Deeming Regulations have been released!!!!

Spazmelda

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I see what you did there.
I almost can't wait until the CDC youth smoking report comes out after these idiots have destroyed the vaping industry, showing that cigarette use among youth is up 30%+ to pre-2013 levels.

Yep, that's saving the children, all right.

That might be what happens, but I'm sure they will use it to say they were right about vapor being a gateway to cigarettes. I guess there's only so long that line can work now if things don't change.
 

sparkky1

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And in 90 days any NEW (to the market) piece of vape gear will be illegal contraband unless it has an approved PMTA, China is not exempt from this!

The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA's for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.
 

StormFinch

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We've all known that these people have been against us from the beginning, of course they have, they're pharma puppets. It's just shocking to see them all gathered in the same place.

When stumping on the Hill, I was personally told by an aide that they place a lot more weight on voter contact than they do on lobbyist contact. Of course he worked for one that wasn't quite as in bed with special interests, but we already know who those happen to be. :confused:

Use that letter as your template and refute their arguments, line by line, and contact your senators. Do it by paper mail as well as e-mail and phone call. Letters, like books, make more of an impact.
 

mikepetro

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The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA's for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.
That is for "existing" products. I specifically stated "NEW" products, which are not allowed at all after August 10th unless they have an approved PMTA..

"Tobacco products imported or offered for import into the United States must comply with all the applicable requirements"

My point being, that if they choose, they can (and have the ability to) start seizing stuff.
 

Robert Cromwell

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That is for "existing" products. I specifically stated "NEW" products, which are not allowed at all after August 10th unless they have an approved PMTA..

"Tobacco products imported or offered for import into the United States must comply with all the applicable requirements"

My point being, that if they choose, they can (and have the ability to) start seizing stuff.
And they are preparing to do just that.
 
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DC2

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American Lung Association exists because of cigarettes. Now let's see how much these organizations contributed to the FDA and the campaigns of those who want these regs.
The American Lung Association does not contribute, they get contributed to.
They are a minion of the big money players.

They gather funds from MSA money grants and Big Pharma handouts.
And then go do their bidding.

Peruse your way through these listings...
Robert Wood Johnson Foundation Grant Archive

Robert Wood Johnson Foundation (RWJF) is Big Pharma...
FORCES International - News Portal
 

StormFinch

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That is for "existing" products. I specifically stated "NEW" products, which are not allowed at all after August 10th unless they have an approved PMTA..

"Tobacco products imported or offered for import into the United States must comply with all the applicable requirements"

My point being, that if they choose, they can (and have the ability to) start seizing stuff.


BTW, it's August 8th to be exact. There are two 31 day months between, deeming was filed today.
 

Train2

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Right because without all those smoking patients, the docs will lose some $$ too.
G-damn bastidz.
And it's all about the children.

And here's the first attempt to remove it from the Appropriations bill--just posted by our friend @crxess in another thread. I give up.

http://www.cadca.org/sites/default/files/pdfs/policy/lettertosenateappropriations.pdf

"We are writing to express our strong opposition to two provisions in the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would significantly weaken the Food and Drug Administration’s authority over several tobacco products including e-cigarettes and cigars."
 
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The Ocelot

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My, oh, my...

The FDA is seeking to get "User Fees" from over-the-counter (OTC) drug manufacturers to supplement underfunding. FDA Considers New User Fee Program for OTC Drugs | RAPS

Considering how large the OTC market is (I mean, come on, REALLY large), check this out:

"One of the biggest issues for FDA is a lack of staff working on OTC monographs. FDA currently has 18 full-time-employees devoted to overseeing the entire OTC market, which is the same number of employees it takes to review one novel prescription drug application."

I'll bet those PMTA are just going to be flying out the door!
 

StormFinch

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and representatives. The Cole-Bishop amendment now goes forward as part of an appropriations bill and will be voted on in the House of Representatives.

Yeah, that was a given since it's in CASAA's call. The letter went out to Senate appropriations which means Senators need to be added to the list.
 

StormFinch

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My, oh, my...

The FDA is seeking to get "User Fees" from over-the-counter (OTC) drug manufacturers to supplement underfunding. FDA Considers New User Fee Program for OTC Drugs | RAPS

Considering how large the OTC market is (I mean, come on, REALLY large), check this out:

"One of the biggest issues for FDA is a lack of staff working on OTC monographs. FDA currently has 18 full-time-employees devoted to overseeing the entire OTC market, which is the same number of employees it takes to review one novel prescription drug application."

I'll bet those PMTA are just going to be flying out the door!

I'm curious as to how they handle OTCs, but not enough to give myself a headache by looking it up. Common sense would say they since most everything OTC was at one time a prescription, as long as there was no change in ingredients, there's really no PMTA needed. Then again, we know exactly how much common sense the FDA doesn't have. I do remember one member saying her husband works in OTC and it isn't as involved as scripts.

Needless to say, I really hope Congress looks at them and says that not only do we fund them but pharma already funds them as well, and they still can't get anything done... :p
 

Kent C

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I understand. It's so depressing. And the worst part of it is that they don't even know what the :censored: they are signing. It's all knee-jerk, party-line, save-the-children crap. :cry: Some bureaucrat probably called another bureaucrat and asked if they could add their signature to a letter that will protect America's youth. :facepalm:

Well, yeah, they're more organized than we are, but so was Cruz v. Trump. :lol:
 

Katya

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Yeah, that was a given since it's in CASAA's call. The letter went out to Senate appropriations which means Senators need to be added to the list.

CASAA's CTA (the only live one ATM) is in support of the original HB 2058--not the Cole-Bishop amendment. The latter call has expired because it was addressed to the House Appropriations Committee (where it passed; 31-19). There is currently no active CTA from CASAA in support of the Cole-Bishop rider, which the letter from the alphabet soup is opposing.

Whew.

Somebody correct me, please, if I'm wrong.
 

Katya

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My, oh, my...

The FDA is seeking to get "User Fees" from over-the-counter (OTC) drug manufacturers to supplement underfunding. FDA Considers New User Fee Program for OTC Drugs | RAPS

Considering how large the OTC market is (I mean, come on, REALLY large), check this out:

"One of the biggest issues for FDA is a lack of staff working on OTC monographs. FDA currently has 18 full-time-employees devoted to overseeing the entire OTC market, which is the same number of employees it takes to review one novel prescription drug application."

I'll bet those PMTA are just going to be flying out the door!

proxy.php
 

Kent C

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Kent, I agree. Unfortunately, the signatories to this are a lot of respected (not by me) organizations with heavy lobbyist arms.

That's what is so bad about this fight, we're going against organizations that are typically respected among the population (e.g. American Cancer Society) as well as in government. Most Americans do not smoke or vape, so they don't see it from our perspective.

What's worse is, when I tell non-vapers how corrupt the ACS is and how they shouldn't be supported, I sound like a conspiracy kooky-bird.

Understood, but you might ask "Why is the ACS going against vaping that doesn't cause cancer? Do they want people to keep smoking??"

My main point was how can you be disheartened by something you knew was coming..... :- )
 

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