AbillionLivesFilm – Spread the word on SM

AbillionLivesFilm – Spread the word on SM

And so it begins…

Admit it, you were curious if we could actually pull this off. You probably even thought I was a bit crazy.

“A film about vaping in theaters?”

Well, check out that map we created together!

Today another wave of theaters begins to tell this story to thousands of people. Vapers and former vapers are bringing smokers. Smokers are quitting. They are bringing their loved ones. One sold out show even had scalpers selling tickets for 300% above cost!

The truth is getting out.
Hollywood Premiere

Three ways to help make it grow

1) Purchase tickets today for yourself, your customers, or your loved ones to make sure the message gets out and hosted screenings get enough reservations. Share this new Facebook post.

Many businesses that make the tools smokers are using to quit are forbidden from telling the truth, but A Billion Lives gives them a voice. Use tickets as prizes or giveaways. Educating your community is good business.

Click here to search the map for available showtimes near you. Some of the screenings will be out of tickets today. If that happens, don’t worry (or buy from scalpers), check out #2 below.

Some screenings in smaller markets still need to hit their minimum ticket numbers by the deadline. You can see how much time is left by clicking on the event nearest you.

Please help find shops or groups interested in making each event hit the minimum so the members of the public and media that reserved a ticket are able to see the film.

This is the best chance we have to reach the public since it’s hard to invite them to your home. If the minimum is not reached, nobody is charged…and nobody sees the movie.

2) Host a screening in your city. It’s free to setup. The theater only requires about 100 tickets reserved by the deadline to make it happen. Nobody gets charged if it doesn’t happen. Risk-free.

Buy all the tickets and have a company holiday party for your shop or business. Some of the options are dinner theaters.

Tis the season to invite those who spend Thanksgiving & Christmas arguing about this topic. Not only will A Billion Lives settle the argument, but we also give 5% back to the organizers to support advocacy efforts or conduct research.

We have a facebook group to help.

Charles Ploski is doing a tremendous job volunteering to help make this successful. It’s in 20+ cities only because he offered to help in cities where someone didn’t organize a screening.

If you have a question about how to bring the movie to your city, please join our group that Mike started and ask for help.

3) Support us on social media during our current world tour and help bring awareness to the issue. Keep sharing our posts and leaving comments. The media is taking note.
Here’s a recap of what we’ve done and where we’re going:
Toronto – Oct 21

The Hot Docs theater was packed for our Canadian Premiere. The after-party was also a ton of fun. We did a bunch of Canadian press and received great news about bringing the movie to more places in Canada.

Stay tuned for more word there!

A Billion Lives on BNN in Toronto
Hollywood – Oct 26
The Hollywood Premiere and Global Launch Party was amazing. You can watch my live coverage of the red carpet and search for pictures on Getty Images (we’ll post them on Facebook soon). Big thanks to Von Erl & friends for hosting an epic party afterwards with many familiar Hollywood faces.
This came out the next day
New York City – Oct 28
Thanks to help from Jeff Stier and the organizing committee, we had an amazing evening at our sold-out New York City Premiere at the Cinepolis Chelsea. I got to hang out with media legend Joey Reynolds and former New York Yankees Cecil Fielder and Jim Leyritz.
We finished the evening with a talk back panel including myself, “Winston Man” David Goerlitz, and Dr. Sally Satel MD (AEI & Yale), which was moderated by Jared Meyer (Manhattan Institute & Forbes).
NYC Premiere Panel Discussion
New Delhi, India – Nov 9

I just got home for a few days before we head to New Delhi for our Indian Premiere at the Ojas Art Center. The World Health Organization is holding their secret Framework Convention on Tobacco Control meeting during the US elections and will bar media from attending the majority of meetings.

Why?

Word on the streets says they will vote to ban the use of safer vapor technology products in countries worldwide.

Not only did we make a new trailer about this battle, but we’re bringing “Winston Man” David Goerlitz with us (and to the events below). He was given a medal from the WHO for his role in helping fight cigarette smoking.

