FDA Deeming Regulation - Info and Resources

[Crowedude654]

madvapes is trying to get this thread active again in light of the Final Deeming Rule being released on May 10, 2016. All old links will remain active for informational purposes, but be sure to check out the most recent ones too.

4/22/2014: Proposed Deeming Rule has been released. Follow the links below for more information.

This is the link the the original document:
http://www.ofr.gov/OFRUpload/OFRData/2014-09491_PI.pdf

This link is to the CASAA page regarding the proposed rule:
CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

And this is a recording of conference call among some of our most respected vaping advocates:


Update 4/29/2014: Today CASAA issued a press release, and encouraged everyone to pass it on to every/all local news outlets, including TV stations and newspapers. Linked below.

CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA

Update 5/9/2014: CASAA has released a little bit more background info about the regulations.

CASAA: CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

And they've also released the first part of their Action Plan. This one is extremely important!

CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

Update 5/12/2014: CASAA has released their first Call to Action. We want to extend the comment period from 75 days to 180 days.

CASAA: First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

Update 6/16/2014: CASAA has released their third Call to Action. The second was mostly for vendors and concluded on May 27. This third CTA is basically calling out the CDC and FDA. We're requesting a congressional investigation into the FDA and CDC in regards to the misinformation they have been releasing. More details in the link below.

CASAA: Third Call to Action for FDA Proposed Regulations - Demand Congressional Hearings Investigating FDA and CDC's Actions

Update 7/30/2014: It's our last chance to make your comment heard:

The final countdown to August 8th - your FDA comments NEEDED

Update 8/10/2016: The Final Deeming Rule has been enacted. To find out what this means and what you can do, follow the links below.

Final Deeming Regulation:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

The following link directs you to CASAA's blog page describing how you can get involved. This link is easier to remember and easier to share, so make sure to pass it around:

www.august8th.org

As of 8/10/2016, vapers want to urge their representatives to support HR2058 and the Cole-Bishop Amendment. Both of these are equally important, and both will change the predicate date from 2007 to 2016, allowing current vapor products to remain on the market without having to submit to expensive and time-consuming FDA barriers. This is only a starting point, and not a permanent solution, but it will prevent 99.9% of vapor products from being taken off the market.

What does it all mean?

The following video is the most concise and easy-to-follow way I've found to get a quick breakdown about what the regulations are trying to do, and what its flaws are:



Lawsuits inbound:

CASAA has joined the Right to be Smoke Free Coalition, along with the AVA, SFATA, AEMSA, and NBS:

Nicopure Labs Files Lawsuit Against the FDA on the Same Day Regulations were Filed

 

[spacekitty]

Thanks for doing this, and helping to promote the Cause (and CASAA)!!

I'm sure that a lot of vapers aren't really aware of all the struggle that is going on behind the scenes in all of the different States and/or Cities... but this one from the FDA will effect EVERYONE!!!

I got an email over the weekend from a vendor who is closing his doors, because of a proposed regulation in his State that will impose a 45% Tax on the Wholesale prices, and he just doesn't have the means to fight it.


I hate to say it, but we are probably gonna see a lot more casualties before this battle is over...

 

[therussellv]

These new fda rules are based on emotion and bias, they have no grounding in fact, and they will destroy small business. But then, the stated goal of our government is to destroy jobs, so we can all be dependent on the government teat. When the government has control of vaping, then we will have all we want, government issued juice that tastes like ashtrays. Good thing I have become independent of suppliers, thanks largely to MadVapes.

Last stinky October 15, 2013

 

[Dayglow]

I am hoping that with the new proposals there won't be any off the cuff bans. Taxation, if done the same way as cigarettes, will be state by state and city by city and not necessarily a federal flat rate. It is understandable that we are getting scrutiny as I am sure there are a number of juice cowboys/girls throughout the world that aren't using the most desirable means to produce liquids and devices. Heavy metals, toxins, impurities, trace chemicals, and just plain sanitation are things that rightfully should be monitored. Any one can say they do or don't do something, but only when put under the magnifying glass can we take them at their word. This first step in legislation is just that, a first step. As long as it is approached well and allows room for improvement, this may be the start of future consumer based improvements to come instead of just another bureaucratic resource.
Regulation may mean the end, but it doesn't have to. With the work that appropriately managed scientific research and media exposure can do we can present ourselves not as some band of outlaws sucking on future-stix, but as the people trying to take our bodies back from tobacco and enhance our lives.

P.S. Thanks for being such great local (to me at least) advocates for what we do, I stop in whenever I am near a MadVapes shop even just to shoot the breeze.

 

[liblue1]

DNC.........
I have been paying close attention to this since it was announced...I think that no matter what we do or say now....they will do what ever they want to when it is convenient for them.....I noticed that it is worded that way...if they want to change anything at any time they can and will....I could go on about this...but I don't see the point....I would rather save my energy & time for when I can fight & make a difference.............One of my best qualities is PATIENCE......................

