Regarding petitions

[kristin]

There has been much discussion on ECF and CASAA's Facebook group about the petitions to the White House. Specifically, one calling for a "veto" of the regulations. Below are the comments and opinions we posted to our members in the Facebook group. As some members of CASAA on ECF may not go to Facebook, I am posting here for you to see.

If you are wondering about CASAA's opinion of the White House petition to "veto" the FDA regulations, there is a LOT wrong with it and that is why I haven't allowed it to be posted in the group yet. I will submit it to the rest of the CASAA Board of Directors to get an official ruling on whether or not we will endorse it, but it is unlikely. We'd rather our members start preparing to submit comments to the FDA, where it really counts.

If it was well-written and factual, I wouldn't hesitate to recommend signing it, but that is not the case. You can sign it for the sake of "doing something," but you will be adding your name to a petition that is filled with misinformation and a fundamental lack of understanding of the regulatory process and the FSPTCA. The media and ANTZ could easily use the fact that so many vapers signed such an inaccurate petition against us. Showing a powerful, mass front is good, but showing it on a petition filled with so many errors may only serve to make us look uninformed and unorganized. So, in a way, it actually could "hurt" us to sign the petition and "every bit helps" isn't always true in every case.

Additonally, I am concerned that too many people will sign a petition and when it comes time to send in a comment to the FDA, they will mistakenly think "I already signed something about this" and not do it. In fact, I have already seen it confusing folks, asking why CASAA doesn't want people "submitting comments" and have had to explain to them that signing the petition and submitting comments are two different things. Those petitions could clearly lead to less people submitting comments directly to the FDA and that could hurt us, as well.

After all of that, the FDA will likely never even look at it. We've done White House petitions before (about the FDA and e-cigarettes) and the Administration just kicked it over to the FDA to answer us!

The FDA comment period is a part of the actual process and essentially IS our petiton. It's the time to get our voices heard by the right people.

We have OVER TWO MONTHS to get our comments in and that is plenty of time. The process does not favor those who "get there first," so we have no need to rush into things. Calm, rational and factual comments are needed and that takes a little time to organize.

Anyone who has been a member for some time and attended the member meetings over the years will tell you that we expected to have to analyze the rules and we wouldn't issue a statement, nor advise our membership to take certain actions, without first having a clear understanding of not only the language of the rules, but their greater implications. We are just asking for members to please be patient for a few DAYS, while we scrutinize the rules and craft a comprehensive Call to Action to assist members in submitting their comments.

I'm sorry if people feel we should be doing things faster or doing other things besides focusing on the FDA comment period, but we are doing the best we can. Julie, Carl and Elaine were working on it as soon as they got it this morning, with a short intermision to listen to the FDA Q&A call. Please remember that we are all volunteers with jobs and families, not paid lobbyists. Even so, rest assured that this IS a high priority and is not being ignored.

As promised, I have addressed the subject of the petitions regarding the FDA rules with the rest of the board and we all agree that advertising these petitions in this group and on our FB page is not advisable.

I have also received a request to explain what is "not correct" in the petition seeking a veto of the regulatons. Below is my response, which has been reviewed by other members of the BOD.

Michael B. asked, "Would you mind posting which part of the petition is "Not Correct"??"
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"Veto the FDA Restrictions on E-Cigarettes"

This calls for a veto. However, a veto is something a President does when legislation is passed that he refuses to sign. This regulation is being carried out by the executive branch. The enabling legislation - the Family Smoking Prevention and tobacco Control Act of 2009 (FSPTCA) - was passed many years ago.

"The FDA has classified E-Cigarettes as "tobacco Products" and will now severely restrict their use."

The FSPTCA is what classified as "tobacco products" products which: contain ingredients derived from tobacco, such as nicotine extracted from tobacco; are intended for human consumption; and are NOT approved drugs. The FDA has simply used its regulatory powers under that Act to deem that e-liquid containing nicotine derived from tobacco actually falls under that definition.

The proposed rules do not "severly restrict" e-cigarette use. They do not even address "use." The rules aren't even passed "now," so they have no effect at this time. These are only "proposed" rules.

"These regulations are not like those of tobacco, but instead all manufactures will be required to complete a lengthy and expensive application just for putting new products on the market. This includes Mechanical Mods, Variable Voltage, tanks, drippers,etc.

These regulations, for pre-market approval, are EXACTLY like those of tobacco. Per the FSPTCA, tobacco products must follow the same lengthy and expensive application process and have been required to do so for some time. There are already thousands of tobacco applications awaiting FDA review and approval at this time.

Any new "Model" after 2015 will be required to complete this application."

The "grandfather" date per FSPTCA is February 15, 2007, NOT 2015. It applies to any product that was not already on the market before that date. All products released to the market after that date must apply for either Substantial Equivalence or as new products.

"The FDA has over stepped their boundaries."

Congress, through the FSPTCA, gave the FDA the power to regulate tobacco, tobacco derivatives and component and parts of tobacco products.

"E-Cigarettes CAN NOT be classified as a "Tobacco Product" as there is no tobacco in it. "

E-cigarettes that contain nicotine CAN be classified as "tobacco products" per the law established through the FSPTCA in 2009. The law clearly states that the definition of "tobacco product" includes products that contain materials and/or ingredients derived from tobacco. The nicotine in e-liquid is derived from tobacco and the devices are components in the use of the tobacco products (although, the latter is something which CASAA will argue against.)

