FDA Court orders FDA to set 10 month deadline for PMTA's

[squee]

From the court's ruling:

Accordingly, it is this 11th day of July, 2019, hereby ordered that

1. the FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule ("New Products"), applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order;
   
   
2. New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA's discretion;
   
   
3. New products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;
   
   
4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis
   

H/T Azim Chowdhury (swiped from reddit)


Also, bloomberg.com/news/articles/2019-07-12/judge-gives-e-cigarette-makers-10-months-to-seek-fda-approval

“Today’s ruling is an important step forward for public health,” the FDA’s acting commissioner, Ned Sharpless, said in an emailed statement. “The FDA stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes.”

Thoughts?

 

[Beamslider]

So isn't this what we already have? At FDA discretion

 

[Rossum]

Thoughts?

It will be interesting to see how much "discretion" the FDA exercises.

Winter is a good time to buy nic in quantity because it will stay relatively cool during transport.

 

[Doffy]

Damn

AFAIK, USA is the only country that produces WTA.

The rest of the world will cover nic. But I don't see WTA getting a look in.

 

[Eskie]

Huh. So the judge accepted the FDA compromise. Now we have to see the the Academy of Pediatrics will appeal that.

At least discretion and exemptions were left in.

 

[squee]

It will be interesting to see how much "discretion" the FDA exercises.

Since this covers *all* new tobacco products, I'm more inclined to think that was thrown in for cigar makers rather than us.

Winter is a good time to buy nic in quantity because it will stay relatively cool during transport.

Exactly. I was actually tempted during the July 4th sales even though I don't need any more (LOL) but then stopped myself (July? In this heat? Are you mad?)

 

[Rossum]

Huh. So the judge accepted the FDA compromise.

It's my understanding that this makes it difficult for the FDA to appeal.

Then again, I can't imagine the irony of having the FDA file a court appeal to save vaping for a little while longer either.

Now we have to see the the Academy of Pediatrics will appeal that.

I think that would be a waste of time and money on their part and they know it. I mean, how long would such an appeal take before it was decided? How much could it possibly speed things up?

At least discretion and exemptions were left in.

Hopefully they will exercise that discretion judiciously.

 

[zoiDman]

...

“Today’s ruling is an important step forward for public health,” the FDA’s acting commissioner, Ned Sharpless, said in an emailed statement. “The FDA stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes.”

Thoughts?

This is about the LAST THING I want to hear from an Acting FDA Commissionaire.

 

[Rossum]

This is about the LAST THING I want to hear from an Acting FDA Commissionaire.

I guess it depends on what "accelerate review" means. The insane optimist in me hopes it means they will rubber-stamp every vapor-product PMTA they receive:

I could see at least some folks in the FDA wanting to do that just out of spite for being pushed by the AAP and the court.

But I'm not counting on it.

 

[zoiDman]

I guess it depends on what "accelerate review" means. The insane optimist in me hopes it means they will rubber-stamp every vapor-product PMTA they receive:

I could see at least some folks in the FDA wanting to do that just out of spite for being pushed by the AAP and the court.

But I'm not counting on it.

Yeah... I'm sure there are some at the FDA who would Love to see e-Cigarettes get Rubber Stamp approval.

But they work in Shipping and Receiving, IT and or the Office Pool.

It's the Fine Folks at the FDA's CTP that scare me. And the Views of this man...

 

[zoiDman]

Here is the Memorandum Opinion and Order.

https://bloximages.newyork1.vip.tow...-5f16-b97f-73becd063448/5d292babcd568.pdf.pdf

 

[Mowgli]

If you respect Matt Culley's opinion (I do) then here's his levelheaded opinion.
Matt has a few dogs in this fight and analyzes all the right people's advice.
Open at YouTube to get chat and switch from top chat replay to live chat replay.
There might be some adult language involved.

https://youtu. be/PCgHaQ-VhxI

<Admin note: please don't link vid's with explicit language. I've replaced your link with the URL including an extra space between the "." and the "be". Simply copy/paste and remove the space in your address bar to view. Thank you!>

 

[Rossum]

If you respect Matt Culley's opinion (I do) then here's his levelheaded opinion.

I think to a some degree he's correct. The FDA doesn't have the resources to kill the industry completely. Let's hope he's right that at least some juice manufacturers will be filing PMTAs. It won't affect me personally one way or another, but I know there are plenty of vapers who can't be bothered to stockpile or DIY, and for them hardware is useless without juice.

On several occasions, he mentions that the FDA warning letter to a squonk-mod manufacturer, but has probably rescinded it. Does anyone know what manufacturer or mod that was in reference to?

 

[CublalaLand]

It's just so misrepresentative of what a government should be. There's no huge public outcry against vaping, or any massive threat to the public interests, it's the faceless mass of bureaucracy being whipped to task by the shadow government that sees only one real issue - a threat to it's tax money. Shameful, but it's how they've been running things since the country was founded. They'll never win the so-called 'substance battles' but to them it's not about that, it's about how many lives they can ruin in the process.

 

[Horselady154]

It's an age old story....

"First they came for the socialists, and I did not speak out—because I was not a socialist.
Then they came for the trade unionists, and I did not speak out— because I was not a trade unionist.
Then they came for the Jews, and I did not speak out—because I was not a Jew.
Then they came for me—and there was no one left to speak for me."
Martin Niemöller: "First they came for the Socialists..."

 

[coldgin96]

It's an age old story....

"First they came for the socialists, and I did not speak out—because I was not a socialist.
Then they came for the trade unionists, and I did not speak out— because I was not a trade unionist.
Then they came for the Jews, and I did not speak out—because I was not a Jew.
Then they came for me—and there was no one left to speak for me."
Martin Niemöller: "First they came for the Socialists..."

Then they came for me, and was killed defending the constitution, my home, my family and me.

 

[CublalaLand]

I can see the end game, with my cassandra complex full-blown. They're going to make vaping a black-market, then sell legal products at black market prices. The government is doomed to repeat itself, like puppets.

It's the consequence of taking no responsibility for one's own actions. If the world is ruled by merchants, mercantilism rules the world. Station is a matter predetermined by birth.

Anyways, that's the end-game. Quitting smoking is a sin, according to their logic. Juuls won't be illegal, they'll be the only thing available and they'll cost $80. That is the logic of Merchant-Kings.

 

[puffon]

No appeal:
Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

 

[zoiDman]

I Think we are going to Get Hosed.

 

[ENAUD]

I Think we are going to Get Hosed.

This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation’s youth and especially the potential for them to become traditional cigarette smokers. We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes. I am all too aware of the staggering toll inflicted on the public health by tobacco products. As someone who has dedicated my life to reducing the public health burden and suffering caused by cancer, the importance of preventing youth addiction to nicotine rings especially true to me.

I think he pretty much said so in the second paragraph...