FDA FDA e-cig workshop starts 8AM (Eastern US time) on Dec 10, agenda stacked with staff from FDA and other federal agencies and many ANTZ

[JustJulie]

Bruce--

I think my comments regarding Dr. Eissenberg were fair. The question is a legitimate one . . . if the goal is to make vaping attractive for smokers but unattractive for nonsmokers, what kinds of things would one be willing to support to get to that "sweet spot"? And, of course, that begs the question as to whether finding that sweet spot is even a particularly good or useful goal.

I would, however, agree that the criticisms directed at Dr. Farsalinos for embracing e-liquid standards as him embracing deeming were a bit harsh. Since the FDA cannot act on e-cigarettes unless and until we are deemed tobacco products, I suppose one could argue that endorsing an FDA standard for e-liquids could be seen as endorsing deeming. But I don't expect scientists to parse the legalities of the convoluted mess that is the Tobacco Control Act, and I don't think Dr. Farsalinos intended to have his comments taken as such.

At the end of the day, I think most of us would agree that there could be some regulation of e-cigarettes that would be genuinely beneficial for consumers, and manufacturing standards for basic quality control would certainly be at the top of that list. But the TCA isn't beneficial regulation . . . it is de facto prohibition.

 

[Kent C]

This is not to start a poltiical debate, but I use this analogy - where some people that think that Republicans should become 'Democrat-lite' by offering 'reasonable alternatives' to Democrat proposals. Where here, some suggest that we become "ANTZ-lite" with "reasonable alternatives" to regulations on vaping and eliquids. Watering down unreasonable proposals isn't being 'reasonable' - in fact it is the opposite of using reason.

While I would accept a change in a grandfather date from the view that it's better to have only one finger choppped off rather than a whole hand, (or better - that I can take my hand - all fingers included, to the black market) it is not the end solution - which is to go with the solution offered above:

"Get the new Congress to write legislation that 'un-deems' ecigs" and enough support in Congress to override a veto - or elect someone who wouldn't veto that legislation.

 

[Kent C]

What is 'beneficial for consumers' is to get better informed themselves, rather than relying on gov't or even consumer groups to inform them what is 'best'. Certainly using the information from CASAA and from ECF is one way of informing oneself, but for those who don't - they will learn more from their own mistakes and misjudgments than any gov't intervention that prevents that learning from occurring.

Plus, what and how they vape, so long as it harms no other, is no one's business - gov't or other 'well intentioned' individuals. Regulation is force. 'Some regulation' is some force. Using any force against individuals (again, unless they are harming others) is immoral/unethical, as well as unwanted and undeserved.

 

[r77r7r]

What is 'beneficial for consumers' is to get better informed themselves, rather than relying on gov't or even consumer groups to inform them what is 'best'. Certainly using the information from CASAA and from ECF is one way of informing oneself, but for those who don't - they will learn more from their own mistakes and misjudgments than any gov't intervention that prevents that learning from occurring.

Plus, what and how they vape, so long as it harms no other, is no one's business - gov't or other 'well intentioned' individuals. Regulation is force. 'Some regulation' is some force. Using any force against individuals (again, unless they are hraming others) is immoral/unethical, as well as unwanted and undeserved.

Here, here.

 

[Jman8]

This is not to start a poltiical debate, but I use this analogy - where some people that think that Republicans should become 'Democrat-lite' by offering 'reasonable alternatives' to Democrat proposals. Where here, some suggest that we become "ANTZ-lite" with "reasonable alternatives" to regulations on vaping and eliquids. Watering down unreasonable proposals isn't being 'reasonable' - in fact it is the opposite of using reason.

Yet another reason why I don't understand the vaping community's desire to go with 'no sales to minors.' Again, this is item numero uno in the FDA proposal. I take the opposite stance on this political item and stand on an island of very few vaping advocates that dare to go there. It's as if "for the children" has actually swayed a whole bunch in the vaping community while seemingly not recognizing that as long as we are on board with this, ANTZ will ALWAYS have an inroad to regulations. Admittedly though, if we drew a line in the sand on this, we would likely lose, but is just one of those items that continues to show up to me as not being reasonable, while definitely being politically correct.

