FDA Post-hearing reactions?

[Talyon]

And now for a bit of humor.....

 

[TomCatt]

And now for a bit of humor.....

While funny D), that quote is taken out of context when standing alone. He was talking about those smokers who don't want to quit or (like me) couldn't quit. He went on to say that in the overall population of smokers, those who may have quit, may not if ecigs are available. Not sure where the logic is in that thought process.

 

[TomCatt]

Gummy Bear juice reviews:
https://www.youtube.com/watch?v=OdTkTZPheSA
https://www.youtube.com/watch?v=RzF-PMVFjwk
https://www.youtube.com/watch?v=7NAF1bqx0_U

Rocket Pop juice review:
https://www.youtube.com/watch?v=wIbTUPZ2jUs

Don't see any kids in these YT videos , but ... but ... according to Sen Harkin adults don't like these flavors

 

[toddkuen]

I think somethings were revealed: there is definitely a combustible/non-combustible ideology split.

I think that those who have already quite and do not use analogs were revealed as something they're not sure what to do with - perhaps an ace up the sleeve - nd I think Zeller basically admitted they can't be put back to analogs but is stuck weighing "long term public health" against that.

What are the number of true 6 mo+ quiters on patches etc. vs. 6 mo+ vape onlys? - If vaping starts to exceed their numbers they'll kind of have to listen...

I would focus on building up the list of true vapers (no combustible use whatsoever for more than say 6 months) and throwing that against the flavors, i.e., I don't use combustibles because of the flavors available.

I think there is an argument that very strong self regulation so no "kiddies" get vapes would go a long way as well in a negotiation.

An example: eliminate on-line DELIVERY for on line ordering and have the stuff dropped shipped to your local vape shop where you can be carded. You get to keep on-line ordering and still self regulate like the local convenience store.

I heard nothing about "brewing chemicals in your bath tub" but it was only a brief hearing.

With strong (and growing) numbers of true non-combustible-smoking vapers and strong self regulation Zeller might be willing to play.

 

[Bob Chill]

Flavors are really the least of our worries. As long as unflavored bottled juice is permitted the entire issue is a moot point. I'm not saying I think it's ok because it's a great big bag of stupid to ban them. I'm just saying that if it happens, consumers can still have whatever flavor they want. It will just be Mio style instead of Gatorade style. There is simply no way to rid the industry of things that are approved for other uses.

My largest worry has and always will be getting rid of bottled juice as a whole.

 

[Roger_Lafayette]

I have an more complete answer but not for here I'll just say as an aside that certain unions trump big corporations in support for certain candidates. AFSCUME and NEA (and one other, I forget the designation) are huge - bigger that BP and BT, for example.

Depends how one makes the comparision. If you're going to pick the 3 of the biggest unions and compare them to one large industry (BP) and one relatively small industry group (BT), you might be right.

The broadest classification of political donors separates them into business, labor, or ideological interests. Whatever slice you look at, business interests dominate, with an overall advantage over organized labor of about 15-to-1.

From: Business-Labor-Ideology Split in PAC & Individual Donations to Candidates, Parties Super PACs and Outside Spending Groups | OpenSecrets

 

[Sirius]

It is a Shame when the R vs D things gets Applied. And I wish there were some Proponents and Detractors on BOTH sides of this one.

But it does seem like One Party seems to be Spearheading a Squash e-Cigarettes ASAP Campaign. And the Other Party Seems to be More for seeing what the Studies/Science says.

Does that surprise you zoiDman? In these days and times with all the political correctness, thought police, nanny state BS we have to put up with now. Sports figures have to go to complete educational training,(re-education camp, north of Ho Chi Minh City) for a Tweet!
This is America damn it! I'm tired of all this, "we know what's good for you citizen so shaddup and comply." And if people don't stand together on something the government WILL take it away from us. We need a game plan and a good one FAST! And stick together on it.
OK rant over..sorry.

 

[PepperMonkey]

That's been the dominate view for a long time. Gov't has to 'save the child' from their parents. The 'seed' of that thinking - progressivism - goes back to at least 1913.

