Deeming Regulations have been released!!!!

[Buckeyevapen]

If, as the linked article suggests, this judge still doesn't understand the difference between open and closed system products and plaintiffs' counsel failed to explain it to her, there's a serious and fundamental problem with the way this case is being presented.

I was glad the judge expressed interest in whether the FDA was required to conduct a cost/benefit analysis because the FDA's cost/benefit analysis was essentially nonexistent. If she concludes that it was required, she'll rule for the plaintiffs. Of course, an argument can be made that it isn't required because the enabling statute (FSPTCA) doesn't specifically require it. The counter-argument is it does require that any regulation must be "appropriate," and how can the FDA determine if it's appropriate without a cost/benefit analysis?

That said, I wouldn't try to predict how this is going to turn out based on what transpired yesterday. You can't tell how a judge is leaning based on questions asked at oral argument. I've argued cases in all levels of state and federal courts with the sole exception of the SCOTUS, and I've learned not to read anything into the questions asked or how they're asked. Many judges will question what later turns out to be the winning side much more aggressively.

Also please bear in mine that this case will be reviewed all over again ("de novo") in the Circuit Court of Appeals. New briefs will be written and new oral arguments will be presented. On appeal in cases of this kind the district court's ruling is entitled to zero deference.

Thank you for the SME perspective bigdance!!

 

[Slots]

YES ... thank you bigdancehawk for the explanations
Without you, I would not understand half of this

 

[seminolewind]

I just think that vaping products are deemed tobacco derived products for a reason, the reason being better consequential laws for vaping to be harassed with. If they were honest, (hahaha) they would label vaping products as non tobacco nicotine products.

Maybe e-liquid labels should be truthful and include the phrase TOBACCO FREE in big letters all over their bottles, liquid that is free from deadly cancer causing tobacco but provides nicotine as a stimulant.

Has anyone experimented with using caffeine instead of nicotine? I wonder..............

 

[seminolewind]

Thankyou Bigdancehawk. Your deciphering is wonderful!

 

[Baditude]

Has anyone experimented with using caffeine instead of nicotine? I wonder..............

There have been a few e-liquid manufacturers who added caffeine to their juices.

A couple of years ago a chemist who was a vaper responded to an ECF member's question about adding caffeine to e-liquid by saying caffeine is not sufficiently vaporized at the temperatures we vape at. He added that any perceived effect was a placebo effect. If someone is really interested, they might go looking in the "Not Advisable" sub-forum.

I will add that ECF's policy is to not use any additives (such as caffeine) to e-liquid.

 

[Kent C]

There have been a few e-liquid manufacturers who added caffeine to their juices.

A couple of years ago a chemist who was a vaper responded to an ECF member's question about adding caffeine to e-liquid by saying caffeine is not sufficiently vaporized at the temperatures we vape at. He added that any perceived effect was a placebo effect. If someone is really interested, they might go looking in the "Not Advisable" sub-forum.

I will add that ECF's policy is to not use any additives (such as caffeine) to e-liquid.

Decadent Vapours had caffeine in their 'Doppio Espresso' (which I still vape blended with BWB Espresso). and a few other flavors Kola Kick, Green Cow...- none, no longer available. See:

Doppio Espresso - caffeinated (DV)

...and the Decadent Vapours post - likely Peter who owns DV (was Nick O'Teen when he posted here).

 

[rosesense]

Does anyone know what announcement about A Billion Lives is coming tomorrow? FB says watch your email.

 

[seminolewind]

Haven't heard a thing.

 

[seminolewind]

Rosesense, is that a David Austin rose?

 

[sonicdsl]

If, as the linked article suggests, this judge still doesn't understand the difference between open and closed system products and plaintiffs' counsel failed to explain it to her, there's a serious and fundamental problem with the way this case is being presented.

I was glad the judge expressed interest in whether the FDA was required to conduct a cost/benefit analysis because the FDA's cost/benefit analysis was essentially nonexistent. If she concludes that it was required, she'll rule for the plaintiffs. Of course, an argument can be made that it isn't required because the enabling statute (FSPTCA) doesn't specifically require it. The counter-argument is it does require that any regulation must be "appropriate," and how can the FDA determine if it's appropriate without a cost/benefit analysis?

That said, I wouldn't try to predict how this is going to turn out based on what transpired yesterday. You can't tell how a judge is leaning based on questions asked at oral argument. I've argued cases in all levels of state and federal courts with the sole exception of the SCOTUS, and I've learned not to read anything into the questions asked or how they're asked. Many judges will question what later turns out to be the winning side much more aggressively.

