FDA Congress can stop this thing?

[Jman8]

I ask this question for a few reasons.

Mainly cause I think it makes for very interesting discussion. It removes all that FDA and really ANTZ is up to with regard to (current proposed) regulations. Just double checked the "misconceptions" thread and this isn't specifically addressed, so we ought to be good on that front.

Also because of what I just read on another thread, which I didn't feel like hijacking for this sort of discussion, and didn't see a thread on p.1 of all posts in "FDA Regulations" sub-forum that is making this topic front and center. The other thread is the one dealing with big (and wonderful) news from scientists to WHO. In there, post #10 reads (in part):

a change in the majority in the US senate would almost assuredly stop the FDA's Deeming Regulations

I'd like to have that explained. Pretty sure anyone can do so, but the "almost assuredly stop" language is of high interest. I think anyone reading this thread (the one you are reading now) would readily conclude "well theoretically they can," followed by, "the questions is if they will?" According to this quote, it is nearly guaranteed.

And third reason is because I think while we are in waiting period from CASAA on guidance for how to respond to FDA Regulations, then I think this discussion is good. If for no other reason then it offers hope and new way to mobilize, which I currently feel is being downplayed on ECF. Not ignored as the quote above is about the 8th time I've read something similar to that sentiment from various posters, including myself.

If we are all so certain that FDA can't be moved from the current proposed framework, then I often wonder why we would spend our entire time discussing what to do with regards to FDA, when we could, rather easily go over their head and deal directly with those who wrote FSPTCA, and who do give marching orders to FDA. Clearly our opposition is doing this (asking Dem Senators to urge FDA to not extend comments, not delay on imposing harsh regulations).

Inherent in the quote from above is idea that constantly occurs to me which is Congress that wrote FSCPTA is not the same Congress today, and likely won't be same Congress in say December 2014. That quote is saying a new Congress likely will undo what Congress in 2009 felt was best course of action.

Finally, I know of no way to not make this type of thread bring up partisan politics. But do request that people not make this about Obama and all other instances of his agenda that do not pertain to FSPTCA. Please don't bash those who chime in and wish to express that Dems could do something about this, especially if they cite reasons for that assertion. While I see no way around the partisan stuff, I do see ways in which this thread doesn't need to be heated / obnoxiously partisan. Thread is truly about what Congress could do to legitimately change the proposed regulations.

If using this thread simply to beat up on Dems and/or Obama, please take that Outside. As OP, I may agree with general political ideas that are being presented, but if ignoring what I wrote here in OP, I may just ask moderator to remove it from the discussion. I'll leave moderators to determine if it is type of comment that is better made Outside rather than here in Reality.

 

[DeeLeeKay]

I, really think that Congress does need to address this. The tobacco act was created to discourage new tobacco products. The tobacco act does not address "reduced harm products" and how to encourage their development. To regulate electronic cigarettes as a traditional tobacco product is a travesty in many ways. It will stifle future development in helping more and more people to get what they need in a "reduced harm product".

There also needs to be a serious national dialogue about what nicotine does and why people will choose to smoke despite the grave health outcomes. Which is why "reduced harm products" are a continuation of controlling tobacco. The next step if you will to see a tobacco free society, rather then a nicotine free society.

 

[Vocalek]

Section 911 of the Tobacco Control Act addresses Modified Risk Tobacco Products. https://www.govtrack.us/congress/bills/111/hr1256/text

The devil is in the details, however. The Guidance that the FDA issued for MRTPs (http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf) calls for the submitter to have a crystal ball.

In determining whether it can issue an order under section 911(g) of the FD&C Act for an MRTP, FDA must assess whether the applicant has demonstrated that the product will or is expected to benefit the health of individuals and the population as a whole. In order for an applicant to demonstrate that its product meets the criteria for issuance of an order under section 911(g) of the FD&C Act, the applicant’s MRTPA should address the following key areas of investigation:

• Health risks of the tobacco product;
• The effect the tobacco product and its marketing may have on tobacco use behavior among current tobacco users;
• The effect the tobacco product and its marketing may have on tobacco use initiation among non-users (both never users and former users);
• The effect of the tobacco product’s marketing on consumer understanding and perceptions; and
• The effect the tobacco product and its marketing may have on the population as a whole

Gaining approval has been estimated to cost a boatload of money.

