FDA FDA Extends Comment Period to Aug 8 - no reason cited in article

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DC2

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Yey! Win #1. Here's to many more!
I am thinking that the FDA almost had to extend the comment period.
I'm not sure I count it as a win that they only extended it by 30 days though.

It's feels like a token "well, yeah, we are trying to be reasonable and so we did extend it" type of move.

And yes, I have become that pessimistic.
 

Kent C

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Thanks, Kent. I hadn't read it. The author seems to believe that the FDA could effectively move the grandfathering date without a statutory amendment. Of course, I'd prefer an extensive statutory amendment because there was no consideration given to e-cigarettes when the statute was written. But it might be impossible to get it through Congress.

Re: bold.... but he writes:

"It does not appear, however, that the FDA has the legal authority to change the grandfather date set forth in the tobacco Control Act for the newly deemed products."

Then...
"Rather, the more likely scenario is that the agency will use its “enforcement discretion” to adjust the requirement for e-cigarettes to prevent the collapse of the market."

I think he may be wrong about that - I'm not so sure they want to prevent the collapse of the market :) But his estimates about how long it would take to do applications and either accept or reject them is likely true. So the market won't collapse immediately and in that interim a lot could happen. Just for example, percentage smokers could drop to 15% or lower. This may have an effect on legislators or even on people within the public health community. More positive studies on ecigs will likely be published (but, so will negative studies occur). Other countries, EU, UK could either 'see the light' or turn off the lights - this could affect what the US does. And maybe most important, vapers get better organized and grow in numbers and put more pressure on Congress or change it's makeup.

And as far as the commenting process is concerned, your "no consideration given to e-cigarettes when the statute was written" is important to emphasize. We've had discussions about that regarding how it is close to an ex post facto aspect, although not technically correct. But it is a 'blind' regulation in that respect and a preemption before all known information is known - by their own words.
 

Kent C

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I am thinking that the FDA almost had to extend the comment period.
I'm not sure I count it as a win that they only extended it by 30 days though.

It's feels like a token "well, yeah, we are trying to be reasonable and so we did extend it" type of move.And yes, I have become that pessimistic.

That was my first thought....
 

DC2

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That was my first thought....
I don't know to what extent "appearing to be reasonable" would count in any legal battles against the FDA.
But I do know that in a lot of legal proceedings I have seen, it is important in the judge's eyes.

My wife, who passed the bar exam but does not practice law, thinks it's more of a PR move.
She isn't so sure that "appearing to be reasonable" is as important in regulatory types of legal actions.

Meh, either way, 30 days seems like a token move to me.
 

Kent C

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I don't know to what extent "appearing to be reasonable" would count in any legal battles against the FDA.
But I do know that in a lot of legal proceedings I have seen, it is important in the judge's eyes.

My wife, who passed the bar exam but does not practice law, thinks it's more of a PR move.
She isn't so sure that "appearing to be reasonable" is as important in regulatory types of legal actions.

Meh, either way, 30 days seems like a token move to me.

After all the comments heard in the committee hearings, I'm thinking the whole impact doc was mainly PR as well - well that, and the fact that they had to do it, but nothing in the impact doc made it to the deeming doc.
 

DC2

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After all the comments heard in the committee hearings, I'm thinking the whole impact doc was mainly PR as well - well that, and the fact that they had to do it, but nothing in the impact doc made it to the deeming doc.
Yes, they definitely had to do it, because it's part of the law that they do so.
But they didn't seem to try very hard in my opinion.

Sorry for my pessimism today.
I'm still upset by the last minute goal by Portugal yesterday.
:(
 

Kent C

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Yes, they definitely had to do it, because it's part of the law that they do so.
But they didn't seem to try very hard in my opinion.

Sorry for my pessimism today.
I'm still upset by the last minute goal by Portugal yesterday.
:(

Portugal has a hockey team? :shock: ... just kidding. I have no interest there but condolences.... ;)
 

NorthOfAtlanta

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I am thinking that the FDA almost had to extend the comment period.
I'm not sure I count it as a win that they only extended it by 30 days though.

It's feels like a token "well, yeah, we are trying to be reasonable and so we did extend it" type of move.

And yes, I have become that pessimistic.

This and it keeps the deeming regulations out of what is a contentious election cycle. They don't want it to become a political football as in general the R's are against more regulation that would affect job creation. They may be making a mistake as the regulation as written could cost 50,000 jobs and the closing of ~5000 small business'.

A smart candidate could use this fact to swing a close election.

:2c::vapor:
 

NorthOfAtlanta

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Give Jman more than 10 words and I'll be writing text similar in length to "War and Peace" on just how much regulations will muck things up and how they will surely lead to underground markets... galore.

A possible 45 million customer market, wonder if anyone will try and fill that void?

:D:vapor:
 
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