FDA Deeming Regulations of Vapor Products

Please support our Vaping Community and respond to these Vaping Calls to action as well as for your state. Links provided :

CASAA

11/24/15

National Call to Action! Make a Call to stop the FDA from banning nearly ALL vapor products from the market!

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In addition to sending an email, please make a call to support a provision (Sec. 747) in this year’s budget bill which could save the U.S. vapor industry from being destroyed by the overbearing and burdensome FDA premarket application process.

 

CASAA is asking members to voice support for a provision in this year’s budget bill that would change the grandfather date for products that are about to be subject to the FDA’s tobacco regulations. This provision

Sun Nov 22 2015 at 11:35 am PST [email protected] (Julie Woessner)
DEADLINE for Comment is TUESDAY, November 24, 2015. I. Background The FDA is requesting…

http://blog.casaa.org/2015/11/fda-call-to-action-submit-comments-on.html

 

Post on 11/21/15 

Deadline Tuesday 11/24/15

FDA Call to Action: click here—> Submit Comments on FDA’s Proposed Intended Use Regulation

DEADLINE for Comment is TUESDAY, November 24, 2015.
 Post below NOV2015

CASAA – The Consumer Advocates for Smoke-free Alternatives Association

5 Things You Can Do Right Now To Save Vaping!

(1)  Call the White House! Urge President Obama to demand that the FDA re-work their deeming regulations to allow most vapor products to remain on the market. We have provided talking points HERE.

White House: (202) 456-1111
Alternate Number: (202) 456-1414

(2)  Send a Message! While you’re waiting to be connected to the White House (or after you’ve completed your call), please send a message to your US Representative and Senators urging them to support and co-sponosor HR 2058.

Support HR 2058Send an Email

(3)  Join CASAA! It’s easy, it’s free, and we will keep you up to date on information and opportunities to take action to protect your access to vapor products.

Click to Join CASAA

(4)  Register To Vote! Millions of vapers, including YOU, have the power to influence government decisions by electing candidates who support vaping!

  Click to Register to Vote

(5)  Tell your story! Please visit CASAA’s Testimonials Project and tell us about your experience with low-risk, smoke-free products like e-cigarettes and snus.

Click to Submit Your Story

NEW PETITION FOR VAPER SIGNING

Takes 1 minute and will help save our vaping community!

VapeSling LLC will have their employees on the phone with congress and senators after we reach 100K to qualify.

At this time we are at 62k. only 38k to go.

Follow the advocate fight on Instgram for latest updates. #nodisplaytill100k #vapersarmy #unitywithinthecommunity #vapecommunity

https://petitions.whitehouse.gov/petition/urge-fda-re-work-deeming-regs-so-life-saving-vapor-products-can-remain-market

New Post 11/13/15 from CASAA.org

FDA Deeming Regulations of Vapor Products Moves Forward

The planned “deeming regulation,” with which the FDA will assume regulatory authority over e-cigarettes, has finally started moving forward again. It is now under review at the Office of Information and Regulatory Affairs (OIRA), the White House office that is tasked with making sure regulations create more benefits than costs. There is little doubt that the proposed regulation will eliminate the legal market for 99.99% — perhaps even 100% — of the products over which FDA asserts jurisdiction after a grace period. (The grace period in last year’s draft version of the regulation was two years.) There is an unconfirmed rumor that FDA will attempt to ban all non-tobacco flavors almost immediately.

CASAA is currently working on our presentation to OIRA at a meeting that is scheduled for December 15, 2015. This is a process in which we and other petitioners are required to provide analysis to OIRA without the benefit of seeing the exact current regulation. However, we have every reason to believe that it is, unfortunately, basically the same as the draft FDA published last year. As of now, it is our assessment that OIRA altering or rejecting this proposed regulation is the best hope of saving the diverse e-cigarette marketplace until Congress changes the law. (Please note that some have suggested that individual vapers try to schedule meetings with OIRA. We are not recommending this to our members. We are, however, asking consumers to submit their stories as part of CASAA’s Testimonials Project. We will be sharing those testimonials with OIRA at our meeting next month.)

You will find some of ongoing analysis of the current situation posted by CASAA’s Chief Scientific Officer, Dr. Carl Phillips, on his antiTHRlies blog. Already posted are why this is not really regulation (but rather a ban pretending to be regulation) and why the history of FDA’s actions (and the US government more generally) related to low-risk smokeless tobacco suggest that FDA will not behave moderately or rationally once it has authority. If you want to read about the implications of FDA regulation in more depth, check out CASAA’s comment on the draft version of the regulation (pdf).

Watch For CASAA’s Survey

We will be launching a survey of our members that will provide critical information we can present to OIRA. Please watch for the invitation to participate and then do so. This is an important survey that could make a real difference, but we will need members to participate!

