Deeming Regulations have been released!!!!

[sparkky1]

While I am still fired up about the ISO lab bunk another thing that
has crossed my mind is the FDA's use of the word substantial.
When it comes to the SE applications this is the standard. If
you apply by the premarket standard it is not used at all. One
has apply for each and every variation of juice blend no mater
what ingredient was added,subtracted or adjusted for volume
as it may alter the composition and or delivery of the juice affecting
nicotine dosage. They didn't say substantially change, They say may.

Regards
mike

That would be correct, EVERY VARIATION
Just like I posted The Rest of the Story: Tobacco News Analysis and Commentary: FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry

 

[mikepetro]

Daily mailing sent to:
President President Barack Obama (D)
U.S. Senate
Sen. Mark Warner (D-VA) Sen. Tim Kaine (D-VA)
U.S. House of Representatives
Rep. Morgan Griffith (R-VA)

I am a 57 year old middle class constituent.

I was addicted to tobacco most of my life. I firmly believe that switching to ecigs has extended my life by years. Not only does scientific research show that it is 95% less harmful, but my own body (& my physician) tells me that it is less harmful.

Please see the scientific proof here:
https://www.rcplondon.ac.uk/file/3563/download?token=uV0R0Twz

Now, through regulation, the FDA is making it much easier to buy tobacco than to purchase an ecig that actually works. Tobacco is far more dangerous, this just doesnt make sense.

I urge you to support the
H.R.2058 - FDA Deeming Authority Clarification Act of 2015

Products that existed before the February 2007 "predicate date" simply did not work, where current generation products DO work. As a result I have been tobacco free for 3.5 years. Please allow me the legal means to stay off of tobacco!

I vote, and I will support politicians who support my right to "harm reduction".

Sincerely,
Mike Petro​

 

[markfm]

It was introduced on 28 April, as of 1 May it went to the Subcommittee on Health.

 

[Sugar_and_Spice]

Well, that escalated quickly. I hope this suit is sanctioned by CASAA?

And if it isn't???

 

[Robino1]

Can anyone translate that page into English?

It has been sitting in the Subcommittee on Health since May 1, 2015.
It hasn't even been passed out of that committee.



05/01/2015 Referred to the Subcommittee on Health.
Type of Action: Committee Consideration
Action By: House Energy and Commerce

 

[Robino1]

I honestly hope that more lawsuits are filed.

Edit to add clarification: I hope more lawsuits are filed by companies that have VERY smart lawyers on staff and can sort through the mess the FDA threw at us.

From my understanding, Halo has a VERY smart lawyer at the helm.

 

[Jalcide]

So, surely the FDA will grant one or two uninspiring vaping devices, built from the ground up, that are likely highly "medicalized," have tiny liquid capacities and most certainly will be lacking in aesthetics, and overall desirability. A sort of "there, you got something." If so, the irony being that they will probably be less sophisticated, capable and "safe" as, say, a DNA 200 (let's say the DNA chip on their review table would hypothetically be limited to 30 watts to leave high power out of the equation). My prediction of the FDA's offering likely not being as "safe," is in the sense of temperature control not overheating and releasing undesired components in the e-liquid. I somehow suspect a mature chip like the DNA, or similar, would outperform whatever the FDA oversees, approves, funds or nurtures.

My question is, does anyone expect even one license will be granted for, and let's get specific, a DNA 200 device (say in a lower wattage form factor)? Let's also assume a paired tank with this device is under 2ml and not a cloud chucker, reasonable and modest in all respects and is of high material and manufacturing quality.

I keep having this negative, cynical, defeatist attitude that the approval process may not even allow one current, best-of-class device on the market (not even if simply wattage limited).

Because if one such device gets the green light, it opens the door to "substantial equivalency" claims and potentially unravels all the hard work the FDA has done to (presumably, and in my opinion) kill the industry.

I seem to recall reading a quote from the FDA front guy, when asked a similar question, saying something along the lines of "we can't predict and will have to see the testing results on a case-by-case basis." (paraphrasing)

Yeah, right.

 

[Robert Cromwell]

And if it isn't???

If they do not have enough horsepower behind their lawsuit and it fails it sets a legal precedence. Which can kill future lawsuits.

