Vape ecig FDA Regulation

Vape ecig FDA Regulation

Family Smoking Prevention and Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law on June 22, 2009. It gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.

FDA Deeming Regulation
The Family Smoking and Tobacco Control Act allows the FDA to issue regulations asserting jurisdiction over other tobacco products, such as cigars, cigarillos, e-cigarettes, and hookahs, among others. FDA expects to issue deeming regulation in the Spring of 2013 to cover other tobacco products.

Deeming regulation is proposed regulations that would include products meeting the definition of a “tobacco product” under the Tobacco Control Act to be subject to the FDA’s jurisdiction. The Tobacco Control Act defines a “tobacco product” as meaning “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

See CASAA’s The FDA & Deeming Regulations of E-cigarettes  for more detailed information.

See CASAA FDA Actions  and Previous FDA Actions by CASAA for more detailed information about what CASAA has been doing and to see the FDA Calls to Action.

Federal Tobacco Taxes
Increasing the cost of smoke-free alternatives decreases incentives for smokers to switch to lower risk products. A 2009 law approved by Congress, the Children’s Health Insurance Program Reauthorization Act, increased the federal tax rate on moist snuff, the most common form of smokeless tobacco, by 92.5 cents per pound (from 58.5 cents to $1.51 per pound) and on chewing tobacco by 30.83 cents per pound (from 19.5 cents per pound to 50.33 cents.)

VapersArmy Vape Advocate Personnel

VapersArmy Vape Advocate Personnel

The following Vapers, discovered in FEB2016, advocate above average to full blown activist

Exisenz, Hardcorejuicebox, greeneyedkat, wicked_angel_vapes, thecqw,

scotts_vaping_ Has been discovered since last year when we began the VapersArmy. His activism is admirable and lately, peaceful Social Media Picketing to reach many more. We like to think of him as a rogue Commando for the cause. Thank you scotts_vaping_ for being a Vape Warrior! #SALUTE!

Who’s next? If u VAPE Advocate, let us know. Write an email to [email protected].

Give us your IG, Twitter, FB, or whatever handle you want us to publish. However, we will research you to see if you are truly involved to FIGHT for all OUR RIGHTS to VAPE!!!

There are many others noticed at times when jotting down names is not possible. Please forgive us. However, know your fight is important and will be noticed and recognized. We have an army of Recon, and they will get to us…some nicer than others, however, got to us 🙂

Your Fighting Vape Advocate Business (FAM)…Solid Advocate Battalions:

Fight For Sensible E-Vapor Laws

premium e liquid

ROB CROSSLEY

Director and President
[email protected]

ecig box mod

BRIAN WALTERS

Director and Secretary
[email protected]

e liquid manufacturing

KENNY DAVIS

Director and Treasurer
[email protected]

SCOTT ELEY

Executive Management
[email protected]

NICK GOLLUST

CEO and Owner
[email protected]

ALENA AND GREG OBERG

Owners

CHERYL AND TONY REED

Owners

EVAN MCMAHON

President

STEVE NAIR

President

ALLEN JOSEPH

President

JONATHON LEE

President

SCHELL HAMMEL

President
[email protected]

HOFeliquid/RuthlessEjuice/CosmicFogVapors/KiloEliquids =Raise 1 Million in Advocacy dollars. Please visit them to vape advocate, deliciously.

FluentVapors: Donating 100% of proceeds to #NotBlowingSmoke, when selling a specially made e-liquid called “Addys Yogurt” (created by @fresh0133 on IG). Please purchase a bottle to vape advocate, deliciously.

CharliesChalkDust: Fought at the White House as the vape warriors they are. Balls, Guts, and sacrifice. Time with family, put on hold, to fight for all our vaping rights. Salute!!!

The Businesses below are great Vape advocate fighters at all avenues possible. IG feeds are bombed with artillery of factual information for the public to be armed. Assaults are accompanied by boots on the ground Activism. Thank you battalions of Vape warriors!!!

