FDA In Answer to the "What do I do now" Question

[Myrany]

(Moderators if this belongs elsewhere please move it)

With the release of the proposed deeming regulations by the FDA I am seeing a whole lot of vapers in "OMG what can we do to stop this" mode. I thought I would post my thoughts of what next steps can be taken.

1. First of take a vape and calm down. NOTHING is going to do any good if we are all running in different directions and not really working together or thinking things through.

2. Educate yourself. Read up on the governmental processes involved here. Read up on the studies pro and con of vaping. Find out what rights you actually have. READ the proposed deeming regulations. Not a synopsis by a commentator. Sit down with a a pen and notepad and READ the proposal. Take notes. Write down questions you have about what things mean as you read it. Odds are if you haven't found the answer by the time you finish reading then that is a good question vapers need an answer on.

3. Join CASAA and help them financially if you are able. These folks are on the frontline of our defense. They are the ones that have the staff (if I remember rightly several ARE Lawyers) and the connections to get things done. GET INVOLVED. They will help you with ideas on how you can get involved not just nationally but locally as well. Yes they are silent right now. THey are not going to say anything until they have carefully analyzed the document. Why? See #1 & #2.

4. Realize that even amongst vapers there are going to be differing opinions on the issue. Some think we have no worries and others see potential for big trouble. Try hard not to let the differences become personal or flare into divisiveness. A house divided cannot stand and time spent bickering is time lost fighting. Sometimes it is better not waste time in an argument and why show the cracks in the community to the opposition so that they can widen them.

Once you have done all of the above then
1. Write to legislaters
2. Comment during the 75 day comment period for the proposal
3. Blog/vlog
4. Social media (whichever one you use)
5. Write editorials for your local fishwrap (newspapers)
6. Make the rounds of vape shops handing out CASAA card and making sure they know what is happening. Try to enlist their aid in getting word out to their customers (bring cards and posters for them).
7. Get your family and friends involved even if they do not vape. Never underestimate the power of a spouse who is just happy you are going to be around longer to share life with. Get them onto their social media.

In short stand together as a community and get the word out to grow or community and get our voices heard.

 

[stauglocal]

Does anyone have a link to where we can comment to the FDA?

 

[Myrany]

Does anyone have a link to where we can comment to the FDA?

Comments are supposed to be opened up sometime today so I am not sure if they are even open yet.

 

[AgentAnia]

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

 

[SoonerChris]

Deleted....

 

[williegntx]

I'm waiting for CASAA to wade thru the legal eaze of the FDA's propaganda (maybe they have, got to check).

I started reading it (270 page PDF) yesterday, but I think the main problem we are up against is they want to classify PV's as a tobacco product.

I'm with you on we need to eliminate the 'cracks' and all stand together and support CASAA, too.

 

[Rickajho]

Does anyone have a link to where we can comment to the FDA?

If I may suggest along the lines of what Myrany started: hurry up and wait before commenting. CASAA has only released a preliminary interpretation/view point of the FDA proposals, with a more in-depth follow up coming on Monday. Rushing the FDA with ill thought out comment isn't going to do us any good. We need a little more insight into where the FDA is going or trying to go in order to provide well thought out counter points in our comments. "FDA sucks" won't help.

 

[Myrany]

I'm waiting for CASAA to wade thru the legal eaze of the FDA's propaganda (maybe they have, got to check).

I started reading it (270 page PDF) yesterday, but I think the main problem we are up against is they want to classify PV's as a tobacco product.

I'm with you on we need to eliminate the 'cracks' and all stand together and support CASAA, too.

See that is one of my unanswered questions.

In one section our PVs and toppers are defined as a tobacco product but then in other sections they are not (as they do not contain nicotine). It makes for real confusion.

Does selling the PV or topper empty make it outside the right of the FDA to regulate?
Does putting a label on it that says something to the effect of "Not intended for use with nicotine liquids" put it outside the right of the FDA to regulate?

TO many conflicting statements in the document itself for this to be clear.

This is exactly what I mean by doing homework. We need this clarified and frankly I do not think it will be. The more wiggle room they are allowed to leave themselves the happier the FDA will be. IF we do not think things through we will not find the issues like this one.