FDA expects that the applicant will include, among other things, as part of its submission of relevant documents:
• Study reports,
• Study protocols, and
• Raw data (in electronic format, where available, with instructions about its use).
If any of this information is not available, applicants should provide an explanation for the omission.

In order to assure the quality and integrity of the data from studies and analyses relied on or referenced in an MRTPA, the studies or analyses should, as applicable:
• Be conducted in laboratories accredited by a nationally or internationally recognized external accreditation organization;
• Use appropriate animal models and adhere to the best practices of refinement, reduction, and replacement of animals in research and to applicable laws, regulations, and policies governing animal testing, for example, the Animal Welfare Act (7 U.S.C. 2131 et seq.) and the Public Health Service Policy of Humane Care and Use of Laboratory Animals (available at http://grants.nih.gov/grants/olaw/references/phspol.htm);
• Implement good laboratory practices, for example, as specified in 21 CFR Part 58;
• Be conducted by qualified and appropriately trained investigators;
• Accurately account for and document the receipt, use, and disposition of all investigational product(s);
• Ensure the protection of human subjects by, for example:

o Implementing procedures for informed consent, such as those found in 21 CFR Part 50, and
o Ensuring study oversight by an Institutional Review Board, governed by 21 CFR Part 56.​

• Be conducted in accordance with study protocols and implementation procedures that ensure that all study subjects receiving tobacco products are current daily tobacco product users at least 21 years of age.

At one FDA meeting I asked whether a blanket approval of a class of products could be given for MRTP status (e.g., all snus products) and was told that each manufacturer and each product requires a separate application.

 

[NorthOfAtlanta]

Why not go for broke? If we are going to go to congress lets try and get them moved from under FSPTCA altogether.

Most of the problems are created by trying to fit vapor products into a law that was designed to stop smoking, a known killer.

While I hate to turn on the sausage grinder in DC, if vapor products were a separate category they could be handled under their own laws and rules. They need to be separated from cumbustable tobacco products.

 

[DeeLeeKay]

The question is how does that differ between "reduced harm" and traditional tobacco products? They say one thing but mean something else. It stifles innovation.

 

[DrMA]

I think that's a great idea, NoA. Since ecigs are clearly NOT a tobacco product, why can't they be regulated like generic electronics, or nutritional supplements.

For example, how do you think they would regulate a product that is a coffee mug with a built in MP3 player?

 

[Bobbilly]

I agree that this issue is too great for a unelected regulatory body to handle. Like most bureaucracy they have to use what they have to control vaporizers of it doesn't fit, word it in a way it does. They won't take notice until some elected officials start poking

 

[stevegmu]

Congress has the power of the purse and investigation, so yes, they can stop the FDA. It is a matter of finding a champion for the cause...

 

[CabinetGuyScott]

Does the Achieving appropriate regulations for electronic cigarettes piece offer some ideas to incorporate into / build off of, for a congressional campaign?

Btw, huge KUDOS to JMan for initiating this line of discussion!!!

We all need to embrace his guidelines regarding the political aspects that are inherent to the topic.

 

[Jman8]

Congress has the power of the purse and investigation, so yes, they can stop the FDA. It is a matter of finding a champion for the cause...

I nominate Senator Burr.

Can we get a second to the motion?

 

[aubergine]

Senator Burr is in the hotseat at the moment and might be loathe to take on another controversy, but yeah, he's on our side, if somewhat tepidly.
What I'm not clear on is how and at what point might Congress realistically get involved? What are the actual mechanics here?

 

[DJLEC]

Great Post and Thank You for taking the time to write this.

New to Vaping but I have always been puzzled why a defacto ban when some States are chomping at the bit for your Tax Dollars.

They would love it if your 30 ML Bottle cost the same as a Carton of Analogs.


Sent from my iPhone using Tapatalk

 

[Talyon]

Congress has the power of the purse and investigation, so yes, they can stop the FDA. It is a matter of finding a champion for the cause...