To continue this and our other work, CASAA depends on member donations to be able to keep fighting on your behalf. We do not charge membership dues, but we ask that you consider making a donation of any size.


 

CASAA Files Comments With FDA

CASAA recently filed two comments on FDA’s proposed rules about child-safety features for e-cigarettes and dissolvable smokeless tobacco products. Our main comment on the proposed rules can be found here. In it, we point out that consumers could genuinely benefit from appropriate warning labels and child-resistant packaging. However, we also make it clear that those modest benefits cannot possibly justify the FDA’s deeming regulation. We also wrote this response to one of the many comments from anti-tobacco activists that — as we predicted — were trying to use this reasonable proposal as an opportunity for vilifying e-cigarettes and nicotine. That comment period is now closed. Before it closed, hundreds of CASAA members responded to our Call To Action and submitted their own comments.

Two New Directors Join CASAA Board

CASAA is pleased to announce that Brian Carter, PhD and Bruce Nye have joined our board of directors!

Dr. Brian Carter’s field of study is addictive behaviors with a focus on the pharmacological, psychological, and behavioral foundations of tobacco and nicotine use, dependence, and motivation. As a former faculty member in the Department of Behavioral Science at the University of Texas M. D. Anderson Cancer Center, he conducted multiple National Cancer Institute funded laboratory studies on the emotional, genetic, physiological, and behavioral aspects of nicotine use in cigarette smokers. His work has been published in the journals Addiction, Experimental and Clinical Psychopharmacology, Nicotine and Tobacco Research, and other national and international outlets. He lends his expertise to the review of current research on smoke-free alternatives, collaborates on research projects with other tobacco harm reduction scientists, and assists with the preparation of CASAA’s science-based reports to government agencies and the public at large.

Bruce Nye, RN made the switch to electronic cigarettes on September 27, 2012, immediately ending a 43-year smoking habit he had failed numerous times by all other means to stop. He retired in 2003 from his first career of 25+ years engineering software and hardware solutions as a consultant to become an award-winning nurse specializing in acute care of trauma / surgical patients at a Level I Trauma Center in the Midwest for over 10 years. He joined CASAA as a member within months of discovering vapor products and quickly became an active and passionate advocate for THR. Bruce brings to CASAA’s leadership a strong ability to strategize and craft communications in the legislative, regulatory, and public arenas.

Successful Fundraising For Study

CASAA has completed our fundraising for a study on claims that e-cigarettes and other low-risk products are a gateway to smoking – thanks again to all who donated! A grant was awarded to Karyn Heavner, PhD, a long-time Tobacco Harm Reduction (THR) researcher who is the principal investigator for a research team that includes CASAA’s Carl V Phillips. As you may know, gateway claims play a major role in anti-vaping rhetoric and policy proposals. The research will trace back to their sources prominent claims that there is such a gateway effect occurring, and critically evaluate whether those sources really support the claim. We expect that this research will be very useful for advocacy, providing the first comprehensive look at whether any scientific support exists for this common claim. You can view the research proposal here.

Global Tobacco Networking Forum

CASAA representatives presented at the GTNF, the world’s leading tobacco industry meeting, which now tends to focus more on e-cigarettes than all other products combined. You can read here the presentations by CASAA Executive Director Julie Woessner, JD, and CASAA Chief Scientific Officer Carl V Phillips, PhD.

More FDA Rules

FDA has issued a new proposed rule that could have major implications limiting anything vendors can say about alternatives to smoking. This is complicated and we are reviewing it, with the expectation that we will issue a Call to Action and also submit a comment on behalf of the consumers we represent.


 

These Calls To Action are still active as of the time this newsletter was sent.

U.S.: Support HR 2058 that would change the “grandfather date” for FDA e-cigarette regulation.

California: A ballot initiative (15-0081) has been proposed that would redefine e-cigarettes as “tobacco products” and enact a damaging tax on liquids and devices. CA residents are urged to register to vote so they can Vote NO on the initiative when it is added to the ballot next year. CASAA will issue an alert in the coming weeks.

Cook County, IL: Take action now to oppose a damaging per-milliliter tax on e-liquid by contacting County Commissioners.

Everyone: If you used e-cigarettes, smokeless tobacco, or some other tobacco harm reduction product to quit smoking and have not yet provided a CASAA Testimonial, please add your story to the nearly 7,000  we have already collected! The testimonials are an important tool in our advocacy efforts, providing hope and inspiration to those considering making the switch and also helping regulators, policymakers and legislators to understanding that vapor products really do work and that real people’s lives are being affected. Testimonials collected will be presented to OIRA at our meeting in December to help OIRA understand the profound implications of these policies on the lives of consumers who rely on these products.

 

Recently Closed Calls To Action

These deadlines for these calls-to-action have passed, but they are listed FYI. If you live in these places, you should have received an email asking you to take action. (If not, please update your contact information!)