FDA Post-hearing reactions?

[Fitzie]

Just a Quick Question Jman.

Does the FDA answer to or have to take Directions from Congress?

The FDA is part of the Executive Branch. As the President is the head of the Executive Branch, he's their "boss."

However, Congress can exercise oversight over federal agencies. Per Wikipedia:

"If Congress believes that an agency has drifted from its original mandate, Congress can respond in a number of ways. Congress can pass a law to overrule agency decisions, or to narrow the agency's jurisdiction. Congress can use its appropriations power to restrict the agency's funding. Congress can also narrow the agency's regulatory authority. For example, in the 1980s Congress narrowed the U.S. Environmental Protection Agency's regulatory discretion using detailed substantive criteria to limit EPA rulemaking."

 

[zoiDman]

The FDA is part of the Executive Branch. As the President is the head of the Executive Branch, he's their "boss."

However, Congress can exercise oversight over federal agencies. Per Wikipedia:

"If Congress believes that an agency has drifted from its original mandate, Congress can respond in a number of ways. Congress can pass a law to overrule agency decisions, or to narrow the agency's jurisdiction. Congress can use its appropriations power to restrict the agency's funding. Congress can also narrow the agency's regulatory authority. For example, in the 1980s Congress narrowed the U.S. Environmental Protection Agency's regulatory discretion using detailed substantive criteria to limit EPA rulemaking."

That is How I understood it.

The FDA is an Agency of the Health and Human Services Department. And the Commissioner of Food and Drugs takes Direction from the Health and Human Services Commissioner. And the Health and Human Services Commissioner answers Directly to the Office of the President.

Where as Congress can use Withheld Funding as a Leverage Tool. And in an Extreme and Very Rare Case can Pass a Law to Overrule the rda, that isn't Likely.

 

[aikanae1]

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.

During the hearing, Zeller said that "NICOTINE WAS A DRUG". That left me with little doubt that nicotine will be removed from the market for DIY.

 

[zoiDman]

During the hearing, Zeller said that "NICOTINE WAS A DRUG". That left me with little doubt that nicotine will be removed from the market for DIY.

Unfortunately, I believe this is a Very Realistic Possibility.

What I wonder is Can/Will the FDA do it Immediately After they have the Authority to do so?

 

[Jman8]

There's another group that might use that.

The Borg?

....

 

[Bob Chill]

During the hearing, Zeller said that "NICOTINE WAS A DRUG". That left me with little doubt that nicotine will be removed from the market for DIY.

I could bitterly and reluctantly live with unflavored at a maximum strength of something like 36mg/ml. High test will be gone except for licensed manufacturers. I'm pretty certain of that. If bottles of low test unflavored are taken away then it's a knockout punch of sorts.

Nicotine is a drug but luckily a pretty benign one. I always laugh with all the talk about how incredibly addicting nicotine is. If that was the case, kids would have backpacks full of nicorette and it would be widely abused from coast to coast. It's easier to get than beer. But for some reason the most addicting and evil otc drug in the world draws no attention from anyone. Nobody cares about it. Not kids. Not Parents. Nobody. Until you inhale it of course. It seems so silly when you think about it.

 

[Jman8]

Where as Congress can use Withheld Funding as a Leverage Tool. And in an Extreme and Very Rare Case can Pass a Law to Overrule the RDA, that isn't Likely.

There is no path forward for vaping side that one can say is "likely." It is not likely that we will get an extension, but it is worth pursuing.

It is worth pursuing congressional authority, who's been on top of this issue far longer than FDA has, to address fair and reasonable regulations for FDA proposal to regulate eCigs. Burr's comments in the hearing yesterday, where he was very much outnumbered, show it to be worthwhile to explore this through congressional authority and to push for this BECAUSE the regulation that would potentially impact small businesses dramatically, and thus influence American's right to choose legal use of products, is ENTIRELY unreasonable. If you read FDA's documents, it shows that they know this, but they don't believe they have the authority to change it.

Great. You are no longer needed, FDA, at this juncture. Please go sit over there in the corner while the adults negotiate this mess going forward.

 

[Traver]

Jman8 said.

We are CLEARLY in a negotiation phase.

Yes but we as vapors have almost no influence in that processes.

This is the way I see it.
I think it is more a matter of the FDA negotiating between the demands of the the president, congress, the drug companies and their antismoking allies, the tabacco companies and the law.

The tobacco and drug companies influence both congress and the president by funding political campaigns.

The drug companies want vaping banned. The tobacco companies are in the business of selling e-cigs and want bottled juice banned. The money is in the juice so they want to be the only ones with regulatory approval to sell cartos and juice. They can do this with regulations that make the buy in price prohibitive to smaller vendors.

We as vapors have a very small but rapidly growing influence as voters.

 

[Kent C]

The Borg?

....

Not what I was thinking but that fits.

 

[zoiDman]

Yes but we as vapors have almost no influence in that processes.

...

Has Anyone Discussed submitting Written Documents to TPSAC?

April 16-18, 2014: Written Submissions from the Public

Not sure if this is Viable or has been Brought Up already.