 

[Crowedude654]

DNC.........
I have been paying close attention to this since it was announced...I think that no matter what we do or say now....they will do what ever they want to when it is convenient for them.....I noticed that it is worded that way...if they want to change anything at any time they can and will....I could go on about this...but I don't see the point....I would rather save my energy & time for when I can fight & make a difference.............One of my best qualities is PATIENCE......................

I agree, which is why I'm not asking people to take action this week. Everyone needs to be on the same page first, and I think CASAA will help immensely with that. Just spread the word and inform people for now. We'll take action when appropriate.

 

[spartanstew]

Well, it's tough to get through all the rhetoric and find out exactly what's being said, but it's clear that it's not good.

I'm all for some regulation (making sure juice is safe, prohibiting the sale to minors), but it's gone crazy. It's obvious that they're going to take action no matter what and logic probably won't come into play, unfortunately. I, too, received an Email about a vendor that will be closing and unfortunately, I think there's many more to come.

 

[whodat2112]

I also agree that regulation doesn't have to be a bad thing. But if the Federal Government is involved, chances are it won't be a good thing.

I joined CASSAA a few days ago.

 

[aikanae1]

Thank you for highlighting this cause. I feel our collective response may pave the way for vapng in the future and there are some that I don't think understand or realize how serious this is. Basically, from my understanding, if a shipment were seized, going to court wouldn't be an option after deeming and this has to be done first before any additional restrictions can be added, such as flavors.

So I intend to take my time and listen to what others have to say who have more experience than I do. I am listening to what BT has to say about it too since I think they might have an inside track to more information. We get one response to the FDA and I hope I can use it wisely.

Meanwhile I can petition CONGRESS, complain and fuss my little heart's desire with local reps. I intend to make them sick of me. I am very nervous about the California online sales ban this week (tomorrow).

I'm lucky in that I live in an area with strong local vape meet support and I hope that we can do more "kick the habit" and membership drives. I think local organizing is just as important as national organizing.

 

[traderljp]

I have also been staying well informed during these important times. As far as opinions go, I have to say that I am pretty negative about most of what I am hearing/reading except the underage/kids part. A couple of things that are on my mind as I write this are:

How unfair it is to the vast majority of businesses that are not going to be able to afford the paperwork and regulatory upkeep right off the bat. Like Greg Conley said, “This is worse than I expected,” ...“A lot of these companies, they are supporting several employees, investing any profits back into their business. . . . They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.”

How typical it is to see that the biggest players (some of who have the money and backing/partnership of big tobacco) are the only ones in favor of the FDA's moves.

I have more to read and think about, but I really love that you made a contest out of this and I look forward to reading all the opinions.

Great contest idea...thank you!

 

[1w15h1w45m0ngu]

In my opinion, ecigs are no more a tobacco product than nicotine gum and though not all of us use it to quit, we're not smoking tobacco; we're using nicotine vapor. I'm tired of regulations being passed without actual research being done on the benefits of what we're doing. You would think the powers that be would be happy that cigarette smoking is quickly becoming a thing of the past but I suppose the powers behind the powers that be (I.E. pharmaceutical and tobacco lobbyists) are going to continue to act like hypocrites until their agenda is the status quo. Overall it feels like we're being bullied by those with deeper pockets than us. I hope the celebrities get more involved. Their recognition of the restrictions that are headed our way would turn the public view at least a bit.

Thanks for the contest and good luck everybody!

 

[Monkchip]

I've read some of the information on the links, but I agree that the most important thing that I can do right now is join CASAA. I plan on joining now.
Thanks for the contest and the encouragement to get involved!

 

[iota]

This is such an important topic for us and this contest is a great idea to help broaden the discussion and education of the ECF members. I have bookmarked all of the stories as they have come across my radar this past week. And now I have your links as well, thanks for that. Like Monkchip said, the most important thing I can do right away is to join CASAA, so I will get on that today! Most of what I know about the FDA and their recent decision, is from hearing other's talk about it. My own take, so far, is that the FDA has overreacted and put a lot of businesses up against the wall unfairly. The cost to the consumer will probably be less selection and higher prices. Not surprising to find that the lobbying interests seem pleased with the FDA!

 

[BigNick]

My opinion of the FDA's proposed regulations on e-cigarettes is that some of the regulations are good and some are not. I do agree with the sales being 18 or over and that warning labels on e-cigarette products are good ideas. As for classifying e-cigarettes as tobacco products and making e-cigarette manufacturers fill out a lengthy an expensive form for every product is ridiculous. Thank you for the contest and all the links to the information on the matter.

 

[kathi17]

I joined CASAA the same day as I joined this forum. I am writing a draft of what I would like to say, and the points I want to make to send to our state and federal representatives, as well as the FDA, and more local media. I have also already participated in local call in shows about vaping.

I want people to know me, and hear my story. When you actually know someone who vapes, and see the difference in their lives and health first hand, it makes you question what you see in the media. I want people to know I am approachable to answer their questions about vaping.

When I write to our government officials and the local media, I also invite them to meet with me, and see my equipment so I am not just an anonymous letter writer.