Wait until you see what he does with it…

If you’re going to India to help fight, I’d like to invite you to join us for free at our premiere. I have about 20 tickets reserved for my guests. Reply if you’d like to join us.

Lots of amazing advocates will be there.

Click here to watch the new trailer
Budapest, Hungary – Nov 12
After India, we are proud to have our Hungarian Premiere in one of the most beautiful theaters in the world. It will be in English, with Hungarian subtitles.

Robert Bernarius & Krisztian Pifko have been working tirelessly with the community there to plan this spectacular event. Hungary has been one of the most active international #ABillionLives communities and had almost 2500 Facebook fans within a month of starting.

We are very excited to finally meet our new friends there!

Urania National Film Theatre
Oslo, Norway – Nov 14

Lisbet (our active Norwegian coordinator) is one of the best examples of a non-industry person who quit smoking through the use of vapor technology and is now volunteering to get the truth out there.

She’s worked tirelessly, advocating not only for Norway, but also for nearby Sweden and the rest of the world.

I am very excited to see Norway and meet the other amazing people who are helping their neighbors.

If you’re in the area, come watch the movie with us. Here’s the link to buy tickets. It will be in English, with Norwegian subtitles. We’ll be hanging out afterwards, so plan on making a night of it.

Tallinn, Estonia – Nov 16

We are honored to be invited to the largest film festival in Northeastern Europe, the PÖFF Tallinn Black Nights Film Festival.

Thanks to Ingmar and the community in Estonia for helping invite influential people to our Estonian Premiere.

Buy tickets here (presented in English).

Berlin, Germany – Nov 19
This has been a long time coming. Support in Germany, Austria, and Switzerland has been amazing. The German-speaking community has been our #1 international group with the largest Facebook page and dedicated group.
Our entire European language volunteer team started more than a year ago with Anja, a volunteer in Germany. Now look at how far we’ve come!

I was struggling to find a way to make something special and Günter from Von Erl stepped up to co-sponsor the special after-party with InnoCigs. It’s going to be a very special night, and the beginning of bringing the movie to a wider German-speaking audience.We will have our German Premiere at the famous Kino International in Berlin. There will be two sessions to give more of our German friends opportunities to see the movie in German for the first time.

If you can join us, there are some tickets available still. The first event will be a formal premiere and the second will be a less-formal event. Both will end across the street at the Avenue Club.

Kino International is iconic for movie premieres

After that is Thanksgiving in the US and then it looks like I might be back to Europe again for Portugal, Sweden, Spain, Denmark, and Croatia. We’ll keep you updated.If you’ve read all of this, thanks for caring so much. I just stayed up all night writing/designing this, so hopefully it all makes sense.

Talk soon,

– Aaron Biebert
 
 

 

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Copyright © 2016. All Rights Reserved.

Nevada Vapers: Help Save A Billion Lives

Nevada and U.S. Vapers: Save A Billion Lives

Hello Vape Warriors!. This is J.G., founder of VSLLC, asking you to join me and other vape warriors in joining hands at the “Welcome to Las Vegas” sign on the south strip. We will meet under the sign on Oct 22, 2016, 2:22pm at the sign located on the center median of the southern strip, near Mandalay Bay Casino Hotel. Please join us. For more information, please write an email to: [email protected] We look forward to seeing you vaping and advocating there.

We’re excited to inform you that these 2 exciting events are coming to NYC this month!
Join Us to Save A Billion Lives this Century

Tobacco related illnesses are projected to claim a billion lives this century. The FDA Deeming Regulations threaten to shut down 99% of the vaping industry within the next 2 years. Please help us to oppose this by joining hands on Saturday, October 22 to for a wall to protect a billion lives!

Read details about NYC’s event here. If you are planning to attend, please RSVP on the event page.

  This is a nation-wide event. If you do not live in the NY tri-state area, please  find a local rally near you. They are being added all over the US.

Start time is 2:22 PM when will all form a line side by side to stretch as far as we can. Silently.
You will be a part of history. Make that history positive and make it count! A billion lives are counting on you. Including your own!

