Proposed Regulations - Submit Comment



Fourth Call to Action for FDA Proposed Regulations
Streamlined Version

NOTE: After reading the instructions below, please go here to submit your comment to the FDA. Comments posted to this blog DO NOT go to the FDA. This is NOT a petition!


CASAA has been producing and posting FDA Alerts and Calls to Action since before the proposed regulations were released. For a full background on this issue, please go here:


However, we realize there are recent adopters of these products who may not have had time to familiarize themselves with the politics and what is at stake.  In an effort to engage you and provide a means to have your voice heard, the following is a simplified version of our 4th FDA Call to Action. (For those who have thought about this before and want to maximize the impact of their comments, we urge you to instead send the more detailed letter described in the 4th FDA Call to Action: http://blog.casaa.org/2014/07/fourth-call-to-to-action-for-fda.html)

Thursday, July 24, 2014

Fourth Call to to Action for FDA Proposed Regulations - Submit Comment


UPDATE: We realize there are recent adopters of these products who may not have had time to familiarize themselves with the politics and what is at stake. In an effort to engage you and provide a means to have your voice heard, here is the link to the simplified version of our 4th FDA Call to Action.
XXX

NOTE: After reading the instructions below, please go here to submit your comment to the FDA. Comments posted to this blog DO NOT go to the FDA. This is NOT a petition!



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.
  • On July 23, 2014, CASAA released the second Call to Prepare.
This is the Fourth Call to Action in CASAA's Action Plan.  

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.

Thursday, July 17, 2014

First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment

On Thursday, May 8th, 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.
This is the first Call to Prepare in CASAA's Action Plan.  This Call to Prepare is your opportunity to begin laying the groundwork for your formal, substantive comment to the FDA.  Consistent with our earlier instructions, we are asking consumers to continue to wait to file substantive comments for a few more days, but now is the time to prepare part of your comments in earnest.  For now, write up a few paragraphs on each of these three points so it is ready to assemble into your final comments.


Wednesday, July 9, 2014

CASAA's Second request for extension of FDA's comment deadline

To:   U.S. Food and Drug Administration
From:  Carl V Phillips, PhD
        Scientific Director
        The Consumer Advocates for Smoke-free Alternatives Association 
(CASAA)
        cphillips@casaa.org
8 July 2014
VIA REGULATIONS.GOV AND COURIER
Second request for extension of comment deadline for CASAA
Previously CASAA requested an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.  The text of that request is included below as an appendix, and its substance is incorporated here by reference.  Subsequently, FDA granted a 30-day extension of the comment period.  This is grossly inadequate for the reasons we already noted.  We repeat the request that the comment period be extended to a more appropriate 180 days.
Failing that, we additionally request that CASAA be granted an extension of that length to file comments that specifically respond to the questions posed by FDA in the draft regulations.
The proposed regulations posed approximately 100 separate questions about e-cigarettes and other products that are part of CASAA’s mission.  Even with the existing extension, the comment period is approximately one day per explicitly posed question.  CASAA is in a unique position to be able to provide empirical answers to many of these questions.  However, under the current deadline, we will only be able to comment on the affirmative content of the regulation itself and analyze its implications.  While the length of the comment period is grossly inadequate even for that, we expect to file such comments according to the existing deadline.  However, it will be physically impossible to respond to the requests for information that FDA claims to be interested in obtaining.
A failure to further extend the comment period would be a clear indication that FDA is not genuinely interested in obtaining scientific answers to the questions it posed.