Also please bear in mine that this case will be reviewed all over again ("de novo") in the Circuit Court of Appeals. New briefs will be written and new oral arguments will be presented. On appeal in cases of this kind the district court's ruling is entitled to zero deference.

Thank you @bigdancehawk for your thoughts on the oral arguments. Your insights are valuable, as always!

 

[rosesense]

Rosesense, is that a David Austin rose?

Yes, it is...good eye.

 

[salemgold]

Does anyone know what announcement about A Billion Lives is coming tomorrow? FB says watch your email.

No. I have been looking for the announcement with anticipation though.

 

[rosesense]

No. I have been looking for the announcement with anticipation though.

Apparently, FB was censoring the postings so they are sending info via email. Anyone interested will need to sign up at A Billion Lives.

 

[Fozzy71]

No. I have been looking for the announcement with anticipation though.

Apparently, FB was censoring the postings so they are sending info via email. Anyone interested will need to sign up at A Billion Lives.

Or follow the billion lives thread where people post the emails - Billion Lives Needs Help

 

[salemgold]

Apparently, FB was censoring the postings so they are sending info via email. Anyone interested will need to sign up at A Billion Lives.

Oh, I have been signed up with them for months now
Got the email earlier today.

They tried to bury us


I was worried.

Big organizations were trying to bury us. Facebook was unfairly censoring our posts, making them unseen to the public we were trying to reach. Big Hollywood companies were mysteriously "not interested" after expressing strong support. Our small team starting facing burnout and fatigue.

It wasn't looking good. We fell about a month behind our planned release schedule.

But you stuck with us.

You lifted us up. Many of you volunteered to help.

You made a lot of noise and caught the attention of two distribution companies called Tugg & Demand.Film.

The only thing we needed now were some big publicity events to make a successful partnership with them possible. Without a massive marketing budget, we needed big premiere events in Hollywood and New York City to get the media behind us and lead to wider distribution in theaters, TV, and streaming services.

To the Rescue

After our successful North American Premiere, I watched my best friend's mom (who smoked two packs a day) quit smoking. She was at our after-party and she picked up one of the Von Erl (a party sponsor) vapor devices and tried it. I know many folks think flavors are only for kids, but she loved the chocolate flavor so much she quit smoking on the spot.

The reaction was priceless.

Months later, she has quit for good, so did her husband (who now has a new mod). Their family has gone through a revolution and my best friend will have his parents around for many more years.

959,999,956 lives left to save.

When I told that story to Günter (CEO of Von Erl) over Skype, he told me that's why he got into this business. He asked if he could sponsor our Hollywood Premiere Global Launch Party to help make it an effective event and reach even more people with the truth. He also asked if we could do the same in Berlin. He lives in Austria and really wanted to see the movie in German for his neighbors and loved ones to know the truth.

I said yes, and today after all the worries and hard work and waiting, we can finally announce that this film is going to be seen on hundreds of screens worldwide and will be covered by some of the most prestigious press outlets on the planet.

What they say about this movement will largely be based on what happens in the next 10 days.

The battle truly begins today.

The Plan

Life-saving vapor technology has a PR problem. It's been beaten steadily for the past several years and most of the public thinks it's harming society, addicting children, and supporting Big Tobacco.

Consequently, politicians who are mainly focused on getting re-elected are bullied and threatened by Big Pharma-funded "non-profit" organizations to go along with the bans, restrictions, and extreme taxes.

We need to get the truth out...and we need to do it now.

Our PR team in Hollywood is busy pitching more news outlets and managing our VIP list so that we can make the maximum impact with our message. Jeff Stier and the NYC organizing committee he assembled is doing the same in New York.

We need some help. The majority of big film critics and reporters will only write about something big. Netflix only wants big movies.

We need to get "big". That means box office sales.

Through our relationship with Tugg, we now have 95% of theaters in the entire US willing to show A Billion Lives. The only catch is that we need:

1) An organizer (it's easy and we give back 5%)
2) About 100 tickets reserved at each theater

We also have a similar arrangement through Demand.Film for the United Kingdom, Australia, New Zealand, and Ireland. If these go well, more countries will be added.

If you'd like to see the life-saving truth spread, then please buy tickets right now. The media is watching. Invite your loved ones. Invite your leaders. Invite your neighbors.

Theaters are the best place for community education.

October 26th is our global launch day. We will kick off the launch with our Hollywood Premiere at the famous Cinerama Dome Theatre on Sunset Blvd and a smaller after-party on top the W Hollywood Hotel for invited media, celebs, and special guests.

We'll use that time to make sure the message is heard.

We'll have a huge red carpet at the theater for media to get pictures and footage of the attendees. Getty will be there. LA Weekly will be reviewing the film. It's on the calendar for the LA Times. Other media (reporters, magazines, bloggers, etc.) seeking passes to the red carpet are asked to contact Press@ABillionLives.com.