Get Your Tickets Now!

A BILLION LIVES
New York City
Premiere & Panel

Friday, 10/28
8:10 pm
Cinépolis Chelsea


Award-winning “A Billion Lives” is kicking off its worldwide theatrical release on Friday, October 28, 2016, with a one-week limited engagement playing in New York City at the Cinépolis Chelsea until November 4th.  

To kick off this special engagement, members of the media and concerned thought leaders are invited to join award-winning Director Aaron Biebert for an exclusive screening and panel discussion with  “Winston Man” and Dr. Sally Satel about saving a billion lives. National Center for Public Policy Research’s Jeff Stier will Chair New York City and host the panel immediately following the viewing.


Our fight is heating up. With the election around the corner, we need vapers to contact their Congressmen and Senators to urge them to support our cause before the FDA regulates the vaping business out of existence.  Vapers need to educate themselves about how their local, state and federal legislators stand on the issue of vaping. Please ask your federal representatives to support HR2058 and the Cole-Bishop amendment which would move the predicate date and allow products on the market now to remain on the market.

It’s easy – visit
www.august8th.org. And ask your friends and family to do the same!

We hope to see you in the city later this month!

Sincerely,

National Vapers Club

National Vapers Club, 108 Adee Street, Port Chester, NY 10573

ABillionLivesFilm Premieres all over the U.S.A.

ABillionLivesFilm Premieres all over the U.S.A. and most other countries

Help ABillionLivesFilm and reserve your tickets in your area now!

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 [email protected].
If you have a potential VIP guest that can help bring attention to our fight for truth, please contact [email protected]. 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:

Two days later on October 28th, we’ll be headed to NYC for our New York City Premiere and Media Panel at theCinépolis 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 [email protected]) 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 at8:00pm and subsequent showings (click here). Search forCinépolis 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
 Like us on Facebook   Follow us on Twitter   View our videos on YouTube   View on Instagram

Copyright © 2016. All Rights Reserved.

VapeSling® V3.0 Released 10/1/16

VapeSling® V3.0 Released 10/1/16

VapeSling

VapeSling® V3.0 Released 10/1/16

v3anatomy
v3anatomy

As of October 1st, 2016, all our VapeSling LLC Facility is producing V3.0 Webbed Slings. No, Spider Man is not endorsing us, but that would be cool. Anyway, VapeSling® V3.0 Webbed Slings are the only, secure “Vape-On-THE-GO” mod holders. Reliable and more comfortable than ever. 1.5″ wide webbing.

Your V3.0 Web Slings are covered by our VapeSling® Lifetime Guarantee. You won’t need it, as we expect 0% breaks. All our slings are reliable, however, this version is exceptional. Reliability extends beyond your Mod/Vape weight.

Starched fabric (for wrinkle free flatness) sewn into reinforced edges (Black Gross-Grain) leading to the VapeSling® proprietary cradle (Black VS Logo flap). All Cradles are sewn with a triple stitch square around the VS logo. You can literally pull a truck with your V3.0 sling. Our point: Your sling will last and secure your mod forever!

Your V3 Sling is completely washable as well as heat resistant.

Currently, V3.0 offers 3 types in 9 colors:

The HandCheck

handcheckv3front

Average Joe™ (Neck Sling)

averagejoefront

MODster™ (Cross-Body)

modsterv3fronta

Enjoy a new level of comfort and convenince with your new V3.0 Web Slings

VapeSling

Please subscribe to our Website to receive VapeSling® Latest news on products and Vaping advocacy

© 2016 VapeSling® | All Rights Reserved

Construction Complete! Oct 1st Release: VapeSling® V3.0

Construction Complete! Oct 1st Release: VapeSling® V3.0

slow_wzonev3_2016

We are back!!!

Thank you for your patience with our 3 week expansion/construction.

While away, we developed another great VapeSling® Version.

Enjoy Slinging with the new VapeSling® V3.0 1 1/2″ wide sling.

The comfort level of Vaping just went to 11. Reliable, strong, as well as comforting, your VapeSling®  V3.0 will be your newest best friend.