Indeed. Let's not forget that progressive thought was responsible for quite a lot of very hard censorship during WWI, prohibition, endorsement of eugenics practices (later including the Tuskegee syphilis experiments at the end of the progressive era), indeed the FDA itself (which in response to food safety concerns granted legitimacy to the large meatpackers while wiping out thousands of local butchers overnight), and many other overtly coercive practices. From the people who I know quite well, the intentions are good, and genuinely sincere. But you know what can be said about good intentions, and sincerity can change in an instant.

That said, I think some FDA regulation would be quite good. Think in terms of the Goldilocks principle. From my talks with the guys at the vape shops, they want some sort of official approval, some patina of genuine legitimacy. Something like FDA approval is a heuristic device, a mental shortcut for people that says "This is OK"; we all use them. The point is that if some sort of official approval will encourage more vapers, which then means an expanded market, more innovation, and likely a lot of other benefits that are impossible to foresee. This of course in concert with dramatic improvements in public health - but through the market mechanism, please.

 

[Roger_Lafayette]

I'd like to suggest that focusing on flavors or combustible versus non-combustible is a mistake.

That's not how the statute is written. The FDA only has limited authority to make general pronouncements about all the products that fit a given description, although it has to regulate cigarettes differently from others, and can set up different rules for different delivery systems (gels versus cigars for example, or even premium cigars versus litle cigars).

Also, the FDA can't even consider approved therapies in some kind of public health balancing act. (In other words: if approved medical therapies such as Chantix or the patch killed every user, that would not have any bearing on how the FDA treats products under the tobacco act - the FSPTCA.)

Within products that fit a given class, the FDA can only approve or reject individual applications. And each application has to be individually supported by public health evidence for that particular product, whether that product is a 10 ml. bottle of 30% PG and 70% VG 2% nic. unflavored juice that's manufactured in a particular way, or a trippy tip that has this specific size, shape and color pattern.

Every particular juice (down to size/flavor/composition/etc. combinations) and every piece of hardware (down to the color, size, and composition of separately sold drip tips) will be treated as a separate new type of tobacco cigarette under the deeming regulations, and will be judged on its own merits with regards to its effect on public health.

So, for exampe, it's theretically possible that the FDA might conclude that one drip tip which happens to be black is okay based on the public health studies for that drip tip, but an identical drip tip made by the same manufacturer is not approved because it's made in a color which might attract children, based on the health data.

(That's an absurd hypothetical, because no one is going to do health effect studies on different colors of drip tips. But that's exactly what the statute requires for two types of tobacco cigarettes. Marlboro lights 100s are not the same as Marlboro liights kings. And the FDA has no power to make broad statements about 100s versus king-sized.)

And this is all provided, of course, that the applications are submitted - and have the required public health data.

If the applications aren't submitted, then the products will be illegal after the 2-year window closes. In fact, if they aren't registered within approx six months after the proposed rule becomes final, they'll also have to be pulled from the market.

So let's not be seduced by the general language in which these topics were discussed at this hearing. The FDA must operate according to the tobacco act (FSPTCA).

 

[Roger_Lafayette]

<snip>
That said, I think some FDA regulation would be quite good. Think in terms of the Goldilocks principle. From my talks with the guys at the vape shops, they want some sort of official approval, some patina of genuine legitimacy. Something like FDA approval is a heuristic device, a mental shortcut for people that says "This is OK"; we all use them. The point is that if some sort of official approval will encourage more vapers, which then means an expanded market, more innovation, and likely a lot of other benefits that are impossible to foresee. This of course in concert with dramatic improvements in public health - but through the market mechanism, please.

Vapers are not in a position to pick and choose what sort of regulatory framework will be used.

The FSPTCA is already there. You can't redesign it from scratch. Congress passed the law in 2009. It establishes very stringent standards for all tobacco products introduced after Feb '07.

This is not a negotiation.

