Deeming Regulations have been released!!!!

[DaveOno]

(note: I added the bold)

What it DOES tell me, at least, and something I can be THANKFUL for in this whole mess: the FDA decided to focus it's time on things that KILL and not things that save lives and should be left alone.

IF I have gratitude for one thing, it is THAT. Amen.

Well said, Anna.

I have no idea how many lives vaping has saved. It's logical to me looking at the correlation between the drop in smoking vs the start of vaping in this country.

Sadly, the US has lost over 54,000 souls to this virus. God rest their souls.

And if the trend from the last years continue, we lose 40,000 a month to smoking (and second hand smoke)

Somehow, I pray, in the coming new normal, that we see what works, what doesn't, what we can change if we want. And most important, that we DO make it a new normal.

 

[DaveOno]

And one more thing.

We all have opinions, quite varied indeed.

But I see folks respecting each others opinion here.

Thank you, all. It's rather refreshing.

 

[newyork13]

The stats are clear and consistent worldwide. 99% of the fatalities are of folks with serious underlying medical issues.
As Anna @stols001 has said, to help those folks at greatest risk, while at the time help the rest of society to keep it going, suggest to those at risk that (if they want to) they isolate themselves. We will hire people (all those sadly unemployed) and sanitize their whole damned bodies, and they will get groceries and meds for them and deliver them and it would have cost 1% of these "stimulus" expenditures.
I do worry about my kids and grandkids now, economically.
Corona may kill me, though I doubt it, but I would pay that price to avoid my kids and grandkids suffering.

 

[Javichu]

and sanitize their whole damned bodies, and they will get groceries and meds for them and deliver them

You basically described my job.
Can't work a full time job because whatever measly salary i would make would not even cover half of having someone at home taking care of my pops.
So i stay home and take care of him,goverment doesnt help me much,since my pops has a dependacy factored at medium (just that he depends on others to do certain things) social services got me a special grant.
Not much thou 236 euros a month,no unemployment or nothing,just those 23 euros...so yeah that is that.

Only time my pops leaves home is 3 times a week for his dialysis,doctor appointments he had are done mostly by phone and at the most we go and draw some blood in case some of his doctors orders a test,apart from that he stays home all the time.

About the rest of the folks,well i can only speak for me and the way things were handled in our country but a forced stay in was needed or things would have been much worst.
People are ......,mouth breathers who can't even follow the simplest of rules...i see it when i go out shopping or for meds for my pops.
They cough,sneeze everywhere,they dont maintain distance,etc,etc,etc...maybe if people acted better and followed some simple rules there would be no need to enforce them rules.
And im only talking about here in Spain,situation over there might be different so i cant form an opinion on that.
The mouth breathing ...... are everywhere but worst with our politicians,current woke generation dictates what should and shouldnt be done ands in some cases it allows people to do stupid things.

Take this for example:

There was a manifestation organized and planned for woman's international day,instead of cancelling because you know it's moronic to have that many people huddled together in the current situation they just kept it going.
Now to be perfectly clear,this has nothing to do with the reason of the march for woman's international day,it could have been a march in favor of the sheep's right to bear arms and i still would have thought it was wrong.
Only reason they didn't cancel the march is because they were afraid of the backlash it would come with...yeah smart move.


Here at least in Spain measures had to be taken,bad decisions of the government+moronic people with half a brain amounted to us being in a bad spot.

Our GDP will take at least 2 years to go back to the numbers we had before and trust me those numbers weren't good to begin with.

All i can do now is take care of my pops and me (so i dont get sick) and try to not go stir crazy,apart from that my hands are tied.

 

[Katya]

Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19

Not so fast, Mike. It ain't over till it's over ... Here's the latest from the VTA:

"BREAKING NEWS: 4TH CIRCUIT DENIES APPEAL
PMTA Deadline Remains 9/9/2020
May 4, 2020

Today, the U.S. Court of Appeals for the Fourth Circuit issued a ruling on the appeals of the U.S. District Court of Maryland’s decisions in the American Academy of Pediatrics v. FDA case. In sum, the court dismissed the appeals in their entirety.

Background
In May 2019, the district court in AAP granted summary judgment in favor of the plaintiffs, public health groups and individual physicians who challenged FDA’s extensions of the deadlines for submitting marketing applications for deemed “new tobacco products” that were on the U.S. market on the effective date of the deeming regulation (i.e., 8/8/2016).