For those that continued to read, VS subscribers, and/or regular Sling blog readers, congratulations: You are invited to try our new release, VapeSling® V3.0, at 10% off plus free shipping.

On Oct 1st release date, and while it lasts (1st 10 slingers), can use Checkout code: tryv3 when you choose any sling type in the V3.0 line.

Coupon Note: 1st 10 Slingers; Coupon will be valid on Oct 1st at 12AM PST, for any VapeSling® V3.0 purchase; V2.1 purchases will process with regular prices.

Send Senator Johnson a Thank You Letter

Send Senator Johnson a Thank You Letter

Send Senator Johnson a Thank You Letter

Senator Ron Johnson (WI) is taking the Food and Drug Administration (FDA) to task over the impact of the “deeming rule” on small to medium vapor businesses across the country. Sen. Johnson, Chair of the Senate Committee on Homeland Security and Governmental Affairs, has sent several letters to the FDA requesting to see, among other things, their calculations regarding the number of vapor businesses that would be forced to close as a result of the deeming rule.

 

The FDA has rebuffed his request for information.

 

From CASAA’s perspective, the independent vapor shop is vital for ensuring consumer access to a wide variety of vapor products, as well as for helping smokers successfully transition to smoke-free products. Without a doubt, the FDA regulations will kill the diverse vapor market, which will lead to thousands of vapor shops closing. Senator Johnson is working to prevent that.

 

Please take a moment now to send Senator Johnson a thank you letter.

 

Click here to say,

“Thank you for standing up for vaping.”

 

(For a pre-written letter that you can print and send, click here. To edit this letter, make a copy in google drive and then include your additions)

 

If you live outside of Wisconsin or would prefer to write a letter by hand,

please send it to:

 

The Honorable Ron Johnson

517 East Wisconsin Avenue

Suite 408

Milwaukee, WI 53202

 

If you are collecting many letters to send off to the senator, please share a photo of your effort on social media. Use the hashtags #AnswerRonJohnson and #WeAreVapor

 


 

(Writing Tip #1) If you have a lot to say, please craft your email in a separate word doc and then copy/paste it into the field provided.  If you take too long, they system will time out and you will lose your work.

(Writing Tip #2) Although we’ve provided a prewritten email with compelling talking points, we would strongly encourage you to edit the email because personalized communications to legislators are far more persuasive than form letters.  At a minimum, PLEASE INCLUDE YOUR PERSONAL STORY (just a few sentences) in the text of your email.

 

 

Vape Call To Action AUG2016

Vape Call To Action AUG2016

Or 
Print Flyers for your Vape Shops here-—> Flyer – Do you Like to VapeCasaa Flyer

fifteen-minutes-flyer

Posted Aug 17th

http://casaa.org/call-to-action/local-alert-allegheny-co-pa-take-action-to-oppose-an-indoor-vaping-ban-2/

Posted Aug 16th

Send Sen. Ron Johnson a Thank You Letter, prepared by CASAA. All American and planetary vapers can send the letter.

Wisconsin has the convenient electronic method. As a vaper, you know your duty. Send yours now.

Posted Aug 8th

Monday, August 8th, 2016 marks the start of a two-year countdown to the FDA’s near prohibition of 99% of vapor products currently on the market. To prevent this, we have a specific ask of congress to update the 2007 predicate date to 2016. This is a necessary first step in a larger legislative battle to keep the diverse range of vapor products available.

Take action TODAY by calling your congressman and urging them to support a change to the predicate date in the tobacco control act.

 

For contact information and points to discuss on the call,

click here to Take Action!

