Whats really going on with the FDA?

[Robino1]

The last I heard, the FDA intended to send a proposal to the Office of Management and Budget which falls under the executive branch (so at this time Obama would be the one to approve it). Until that happens we will not definitely know exactly what is in the proposal. The other route they could go is through congress but it doesn't appear they intend to take that route unless the industry can proves ecigs can't be deemed a tobacco product or can but current law can't be applied to regulations for e-cigs which would mean congress would have to put up new legislation or alter existing. An existing Supreme Court ruling indicates that won't happen.

After the proposal to the Office of Management and Budget there will be a period for comment meaning both public and the businesses affected would be able to put in their two cents. That period is usually 2 or 3 months.

After that period how the regulations will be put into play. Usually at that point it is 6 months to a year for businesses to make preparations for the changes based on what is discussed in the comment period.

So to sum up: We don't know for sure what is in it. It will be 8 months to a a bit more than year after we know that for regulations go into effect.

I've heard that they have already sent it to the OMB for review. I can't find where that was stated. I think somewhere in the Legislation Section on ECF.

 

[Penn]

I usually don't look at that section. Last few times I did it was just overrun with speculation and paranoia. I get a high enough dose of that here in general.

If it was submitted the proposal should be public info. What was in it?

 

[tj99959]

I've heard that they have already sent it to the OMB for review. I can't find where that was stated. I think somewhere in the Legislation Section on ECF.

I saw it on the CASAA facebook page. Seems like the OMB has some questions about economic impact.

probably worried that they won't be able to tax that 2 billion dollars/year if the FDA destroys the e-cig industry

 

[Robino1]

I usually don't look at that section. Last few times I did it was just overrun with speculation and paranoia. I get a high enough dose of that here in general.

If it was submitted the proposal should be public info. What was in it?

I can't remember

I saw it on the CASAA facebook page. Seems like the OMB has some questions about economic impact.

probably worried that they won't be able to tax that 2 billion dollars/year if the FDA destroys the e-cig industry

That's probably where I saw it then.

 

[AgentAnia]

....If it was submitted the proposal should be public info. What was in it?

As I understand the process, the proposed rule as submitted by FDA to OMB for review will not be published until OMB has cleared/approved it and returned it to FDA. Until then, the content may be regarded as a closely guarded FDA secret.

 

[Penn]

As I understand the process, the proposed rule as submitted by FDA to OMB for review will not be published until OMB has cleared/approved it and returned it to FDA. Until then, the content may be regarded as a closely guarded FDA secret.

If the OMB is going to give time for public response they have to disclose what is in it. How can anyone comment without seeing it. I know "we have to pass it to see what's in it" now has a precedence but I think we are seeing why that is such a stupid idea. It has to be subjected to review.

 

[tj99959]

If the OMB is going to give time for public response they have to disclose what is in it. How can anyone comment without seeing it. I know "we have to pass it to see what's in it" now has a precedence but I think we are seeing why that is such a stupid idea. It has to be subjected to review.

The OMB will not disclose it for public responses. They will approve it or suggest modifications to the FDA. The FDA will then publish the final draft, and open it up for public response.

 

[bikerbeagle]

Yeah but most of it is going to China. If we want to protect it we'll need to see more hardware products coming from America or at least owned by american corporations even if the work is farmed out overseas.

I would not say that "most of it" is going to China. Yes, the vast majority of devices are produced in and bought from China, but when you consider the sheer number of AMERICAN small e-cigarette RETAIL businesses - online and B&M - selling those products at mark-up (profit), I would say that "most of it" is spent and stays right here in the USofA on real estate (lease/buy), payroll, and various other services that businesses need to maintain/grow/survive.

It would be nice if all the money we spend on Chinese (and other foreign) products would go to US manufacturing, but I'm afraid that ship has long-since sailed.

 

[bikerbeagle]

The stuff I've read/heard over the last couple of weeks:

1) The FDA has already submitted their recommendations to the OMB on Oct 1.
2) The FDA hasn't submitted their recommendations at all and can't now until April '14.
3) The OMB has 30, 60, or 90 days review the FDA recommendations.
4) The consumer feedback period is 30, 60, or 90 days.
5) The FDA has no plans to regulate e-cigarettes.
6) Even if/when they do regulate e-cigarettes, it will be 3, 6, 9, 12, 18, or 24 months to implement.
6) Santa Claus/Easter Bunny does not exist.
7) Santa Claus/Easter Bunny does exist, but is funded and supported by Big Pharma/Big Tobacco/Big Government.