While I would accept a change in a grandfather date from the view that it's better to have only one finger choppped off rather than a whole hand, (or better - that I can take my hand - all fingers included, to the black market) it is not the end solution - which is to go with the solution offered above:

"Get the new Congress to write legislation that 'un-deems' ecigs" and enough support in Congress to override a veto - or elect someone who wouldn't veto that legislation.

I personally think it is too late in the game for this, but not 100% certain. Pubs are going to back item numero uno, of this I'm sure. And they'd likely back a few other things (like warning labels and childproof caps). So, then we ought to be concerned with reasonable alternatives, which grandfather date is arguably the most important one.

The only way I see undeeming ecigs a possibility is if FDA takes until 2017 to publish Final Rule, which is possible, but not like any Pub presidential candidate is going to make widely known their stance on eCigs. And if they do, it'll likely be of the 'reasonable alternative' variety rather than undeeming. And if they went, magically, in direction of undeeming, but somehow Dems took back part of Congress, then we'd be screwed. Too much has to go exactly perfect over next 2 years for undeeming to have a chance.

 

[JustJulie]

Yet another reason why I don't understand the vaping community's desire to go with 'no sales to minors.' Again, this is item numero uno in the FDA proposal. I take the opposite stance on this political item and stand on an island of very few vaping advocates that dare to go there. It's as if "for the children" has actually swayed a whole bunch in the vaping community while seemingly not recognizing that as long as we are on board with this, ANTZ will ALWAYS have an inroad to regulations. Admittedly though, if we drew a line in the sand on this, we would likely lose, but is just one of those items that continues to show up to me as not being reasonable, while definitely being politically correct.

I would agree that there's a certain amount of political correctness driving the support of banning sales to minors.

From what we can see, the few minors who are actually using e-cigarettes (as opposed to experimenting because, you know, they're kids) are using them in much the same way as their adult counterparts . . . as THR. Looking at it from that perspective, I personally would rather see a kid vaping than smoking.

That being said, the kids using it in that fashion have presumably been able to get a hold of traditional cigarettes (because they're using e-cigs to replace or reduce smoking), so it's probably safe to assume that they'd get their e-cigs in a similar underground route.

Also, we regulate certain activities based on age . . . you can't get a driver's license until you're a certain age, you can't vote until you're a certain age, you can't drink until you're a certain age . . . . I often wonder at the rationale behind saying an 18 year old can join the military but can't have alcohol, but that's a different discussion. But be it as it may, as a society, we do prohibit minors from engaging in some activities, and so prohibiting sales of e-cigs to minors isn't really all that different. (And unlike the vast majority of ANTZ arguments which are largely baseless and often silly, I do think there is an open question of the effects of nicotine on a developing brain, although I readily admit that there are other substances children are routinely exposed to that might be equally problematic and that we don't regulate, like caffeine).

At the end of the day, I just don't think it's terribly responsible to sell nicotine-containing products to children, even if, as you say, it will always give the ANTZ an "inroad to regulation."

As an aside, while CASAA supports bans on sales to minors, we have taken the position that use and possession by minors should not be criminalized. We feel that the responsibility for ensuring that sales are not being made to minors (and the consequences for violating that rule) should be squarely placed on the industry. Criminalizing sales to minors but not criminalizing use and possession allows parents to make the ultimate decision for their own children.

 

[Kent C]

It's as if "for the children" has actually swayed a whole bunch in the vaping community while seemingly not recognizing that as long as we are on board with this, ANTZ will ALWAYS have an inroad to regulations. Admittedly though, if we drew a line in the sand on this, we would likely lose, but is just one of those items that continues to show up to me as not being reasonable, while definitely being politically correct.

I agree. I have no desire to turn responsibilities for children over to the state on any issue. I'd strongly urge any vendor to have a firm policy not to sell to certain items to children or to ask for parental permission. I'd strong urge parents to be responsible for their children and if they know that their children smoke cigarettes, that they introduce them to ecigarettes and teach them the safe use of them.

I also agree with Julie's view of this aspect of reality:
"From what we can see, the few minors who are actually using e-cigarettes (as opposed to experimenting because, you know, they're kids) are using them in much the same way as their adult counterparts . . . as THR. Looking at it from that perspective, I personally would rather see a kid vaping than smoking.