If you have a potential VIP guest that can help bring attention to our fight for truth, please contact LA@ABillionLives.com. I'm saving some seats for anyone that can bring more celebs.

Sadly, that's the only people the public listens to anymore...which is why this Hollywood Premiere is so vital.

We're also reserving complimentary premiere tickets for the following:

• Anyone who organizes a showing through Tugg or Demand.Film
• Anyone that adopts one of four screenings per day at the Laemmle Music Hall in nearby Beverly Hills
• State leaders for the independent Hands for a Billion Lives silent protest event
• Volunteers

Two days later on October 28th, we'll be headed to NYC for our New York City Premiere and Media Panel at the Cinépolis Chelsea. Thanks to planning committee chairman Jeff Stier, this event will be a massive success. I'll be interviewed on The Street TV. The New York Times will be covering the film, so will The Village Voice. Others are RSVP'ing as I type this.

After the premiere, we'll have a panel for the media that is moderated by a Forbes writer, including: "Winston Man" David Goerlitz, Dr. Sally Satel MD, and myself.

I will be reserving tickets for media (contact Press@ABillionLives.com) and anyone who adopts (buys a block of tickets and help promotes it) one of four screenings per day at Cinépolis Chelsea on October 28th to November 4th.

Tickets are now on sale for the NYC Premiere & Panel at 8:00pm and subsequent showings (click here). Search for Cinépolis Chelsea and the date (October 28th and beyond).


The Battle for #ABillionLives

After NYC, we begin one of the most difficult battles of this entire journey. We head to India to fight for truth at the World Health Organization FCTC COP7, which is responsible for the bans popping up around the world.

They're protecting cigarettes and we've got plans to make sure the world knows it. The majority of the billion deaths will happen on their watch, and it's time to bring them out of their secret shadowy meetings.

Stay tuned.

Upcoming dates (more details soon):

November 9th - Delhi, India
November 12th - Budapest, Hungary
November 14th - Oslo, Norway
November 16th - Tallinn, Estonia (PÖFF)
November 19th - Berlin, Germany (after-party sponsored by Von Erl & Innocigs)


Tl;DR?

Basically, this entire email boils down to this:

1. Help organize a screening in your US city (other countries click here).
2. Buy tickets throughout the entire US at Tugg, Laemmle (LA), or Cinepolis (NYC) theaters.
3. Invite your neighbors and loved ones.
4. Promote any positive press
   we get to build momentum. Facebook is censoring our big posts.
5. Get ready for a wild ride this fall!

We're going to win this battle!


See you at the movies!
- Aaron Biebert & the team

Copyright © 2016. All Rights Reserved.

 

[seminolewind]

Yes, it is...good eye.

Give me a few weeks (not internet) to try to recall the name. Don't tell me yet. 1st guess, Sharifa asma ?

 

[rosesense]

Give me a few weeks (not internet) to try to recall the name. Don't tell me yet. 1st guess, Sharifa asma ?

No, but good guess.

 

[salemgold]

Getting closer...

After my email last week, you responded strongly and organized a great launch day on October 26th!

New Zealand
6:10pm Hastings, Hawke's Bay

Australia
6:30pm Glendale, New South Wales
6:30pm Adelaide, South Australia (14 left)
6:30pm Bundaberg, Queensland (7 left)
6:30pm Perth, Western Australia

United Kingdom
8:30pm Glasgow (27 left)

United States
6:30pm Hollywood, CA
8:30pm Orlando, FL (Sold out!)
8:30pm Dallas, TX (Sold out!)
7:30pm Phoenix, AZ
7:30pm Carlsbad, CA
8:00pm New York City (October 28th)


The Second Wave

People always ask "How can I help fight?"

I always responded: "We don't need money, we just need you to help get the word out."

Sadly, the launch showings above aren't going to be enough to wake up the media and politicians. We need more, or they will dismiss this message as a "niche film".

Thankfully, our supportive community is planning a second wave of theater showings and in the next couple days we have to demonstrate adequate demand for the movie (and our message) or they won't be approved by the theaters.


I hate to ask, but it's really important

In the US alone, there are about 70 screenings that can only happen if we get enough tickets reserved. Some only have a couple days left before the deadline so it can be shown before the US elections.

Click the map below to find one near you and buy some tickets.

Give them to a smoker.
Give them to a loved one.
Give them to your customers.
Give them to your doctor.
Give them to your media.
Give them to your politicians.

The theater is a safe place for the community to learn. This is our best chance at making an impact.



