FDA Deeming updates VTA issues FDA regulations calendar

[Kent C]

I have occasionally felt the need to cross reference zip codes and addresses. I've found it isn't too hard using these two websites. Google maps has also come into play a few times.

Yeah, I thought of doing that then didn't feel that good about using someone else's address. Zipcode was as far as I could go :- )

 

[ZCAR1]

"Yeah, I thought of doing that then didn't feel that good about using someone else's address. Zipcode was as far as I could go :- )"

That was was my 1st thought also: getting a little too close to ID theft.

 

[Lessifer]

Yeah, I thought of doing that then didn't feel that good about using someone else's address. Zipcode was as far as I could go :- )

You could always use Yelp to find an apartment building... then you wouldn't be using anyone's "complete" address, if you still wanted to do it.

 

[Ryedan]

Yeah, I thought of doing that then didn't feel that good about using someone else's address. Zipcode was as far as I could go :- )

I hear ya and also had the same thought but decided to toss it out there anyway just in case it might help in some way. They can also pretty easily figure out where the email came from if that is not dealt with.

I blame it all on my geeky nature

 

[zoiDman]

I totally agree zoiD!
What sucks though is by them getting what they deserve ultimately affects the rest of us!
Of all the vapers I personally know, only my wife answers the calls to action and sends emails and letters.
The rest couldn't be bothered. I can't even get my 23 yr old stepson to lift a finger. He's really good at shrugging his shoulders though!
I hope they're not counting on me to keep them stocked, they're in for a rude awakening.

I hear you. Because I know a Lot of People like your Stepson.

And I tend to be Very Careful around them when they Get Wound up on things that They Don't Like that government is doing.

 

[zoiDman]

I truly value you taking the effort to keep the dialog open and to try and get people interested.

I'm nobody, and I'm here on ECF to be with like minded individuals and I follow vapers on Twitter. For the life of me, I do not know how leaders in the vaping community deal with people who refuse to get off the couch to do anything. They have one heck of a spirit!

I'm willing to do anything legal to push for better vaping regs in my City, State or Nation.

Hey No Problem Tommy. We are All Kinda Tied together by invisible strings when it comes to vaping.

This whole e-Cigarette thing May end up going South on All of Us. And it might get a Lot Worse before it gets Better. But I just Didn't want to sit on the Sidelines and be one of those People who Didn't Try.

 

[crxess]

This whole e-Cigarette thing May end up going South on All of Us. And it might get a Lot Worse before it gets Better. But I just Didn't want to sit on the Sidelines and be one of those People who Didn't Try.

Many of us are not just going to Sit........)well, with my disability sitting is what I do best lately).........and do nothing. There is plenty that can be done.
Sit and Email
Sit and Write
Sit and Call
Sit and Chat(Vape shop, Park, Mall food court, etc.
Sit and Write a check of Click a Contribute Box and pony up!!!

Or if you can get off your Duff, Do so and do even more!!!

This e-cigarette thing isn't going anywhere without a Fight

Support the Cole-Bishop amendment!!!

 

[speedy_r6]

Not sure if anyone posted this. I didn't see it, but I possibly missed it if someone else did.

Majority Media | Homeland Security & Governmental Affairs Committee | Homeland Security & Governmental Affairs Committee

For those who don't want to click the link:

May 17, 2016

The Honorable Robert M. Califf, MD

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Califf:

The Committee on Homeland Security and Governmental Affairs is examining the regulatory burdens that federal agencies place on small businesses. On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a new regulation that expanded its authority over electronic cigarettes, commonly known as “e-cigarettes.” I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health.

According to the FDA, the final rule extends “the Agency's ‘tobacco product’ authorities in the [Federal Food, Drug, and Cosmetic Act],” as amended by the Family Smoking Prevention and Tobacco Control Act, to include other products such as e-cigarettes. The new rule prohibits the sale of e-cigarettes to people under the age of 18.

The regulations also require e-cigarette manufactures to submit premarket applications to the FDA in order to obtain federal approval for their products. According to recent reports, the new requirements would force e-cigarette companies to complete a burdensome and costly application process. Some manufacturers could spend more than 5,000 hours to complete an application, with a minimum cost of $330,000 per e-cigarette product, according to some estimates. As a result of these expensive and time-consuming applications, many e-cigarette manufacturers—most of which are reportedly small businesses—could close down.

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences. The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.

In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:

1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”

1. Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.
2. How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?

2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.

1. Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why?
2. If so, please provide that data.
3. Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?

3. Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.

Please provide this material as soon as possible but no later than 5:00 p.m. on May 31, 2016. When delivering production sets, please produce to Majority staff in room 340 of the Dirksen Senate Office Building and to Minority staff in room 613 of the Hart Senate Office Building.

The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate “the efficiency and economy of operations of all branches of the Government.” Additionally, S. Res. 73 (114th Congress) authorize the Committee to examine “the efficiency and economy of all branches and functions of Government with particular references to the operations and management of Federal regulatory policies and programs.” For purposes of responding to this request, please refer to the definitions and instructions in the enclosure.

