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).”
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.)
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:
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.
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
Footsoldiers who took part in your Historical Vaping Petition of November 2015
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:
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:
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:
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.
Provide a clear statement of whether you support or oppose the proposed rule or guidance.
Include any of the following that support your position:
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:
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:
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
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
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)
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.
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:
This POST is from the White House Website —> clickhere
Official Food and Drug Administration Response toPrevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids
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.