That being said, the kids using it in that fashion have presumably been able to get a hold of traditional cigarettes (because they're using e-cigs to replace or reduce smoking), so it's probably safe to assume that they'd get their e-cigs in a similar underground route."

But would not advocate transferring parental responsibliity to vendors by making sale to minors against the law, where the vendor not the parents are held accountable, and would advise, not force, the vendor not to make such sales and/or contact the parents when that is feasible.

 

[DC2]

So I've just "liked" a bunch of the most recent posts on this thread, all with somewhat divergent views.
In the end it seems to come down to truth versus tactics.

I would love to side only with the "truth" as THAT would be the world I want to live in.
Unfortunately, I don't think we live in that world at this time.

 

[NorthOfAtlanta]

So I've just "liked" a bunch of the most recent posts on this thread, all with somewhat divergent views.
In the end it seems to come down to truth versus tactics.

I would love to side only with the "truth" as THAT would be the world I want to live in.
Unfortunately, I don't think we live in that world at this time.

For an example, see Washington DC.

 

[Kent C]

So I've just "liked" a bunch of the most recent posts on this thread, all with somewhat divergent views.
In the end it seems to come down to truth versus tactics.

I would love to side only with the "truth" as THAT would be the world I want to live in.
Unfortunately, I don't think we live in that world at this time.

The truth/reason still exists and is manifested in reality as well. And the truth is masked by lies - also manifested. This isn't a choice between some fantasy that doesn't exist and that which does. Both exist now in some form or another. The choice is which to support. I choose to support reason rather than 'reasonableness' (which to me is to cave in to the lies because they are popular or viewed as 'pragmatic').

 

[DC2]

The truth/reason still exists and is manifested in reality as well. And the truth is masked by lies - also manifested. This isn't a choice between some fantasy that doesn't exist and that which does. Both exist now in some form or another. The choice is which to support. I choose to support reason rather than 'reasonableness' (which to me is to cave in to the lies because they are popular or viewed as 'pragmatic').

I imagine if the whole of the populace had such resolve, we might be able to make significant headway.

 

[Kent C]

I imagine if the whole of the populace had such resolve, we might be able to make significant headway.

Yep. Many are the proper recipients of that Jack Nicholson line

 

[philoshop]

That those lies are somehow viewed as expedient by our government officials troubles me more with regard to this issue.

 

[Jman8]

Me bringing up the kids tangent is me speaking up on issue I very much care about and explaining it in short order. Moreover, in context of recent discussion, it shows how we likely will give into certain regulations that are 'reasonable' and thus 100% opposition to FDA deeming is, IMO, impractical. With Pubs in Congress, we stand less of a chance of being entirely railroaded by whatever FDA wants to do to control the industry.

The kids issue is the #1 issue from FDA/ANTZ (well perhaps not really really from ANTZ perspective) but is also #1 issue to me, and how I filter all other regulations. All the other ones are secondary IMO. Thus, unless you are vaping advocate that is willing to take opposite stance as FDA on the kids issue (as I am), then I do think you can succumb to other regulations and hopefully you realize that Pubs will even if you don't. Would take a libertarian majority to think another direction is feasible any time soon.

 

[Bill Godshall]

Back on topic, below are Scott Eley's comments at the FDA's so-called public workshop on e-cigs.


My name is Scott Eley. I’m with NicQuid, and also the Vice President of the American E-Liquid Manufacturing Standards Association. I want to thank the FDA for the workshop and public comment period. I encourage the agency to have more public comment opportunities given the extremely high interest in electronic cigarettes and vapor products.

As stated during this public workshop, initial studies are showing that vapor products are more successful in transitioning a user’s dependence on combustible tobacco than prescription medications or NRT products.