 

[pamdis]

That said, I think some FDA regulation would be quite good. Think in terms of the Goldilocks principle. From my talks with the guys at the vape shops, they want some sort of official approval, some patina of genuine legitimacy. Something like FDA approval is a heuristic device, a mental shortcut for people that says "This is OK"; we all use them. The point is that if some sort of official approval will encourage more vapers, which then means an expanded market, more innovation, and likely a lot of other benefits that are impossible to foresee. This of course in concert with dramatic improvements in public health - but through the market mechanism, please.

Just remember: FDA regulation does not equal FDA approval.

Cigarettes are not FDA approved, although they are FDA regulated. And e-cigarettes will not be FDA approved either. After regulation is final, we will see FDA and CDC continue to demonize them the same way they do now. Nothing will change in that respect.

 

[PepperMonkey]

This is not a negotiation.

Thx Rog, and please pardon my ignorance. I understand the point more clearly now.

 

[Sirius]

Just remember: FDA regulation does not equal FDA approval.

Cigarettes are not FDA approved, although they are FDA regulated. And e-cigarettes will not be FDA approved either. After regulation is final, we will see FDA and CDC continue to demonize them the same way they do now. Nothing will change in that respect.

And the FDA does not write laws. They just regulate the existing laws. Good point.

 

[DeeLeeKay]

Here is my comment on Harkins facebook page.

I am 56 years old. I started smoking when I was 12. 3 1/2 years ago I found APV's(advanced personal vaporizers, i.e. electronic cigarettes) and never looked back.

On January 20 2011 I had my last combustible tobacco product. My entire family, two daughters, one son, and two son-in-laws have all quit using combustible tobacco. We are a family of vapers now, not smokers. We use all different types of flavors. Swedish fish, blueberry, banana creme, watermelon, and many other flavors. We are all adults my youngest child is 30 years old. We all love candy and candy flavors as well as fruit flavors. Do not take away our ability to chose flavors that appeal to us.

The FDA's intent to use the February 2007 date for grandfathering in APV devices would decimate the industry as it stands to day. We all know that the APV industry is relatively new and a later grandfather clause would help a great deal in keeping millions of people off of combustible tobacco products.

Prior to February 2007 the only APV's on the market were small cig-a-like products that did very little in terms of keeping people off of combustable tobacco products. It has been the amazing advances in the last few years that have created the devices on the market today that have helped millions switch from combustible tobacco to a smoke-free, healthier alternative.


I urge you and all of our elected representatives to tell the FDA to use a later grandfather date in their "deeming regulations".

Thank You,
Donna

 

[Traver]

For those of us who are using bottled juice.
We are vaping food flavorings diluted in pg/vg with the addition of nicotine. I don't see how they can ban diluted food flavoring. The nicotine we use is derived from tobacco but there is synthetic nicotine. So is there any reason why vendors couldn't switch to synthetic?

 

[zoiDman]

And the FDA does not write laws. They just regulate the existing laws. Good point.

I think this is Lost on Many People.

It is Also why I believe Mr. Zeller Repeatedly Reminded Harkin that the FDA was a Regulatory Body.

Which, to me, was a Subtle way of Saying... "Hey don't Whine at me If you Don't like the Law. We Didn't Make them. You Did."

 

[zoiDman]

For those of us who are using bottled juice.
We are vaping food flavorings diluted in pg/vg with the addition of nicotine. I don't see how they can ban diluted food flavoring. The nicotine we use is derived from tobacco but there is synthetic nicotine. So is there any reason why vendors couldn't switch to synthetic?

Two Words:

"Extreme Cost"

 

[zoiDman]

BTW - Here is an article regarding FDA Funded e-Cigarette research.

DURHAM: Triangle research will help guide new e-cigarette regulations | Local/State | NewsObserver.com

 

[Traver]

Two Words:

"Extreme Cost"

and

"Doesn't Matter"

Considering the low amounts we use what would the cost actually be?

Why doesn't it matter?

 

[Dave_in_OK]

One of the FDA's comments really got me "THE COMMENT PERIOD IS THE PUBLIC'S OPPORTUNITY TO THINK OF ADDITIONAL THINGS WE SHOULD BE DOING." at about (at 53:47)