AngryScotsMan

DominitionVapor /Ohm Man VapeShop

WorldsFinestVapor

theCloudCompMaps

DesertVapors

Solygrn

HolyCowEliquid

Avidlyfe/AVlyfe

BirdeJuiceOfficial

The following Vapers, discovered in JAN2016, advocate above average to full blown activist

@Anjelvape77 is your new VapersArmy1 Star Brigadiere General
Your old LT is now your new General (1star).
As an LT, she has relentlessly continued her assault with fresh, effective posts. Researching all avenues for new information. An Elite advocate Soldier rightfully earning her position with the VapersArmy Ranks of Generals:
@TheVapingDragon (4star) @Dave.Seeker.of.Clouds (2star), and @VapeStars (your rogue 3star). We love and respect all these fine Vape Advocate/Activist officers. Please do as well with a visit and follow.
Please join us in a recognizing your Elite
fighting Advocate/Activist Soldier!!!

Imaginaryechoes is your VapersArmy Captain. Your new Captain has a keen eye and recognized the fight ALL VAPERS face in 2016 and on. The Captain, as a foot soldier, donned her battle gear, and honorably engraved the VAPE WAR PAINT!!! Her message, we all share: All of us vapers, are part of a-billion-lives saved. Please join us in a recognizing this dedicated fighting Vape Advocate Soldier.

 

Footsoldiers discovered in December 2015
arbitrarymonster claudi_bot kevinboom123 nikki_fyink get_vape juicegodvapors vapeshield kingj_mookie_thedripaholic notsogirlyvapes unitedvapors country_mama1 thecqw 9thislelv vaping.rose lisa.wolford infinitecircles 702vapes officialvapebox shadowmode13 selenaleighton thevapingsiren vapedrdan wrathkatt juicegodvapors nikki_fyink kevinboom123 candybrewerejuice dampftbeidir.de clubvaporusa shishavapes dmneliquid unclemikeselixir chasecovert_509 ayyytyler gabereal287 btstattoos missbabyd1993 christinavapes tw11tch tankvapes360 mooseknucklellc sumovapor.ak strawberryshortvape mysticchyna subohm_banana la_vapes vapemaponline ms.drea.vapes frozen_cellmate vaping_kitty proud_momma_that_vapes da_blonde_bomber111912 j.dunn085 anjelvape77 chelmarietattoo halastarvapes mikey8180 t.noteam S.kyle77 subohmmills dominationvapor thatoneduderyan _catch_the_vaporz_ worldsfinestvapors ashkans8808 Kellymarguerite omniousohms
The following Vapers, discovered in Dec2015, advocate above average to full blown activist
Latest Foot soldier to Officer promotions:

mikey8180: E-4 Specialist Mortar Division
dave.seeker.of.clouds: 1st Lieutenant of Mortar battery promoted to Major General (2star)
Vape_vixen: 2nd Lieutenant of Platoon ohm_xgrls
vapestars: 3 Star General: All our previous 3star Generals, apparently need to go ROGUE. Another section 8 that we love and cherish.
We don’t care how they do it, as long as they

Txteddybear_stm: Promoted from foot soldier to E-7 1st Sargent in charge of Battery Company “Bravo Badass”. This soldier was detained in IG Jail and still managed a Mute campaign that woke sleepers anywhere in his vicinity. Relentless advocate fighter.

Delatorredustin1 has done “boots on the ground” Activist battle and got us nearly 400 signatures for our #petition mission. Commendable and promo-table advocate fighting. Promoted to E-6 Staff Sargent in charge of ground troops.

Ashkans8808 has been noticed and promoted to SP4 Intelligent imagery section

Anjelvape77: Promoted from foot soldier to 1st Lieutenant for her outstanding bombardment of “sleeper wake” Artillery.

1happyinfidel: Promoted to E-5 SGT for his working IG jail time and Fight resumed afterwards. He never gave up even as lonely as he felt. He just KEPT GOING!!! He is hereby transfered to Company “Bravo Badass” under the 1st Sargent txtteddybear_stm
KEEP GOING!!!! #vapersarmy

vs_vaper: has been noticed in a BIG WAY. This is not only a soldier, but a business owner VAPE ACTIVIST!!! The efforts on her page are above and beyond. She has had posters and flyers printed to help save the Vaping Community. This is a solid warrior. We promote her immediately to Full Bird Colonel.

tat2sbymichaelloveless: This Vape Advocate Fighter was finally found. After long search, he was in the MASH unit. He was vaping and flirting with a couple of nurses. No business whatsoever to do there. However, his talents can’t be overlooked futher. He is like an OWL: flies low and quiet, till he sees his SLEEPER…then with talons out, he strikes a campaign of sleeper bombardment. We promote him immediately to MAJOR in your Vapers Army.