Perhaps Paying would be more appropriate, isn't that the way it's done?

 

[Kent C]

Inherent in the quote from above is idea that constantly occurs to me which is Congress that wrote FSCPTA is not the same Congress today, and likely won't be same Congress in say December 2014. That quote is saying a new Congress likely will undo what Congress in 2009 felt was best course of action.

There are many, including the current Prez (now for almost 6 years) who blame the financial meltdown in 2009 on "8 years of Republican rule". Yet the 110th (January 4, 2007-January 3, 2009) had Democrat majorities in both Houses for the last 2 years of the Bush presidency.

I point this out because the current 'grandfather date' that is used is from Feb. 15, 2007 - so it didn't take then Chairman Rep. Waxman long to introduce one bill (HR1108) on the Family Smoking Prevention and Tobacco Control Act.

And yet, wiki reports that the actual Act was HR1268...

Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia

"The bill passed the United States House of Representatives on April 2, 2009, by a vote of 298 to 112"
"The Capitol Hill newspaper The Hill reported on May 25, 2009, that Senate Majority Leader Reid planned to move on the bill during the month of June 2009; however it noted that Senators Burr (R) and Hagan(D and the only D) of North Carolina were proposing alternative legislation.[6]

On June 2, the Senate voted 84-11 to proceed to consideration of the House bill."

Now in both Houses the Democrats had the majority of 'yes' votes but there were Republicans in both Houses who voted for the bill, and only one Democrat in the Senate, Kagan, who voted against it. If you have any information on who's who, you may know of what I speak, and while "RINO" is overused, many of those are the Repubs who voted for the bill (with exceptions). I happen to know that many of the Club for Growth candidates (libertarian leaning Repubs) voted against the bill in the House and the Senate (with few exceptions). Those looking for candidates that support reduced regulation, taxes and growth in industry rather the growth in gov't ought to look at Club for Growth - it's not the tea party or the 'religious right' although there is some crossover, but the emphasis is anti-regulation, anti-tax and growth in business and hence jobs.

The bill was signed into law by Barrack Obama on June 22, 2009.

This was asked earlier in the economic impact thread, 'why was Feb. 15, 2007 the grandfather date?' And I found that this is when Waxman introduced the HR 1106 bill into the House. But why is that significant? Because, again, the bill stated in wiki as the final bill (I'm supposing the 1106 bill was amended or changed in some manner to get) HR1256 (also introduced by Waxman, btw). Why not use the introduction date of that bill - 3/3/2009? Or better yet, how about the date it actually became LAW - June 22, 2009?

I did a search on 'effective date of legislation' and most of what I found were references of 'when the bill was enacted into law'. One thing also brought up in the 'impact thread' was the idea of ex post facto laws - where someone is now a criminal because a law was passed after the fact of their 'crime' when the actions were not against the law before that date. Ex post facto laws are unconstitutional. And while this isn't exactly an 'ex post facto' situation - no one will go to jail - it does border on it. Bill G and others have commented that on Feb 15, 2007, there was likely no thought whatsoever about ecigarettes when this bill was introduced by Waxman. Yet that date is quite 'operative' in that there are little or no predicate products for ecigs that were manufactured in the US at that time. I think this 'date' should be questioned, (in the comment period) about why that was used rather than the date the bill actually became law, AND that it was another bill HR1106, not the actual bill HR1256 (and the senate equivalent) that DID become law.

The other obvious question should be, imo, why not use the final rule (when this 'proposed rule' is no longer 'proposed') as the grandfather date, as has been offered in the 'impact doc' from the FDA and upon which they 'request comments' on, just as they do in the deeming doc. Using the 'final rule' date makes sense on so many levels. First, nothing is 'in force' until the 'final rule' and secondly, everyone after that date then knows with what they'd have to comply. And it doesn't 'punish' retroactively, those vendors (and consumers) who have been developing their businesses (and saving their lives) on products that are in demand now, and have foreseen in the past the direction of the industry and have made significant investments to accommodate the evolution that has occurred in the industry since it's inception. IOW, they've practiced within a free market rather well and if now, they are going to be regulated, then don't punish them for what they've done and invested in the past. If regulation is from the 'final rule,' forward, they'll learn to adjust to that!