• In July 2019, the district court moved the August 2022 deadline for submission of PMTA applications to May 12, 2020.
• In October 2019, the district court issued an order (1) permitting vapor industry trade associations to intervene for the purposes of appeal; (2) denying the cigar associations’ motion to intervene for purpose of appeal; and (3) denying the vapor associations’ motion for stay pending appeal.
• Subsequently, FDA and the vapor associations appealed the district court’s summary judgment and remedy orders, and the cigar associations appealed the denial of their motion to intervene for purpose of appeal.
• On January 2, 2020, while the appeals remained pending, FDA finalized its new compliance policy guidance, replacing the original August 2017 guidance that had been challenged in the AAP case. The FDA also indicated it would impose a May 12, 2020 PMTA deadline irrespective of the district court’s order.
• On April 22, 2020, and at FDA’s request, the district court modified its remedy order to change the May 12, 2020 deadline to September 9, 2020 due to the impacts of the COVID-19 pandemic.
• On April 30, 2020, FDA issued a revised version of the January 2020 guidance to reflect the extension to September 9, 2020.

Today's Ruling
The Fourth Circuit's decision today held that: The vapor associations’ appeal is now moot in light of FDA’s replacement of the challenged August 2017 guidance, “leaving no possible meaningful relief that this court could grant,” and

1. The district court did not abuse its discretion when it denied the cigar associations’ motion to intervene on timeliness grounds.
2. The FDA's appeal is dismissed (something the FDA requested if the court reached the foregoing conclusions).

Moving forward in this case, the industry appellants have the following options:

1. File a petition for rehearing and/or rehearing en banc (i.e., a hearing before the full appellate court) within 45 days, or
2. File a petition for a writ of certiorari with the Supreme Court of the United States within 90 days. (A writ of certiorari is a request for the Supreme Court to hear an appeal. The Supreme Court decides whether it will hear an appeal.)

Of course, the court also noted that parties could challenge the FDA's 2020 Guidance "in a separate action brought in the appropriate district court.”

We will keep you posted on any further developments. But, in the meantime, the September 9, 2020 deadline for submitting PMTA applications remains in place for deemed “new tobacco products” that were on the U.S. market on August 8, 2016."



Howdy y'all!

 

[Javichu]

Not so fast, Mike. It ain't over till it's over ... Here's the latest from the VTA:

"BREAKING NEWS: 4TH CIRCUIT DENIES APPEAL
PMTA Deadline Remains 9/9/2020
May 4, 2020

Today, the U.S. Court of Appeals for the Fourth Circuit issued a ruling on the appeals of the U.S. District Court of Maryland’s decisions in the American Academy of Pediatrics v. FDA case. In sum, the court dismissed the appeals in their entirety.

Background
In May 2019, the district court in AAP granted summary judgment in favor of the plaintiffs, public health groups and individual physicians who challenged FDA’s extensions of the deadlines for submitting marketing applications for deemed “new tobacco products” that were on the U.S. market on the effective date of the deeming regulation (i.e., 8/8/2016).

• In July 2019, the district court moved the August 2022 deadline for submission of PMTA applications to May 12, 2020.
• In October 2019, the district court issued an order (1) permitting vapor industry trade associations to intervene for the purposes of appeal; (2) denying the cigar associations’ motion to intervene for purpose of appeal; and (3) denying the vapor associations’ motion for stay pending appeal.
• Subsequently, FDA and the vapor associations appealed the district court’s summary judgment and remedy orders, and the cigar associations appealed the denial of their motion to intervene for purpose of appeal.
• On January 2, 2020, while the appeals remained pending, FDA finalized its new compliance policy guidance, replacing the original August 2017 guidance that had been challenged in the AAP case. The FDA also indicated it would impose a May 12, 2020 PMTA deadline irrespective of the district court’s order.
• On April 22, 2020, and at FDA’s request, the district court modified its remedy order to change the May 12, 2020 deadline to September 9, 2020 due to the impacts of the COVID-19 pandemic.
• On April 30, 2020, FDA issued a revised version of the January 2020 guidance to reflect the extension to September 9, 2020.

Today's Ruling
The Fourth Circuit's decision today held that: The vapor associations’ appeal is now moot in light of FDA’s replacement of the challenged August 2017 guidance, “leaving no possible meaningful relief that this court could grant,” and

1. The district court did not abuse its discretion when it denied the cigar associations’ motion to intervene on timeliness grounds.
2. The FDA's appeal is dismissed (something the FDA requested if the court reached the foregoing conclusions).