 

[AgentAnia]

....In one section our PVs and toppers are defined as a tobacco product but then in other sections they are not (as they do not contain nicotine). It makes for real confusion.

Does selling the PV or topper empty make it outside the right of the FDA to regulate?
Does putting a label on it that says something to the effect of "Not intended for use with nicotine liquids" put it outside the right of the FDA to regulate?....

I suspect that unless these conflicting statements are resolved in the final rule, such conflicts will only be resolved in the courts after the fact.

 

[Myrany]

I suspect that unless these conflicting statements are resolved in the final rule, such conflicts will only be resolved in the courts after the fact.

Agreed but we need to find them. So they can be addressed one way or the other.

 

[Maxwell_Edison]

I would hope that a donation to CASAA is a part of everyone's monthly vaping expense. I would hope that small ecig businesses would donate a larger amount. They are our MAIN ally, and do more than anyone else to help our cause. They do need money to operate, that's just the way it is, and if everyone would donate they could do more. Support CASAA.org !!! Respond to Calls for Action too.

 

[blueGrassTubb]

In one section our PVs and toppers are defined as a tobacco product but then in other sections they are not (as they do not contain nicotine). It makes for real confusion.

This is no mistake. It's exactly as they intend. How can they rule arbitrarily in the favor of "industry leaders'" desires if things are straightforward and there is no wiggle room.

All regulation is this way. It's to give them latitude to regulate further.

 

[Janet H]

See that is one of my unanswered questions.

In one section our PVs and toppers are defined as a tobacco product but then in other sections they are not (as they do not contain nicotine). It makes for real confusion.

Does selling the PV or topper empty make it outside the right of the FDA to regulate?
Does putting a label on it that says something to the effect of "Not intended for use with nicotine liquids" put it outside the right of the FDA to regulate?

TO many conflicting statements in the document itself for this to be clear.

This is exactly what I mean by doing homework. We need this clarified and frankly I do not think it will be. The more wiggle room they are allowed to leave themselves the happier the FDA will be. IF we do not think things through we will not find the issues like this one.

I'm glad you said that about the confusion. I got through the first 50 pages and it seemed to me that they were contradicting themselves about the "accessories" and whether or not they were to be included as a tobacco product.. My head was spinning. It's probably much smarter to let CASSA digest this and pick it apart so we have a better understanding of the best way to respond. Geeze, I wish cigarettes had to list their ingredients on the package! Wouldn't that be interesting to compare with eLiquids!

 

[Rickajho]

Sign this.

https://petitions.whitehouse.gov/petition/veto-fda-restrictions-e-cigarettes/kdKtpFH4

Ummm - no. That petition has no point - literally. It makes no reasoned or rational arguments. In context of the FDA proposals "veto" is a legislative non sequitur. It was a half fannied knee jerk reaction that serves no purpose. It's a rant, not a petition.

I'm waiting for a much better thought out petition to come out next week.

 

[Ms.P]

(Moderators if this belongs elsewhere please move it)

With the release of the proposed deeming regulations by the FDA I am seeing a whole lot of vapers in "OMG what can we do to stop this" mode. I thought I would post my thoughts of what next steps can be taken.

1. First of take a vape and calm down...

(Didn't want to quote your whole post.)

Beautiful. Even if I disagreed with you I could kiss you. Thank you.

 

[patkin]

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

Oh... thank you soooo much. I can always count on you to make things easier for me!

 

[WorksForMe]

Does anyone have a link to where we can comment to the FDA?

I just got this email from whitehouse.gov


Regulation of Electronic Cigarettes by the FDA

By Mitch Zeller, the Director of the Food and Drug Administration's Center for Tobacco Products.

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:

See the proposed rule


Submit a comment on the proposed rule

 

[Skwerl]

I got the same email moments ago too. There is a lot of wiggly language in there. I agree with Myrany- relax, think things thru before replying, and see what CASAA has to say. A rational, unified front is our best defense.

 

[stauglocal]

"We know that those applications may require time and resources to develop." Yeah, which most small ecig companies DO NOT have! But guess who does? Yeah, big tobacco, the ones in your pocket Mitch.

 

[Mowgli]

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014