 

Thank you,

CASAA Legislative Team

 

 

Posted July 21st
Credit to @tw11tch of IG for preparing this letter:
Please download and send this prepared letter or your own to  Sen Johnson—->SenJohnsonLetter
Send to:

Sen. Ron Johnson

328 Hart Senate Office Building

Washington, DC 20510

Posted July 19th
Posted July 18th
Sun Jul 17 2016 at 8:31 am PDT [email protected] (Alex Clark)
[Update – 07.17.16] On Wednesday, July 13th, 2016, the Pennsylvania legislature chose to protect…
Posted July 8th
Posted July 1st  2016
Until further notice, the following 4 items are the main Calls To Action for our Vaping community.
Sun Jun 19 2016 at 8:07 am PDT [email protected] (Alex Clark)
Updated – 05.18.16 CASAA is urging our members to support both HR 2058 and the Cole-Bishop…
Posted July 18th
Sun Jul 17 2016 at 8:31 am PDT [email protected] (Alex Clark)
[Update – 07.17.16] On Wednesday, July 13th, 2016, the Pennsylvania legislature chose to protect…

VapeSling® V2.1 Released 8/3/16

VapeSling® V2.1 Released 8/3/16

VapeSling

VapeSling® V2.1 Released 8/3/16

As of August 3rd, 2016, all our Slings are sewn in our VapeSling LLC Facility. VapeSlings will no longer use Knots as fasteners, rather permanent, durable, and reliable stitching.

No more worries of knots becoming undone in extreme heat nor moisture. Your Lifetime Guaranteed Sling is now washable as well as heat resistant.

VapeSling® V2.1 Released 8/3/16 is even more durable and reliable than before. We fasten your Sling cradle, using the paracord color of your choice (as shown in the pictures below), with black thread for cosmetic purposes.  After weaving thru the upper apertures, the cording is sewn onto the tough 4 layer (2 PVC layers) canvas cradle (Flap that holds your mod). For extra strength, we use multiple stitches on both fasteners till the cording becomes one with the canvas.

Your new V2.1 Sling will hold well over a 70 lb. load.

BackV21Avg
BackV21Avg Paracord Stitch
V21frontAvg
V21frontAvg Paracord Stitch

Get yours now at this link—>Click Here

VapeSling

Please subscribe to our Website to receive VapeSling® Latest news on products and Vaping advocacy

© 2016 VapeSling® | All Rights Reserved

Sen Ron Johnson: Fights FDA Vapor Regs

Sen Ron Johnson: Fights FDA Vapor Regs

Chairman Johnson Demands Further Answers from FDA on E-Cigarette Regulations

Please help if you approve of Vapor products as a Life saving and/or Harm reduction industry.
Credit to @tw11tch of IG for preparing this letter:
Please download and send this prepared letter or your own to  Sen Johnson—->SenJohnsonLetter
Send to:

Sen. Ron Johnson

328 Hart Senate Office Building

Washington, DC 20510

WASHINGTON —  Sen. Ron Johnson, chairman of the Senate Homeland Security and Governmental Affairs Committee, demanded further answers from the FDA on Friday after sending a third letter to FDA Commissioner Robert M. Califf seeking information on the recent e-cigarette regulation.

Johnson raised concerns in May about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.

“In my initial letter, I asked the FDA for data on the number of e-cigarette businesses that will be affected by the rule,” Johnson said in the letter. “The FDA gave an inadequate response that lacked the requisite details.  Further, the FDA noted that it did not possess some important information about the economic effect of the rule, writing that ‘[t]he baseline number of manufacturers and importers of [e-cigarette] products is uncertain.’  The FDA’s acknowledgement that it has, at best, incomplete information raises questions about the adequacy of the FDA’s justification for the rule.  Further, many job creators in the e-cigarette industry fear that they will be forced to shut down if the rule is implemented.  Without a concrete understanding of the rule’s effect on growing industry, the FDA’s decision to implement this regulation could lead to the elimination of thousands of jobs and businesses.”

The FDA responded to Chairman Johnson’s inquiry on June 16, 2016 with insufficient answers. On July 8, 2016 the FDA provided the Committee with an initial document production consisting of materials that were already publicly available.  Johnson originally sent a letter to FDA Commissioner Robert M. Califf about the e-cigarette regulation on May 17, 2016 and then sent a second letter to the FDA on June 6, 2016.

The FDA’s June 16, 2016 response can be found here.