Moving forward in this case, the industry appellants have the following options:

1. File a petition for rehearing and/or rehearing en banc (i.e., a hearing before the full appellate court) within 45 days, or
2. File a petition for a writ of certiorari with the Supreme Court of the United States within 90 days. (A writ of certiorari is a request for the Supreme Court to hear an appeal. The Supreme Court decides whether it will hear an appeal.)

Of course, the court also noted that parties could challenge the FDA's 2020 Guidance "in a separate action brought in the appropriate district court.”

We will keep you posted on any further developments. But, in the meantime, the September 9, 2020 deadline for submitting PMTA applications remains in place for deemed “new tobacco products” that were on the U.S. market on August 8, 2016."



Howdy y'all!

I'm so lost,read it twice and still haven't a clue on what it's supposed to say.
Summarized version (Sesame Street style) for those of us that a)are Spanish and b) don't know the intricacies of American law

 

[Katya]

View attachment 883675


I'm so lost,read it twice and still haven't a clue on what it's supposed to say.
Summarized version (Sesame Street style) for those of us that a)are Spanish and b) don't know the intricacies of American law

It says that ANTZ (anti-tobacco zealots) never, ever give up. But it looks as though, at least in this case, they may be running out of time.

 

[Javichu]

It says that ANTZ (anti-tobacco zealots) never, ever give up. But it looks as though, at least in this case, they may be running out of time.

Roger that,thanks for the info

 

[Katya]

Roger that,thanks for the info

De nada. We aim to please!

 

[Katya]

Hello, my Deeming Friends. Time to wake up this thread.

So CA SB 793 (statewide flavor ban) received a rubber stamp from the California Senate and is now moving on to the Assembly. So I reread the bill and I need help interpreting it. This is what caught my eye:

"(14) “Tobacco retailer” means a person who engages in this state in the sale of tobacco products directly to the public from a retail location. “Tobacco retailer” includes a person who operates vending machines from which tobacco products are sold in this state.
(b) (1) A tobacco retailer, or any of the tobacco retailer’s agents or employees, shall not sell, offer for sale, or possess with the intent to sell or offer for sale, a flavored tobacco product or a tobacco product flavor enhancer.
(2) There shall be a rebuttable presumption that a tobacco product is a flavored tobacco product if a manufacturer or any of the manufacturer’s agents or employees, in the course of their agency or employment, has made a statement or claim directed to consumers or to the public that the tobacco product has or produces a characterizing flavor, including, but not limited to, text, color, images, or all, on the product’s labeling or packaging that are used to explicitly or implicitly communicate that the tobacco product has a characterizing flavor.

(2) “Constituent” means any ingredient, substance, chemical, or compound, other than tobacco, water, or reconstituted tobacco sheet, that is added by the manufacturer to a tobacco product during the processing, manufacture, or packing of the tobacco product.

(9) “Retail location” means both of the following:
(A) A building from which tobacco products are sold at retail.
(B) A vending machine."

As I understand it, places that sell flavorings online like BCF are exempt, right? Or do I need to stock on flavorings also?

 

[zoiDman]

Hello, my Deeming Friends. Time to wake up this thread.

So CA SB 793 (statewide flavor ban) received a rubber stamp from the California Senate and is now moving on to the Assembly. So I reread the bill and I need help interpreting it. This is what caught my eye:

"(14) “Tobacco retailer” means a person who engages in this state in the sale of tobacco products directly to the public from a retail location. “Tobacco retailer” includes a person who operates vending machines from which tobacco products are sold in this state.
(b) (1) A tobacco retailer, or any of the tobacco retailer’s agents or employees, shall not sell, offer for sale, or possess with the intent to sell or offer for sale, a flavored tobacco product or a tobacco product flavor enhancer.
(2) There shall be a rebuttable presumption that a tobacco product is a flavored tobacco product if a manufacturer or any of the manufacturer’s agents or employees, in the course of their agency or employment, has made a statement or claim directed to consumers or to the public that the tobacco product has or produces a characterizing flavor, including, but not limited to, text, color, images, or all, on the product’s labeling or packaging that are used to explicitly or implicitly communicate that the tobacco product has a characterizing flavor.

(2) “Constituent” means any ingredient, substance, chemical, or compound, other than tobacco, water, or reconstituted tobacco sheet, that is added by the manufacturer to a tobacco product during the processing, manufacture, or packing of the tobacco product.

(9) “Retail location” means both of the following:
(A) A building from which tobacco products are sold at retail.
(B) A vending machine."