If you have any questions about this request, please contact Scott Wittmann or Josh McLeod of the Committee staff at (202) 224-4751. Thank you for your prompt attention to this matter.

Sincerely,

Ron Johnson

Chairman

 

[crxess]

Not sure if anyone posted this. I didn't see it, but I possibly missed it if someone else did.

Majority Media | Homeland Security & Governmental Affairs Committee | Homeland Security & Governmental Affairs Committee

For those who don't want to click the link:

It's posted here and there

 

[zoiDman]

Many of us are not just going to Sit........)well, with my disability sitting is what I do best lately).........and do nothing. There is plenty that can be done.
Sit and Email
Sit and Write
Sit and Call
Sit and Chat(Vape shop, Park, Mall food court, etc.
Sit and Write a check of Click a Contribute Box and pony up!!!

Or if you can get off your Duff, Do so and do even more!!!

This e-cigarette thing isn't going anywhere without a Fight

Support the Cole-Bishop amendment!!!

Absolutely.

My theory is if I can somehow Find the Time to make 20,000 Posts on a e-Cigarette forum, I should be able to find Enough Time to write a Letter to my State/Fed Reps. Or the FDA.

Or the Office of the Whitehouse.

Submit Your Comments and Questions Online

 

[sparkky1]

SEVIA Breaks New Ground With Leading Manufacturers | Guide To Vaping

 

[Katya]

SEVIA Breaks New Ground With Leading Manufacturers | Guide To Vaping

I'm a bit disappointed that iSmoka/Eleaf is not on the list, but maybe it's because they are a subsidiary (or some other sub) of Joyetech?

 

[crxess]

I'm a bit disappointed that iSmoka/Eleaf is not on the list, but maybe it's because they are a subsidiary (or some other sub) of Joyetech?

You would likely be correct. Parent company taking the front line stance.

 

[sparkky1]

I'm a bit disappointed that iSmoka/Eleaf is not on the list, but maybe it's because they are a subsidiary (or some other sub) of Joyetech?

Wismec , eleaf are a sister company of joyetech

 

[Yerba]

If anyone is still not a CASAA MEMBER then here are a couple of ways to help. I don't post BS, all my info is here. This links can be found at CASAA web.

Fight the FDA Now » Larry W Faircloth; West Virginia

The United States Vapers’ Survey: Home | My CMS

 

[Robino1]

Another shot fired against the FDA: Lost Art Liquids, LLC Files Lawsuit Against FDA

 

[UnclePsyko]

Another shot fired against the FDA: Lost Art Liquids, LLC Files Lawsuit Against FDA

Nice! I would like to see a "Firing Squad" rather than the snipers, but it's a good start!

 

[Rickajho]

Another shot fired against the FDA: Lost Art Liquids, LLC Files Lawsuit Against FDA

Wanna read the complaint filing!!! Wanna read the complaint filing!!! But it's too soon to locate it.

 

[UnclePsyko]

If anyone is still not a CASAA MEMBER then here are a couple of ways to help. I don't post BS, all my info is here. This links can be found at CASAA web.

Fight the FDA Now » Larry W Faircloth; West Virginia

The United States Vapers’ Survey: Home | My CMS

Thanks! I was a bit suspicious of the Petition at first, the site seems a little amateur but it looks like it checks out.
But... I'm done (personally) with filling out surveys. Especially when I see this:

What is the purpose of this survey?
We feel that regulators too often make decisions that affect the future of vapers and the products they use without having duly consulted or listened to the stories and experiences of the people who actually use these products.

We believe that vapers’ voices should be heard by regulators, and they should be central to any decision that affects how vapor products are to be regulated.

We are running this survey to ask the millions of vapers in the United States about their use of e-cigarettes and other vapor products, and to give vapers an opportunity to express their views and experiences of vaping.

The answers that vapers provide on this survey will be put to regulators as evidence of how and why people actually use e-cigarettes in the real world.

I'm thinking these surveys helped contribute (directly or indirectly) with the regulations we see before us today. The FDA got their ammunition from many sources and used it against us to close every available loophole they could find.

I don't blame the survey authors, but the information they provided to the regulatory bodies has been turned against us.
Besides, I've filled out survey after survey over the last 3 years and they always ask the same questions, just worded differently.
If CASAA feels it's necessary to complete another in the future, I may reconsider.
That's my feelings and I may be wrong, but not filling it out will not cause further damage.
With that said, Thank You for the heads up!

 

[Screwtape]

"Manufacturers of nicotine-free tobacco products may instead certify to FDA that their products contain zero nicotine and that they have the data to prove it. Such products may instead use the statement 'This product is made from tobacco' using the same size and format as the nicotine warning statement."

So e-liquid with 0mg nicotine has to carry the label "'This product is made from tobacco"? This is beyond absurd.

That caught my eye as well. There is no such thing as a "nicotine-free tobacco product," and I'm fairly certain tanks, coils, drip tips, and batteries are not made from tobacco. I could be wrong, but something tells me that head shops aren't submitting PMTA's for every product they sell for "tobacco use," and I know damn well there are no "this product is made from tobacco" statements on any pipe, screen, or pack of rolling papers I've ever purchased...