 

 

Updated 12/1/15 Officer Roster

VapersArmy12_2015
VapersArmy12_2015

Footsoldiers who took part in your Historical Vaping Petition of November 2015

@robert.t.shepherd @holy_cow_ejuice @thirstyvaper @thevapingdragon mile_high_vapin ourvapinglife
pacovapes
@timbootz
ebvapez
sub_ohm_redneck
maleficent_heretic
solygrn
serenityvaporlounge
simplysam3182
ramtuff2000
magicdavaper
willwhiddon
letitbleedtattooslangford
riverrockvapes
preembargo
grimvaper
sweet_t_angel
josephtreadaway
magicdavaper
rmvolbert
veritas92fs
backwoodsbarbieal
turbovegas
ms.drea.vapes
jeremy_newton_c4
mattthegoodwood
thecouplethatvapes_avm
ivape_ink

darknessthrough.vape
@dbunch_gnm
_the_gingerbeard_man_
@la_vapes
@frozen_cellmate
@bella_izusia
@vaping_kitty

legacygt1287
diversepeoplevape
maleficent_heretic
josephtreadaway
dbunch_gnm
_the_gingerbeard_man_
master_chubs714
mikey8180 Joined!
mile_high_vapin
vapesmitheliquid
acookie22
tarhettz
surefirevapor
peytons.e.juice.review
dylanbradford1894
notoriousb.o.b_duvo
wr3ckin_it
frankie_vapes Joined
twiztid_anarchy1 Joined
sillykrn24 Joined
24mg_nic Joined
surefirevapor
vapesmitheliquid
legacygt1287
diversepeoplevape

_deerayill520_
jeremy_newton_c4
mattthegoodwood
subohm_banana
michel.jr
@pl00min_m0mma
thestudiobrand
rastavapors
flip_deez
tamed_tiger
risemynite43_duvo
sub_ohm_redneck
scotts_vaping
wr3ckin_it
twogunzpremiumejuice
blend_liquids
scoopseliquid
vape_angel77
justinvapeaddict
drippidy__dooda
ootdleggings
dave.seeker.of.clouds
@drifting_buds247
poetindinc
vapestars

November 2015 Roster of the 1st and 2nd Vapers Army officer promotions under 4 star General @thevapingdragon

IGArmy

VapersArmy11_9_15

 

FDA Vape Deeming draft docs leaked

FDA Vape Deeming draft docs leaked

Two Leaked FDA Deeming Draft Documents For Vapers. The Final Rule?

Post from vapefight.com
October 30, 2015

During the last few days the Tobacco Vapor Electronic Cigarette Association (TVECA) has released two leaked “draft” documents which they claim are recent drafts of the Final Rule. The Deeming is currently in the final two stages before it becomes the law of the land. The Final Rule is on the desk of the OMB and this may take up to 90 days or more for them to complete their review and then the last step is a review by Congress. I’m reasonably certain that these “leaked” documents are authentic since they were released by a well known and supported trade group.

The first leaked document is titled “Draft T.O.C. of the Deeming Regulations“. This document contains a troubling reference to flavors and B and M’s. Please remember that it’s only a Table of Contents so the gory details are not included in this document. The real shockers are found in the second leaked document titled “Guidance for Industry/Draft Guidance” Fasten your seat belts and grip your mouse firmly while I dive down into the gory details of this document. Please study this section which pertains to B and M’s:

B-and-M-from-industry-guide-section-and-more-1

Here is a quick summary of the above text. Almost all B&M’s will vanish. This is a tragedy. People who currently smoke will face huge obstacles in switching to ecigs. That’s criminal. A death sentence if you will. People will loose their jobs and the only way to embrace vaping will be those ecig sticks sold at gas stations and convenience stores or deal with BT. “House Blends” for ejuice are a huge source of revenue for a shop. This also generates return visits for more sales. Many shops also provide “builds” for toppers. The customer buys a topper and the shop will build the coil and wick. The critical revenue source is the sale of the topper. Customers continue to return for new builds which generate more sales opportunities. If a shop wishes to engage in the sale or distribution of the issues noted above they must obtain Premarket approval from the FDA. This is a very costly (300K or more per item) plus mountains of paper work and huge amounts of time. Vegas has both large shops and small shops. I don’t know any of these shops which could afford this expensive procedure and I doubt any shop in the US could afford this expense. Please remember, if my shop offers 30 flavors in 4 different NIC strengths then every one of these mixes must comply with the FDA rules. Due the math, that’s potentially millions of dollars in expenses for the shop. The same holds true for toppers or any other item noted abover. Think you are clever and will only sell pre-mixed flavors (not finished ejuice) and send the customer someplace else for the NIC. That’s not going to work either.. Next, lets take a look at what products are covered in the following screen capture:

batteries-2-from-industry-guide-section-and more

Here is a quick summary of the above text. Almost everything used in vaping will require the very expensive FDA Premarket approval. It’s also important to remember that the FDA has “enforcement discretion” and vapers may also be subject to “Medical Device” regulatory enforcement. If a given component doesn’t fit into the Tobacco Control Act then it’s regulated as a medical device. The net affect is that only a very small number of companies can afford the very  expensive premarket approval from the FDA. Premarket approval is also a defacto ban on innovation. Modify the style of a topper or mod, invent a new topper or mod, change the formula for a ejuice mix, and these actions will all trigger the requirement for a new premarket approval.  Essentially BT and perhaps a few large players in the Vaping industry such as VaporShark will survive. Think your going to China for your vape gear? Customs procedure in concert with the FDA may lead to embargoes.

Finally, embrace activism today! It’s never to late! Get off the couch and if your head was in the sand then please face reality. Will the FDA obliterate vaping tomorrow? Nope. My ballpark guess is the final FDA regulations (the final rule) will become the law of the land (the effective date) in the first or second quarter of 2016. Then the compliance date would be 24 months after the effective date of the final rule. All products (99.9%) remaining on the market past the compliance date would need to comply with these FDA premarket approval requirements. Some have referred to the 24 month period as a “grace period”. In reality, the 24 month compliance date is more about the time necessary for the FDA to create the necessary infrastructure for aggressive enforcement actions. Certainly the “Black Market” will flourish but that’s a subject for another post. Given the draconian nature of these provisions, the FDA will definitely get sued by Vaping trade groups and perhaps others. The effective date of the final rule will create “panic” in the marketplace so my advice is “Better safe than sorry” so start today to prepare for the worst possible outcome. Become a “hoarder” consistent with your budget. Make friends with a DIY geek or try it yourself. It’s not that hard. . Although this posts deals with “leaked documents”, I would not expect the Final Rule to differ in any significant fashion from these leaked documents. That’s my best guess. ECF has a great thread on these issues started by the founder, SJ/Oliver Kershaw. I encourage you to read it, participate, and reach your own conclusions. You may also wish to read E-cig firms steel for legal battle which provides some backround on these “leaks” and reactions from opponents of vaping. TVECA has promised to release more leaked documents. If and when they do, I plan to cover these in additional posts.

10/31/15: Edited for clarity and deployed the following banner on ECF:

 

 

11/4/15 Update: You can read my latest post about TVECA and the surrounding issues.

Vape e-cig Calls to Action DEC2015

Vape e-cig Calls to Action DEC2015

2 FDA deeming regs Docs leaked —>click here

CASAA

Posted on 12/7/15

We have till 12/30/15 to BLAST the FDA.

The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The 1st link is if you done this before and just want to get to the FDA site with your comments.

The 2nd set of links is a CASAA guided procedure to prepare your comments. If this is your 1st time submitting comments to the FDA, use this guide if this to prepare your comments, is your 1st time. Once prepared click here to submit the comment to the FDA

1st Link: Direct to FDA for 2nd time users with already prepared comments

The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, 2015.