 

[zoiDman]

There is no path forward for vaping side that one can say is "likely." It is not likely that we will get an extension, but it is worth pursuing.

It is worth pursuing congressional authority, who's been on top of this issue far longer than FDA has, to address fair and reasonable regulations for FDA proposal to regulate eCigs. Burr's comments in the hearing yesterday, where he was very much outnumbered, show it to be worthwhile to explore this through congressional authority and to push for this BECAUSE the regulation that would potentially impact small businesses dramatically, and thus influence American's right to choose legal use of products, is ENTIRELY unreasonable. If you read FDA's documents, it shows that they know this, but they don't believe they have the authority to change it.

Great. You are no longer needed, FDA, at this juncture. Please go sit over there in the corner while the adults negotiate this mess going forward.

Congress is Going to Be Involved. What does Congress Not Want to be Involved in and Influence?

But some people Approached me Last Night with the Belief that Congress is going to "Order" the FDA to do Something. And that is a Misconception that I think Many People have.

I also think it is Why Mr. Zeller looked at Times kinda Disgusted with the Tone and Comments of Harkin.

I can Almost hear his Thinking... "Back Off Man. Your Not my Boss. We Don't Answer to you on All Things.".

LOL

 

[toddkuen]

Apparently the FDA Center for Tobacco Products (CTP of which Zeller heads) will meet with small business and just about anyone else in person that follows their guidelines of not asking about things like pending litigation.

See this link: For Industry: How to Contact Us or Request a Meeting

It also encourages people to show up at TPSAC.

In fact it says that the CTP has "... many informal and formal communications channels we encourage you to use to express your views, submit data, and ask questions."

Is anybody making use of them?

 

[zoiDman]

Apparently the FDA Center for Tobacco Products (CTP of which Zeller heads) will meet with small business and just about anyone else in person that follows their guidelines of not asking about things like pending litigation.

See this link: For Industry: How to Contact Us or Request a Meeting

It also encourages people to show up at TPSAC.

In fact it says that the CTP has "... many informal and formal communications channels we encourage you to use to express your views, submit data, and ask questions."

Is anybody making use of them?

This is Why I mention it.

That, and Mr. Zeller made a Point to say that TPSAC would play a Major Role going forward.

(Not sure How Much of this is True? But he Did Mention it.)

 

[Jman8]

Yes but we as vapors have almost no influence in that processes.

This is the way I see it.
I think it is more a matter of the FDA negotiating between the demands of the the president, congress, the drug companies and their antismoking allies, the tabacco companies and the law.

The tobacco and drug companies influence both congress and the president by funding political campaigns.

The drug companies want vaping banned. The tobacco companies are in the business of selling e-cigs and want bottled juice banned. The money is in the juice so they want to be the only ones with regulatory approval to sell cartos and juice. They can do this with regulations that make the buy in price prohibitive to smaller vendors.

We as vapors have a very small but rapidly growing influence as voters.

I do relate to what you are saying here, but I think our influence is actually the greatest of them all. In the way politics is often discussed so that we can grasp large segments of populations and data, it is easy to dismiss the influence of individual citizens. Super duper easy.

Which is why when a poster comes to ECF and says CASAA has zero chance of influencing FDA regulations, this ought not to be treated as anything other than getting at what you are getting across.

But, I think, and also believe that many politically aware vapers think, that we do influence this process and at times sway the direction. Local bans would be prime example. But at federal level, we could organize that energy we put into local bans and find allies that have authority to change proposals and/or sway how Congress will frame the debate. And how that debate is framed, at this particular juncture, matters significantly going forward. What I saw in hearing yesterday is Burr representing pro-vaping/harm reduction and Harkin representing ANTZ. These two are likely more politically aware of eCigs than their counterparts, but right about now, their counterparts are catching up. Still not a super high priority in scheme of things, but also still time (from their perspective) to slow down and consider a few things before an actual debate in congress occurs.

Politically aware vapers can likely exercise more influence on behalf of some vendors than those vendors themselves. The kind of vendor that isn't likely to pay an attorney umpteen thousand dollars to be heard and considered going forward.

Politically aware vapers can sway a whole bunch of non-vapers in understanding this issue beyond sound bites. Many of us already do this, and will continue to do this, especially at this juncture. All of what you mentioned will only focus on sound bites to sway influence.

And politically aware vapers, along with group like CASAA can sway how federal/national politicians understand the issue. Not just from perspective of "vaping saved my life," but also from perspective of, "do you really want to be on side that sought to kill small businesses?"

 

[Roger_Lafayette]

Perhaps no one has performed the research that you have. (Or not.)

Certainly, no one here has claimed that they have out-done entire nations with their software and/or "disruptive" approaches to technology (that's a rather sloppy mishmashed paraphrase of some of your posts, please forgive me if I've erred).

Here's your chance to prove that you've got what it takes to lead this movement, by showing that you can prove the "experts" wrong, yet again - this time with your "disruptive" approach to regulation - by producing some game-changing results that no one can question.

You could fix this whole thing in a meeting or two, perhaps.

Your wife is a stakeholder, she runs a vape shop, right? So you have an interest.

Give 'em a call. Set up a meeting. Show us who's boss!

Good luck.