 

[OCD]

I got to thinking about the numbers the other day of smoking related deaths in the US which is reported as close to half a million a year.

There are 525,000 minutes in a year, kind of struck me how close these numbers are. I thought it relevant that one could then use the argument that just about every minute someone in the US dies due to a smoking related illness. This is something that probably should be kept in the forefront of our thoughts when addressing those who would limit or delay the adoption of vaping as a reduced harm alternative, even hesitating for a minute is a tragedy.

 

[the_vape_nerd]

The FDA and really all federal agencies are creatures of the legislature. They were created by legislative act, in essence to do things that the Congress itself cannot get bogged down in. So, I certainly do agree that appeals to the Congress are better than appeals to the FDA itself.

Can someone tell me why it is a "certainty" that if we had a majority change in the Congress, that the deeming and eventual other regs would be stopped?

 

[Myrany]

IF I understood what Bill Godshall was saying right in the video that came out right after the proposed deeming was released (sorry I am playing heck finding it atm). Then the logic went something along the lines of if we can get the comment period extended and things pushed back past the elections in the fall AND the balance of power changes, THEN it is likely the legislative focus will change as the current administration will have to pick and choose what it wants to get passed rather than passing anything it wants.

Yeah I know that was a mess of run on sentences but there are alot of ifs and steps that need to happen. Basically the President will have to be choosy in what he pushes for since getting anything through will be a tough fight and regulation of eCigs just isn't that important in the grand scheme of things.

I got the impression that if that happened it was possible the whole thing would just fizzle if not permanently then certainly for years.

 

[Jman8]

The other obvious question should be, imo, why not use the final rule (when this 'proposed rule' is no longer 'proposed') as the grandfather date, as has been offered in the 'impact doc' from the FDA and upon which they 'request comments' on, just as they do in the deeming doc. Using the 'final rule' date makes sense on so many levels. First, nothing is 'in force' until the 'final rule' and secondly, everyone after that date then knows with what they'd have to comply. And it doesn't 'punish' retroactively, those vendors (and consumers) who have been developing their businesses (and saving their lives) on products that are in demand now, and have foreseen in the past the direction of the industry and have made significant investments to accommodate the evolution that has occurred in the industry since it's inception. IOW, they've practiced within a free market rather well and if now, they are going to be regulated, then don't punish them for what they've done and invested in the past. If regulation is from the 'final rule,' forward, they'll learn to adjust to that!

(You, Kent, know) I fully agree with this.

In light of this thread, I think we push really hard on "stop the bill" (via Congress) and then act like we are settling for the final rule date as a concession on our part.

Come up with reasonable, well thought through positions for both options and treat the 'stop the bill' campaign as one we really want. Who knows, we may win on that front. But if not, oh well, we'll accept this other option which makes all the sense in the world and allows us to accept that regulations are going to happen.

With 14 million+ products no longer needing to file applications for compliance with FSPTCA.

 

[Kent C]

The FDA and really all federal agencies are creatures of the legislature. They were created by legislative act, in essence to do things that the Congress itself cannot get bogged down in. So, I certainly do agree that appeals to the Congress are better than appeals to the FDA itself.

Can someone tell me why it is a "certainty" that if we had a majority change in the Congress, that the deeming and eventual other regs would be stopped?

There is no such certainty and I don't believe anyone has ever said so. If they did, they're mistaken. What is more probable though, is if Sen. Alexander or Sen. Burr, for example, were the Chairman of the Senate Help committee, there might not have been the urgency to come up with the deeming doc and there may have been alterations of the grandfather date. When the majority side sends letters to the FDA, it means something more to those who have to carry out laws that are made by that body.

 

[nomore stinkies]

Excellent article. Now that made sense.

Does the Achieving appropriate regulations for electronic cigarettes piece offer some ideas to incorporate into / build off of, for a congressional campaign?

Btw, huge KUDOS to JMan for initiating this line of discussion!!!

We all need to embrace his guidelines regarding the political aspects that are inherent to the topic.