  1. Provide a clear statement of whether you support or oppose the proposed rule or guidance.
  2. Include any of the following that support your position:
    • data
    • research
    • analysis

2nd FDA comments Link: CASAA FDA comments Call to Action guided for 1st time users

Please use this guide to prepare your comments and submit to the FDA

To prepare your story to the FDA:

Severe PA Call to Action:

Mon Dec 07 2015 at 4:17 am PST [email protected] (Alex Clark)
Update – 12.07.15 Update – 12.04.15 The Pennsylvania Vapor Tax is back and more threatening than…
Mon Nov 23 2015 at 5:47 am PST [email protected] (Alex Clark)
A provision (Sec. 747) in this year’s budget bill could save the U.S. vapor industry from being…
Wed Nov 25 2015 at 6:25 am PST [email protected] (Julie Woessner)
Update 11/25/15: Yesterday, FDA announced, “In response to a request for more time to submit public…
Fri Nov 13 2015 at 12:16 pm PST [email protected] (Alex Clark)
Update – 11.13.15 HB 682 — an indoor vaping ban — will move to a vote in the House Health…
Thu Nov 12 2015 at 5:36 am PST [email protected] (Alex Clark)
Update – 11.12.15 Pennsylvania lawmakers are desperate for a quick fix to the state’s budget…
Sun Oct 18 2015 at 7:44 am PDT [email protected] (Alex Clark)
The FDA Deeming Authority Clarification Act of 2015 (HR 2058), introduced by Representative Tom…
Tue Oct 06 2015 at 6:16 am PDT [email protected] (Alex Clark)
Update – 09.15.15 The California legislature concluded its Second Extraordinary Session on Public…
Tue Sep 29 2015 at 4:54 am PDT [email protected] (Julie Woessner)
Update August 21, 2015: The comment deadline has been extended to September 30, 2015. Update…

CASAA

LOCAL ALERTS for Your Region:
Mon Nov 23 2015 at 9:53 pm PST

Boston, MA The Boston Public Health Commission will be accepting public comments on a proposed…

Click title to read full Local Alert.

Sun Nov 15 2015 at 7:35 pm PST

Cleveland, OH An ordinance (Ord. No. 929-15), which would limit the sale of flavored smokeless…

Click title to read full Local Alert.

Wed Nov 18 2015 at 3:52 pm PST

Kansas City, MO Update – 11.18.15 The ordinance that would ban vaping in the same places…

Click title to read full Local Alert.

Fri Nov 13 2015 at 11:03 pm PST

Englewood, CO Council Bill 58 which would prohibit vaping in the same places where smoking is…

Click title to read full Local Alert.

Fri Nov 13 2015 at 7:44 am PST

Cook Co., IL URGENT Update – 11.13.15 The initially proposed $0.20 tax per milliliter on…

Click title to read full Local Alert.

Tue Nov 17 2015 at 9:39 am PST

Update 11.17.15 Good news, Laredo, TX . . . your City Council listened to you. The Laredo City…

Click title to read full Local Alert.

Tue Nov 17 2015 at 4:51 pm PST
Saint Paul, MN [Updated to reflect meeting time change] An ordinance (ORD 15-57) has been…

Schedule meetings with OIRA/OMB TODAY

Vape shop owners, manufacturers and distributors should schedule meetings with OIRA/OMB TODAY!

November 5, 2015

The FDA’s Final Rule is on the desk of OMB. This is a critical step before the Final Rule is published in the Federal Registry. The industry’s last opportunity to voice their views with a regulatory agency. Our goal should ideally be that OMB rejects the FDA’s Final rule but that’s unlikely to happen. Vape shop owners, manufacturers, trade groups, and distributors have a unique opportunity to offer well crafted suggestion which could significantly modify the final rule with provisions that are less draconian than what has been proposed and I documented in this post.

The first step is to listen to the following podcast which features FDA/Ecig Attorney Azim Chowdhury and long time advocate Bill Godshall from Smoke Free Pennsylvania. This podcast contains lots of details and strategy’s to use in your meeting.