Click here to see available US showings


There are about 30 more in the other three countries below. Please help spread the word about the showing near you, buy tickets, or organize a showing in your city if there isn't one.

Ask me if you need help.

We're only going to get one chance at this. The media is watching. The politicians are watching.

Now's our chance.





Potential United Kingdom Showings

Odeon Cinemas through Demand.Film is bringing you a special message from our team before each showing.

Please purchase tickets below and show Odeon that their choice to support our life-saving movie was a good investment.


5 Days Remaining

1 Nov at 6:00pm Tamworth, Staffordshire (Birmingham)
1 Nov at 6:00pm Worcester , Worcestershire
1 Nov at 8:30pm Lincoln, Lincolnshire
3 Nov at 6:00pm Newark, Nottinghamshire
3 Nov at 6:00pm Bracknell, Berkshire


12 Days Remaining

7 Nov at 8:30pm Bristol, Gloucestershire
14 Nov at 6:00pm Belfast, Northern Ireland
16 Nov at 6:00pm London
16 Nov at 6:00pm Hatfield, Hertfordshire
23 Nov at 6:00pm Swansea, Glamorgan


Not in your city?

Bring it to your city (risk free) and we'll give you 5% back to give to an advocacy organization of your choice.





Potential Australia Showings

13 Days Remaining

6 Nov at 4:00pm Launceston, Tasmania
9 Nov at 6:30pm Hornsby, New South Wales (Sydney)
9 Nov at 6:30pm Parramatta, New South Wales(Sydney)
9 Nov at 6:30pm Sydney, New South Wales
9 Nov at 6:30pm Canberra, Australian Capital Territory
9 Nov at 6:30pm Wollongong, New South Wales
9 Nov at 6:30pm Brisbane City, Queensland
16 Nov at 6:30pm Taylors Lakes, Victoria (Melbourne)

Not in your city?

Bring it to your city (risk free) and we'll give you 5% back to give to an advocacy organization of your choice.







Potential New Zealand Showing


6 Days Remaining

2 Nov at 8:00pm Tauranga, Bay of Plenty

Not in your city?

Bring it to your city (risk free) and we'll give you 5% back to give to an advocacy organization of your choice.


Summary

1. Buy tickets at the links above.
2. Help organize a screening in a new city the US. Or bring it to a new city in the UK, Australia, and New Zealand by clicking here.
3. Buy tickets throughout the entire US at Tugg, Laemmle (LA), or Cinepolis (NYC) theaters.
4. Invite your neighbors and loved ones.

If we're going to win this battle, now's the time to help us make news. We're close, but need to get all these screenings approved.

Thanks for fighting with us!
- Aaron Biebert & the team

Copyright © 2016. All Rights Reserved.

 

[Mazinny]

Dimitris' thoughts on the oral arguments ( starts about minute 14 ) :

Smoke Free Radio Network

Cliffs if you don't want to listen to it :
- Judge was very thorough and asked over 100 questions
- Nicopure attorneys got blindsided in the first 30 minutes or so, but recovered and were a lot better later on. He was a lot more complimentary of the R2b smokefree attorneys.
- Judge flat out declared that it is not within her power to change the predicate date. Only congress can do that.
- Based on his interpretation of questions asked, he thinks the FDA is favorite to win on the 1st amendment, modified risk claims, and free sampling.
- We have a lot better shot on winning on the PMTA issue. The judge grilled the FDA on that issue relentlessly. At one point she even said " It seems that you have set up the industry to fail ". He said those were her words verbatim.

 

[Eskie]

Dimitris' thoughts on the oral arguments ( starts about minute 14 ) :

Smoke Free Radio Network

Cliffs if you don't want to listen to it :
- Judge was very thorough and asked over 100 questions
- Nicopure attorneys got blindsided in the first 30 minutes or so, but recovered and were a lot better later on. He was a lot more complimentary of the R2b smokefree attorneys.
- Judge flat out declared that it is not within her power to even consider changing predicate date. Only congress can do that.
- The FDA is favorite to win on the 1st amendment, modified risk claims, and sampling.
- We have a lot better shot on winning on the PMTA issue. The judge grilled the FDA on that issue relentlessly. At one point she even said " It seems that you have set up the industry to fail ". He said those were her words verbatim.

So, assuming this is a proper reading of the tea leaves, claims and sampling regs are likely to stand, hardly terrible aspects. A finding that the PMTAs in their current form are overly burdensome would be helpful to the industry. Two actions in Congress right now, H.R. 2058 and the Cole Bishop amendment are likely to address the predicate date issue if passed. Pretty much the same mixed bag we've been stuck with.

Now we continue to wait.

@Mazinny thanks for the Cliffs version. Saved us a lot of time, and appreciate the effort.