 

[MikeNice81]

CASAA

For example, there are vague assertions that regulation will address problems of unsanitary manufacturing processes or contamination. Addressing these would benefit consumers. But the regulations, which primarily involve busy-work information filings and applications, would do nothing to address such problems.

This is a typical government regulation move. You have to provide a reason for you to have a job.

Plus, this is a typical move to create a scenario that benefits established players while cutting out competition. Small companies can't afford the increased direct cost of the filing fees. They will also struggle to hire personnel to ensure government compliance.This makes it easier for the larger corporations that have the money to influence regulation to stay in business. Many cities did the same thing to food service trucks when they popped up during the recession. The congress did it before with their earlier cigarette regulations known as the Marlboro Monopoly Act.
Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia

Similarly, they declare that their application process for allowing new or “substantially equivalent” products onto the market protects good products and eliminates bad ones. But there is no evidence that their process actually accomplishes this.

Again, this is a move to protect existing moneyed interest. It does nothing to promote safety or innovation. It actually goes a long way in preventing competition from improving the safety of products. It completely eliminates the ability for disruptive competition to spring up and change market forces.

Discussions of the cost of the proposed regulations focus entirely on the compliance costs for manufacturers. There is no apparent awareness of the costs imposed on consumers.

We are about to see a significant increase in the price of vaping. The FDA completely ignores the fact that all costs will have to be passed on to consumers. That means that many smokers that would switch to vaping for cost savings will lose the incentive. Many that would find relief by vaping will be forced to turn to insurance for other harm reduction and cessation methods. These methods have proven to have a less than stellar success rate. Many people turn to them time and time again because they keep failing. That means an increase in insurance costs and premiums. That doesn't include the emotional costs or lost opportunity cost as people spend time off of work sitting in doctors' offices instead of working. There is also the loss of productivity costs as people struggle through the symptoms of withdrawal including depression and lack of concentration.

The regulations will have far reaching economic consequences that no one at the FDA is contemplating. That includes the impact of lost employment as companies close down. (It is already happening.)

There are signals that FDA would take actions that are harmful to consumers. FDA is aggressively soliciting reasons to ban e-cigarette flavors and there are several hints that they intend to take this step.

Several Democrats tried to get a bill rolling under the guise of protecting children from e-cigarettes. One of the main thrusts of the bill was eliminating candy and fruit flavored e-juice. The FDA has done that with cigarettes and is now (in this proposal) saying they plan to do it with cigars and pipe tobacco. They point to the shift from flavored cigarettes to flavored pipe and cigar as proof of substitution. What they ignore is that millions of adults choose these flavors. There is no age at which people stop enjoying sweet flavors. It is another example of how the government cares less about truth and more about pushing a personal agenda at the expense of consenting and knowledgeable adults.

We are very concerned with FDA’s apparently tenuous grasp of the relevant science. They ignore the bulk of what is known, repeatedly misinterpret studies, and accept as fact politically-motivated assertions of authors. They have some out-and-out factual errors in their review of the science, but far worse is the spin and innuendo. They cherry-pick single sources with particular conclusions about topics that are far more uncertain when all the evidence is considered. In almost every case, the uncritical acceptance of bad information tends to justify restrictions and deny the harms they will inflict on the public with these restrictions. This bodes ill for what they will accept as new evidence in response to their requested comments.

There is no desire to understand the subject. Goal one is to protect the moneyed interest that are their former and future employers. The second goal is to pass an ideological agenda. We have seen time and again that money and ideology combine to squash the needs and concerns of the common person.

I don't know if that counts as opinion or interpretation. I guess you could call it an interpretation based on my opinion as someone that studied political science and economics.

 

[Crowedude654]

Just wanted to give everyone a heads-up: I will be updating the original post at the top of this page as new information arises. Also, after the contest is over, this thread will be renamed and remain stickied. It will essentially become the FDA Regulation and Action thread, so please keep checking back here for more info, even after the contest ends.

 

[_JB_]

I read the links provided and found some easy to understand and some difficult. I then went the American Lung Association website and looked around. At the American Lung Association site I found this link> Quitter In You | Brought to you by American Lung Association and Wellpoint At quitterinyou I did a live chat with a person about my success at quitting smoking by using a PV. There is also a place where you can write and post your success story there.
I may have only got my story to one person but that person I hope will share my story with others within their organization.

Joining CASAA is next on my list.

 

[kathi17]

When do you expect the Kayfun lite plus to be back in stock? I tried to place an order for a bunch of stuff a few minutes ago, but after I tried to pay, it said it was out of stock.

 

[Sean Brown]

I don't mind the health regulations or even taxing it's that large stack of money they want that will kill the smaller juice companies and the smaller mod companies that many have come to love. I just see this as was stated earlier in the originating post that this is a way to get all vaping companies into the pocket of big tobacco which a lot of the vaping community has come to not depend on the 4000+ chemicals that are in thier product to the few chemicals and nicotine that we use in our vaping e-liquids.