The scientific and empirical evidence has consistently found that e-cigarettes:
have replaced more than 3 Billion packs of cigarettes worldwide in the past seven years
have helped several million smokers quit smoking, or reduce their cigarette consumption,
are more effective than FDA approved NRT smoking cessation products which have a 84 - 95% failure rate
pose fewer risks than FDA approved Chantix
have never been found to be a gateway to cigarette smoking
emit trace levels of nontoxic aerosol that poses no harm to nonusers
and have further de-normalized cigarette smoking as youth and adult smoking rates and cigarette consumption have declined every year since 2007 when vapor sales began to skyrocket

I very strongly encourage the FDA to re-evaluate the currently intended application of the 275 million dollars set aside for e-cig and vapor product research:

Youth experimentation is common with many substances. The CDC survey of youth “ever try” misrepresented data by including those who indicated they would CONSIDER TRYING, AND those who have MERELY tried the products under the category as “users” of the products and year over year data indicated the only increases were amongst those identifying themselves as smokers. Resources targeted to build a virtual convenience store targeting 13 to 17 years old to assess how e-cigarette displays and pricing affect the tendencies of minors to buy the devices could be better spent on verifiable and scrutinized real science, especially considering that 41 states already have laws banning sales to minors and many other states have bills planned for 2015.

$2.7 million the agency gave to a group to monitor Facebook posts to determine how people modify devices is also wasteful as the results would be outdated before the study even concludes.

Verifiable and professionally scrutinized – thru the process of peer-review and publication – should be the policy for all research including any/all funded by the FDA and tax payer.

I, and millions of other former smokers around the world, embraced these alternatives while tobacco cigarettes sales are simultaneously falling.

We all agree, reasonable, realistic and sustainable regulations are needed to establish consumer protections and good product stewardship, but without devastating a multi-billion dollar industry and/or eliminating viable and effective options for both current consumers and current smokers. The agency has already clearly acknowledged these products are providing harm reduction by orders of magnitude.

Thank You

 

[Krashman Von Stinkputin]

Konstantinos,

Many thanks for attending, and for your many excellent comments at, today's FDA workshop.

But please note that the FDA has no legal authority to propose or impose ANY standards on e-cigs unless/until the FDA first issues a Final Rule for the deeming regulation (i.e. approves its proposed deeming regulation), which would ban nearly all e-cig products. By the time FDA gets around to proposing any e-cig standards, most vapor products will be sold on the black market created by FDA's deeming regulation (unless the courts strike down the deeming regulation, or unless the FDA never issues a Final Rule for the deeming regulation).

That's why I've been warning THR and vaping advocates to NOT propose any FDA standards for e-cigs, as FDA will consider that to be an implicit endorsement of their deeming regulation.

Bill:
First let me thank you for all your work on vaping advocacy.
Two questions:
1) Do I understand this correctly that the FDA has no legal authority to propose/impose/regulate ecigs until they GIVE THEMSELVES the authority to do so?

2) I believe there is a place for some standards ( I don't necessarily think we need brand new ones, but could use existing standards for similar products or products produced for consumer consumption). You mentioned that any acceptance of individual standards suggested in the Deeming Regs (ala Dr F's comments), could imply or be used by FDA as endorsement.
So is there a method (or a precedent) in which the current Deeming Regs could be scrapped or amended by the FDA, either internally due to emergent findings (probably unlikely) or externally(eg: SOH Boehner-a smoker BTW) , in favor of--call it-- Deeming Reg Version 2.?
In short, could the FDA start from scratch at this point with a new set of Deeming Regs?

 

[Bill Godshall]

Krashman asked

1) Do I understand this correctly that the FDA has no legal authority to propose/impose/regulate ecigs until they GIVE THEMSELVES the authority to do so?

That is correct. The FDA has no legal authority to regulate e-cigs as Tobacco Products unless/until the FDA first issues a Final Rule for its proposed Deeming Regulation (which would give the FDA the legal authority it seeks to regulate/ban e-cigs). This fact is not in dispute, and the FDA acknowledged it in its proposed Deeming Regulation (that it didn't have the legal authority to propose a regulation to restrict/ban flavored e-cig products until after the deeming reg is imposed).

Krashman wrote

2) I believe there is a place for some standards ( I don't necessarily think we need brand new ones, but could use existing standards for similar products or products produced for consumer consumption). You mentioned that any acceptance of individual standards suggested in the Deeming Regs (ala Dr F's comments), could imply or be used by FDA as endorsement.

Since the FSPTCA only allows FDA to propose/impose standards on tobacco products that are regulated by Chapter IX of the FSPTCA, the only way the FDA can propose/impose tobacco product standards for e-cigs is if the agency first imposes the deeming regulation (to add e-cigs to the list of tobacco products regulated by Chapter IX), and then proposes additional regulations (i.e. product standards) for e-cigs (which would probably take at least several more years, if ever).