"They fret about the nicotine, but there is nicotine in many plants including tomatoes."

The nicotine in other plants, such as tomatoes and eggplants, is so low that it does not have the same effect on the body. It is also not the nicotine being used in e-cigarette liquids. This comes down to "intended use." People do not consume vegetables for the effects of nicotine, but they do use tobacco for those effects.

"They fret about the flavors, yet allow Smirnoff Vodka to advertise candy and fruit flavors."

True.

"DoNot, allow the FDA to take control of a life saving prod(sic)."

The FDA was given this control back in 2009, when President Obama supported the FSPTCA, as passed by Congress, and signed it into law. That he would now tell the FDA not to follow the law is highly unlikely.
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We know that this petition, and others like it, are well-meaning and show an incredible desire to take action. We truly appreciate that and we will need people to take action! But we caution that such petitions could not only backfire, they could result in less people submitting their comments to the FDA. We need people to act when the time is right and with the right information.

We ask that members read the initial summary of CASAA's review of the regulations (here: https://www.facebook.com/groups/casaamembers/permalink/657242640980253/?stream_ref=2) and watch for the continuing summary to be posted on Monday, April 28th.

Since then, FDA's Mitch Zeller sent an email out regarding petitions:

RE: Petition

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.

Some have seen this as a response only to the 2013 White House petition. However, the reference to the proposed rule released Thursday (ie "The opportunity to comment on FDA's proposed rule is NOW open and comments are due on July 9...") clearly show this letter is also an unofficial response to recent petitions. The FDA is essentially saying, "There is a process to implementing rules and we provide a period for you to weigh in with your opinion. Please use that process." This basically makes the petition look unnecessary and unreasonable (at this point in the process) in the eyes of the general public and media.

A petition is a tool for getting your voice heard when regular channels fail to achieve the desired response. At this time, no one has really even used the regular channels (ie. the public comment period) so a petition at this point looks like we are ignoring the opportunity of the public comment period. It's akin to wanting a job at a company and posting "This company discriminated against me and won't give me a job!" on the company Facebook page before even giving them an application and having an interview. Who would take that seriously? Not only that, but putting the claim on the wrong company's Facebook page to boot. (ie. all of the inaccuracies in the petition.)

Just because you are "doing something," "making noise" and "getting attention," it doesn't mean those things are benefitting your cause when it makes you look unreasonable and uninformed.

 

[classwife]

Thank you Kristin !

 

[Ms.P]

Beautiful. Perfect. Thank you, Kristin!

 

[carlvphillips]

To paraphrase multiple comments from every other thread I have seen about this petition: "I don't understand what is wrong with asking the POTUS to veto a regulation, and who cares about sloppy typos, those are just details. Spending 10 second clicking a button on a webpage really matters and it shows how much I care about this. How dare they demand making e-cigarettes standardized and foolproof; do they think I am not capable of self-administering drugs and operating a complicated ad hoc health-affecting device?"

 

[Talyon]

To paraphrase multiple comments from every other thread I have seen about this petition: "I don't understand what is wrong with asking the POTUS to veto a regulation, and who cares about sloppy typos, those are just details. Spending 10 second clicking a button on a webpage really matters and it shows how much I care about this. How dare they demand making e-cigarettes standardized and foolproof; do they think I am not capable of self-administering drugs and operating a complicated ad hoc health-affecting device?"

I believe post number 1 in this thread has answered your question, however perhaps u didn't understand or even require more explanation, this will be forthcoming in a few Days or so, Ty for your patience and Ty for helping.

 

[Ms.P]

I believe post number 1 in this thread has answered your question, however perhaps u didn't understand or even require more explanation, this will be forthcoming in a few Days or so, Ty for your patience and Ty for helping.

I believe Carl was being facetious.

 

[Fitzie]

Now if only the folks who need to read this will find their way here and stop spinning their wheels with ineffective tactics ...

 

[sonicdsl]

To paraphrase multiple comments from every other thread I have seen about this petition: "I don't understand what is wrong with asking the POTUS to veto a regulation, and who cares about sloppy typos, those are just details. Spending 10 second clicking a button on a webpage really matters and it shows how much I care about this. How dare they demand making e-cigarettes standardized and foolproof; do they think I am not capable of self-administering drugs and operating a complicated ad hoc health-affecting device?"

I believe post number 1 in this thread has answered your question, however perhaps u didn't understand or even require more explanation, this will be forthcoming in a few Days or so, Ty for your patience and Ty for helping.

I believe Carl was being facetious.

Yes, Dr. Phillips was making a point with a facetious post. See Anti-THR Lies and related topics | because cultivating the truth requires both seeding and weeding for examples of many of his other analyses, and sardonic wit.

 

[SensesFailed]

I agree with everything put. The problem is people are quick to rush(usually with good intentions) to try and get things. Good intentions from all, completely understandable, but when it comes to this(and this applies to many other topics), not giving ammo to anything is an important step into making sure the voices are heard. The quick, over-the-top reactions actually can be used to even drown out the statements from those bringing facts and information to the fray.

Again, good intentions all around, but making sure all ducks are in a row and everything is known is a very important step.

 

[DC2]

Unfortunately, I already signed that petition.
I guess I always figured that it can't hurt to sign just about every petition.