P.S.: For anyone who has not yet seen it, here's the rule making process:
http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf
As part of the process, CASAA is suggesting that vapers submit comments and has explained its reasons for asking for specific types of comments at particular points in the process here:
CASAA: First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

Apparently the FDA Center for Tobacco Products (CTP of which Zeller heads) will meet with small business and just about anyone else in person that follows their guidelines of not asking about things like pending litigation.

See this link: For Industry: How to Contact Us or Request a Meeting

It also encourages people to show up at TPSAC.

In fact it says that the CTP has "... many informal and formal communications channels we encourage you to use to express your views, submit data, and ask questions."

Is anybody making use of them?

 

[DaveP]

I'm patiently waiting for the transcript of yesterday's hearing to be released.

Nicotine being controlled through the pharma route would be a little like prohibition in the 20's. It would be available for sale on the grey market, but probably derived from questionable sources and with questionable purity without the FDA's approval. Nicotine is available in industrial brands for pesticides and other uses. I wouldn't want to have to worry that my DIY nic was some nasty concoction that I wouldn't want to ingest or inhale. I want at least USP pharma grade.

I don't think the FDA wants ecig users to revert to tobacco to get their nicotine, but I'm thinking that they are going to devise a way to control production and determine purity in the juices that are sold commercially. That's not necessarily a bad thing. We all want to know that the juice we vape is clean and pure and contains only what is listed on the label. We also don't want FDA control to add 100% premium or more to the price. If I had to pay $50 or more for a 15ml bottle of juice, I'd start weaning myself down from 11mg nic to 0 and vape only PG, VG and flavorings in my own DIY juice.

Of course, I don't want to do that. I'm one who believes that a little nic is good for the mental processes just as a little caffeine is good for starting off the day. If that weren't true, doctors wouldn't be prescribing nicotine patches for the elderly for just that reason.

 

[Dave_in_OK]

I think it's time we remember this is the ECF we're on the same side and although we may disagree no ones is worth more than Of course this is Just my

 

[irwink]

Both Dems and Reps are not who they were in the 60's that's for damn sure.

I'll second that for damn sure. I'm approaching age 61. I've seen this government slowly slip away from the control of the citizens. Now all politicians care about is funding for their next election campaign and that of their respective parties. Both R's & D's are equally guilty. D's want a nanny state. R's want a police state with the imposition of their vision of medieval morals. Both disgust me. Both serve their financial masters and their absolute lowest priority is the welfare of the nation and its citizens.

We Americans still at the very least give lip service to the Declaration of Independence. An excerpt of that document:

Governments are instituted among Men, deriving their just powers from the consent of the governed, --That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. Prudence, indeed, will dictate that Governments long established should not be changed for light and transient causes; and accordingly all experience hath shewn, that mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed. But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security.--Such has been the patient sufferance of these Colonies; and such is now the necessity which constrains them to alter their former Systems of Government.

 

[Traver]

deleted double post see below.

 

[Traver]

Jman8, I see you as one of the voices of reason on this forum and I agree with almost everything you said. Still don't think FDA isn't going to pay much attention to us now in this processes. In no way is that the same thing as believing that we shouldn't put up a fight.
Everything we do even just vaping on the street helps to convince the public that vaping should at least be acceptable. Numbers do matter in this game. We may not have enough political capital at this time to change this processes but I think that there are congressman who are beginning to pay attention. At the rate we are growing they had better start paying attention to us.
It isn't just the number of vapors but family friends and every one else that we convince. We are also passionate about vaping and willing to fight for it. That also counts a lot.

I do relate to what you are saying here, but I think our influence is actually the greatest of them all. In the way politics is often discussed so that we can grasp large segments of populations and data, it is easy to dismiss the influence of individual citizens. Super duper easy.

Which is why when a poster comes to ECF and says CASAA has zero chance of influencing FDA regulations, this ought not to be treated as anything other than getting at what you are getting across.

But, I think, and also believe that many politically aware vapers think, that we do influence this process and at times sway the direction. Local bans would be prime example. But at federal level, we could organize that energy we put into local bans and find allies that have authority to change proposals and/or sway how Congress will frame the debate. And how that debate is framed, at this particular juncture, matters significantly going forward. What I saw in hearing yesterday is Burr representing pro-vaping/harm reduction and Harkin representing ANTZ. These two are likely more politically aware of eCigs than their counterparts, but right about now, their counterparts are catching up. Still not a super high priority in scheme of things, but also still time (from their perspective) to slow down and consider a few things before an actual debate in congress occurs.

Politically aware vapers can likely exercise more influence on behalf of some vendors than those vendors themselves. The kind of vendor that isn't likely to pay an attorney umpteen thousand dollars to be heard and considered going forward.

Politically aware vapers can sway a whole bunch of non-vapers in understanding this issue beyond sound bites. Many of us already do this, and will continue to do this, especially at this juncture. All of what you mentioned will only focus on sound bites to sway influence.

And politically aware vapers, along with group like CASAA can sway how federal/national politicians understand the issue. Not just from perspective of "vaping saved my life," but also from perspective of, "do you really want to be on side that sought to kill small businesses?"