While I (and many/most vapers, vapor product manufacturers and THR advocates including Farsalinos) strongly support the development of vapor product standards (and voluntary compliance) within the vapor product industry (e.g. AEMSA's e-liquid manufacturing standards), we need to be very careful to not endorse any FDA proposed/imposed vapor product standards (which is the only type of "product standards" for e-cigs that FDA and other deeming regulation proponents consider as acceptable).

The primary purpose of these FDA e-cig workshops has been and is to consider many different types of future "product standards" and other regulations that FDA might consider proposing on all e-cigs several years AFTER the deeming regulation (which would ban >99% of e-cigs now on the market) takes effect.

Krashman inquired:

So is there a method (or a precedent) in which the current Deeming Regs could be scrapped or amended by the FDA, either internally due to emergent findings (probably unlikely) or externally(eg: SOH Boehner-a smoker BTW) , in favor of--call it-- Deeming Reg Version 2.?
In short, could the FDA start from scratch at this point with a new set of Deeming Regs?

The FDA can (and should) voluntarily scrap the Deeming Regulation at any time (by just doing nothing), just as many (perhaps most) proposed federal regulations during the past 25 years have been scrapped (never to be heard about again by the agency that proposed them). But the Obama admin would never consider scrapping FDA's proposed deeming regulation just so it could propose the same deeming regulation again.

Please remember that the US DOT proposed a federal regulation to ban vaping in airlines back in 2011 (after DOT officials lied to the news media by claiming the agency had already banned vaping in airlines), and that public comment period expired in 2011. Every year since then, someone from DOT has told the news media that the agency will soon issue the final rule for that proposed regulation, but the agency hasn't taken any action yet (because it knows that its proposed vaping ban regulation would almost certainly be struck down in court).

Meanwhile, Congress can exert enormous pressure on Obama's DHHS/FDA to scrap, amend, delay, and/or refuse to finance FDA's proposed deeming regulation (e.g. the recent letter from Republican House leaders to DHHS Secretary Burwell requesting changing the SE grandfather date from 2007 to 2014/15).

And of course, Congress can also amend the FSPTCA and/or enact new legislation to prohibit FDA from imposing the deeming regulation on e-cigs (and/or other OTP).

There won't be a Deeming Reg Version 2 (in the foreseeable future), as Obama's appointees have insisted upon (since April 2011) putting all of their e-cig regulatory eggs in the tobacco deeming regulation basket.

 

[SeniorBoy]

@Krashman - Perhaps this will help answer your questions and of course Bill can chime in.

Here is the legislative procedure which is dictated by statute:

We currently have FDA Deeming regs and the comment period is closed.

Next the FDA will issue a final rule. IMHO, not a chance in hell they will start over. None of us know what will be in the final rule but we can offer our opinions. My guess for the time line is the last quarter of 2015 for the final rule.

Next the final rule goes to OMB for review. That's basically a rubber stamp

Finally, the Final rules goes to Congress where it could either be changed/tweaked or in a best case scenario but unlikely IMHO, Congress could eliminate the regulatory authority of the FDA via the FSPTCA with respect to Vaping.

All of these steps MUST be completed if and when the Final Rule becomes the law of the land.

HTH



EDIT: Just saw Bills response with lots of great details. Thanks!

 

[Kent C]

Finally, the Final rules goes to Congress where it could either be changed/tweaked or in a best case scenario but unlikely IMHO, Congress could eliminate the regulatory authority of the FDA via the FSPTCA with respect to Vaping.

Not so sure about that 'last step to Congress'. I think White House Office of Information and Regulatory Affairs (OIRA; part of the Office of Management and Budget), is last. There may be an 'intervention' by Boehner/new majority... but that's not part of the regulatory rulemaking timeline.

http://www.cspnet.com/category-news/tobacco/articles/next-steps-tobacco-deeming-regulation-process

 

[Cool_Breeze]

...(e.g. AEMSA's e-liquid manufacturing standards),...

Should a voluntary standards organization such as AEMSA, be offering support to governmental regulatory entities..?

Finally, AEMSA welcomes opportunities to meet with Governmental agencies and legislators for the purposes of contributing to the formation and establishment of reasonable and realistic governmental regulation. We feel we have much to offer and contribute to the regulatory considerations.