The letter can be found here and below:

July 15, 2016

The Honorable Robert M. Califf, M.D.

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Califf:

I write to reiterate my request for information about the U.S. Food and Drug Administration’s (FDA) regulation over e-cigarettes and its potential consequences.  I first wrote to you on May 17, 2016 requesting information and data regarding the consequences that this new regulation may have on small businesses and the public’s health.   After I did not receive a response, I wrote a follow-up letter on June 6, 2016 that reiterated my initial questions and requested documents and materials based on FDA communications relating to the regulation.  The FDA provided partial responses on June 16, 2016 and July 8, 2016.   The FDA’s answers to my questions, however, provided only limited new information, and the FDA did not provide a complete document production.   While I appreciate the FDA’s offer of a briefing, the Committee must first possess the full universe of requested documents and materials to fully understand FDA’s decision-making process.  Therefore, I write to again reiterate my requests.

In my initial letter, I asked the FDA for data on the number of e-cigarette businesses that will be affected by the rule.   The FDA gave an inadequate response that lacked the requisite details.  Further, the FDA noted that it did not possess some important information about the economic effect of the rule, writing that “[t]he baseline number of manufacturers and importers of [e-cigarette] products is uncertain.”

The FDA’s acknowledgement that it has, at best, incomplete information raises questions about the adequacy of the FDA’s justification for the rule.  Further, many job creators in the e-cigarette industry fear that they will be forced to shut down if the rule is implemented.  Without a concrete understanding of the rule’s effect on a growing industry, the FDA’s decision to implement this regulation could lead to the elimination of thousands of jobs and businesses.

Additionally, I asked whether the FDA would issue a revised rule if sufficient data demonstrates that e-cigarettes are a safer alternative to traditional cigarettes.    The FDA did not answer this question.  Instead, the FDA gave an ambiguous answer, reasoning that the FDA must regulate in order to obtain more information about e-cigarettes.  The FDA stated:

The rule is the beginning of the process of the regulation of e-cigarettes, and the other products covered in the final rule.  That regulatory framework will evolve over time as we learn more about the products.  Now that FDA will finally have regulatory authority over these previously unregulated products, the Agency can expand its knowledge base regarding these products.

The FDA’s statement is concerning.  Rather than conduct research to better understand the effects of the product prior to regulating, the FDA chose to issue a rule without a proper understanding of the product itself.  Because federal regulatory agencies seldom shrink their own jurisdiction, the FDA’s action could result in a far-reaching regulation that fails to consider the regulatory impact on small businesses selling e-cigarettes, product innovation, and the public’s health.

I also questioned the FDA about the potential unintended consequences of its rule that may result in decreased access to e-cigarettes and increased consumption of traditional cigarettes.   The FDA responded by citing to a scientific paper that concluded that the decline in adolescent smoking rates slowed in states that enacted restrictions on access to e-cigarette products.   However, the FDA also cited “several limitations” with the study.   The FDA states that it “acknowledges this paper as a first attempt to study the potential impacts of youth [e-cigarette] access restrictions, but more research will be necessary to explore the potential effects of this rule on product switching or dual usage.”

In addition to asking the FDA to respond to several questions, I also requested documents and communications referring or relating to the FDA’s regulation of the e-cigarette industry.  On July 8, 2016 the FDA provided the Committee with an initial document production that consisted of materials that were already publicly available.   Based on conversations between my staff and the FDA, I am willing to accommodate the FDA’s request to prioritize the production of certain material.  As discussed between our staffs, I ask that the FDA initially prioritize its production of documents and communications referring or relating to the FDA’s interactions with industry, advocacy groups, government entities, and other stakeholders as the FDA developed its regulation.

The American public deserves complete answers from the FDA about its rulemaking.  The information and material that I requested from the FDA will help to inform the Committee’s oversight responsibilities and address the public’s concerns about the e-cigarette regulation.  Therefore, I request that you please provide complete responses to my prior letters as soon as possible but no later than 5:00 p.m. on July 29, 2016.  Thank you for your attention to this matter.

Sincerely,

Ron Johnson

Chairman