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Deeming Regulations have been released!!!!
- Thread starter Oliver
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If I had a legitimate need for accurate information, I would have no confidence that calling that number would yield anything useful.
It's likely that all of these lawsuits will have to be filed and the United States District Court for the District of Columbia and that they will eventually be consolidated there before there is any sort of adjudication on the merits. It will then go to the DC Court of Appeals. If the case turns on a significant constitutional issue, it will most likely end up in the Supreme Court.
ETA: if they are not all filed initially in the DC District Court, they will be managed under the procedure for multidistrict litigation, which effectively results in a consolidation so as to promote efficiency and get a consistent result.
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I get it. I really do and I feel the same way.
At the same time, I can't help but feel like they may just see what a crap storm they stirred up by the volume of calls they receive.
I only feel bad for the secretaries, that did not have anything to do with the making of the regulations, having to listen to millions of irate citizens.
Well this is all well and good for them. I say bah hum bug. They upgraded their facilities
to ISO 7 certification for one reason. This standard still eliminates at least 90% if not all
mom and pops.
I have said this before this lab standard clean room stuff is a canard. The very
nature of the ingredients in e-juice and the simplicity of the production process
makes the manufacture of juice one of the most easiest and safest consumable
products on the market.(think bottling Coca-Cola) The hardware in its basic form
is a flashlight.
Inspection at the local level by state or county agencies is more than enough to insure
safe production of e-liquid and not cost the Feds one single dime. OSHA can handle
what OSHA handles and we are all good. We are not making and fueling ICBM's.
We are dealing with stable chemicals that can be safely used with minimal safety
and equipment requirements and the most basic electronic components.
Lets put this this myth to rest. To my knowledge no one has died nor have
I even heard of any serious injury resulting from the manufacture of e-liquid
or hardware. Incidents with the hardware aside does anyone know of any
serious harm caused to a customer by any e-juice they have purchased for use.
I am not talking about the hypothetical harm similar to smoking but immediate
harm caused by contaminants. Aside from strictly controlling the percentage of
nicotine the worst scenario would be bad tasting juice. What are we protecting
ourselves from? The only way to make juice poisonous is to do it deliberately.
Monkey's can be taught to make e-juice easily and safely. The problem is
they won't do it. It's too boring.
Regards
Mike
They get paid well.
A prime example of why we are where we are today with this kind of attitude. You don't care about everyone's personal freedoms, just the ones that affect you. Just to let you know it was those "kids" 40 odd years ago that are the reason you are able to post that comment today.
Very Good Point Robino.
Any/Everyone who calls the FDA should be Courteous and Professional when talking with the FDA Support Staff.
They are just doing their Job as best they can. And did Not have any Input into how the "Deeming" was written.
Ya, but were just getting started, so lets see what "our" representatives come up with
101st Annual Meeting and Conference: The Impact of the Deeming Rule on Harm Reduction
+1
I was trying to finish a Blog post on the PMTA Draft Guidance and also headed out of my crib so I didn't have much time. I'm sure that when I have more time I will get an answer from the Press geek so later today. Maybe I should ask this single question in this thread:
What is the application fee to file a PMTA? With a reliable and trustworthy link source please.
Danka
While I am still fired up about the ISO lab bunk another thing that
has crossed my mind is the FDA's use of the word substantial.
When it comes to the SE applications this is the standard. If
you apply by the premarket standard it is not used at all. One
has apply for each and every variation of juice blend no mater
what ingredient was added,subtracted or adjusted for volume
as it may alter the composition and or delivery of the juice affecting
nicotine dosage. They didn't say substantially change, They say may.
Regards
mike
has crossed my mind is the FDA's use of the word substantial.
When it comes to the SE applications this is the standard. If
you apply by the premarket standard it is not used at all. One
has apply for each and every variation of juice blend no mater
what ingredient was added,subtracted or adjusted for volume
as it may alter the composition and or delivery of the juice affecting
nicotine dosage. They didn't say substantially change, They say may.
Regards
mike
used in manufactured ejuice, yes.
Since each juice recipe will have to go thru the PMTA approval process and the associated costs.
so do not expect many different flavors of ejuice 2 years from now.
For DIY I don't think so unless the ejuice is sold for vaping use by a vaping retailer or bought by an ejuice manufacturer. Most all flavorings are technically food and beverage flavorings and if bought as such are exempt from the regs
Can anyone translate that page into English?
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