FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

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tombaker

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Oct 21, 2013
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So, the OMB is still reviewing the cost/benefits to proposed regulations.

No.

Do you really think if all these horrible fear inducing regulations were put to paper, anywhere by the Government, that there would not be a leak of what they were, as they are being passed from Agency to Agency. You think that the OMB has them in hand, has meetings, and does not even hint to what they are.

The Rule Deeming, that the FDA has the power over E-Cigarettes via the 2009 tobacco Control Act, is in the hands of everyone, including the OMB that has to bless it, a blessing that will happen....then the Deeming Rule (not to be confused with regulations) has to go through all the hoops...which it will. But those hoops could take many more months, and years.

Because its already been 3 years since the Appeals Court said they had to. Tick Tock

After all of this, all of it, then the FDA can use 2009 Law to do only what the 2009 law allows, and it definitely does not allow bans or de facto bans. And it definitely does not allow as CASAA portrays, that banning of Provari could happen.

The only thing on the table is the FDA saying it can regulate under 2009 Act...... nothing more

-----on the other hand----Hayward wants to define under all of its existing Smoking rules, that Vapor is smoke, when it comes from an E-Cig
 

rolygate

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This thread was started to discuss a statutory requirement for the FDA to seek comments on the SE process and how it may affect ecigs. There has been some discussion about the validity of any FDA action against ecigs, or even if they intend to take such action. In the interests of clarity I will make the following points, then close the thread - because the subject has been discussed efficiently and, like many threads, once that has been done it only remains for members to attack each other for their differing opinion.

1. The FDA would ban electronic vaporisers (ecigs) tomorrow if it could so so without opposition. It is the property of and the legal arm of the pharmaceutical industry, and is regarded as the world's best example of a 'regulatory-captured' government agency (please google 'regulatory capture' if you are not familiar with the term). The FDA exists to protect pharmaceutical industry income, at least in any area where there is a conflict between public health and industry income; and it will do so at any cost. Your health is completely and utterly irrelevant to them.

2. Because the FDA cannot ban ecigs outright (it tried), it has been forced to find ways of applying restrictions that will do as much of the job as possible. Initially it is expected that such restrictions will be marginal, in order to avoid court action filed on the basis that harsh restrictions are a repeat of its previous ban attempt. However, this opinion could be wrong - we just don't know.

3. Even if initial restrictions are minor, we can expect that regulations will become more and more strict, in order to tighten the noose. These are their orders, so we can expect nothing else. Ideally, the FDA would like to see a ban on any modern hardware, bottled e-liquid, flavors, and web sales. This would enable a 99.9% ban. Such measures could not be implemented (in total) without an extended timescale and major court actions.

4. It is likely that they will attempt to impose some sort of restrictions, because these might be able to be implemented without too much opposition; so we can expect an initial tranche of legislation that will attempt to exert control over the product area. No one knows what such regulations might include: an all-out war on ecigs; or a very gentle initial implementation, to create a wedge to begin with; or something in the middle.

5. The White House can hold on to the deeming regulation indefinitely if it wishes to. This is illegal from the end of this week; but I've been told (without evidence though) that they have done this before. However, the White House seem, as Democrats in general are, in favor of increased regulation (of everything); they did, after all, put a pharmaceutical industry appointee in charge of the FDA (after extensive evidence that the FDA protects pharma at the expense of public health). We do not know what they will do, but crunch time is coming up fast. If they do hold on to the deeming proposal after this week, it's a good sign that external pressure has been placed on them to hold off doing something they want to do (which is to protect the pharma and tobacco industries, MSA payments to States, and all of the other economic benefits of smoking that no one will admit to).

6. It is impossible that the FDA will not be able to implement some sort of regulations, at some point. Because of what they are, such regulations are extremely unlikely to be favorable to our community and the businesses that support us. Therefore we must expect some restrictions, although we do not know what they will be; and it is virtually certain that once control has been exerted, it will be tightened - and this cannot be to our favor. The ecig trade will need to fight restrictions at some point - this is certain. That costs money - huge amounts of money. The last action against the FDA cost about $500,000. That means it is an attack on our community because those costs are passed on to us.

7. Somebody somewhere needs to oversee the quality of consumer products, especially when those products may be inhaled in large quantity over several decades. To say otherwise is lunacy. Thus the FDA have a role to play here, and are, in the US, the only people who have a statutory Federal right to do so. They do have a right to oversee quality control, and we should support the right of someone to do the job. It may be that there could have been alternatives (that is certainly my view) but now it is too late, and only the FDA can do that job, at this point. Therefore it is not possible to stop them introducing some regulations, although because their mission is to destroy ecigs however it can be achieved, it is simply not sensible to expect them to play fair.

8. The players: you have to pin your hopes on CASAA and Bill Godshall, because they are in the best position to help. People may not be fans but if you are a US vaper, these are your best friends - unless your brother or sister is a Senator and does exactly as you ask.

9. Please be advised that I will personally remove the posts of and/or ban anyone who attacks CASAA or Bill Godshall unreasonably on these matters. You can state your case; but don't over-egg the pudding. If you ever manage to achieve one ten-thousandth of what they have done for us, you will have achieved something notable; but it's extremely unlikely because, for a start, you have shown you don't have a clue about the issues. We tolerate you here because we don't ban stupids as long as they are polite; everyone has an opinion and a forum has to hear it. But: be polite, or be gone.
 
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