Deeming Regulations have been released!!!!

[Doffy]

this came up in semi related search

i don't understand it, but reduction in paperwork of tobacco product stuff by fda or sumfink Federal Register :: Request Access

sorry if irrelevant, search limited to last hour so thought i'd post it

 

[WorksForMe]

this came up in semi related search

i don't understand it, but reduction in paperwork of tobacco product stuff by fda or sumfink Federal Register :: Request Access

sorry if irrelevant, search limited to last hour so thought i'd post it

"The total number of burden hours for this collection of information is estimated to be 1,820 hours (650 hours to prepare and submit meeting requests and 1,170 hours to prepare and submit information packages)."

They estimate that it will take a company 1,820 hours to get ready for one meeting with the FDA. It's no wonder that it takes several years and millions of dollars to get a PMTA approved. It's a bureaucratic labyrinth that no small company can navigate.


.

 

[DavidOck]

& nicotine replacement therapy (NRT) formulations ONLY.

Well, then, clearly for us

 

[Bronze]

This is the best one yet...

 

[UncLeJunkLe]

That's it, I quit.

 

[hittman]

This is the best one yet...

That's hilarious! I hadn't seen that one. I wish I was that flexible. Maybe I need to vape more.

 

[Territoo]

Here's another one.



She obviously hasn't learned to have a backup.

 

[hittman]

Here's another one.



She obviously hasn't learned to have a backup.

I've seen that one a few times.

 

[WorksForMe]

Six companies get a temporary reprieve from the FDA. They get to continue selling their products while the FDA reconsiders their PMTAs.

Federal Court Rules Against FDA in Six MDO Appeals​

A three-judge panel of the Eleventh Circuit Court of Appeals ruled 2-1 that the MDOs were arbitrary and capricious because the agency didn’t consider the marketing plans submitted by the small businesses in their applications. The six companies are:

• Bidi Vapor
• Diamond Vapor
• Johnny Copper
• Pop Vapor Co.
• Union Street Brands
• Vapor Unlimited

 

[zoiDman]

Six companies get a temporary reprieve from the FDA. They get to continue selling their products while the FDA reconsiders their PMTAs.

Federal Court Rules Against FDA in Six MDO Appeals​

"The FDA could choose to ask the court for an en banc review—a reconsideration of the appeal by the full Eleventh Circuit. If that happens, the court’s decision could change. If it doesn’t, the six companies’ PMTAs will go back to the FDA to be reconsidered.

While there’s a good chance the agency will arrive at the same conclusion (as long as it considers flavors a de facto reason for denial), these manufacturers’ PMTAs will presumably move to the back of the review queue, potentially giving them additional years of sales before they must fight another round of MDOs."

Federal Court Rules Against FDA in Six MDO Appeals

A federal appeals court has ruled against the FDA in appeals of marketing denial orders issued to six vaping manufacturers.

vaping360.com

Somewhere Dick Durbin just threw his Eggs and Toast against the wall.

 

[Rossum]

Somewhere Dick Durbin just threw his Eggs and Toast against the wall.

 

[WorksForMe]

AVM: FDA Misreports PMTA Acceptance Numbers

A vaping industry trade group says the FDA misreports its own premarket application results to avoid criticism from anti-vaping organizations.

vaping360.com

.

 

[hittman]

I’m really not surprised at all.

 

[WorksForMe]

Vape Company to Spend More Money Preventing Youth Vaping Than States

Much like the then-celebrated state attorneys general's “win” against the tobacco industry in the 1990s, more state attorneys are cheering another so-called win against JUUL Labs Inc. (JLI) after 32

townhall.com

.

 

[somdcomputerguy]

Perhaps the e-cigarette maker’s money can help to encourage states to invest more funding towards tobacco control.

More tobacco control funding? I think not. I think more golf carts.

 

[WorksForMe]

The FDA is starting to go after vape manufacturers that didn't file PMTA applications for their products.

FDA Targets Unauthorized Vapes With Lawsuit Threats, Destruction Orders

An unprecedented escalation through the DOJ is confirmed in a letter obtained by Filter. Could companies with PMTA denials be next?

filtermag.org

"Filter has confirmed that the FDA, by September 1, advised the Department of Justice (DOJ) that at least two open-system vape companies were in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because the manufacturers did not file premarket tobacco product applications (PMTAs) and were continuing to sell their products. According to a letter to one of the vape companies, viewed by Filter, the feds are seeking court orders, threatening lawsuits and demanding the destruction of unauthorized products."

.

 

[WorksForMe]

Amanda Wheeler's trying to make trouble for Dick Durbin. She complained to the Senate Ethics Committee about him. I doubt if this will accomplish much, but it could be interesting to watch.

"We believe Senator Durbin is attempting to interfere with and influence the outcome of an ongoing executive branch agency review process in violation of Senate Ethics rules.Senator Durbin has not reviewed the evidence manufacturers have presented to the FDA as required by the agency’s PMTA guidelines, but continues to pressure the FDA Center for Tobacco Products to abandon its duty to thoroughly review those applications in favor of his desired result –the total prohibition of all vaping devices."

AVM Files Senate Ethics Complaint Against Durbin

A vaping industry group has asked the Senate Ethics Committee to investigate Illinois Sen. Dick Durbin for improperly influencing the FDA.

vaping360.com

.

 

[zoiDman]

Dick Durbin needs to be Served with a Cease and Desist Order.

And in the C&D, it should explain to Mr. Durbin's that the Vast Majority of his statements regarding Tobacco Products, e-Cigarettes and the e-Cigarette Market are NOT Protected by the Speech and Debate Clause in Article 1, section 6 of the U.S. Constitution.

 

[WorksForMe]

Dick Durbin needs to be Severed with a Cease and Desist Order.

And in the C&D, it should explain to Mr. Durbin's that the Vast Majority of his statements regarding Tobacco Products, e-Cigarettes and the e-Cigarette Market are NOT Protected by the Speech and Debate Clause in Article 1, section 6 of the U.S. Constitution.

I think you meant served instead of Severed, but I'd be OK with him being severed too.

 

[zoiDman]

I think you meant served instead of Severed, but I'd be OK with him being severed too.

Either / Or. I'm Not Choosy.

LOL

BTW - There used to be a Member here, DC2

, who said He would get So Mad sometimes about the way e-Cigarettes were portrayed that his Hands would Shake. Shake so bad that it was hard for Him to Type.

I get that way sometimes also when it comes to Dick Durbin.