Edited: Here is a detailed video which advocates that vapers like myself and my readers should also meet with OMB and tell our story. I call this a grass routes approach:

Next, Vape shop owners, manufacturers, trade groups, and distributors should schedule a meeting by contacting:

Email: [email protected] or call 202-395-6880Source

This action is time sensitive since normally the OMB will issue the Final rule around 1/15/16 or even sooner. They can also choose to extend their review. They will probably cap the number of 30 minute meetings they will have at a certain point. All of this means YOU need to act today. Consumers like myself and most of my readers should spread the word.

(Edited on 11/7/15) I’m not very optimistic with respect to actions by OMB to modify the FDA’s final rule in a manner and fashion which helps vapers. I would be very surprised if the final rule contains any significant and helpful changes. However, we should still try like Hell. OMB may make a few small and insignificant changes to the FDA’s final rule so they portray themselves as actually trying to help the vaping industry. While I could certainly be wrong (I hope I am), it’s important to me that you draw your own conclusions so here are a few links/documents to study, courtesy of the ECF thread:

Oversight of the Office of Information and Regulatory Affairs | Testimony

http://object.cato.org/sites/cato.org/files/serials/files/regulation/2013/6/regulation-v36n2-4.pdf

OIRA Watch

Documents Show OMB Weakened FDA’s Food Safety Rules

Related post:

Posted 12/1/15

Click here for notes and links  from the Nov 30th 2105 Links-info from Vape Advocacy Webinar

Links-info from Vape Advocacy Webinar

Links-info from Vape Advocacy Webinar

Nov 30, 2015

Notes from Webinar Chat (expert to vapers)

email me at: [email protected]

email [email protected]
to ask for a meeting reference RIN: 0910-AG38

the survey to those who haven’t https://goo.gl/RAO40p
http://testimonials.casaa.org/submission-form/

IF your shop is pro active and I mean aggressive to help our cause then send me a feedback form on my site for some “ink” @ www.VapeFight.com. Please 🙂

NBS also has docs available: http://fdaregs.info/documents

https://www.congress.gov/bill/114th-congress/house-bill/2058/cosponsors

[email protected] to stay in touch

Anyone can keep in touch with me through email at [email protected] or instagran at Tw11tch or on facebook through my name Chris

Emails go to Senators and Reps: http://blog.casaa.org/2015/11/national-call-to-action-stop-fda-from.html
And make a call too: http://cqrcengage.com/casaa/app/make-a-call?0&engagementId=147573

This is the letter that the Senators are writing to the OMB

Click to access 10.21.15%20Letter%20to%20OMB%20Director%20Donovan%20on%20the%20Tobacco%20Deeming%20Rule.pdf

http://e-researchfoundation.org/direct-from-the-experts/current-studies-2/

http://e-researchfoundation.org/gfn-2015/

www.sfata.org

list of who is co sponsoring
Use govtrack. https://www.govtrack.us/congress/bills/114/hr2058

End notes in CHAT

VSLLC brief Observations:

These were real vapers as you and VSLLC, asking the hard questions to the experts. However, the opportunity was so shockingly grand, that the webinar was over before we understood, the folks answering us were the actual speaking experts…answering as they waited their turn at the MIC. Of course, all of us jumped in. 🙂

The Webinar itself was priceless. It offered a real in your face view of the big picture. If you missed it, there will be a recording. VSLLC will post the recording here when available.

The experts on hand were:

Featuring: Julie Woessner (CASAA) and Cynthia Cabrera (SFATA)
Special Guests: Greg Conley (AVA) and Mike Hogan (Federal Lobbyist, Alpine Group)
Hosted by: Cheryl Richter (National Vapers Club, Inc.)
Follow #VapersArmy on IG @vapesling
KEEP GOING!!! The fight is never over!!!
Vaping means Advocacy. We have no Friends, only each other.
9 million vapers, however, Sleepers are in the majority.
Cloud Comps and Vape Shops are full of em.
Get out there and spread the word: FIGHT FOR YOUR RIGHT TO VAPE NOW!!!
Related Post:
Posted 12/1/15

Vape shop owners, manufacturers and distributors should schedule meetings with OIRA/OMB TODAY! Click Here

Follow us on our most active Social media: Instagram @vapesling
Twitter is monitored. FaceBook is an issue we need to resolve.
VapeOnVSLLC

CASAA E-Cigarette Survey – 2015

CASAA E-Cigarette Survey – 2015

 

Out of all the surveys you’ll likely fill out this weekend (from what’s your favorite holiday food to who’s the best sportsball team) the CASAA E-Cigarette Survey is probably the most important. It’s also short and painless and you can know you’ve contributed something to science and THR advocacy — as opposed to just doing another survey for fun. This one is really important.