As I understand it, places that sell flavorings online like BCF are exempt, right? Or do I need to stock on flavorings also?

The Key Wording is a "Rebuttable Presumption".

Rebuttable presumption - Wikipedia

So if I am a Company called "Crazy DIY Vape Flavors", and sell a bunch e-Cigarette related stuff, and have pictures of Vapor coming out of Mods in my Banner Headers, I might have a Hard Time arguing that there wasn't an Implied Intent that my DIY Flavoring were being sold to Flavor e-Liquid "Juice".

Whereas, if I made No Mention of e-Cigarettes, and just listed Flavorings as... wait for it... Flavorings, I could argue that the Reasonable intent was for Food and Drink recipes.

And I would Most Likely pass under the RADAR.

I'm Not Sure I would be Overly Concerned about Flavorings going away in Kalifornia. But being able to buy them from where you want, and the Cornucopia of flavors available might become more Limited.

 

[zoiDman]

...

As I understand it, places that sell flavorings online like BCF are exempt, right? Or do I need to stock on flavorings also?

BTW - Who is "BCF" ?

 

[Katya]

I'm Not Sure I would be Overly Concerned about Flavorings going away in Kalifornia.

Yeah, I agree. They also very specifally state that the law applies to "(14) “Tobacco retailer” means a person who engages in this state in the sale of tobacco products directly to the public from a retail location. “Tobacco retailer” includes a person who operates vending machines from which tobacco products are sold in this state."

Well, BCF is most certainly not a tobacco retailer, and is not "selling directly to the public from a retail location."

But you never know what else they can come up with. Or if this bill will even pass. In the meantime, you know the drill:

CA - Stop a Statewide Flavor Ban! (Updated)

 

[Katya]

BTW - Who is "BCF" ?

Bull City Flavors.

ETA: They changed their name a few years ago, wisely, from Bull City Vapors.

 

[SlowTalker]

My grocery store sells cigarettes. They also sell flavorings. Uh oh....

 

[zoiDman]

Yeah, I agree. They also very specifally state that the law applies to "(14) “Tobacco retailer” means a person who engages in this state in the sale of tobacco products directly to the public from a retail location. “Tobacco retailer” includes a person who operates vending machines from which tobacco products are sold in this state."

Well, BCF is most certainly not a tobacco retailer, and is not "selling directly to the public from a retail location."

But you never know what else they can come up with. Or if this bill will even pass. In the meantime, you know the drill:

CA - Stop a Statewide Flavor Ban! (Updated)

There's a term in business (Shamrackeling ?) when a State wants to stop you from Selling something you Sell, but they Can't effectively do so. So they Cook Up a Law/Regulation that prevents the Way you can sell it. Or what it can be Called. Or Marketed as.

This is what CA SB 793 is.

It doesn't stop you from Selling it. Just some Hoops to jump thru. And It gives the Appearance that the State is actively Engaged in doing something that someone Thinks should be done.

Kinda like when You would go into a Head Shop and all the Pipes would have some 3-x-5 Card in front of them saying "Tobacco Only".

Fast Forward to Today and now when you go into a Tobacco Shop the 3-x-5 Cards all say "Pot Only".

LOL

 

[zoiDman]

Bull City Flavors.

ETA: They changed their name a few years ago, wisely, from Bull City Vapors.

Gotcha...

Hit a Blank there for a Second.

Kinda Like Bumping a Sticky Thread.

LOL

 

[Katya]

Fast Forward to Today and now when you go into a Tobacco Shop the 3-x-5 Cards all say "Pot Only".

*sigh*

I can't have my peach vapes because it's a kid flavor, but the state has no problems allowing sales of flavored THC oils, edibles, candy, friggin brownies!!!! Because no kid in CA likes brownies and candy bars and chips.

The Best California Edibles For Every Situation - Journal | Proper

 

[zoiDman]

...

So if I am a Company called "Crazy DIY Vape Flavors", and sell a bunch e-Cigarette related stuff, and have pictures of Vapor coming out of Mods in my Banner Headers, I might have a Hard Time arguing that there wasn't an Implied Intent that my DIY Flavoring were being sold to Flavor e-Liquid "Juice".

...

BTW... If I was the Owner of Crazy DIY Vape Flavors, I would probably want to have a DBA in the works for something like "Aunt Molly's Ode Time Candy Flavoring Emporium".

Just to be on the Safe Side.

 

[JCinFLA]

Deleted - Due to apparently experiencing a "senior brain fart" while writing it.