 

Your honest and accurate responses to this survey will help CASAA better understand your experience and preferences when it comes to e-cigarette use, which is critical for our upcoming advocacy work. Information directly from our members is how we can most effectively speak on your behalf and make your voices heard.

 

The larger the portion of our membership who take the survey, the more effective it is. So please do not just leave it to others. Even if you are not an e-cigarette user, your participation is still important to show that our membership is interested and engaged in our policy actions. We are collecting responses from all CASAA members.

 

Please take a few minutes now to complete the survey.

 

Take the CASAA Survey

 

Critical Webinar Hosted by National Vapers Club

Monday
November 30, 2015
7pm-8:30pm EST

Time is Running Out to Save Vaping!

A Critical Webinar Hosted by National Vapers Club
All vapers and business owners are running out of time to take action. Don’t let vaping become a thing of the past.

This 90 minute webinar will explain the different Federal strategies, and what consumers and business owners can do to try to save the vapor industry as we know it.
We’ll cover:
*The two bills that could effectively save 99% of vaper products on the market:
*The Cole Bill (HB 2058)
* The 2016 Appropriations Bill
* The FDA’s Deeming Regs
* The importance of meetings
   with OMB/OIRA
* Consumers’ Call to Action
* Industry’s Call to Action
* Why YOU can make a
   difference!

FEATURED SPEAKERS
Julie Woessner, President
CASAA

The Voice of the Consumer

Join >

Cynthia Cabrera, President
SFATA

The Voice of the Industry.

Join >

SPECIAL GUESTS & HOST
Gregory Conley

President, American Vaping Association

Learn More >

Mike Hogan

SFATA Federal Lobbyist, Alpine Group

Learn More >

Cheryl Richter, Host

NVC Secretary Treasurer, SFATA NY Co-Chair,
Cherry Vape Co-Owner

Learn More >

April 2014 Petition – FDA Vapor Products

April 2014 Petition – FDA Vapor Products
This POST is from the White House Website —> clickhere
Official Food and Drug Administration Response to Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids
This response was published on April 24, 2014.

Regulation of Electronic Cigarettes by the FDA

By Mitch Zeller

Thank you for your petition on electronic cigarettes.

First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them.

Some background, which you may already know: The Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products — cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco — under the Federal Food, Drug, & Cosmetic Act. And while it didn’t apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation.

We’ve issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of “tobacco product” and so they’d be subject to the FD&C Act when the proposed rule is finalized.

Now the petition states that sections 905 and 910 of the FD&C Act would “ban all e-cigarettes,” and that’s not true.

If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 — but this doesn’t mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products.

There will be two primary ways for tobacco products to obtain that authorization: either an application for “substantial equivalence,” or an application for premarket approval.

“Substantial equivalence” would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent — though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be “appropriate for the protection of public health” to allow the product to be marketed.

We know that those applications may require time and resources to develop. That’s why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application — so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review.

So why are we seeking to regulate these products in the first place? As we discuss in the proposed rule, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. There’s still a lot we don’t know about these products, and this rule will expand the amount of information available to the FDA and the public — that’s good for everyone.

Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don’t know enough to make that call. This rule would help us to continue to analyze the potential benefits and risks of e-cigarettes, including their impact on nonusers and on the population as a whole.

It’s important to remember that this rule isn’t final yet, though. We’re seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes.

The opportunity to comment on FDA’s proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments.

Related links:

Mitch Zeller is the Director of the Food and Drug Administration’s Center for Tobacco Products.

Tell us what you think about this response and We the People.

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!)