 

[ZeroedIn]

And if it isn't???

Doesn't really matter, I am just curious.

...and what R Cromwell said above.

 

[Pamawoman]

Actions - H.R.2058 - 114th Congress (2015-2016): FDA Deeming Authority Clarification Act of2015

I listened three times. It's around 26:53. He even says the vote numbers!!! WTH!

 

[Robino1]

I was watching the White Cloud webinar with Dr. Siegel. Did they just say that HR 2058 PASSED?

I don't think that is what was said. The sister to HR2058, which is buried in the Agriculture something or other budget thingamabobber, has passed out of committee and is set to be voted on by the House(?). If passed by the House, then goes to the Senate. If passed by the Senate, gets put on the President's desk to either be signed or vetoed.

Sorry for mangling all the technical/legal jargon.

 

[zoiDman]

I listened three times. It's around 26:53. He even says the vote numbers!!! WTH!

Can you post a Link to what you were Listening to?

Because as far as I know, this is the status of HR2058.

 

[Robino1]

I listened three times. It's around 26:53. He even says the vote numbers!!! WTH!

It passed out of committee with a vote in favor 31 - 19 (if I remember correctly) Heading to the House next.

Did you hear the word Agriculture?

 

[mostlyclassics]

I spent the morning sending this, attached to the top of the CASAA "call the FDA" email, to a whole bunch of friends (well over 100, but I lost count):

Dear Xxxxx —

You may have heard on the news that the FDA (Food and Drug Administration) has issued its "deeming regulation" on e-cigarettes. This regulation prohibits manufacture of eliquids and vaping gear by setting regulatory hurdles so high that no one can get approval. Even regular cigarettes don't have to jump these hurdles. The FDA's unstated aim is to destroy vaping in the United States.

The FDA is doing this via unvoted-on administrative fiat. Congress has not voted on nor approved this extreme regulatory overreach.

The reason the FDA is doing this is to protect tax revenues the federal and state governments get from Big Tobacco (which has seen a significant decline in cigarette sales over the last few years, since vaping has become more popular) and revenues for Big Pharma (the sales of their useless quit-smoking "aids" and prescription drugs have cratered recently). By their deeming regulation, the FDA clearly wants cigarette smokers to keep smoking cigarettes.

Despite the FDA's and the CDC's disinformation campaign (which has cost nearly a hundred million of your tax dollars to date), e-cigarettes are both effective quit-smoking devices and much less risky than regular cigarettes to their users and those around them than regular cigarettes. Quite a few public health officials worldwide have called them the greatest public health advance since the invention of antibiotics. The British National Health Service, after extensive studies, calls them 95% safer, and the UK is even considering distributing them free to their citizens.

[insert blurb about what vaping has meant to you and your health]

Below is an email from CASAA (Consumer Advocates for Smoke-free Alternatives Association). In it, CASAA suggests calling the FDA hotline with questions. I'd appreciate it if you'd do just that. The questions and answers may be meaningless to you. That doesn't matter. The object is to register as many phone calls with the FDA as possible. It's an 800-number, so the call is free to you.

After that, if you could donate to the cause, you would help extend the health and lives of millions of current and former smokers. Here's the llink: Donate to CASAA . We desperately need funds: tens of millions of dollars for legal actions, lobbying and a nationwide information campaign of our own.

Please help us.

Thanks,
Txx Kxxxxxx

It might be a good idea if all of us did the same.

[Added later] I sent one of those emails to a radio buddy and got 20 minutes on his talk show early Tuesday afternoon. Every little bit helps.

 

[Bronze]

I don't think that is what was said. The sister to HR2058, which is buried in the Agriculture something or other budget thingamabobber, has passed out of committee and is set to be voted on by the House(?). If passed by the House, then goes to the Senate. If passed by the Senate, gets put on the Presidents desk to either be signed or vetoed.

Sorry for mangling all the technical/legal jargon.

It's the Agricultural Appropriations bill. There are 12 different appropriation bills that fund our government. They make up the budget. HR2058 provisions were amended to the Ag appropriations bill as another avenue to get them passed. The 12 appropriation bills are written and voted on each year...at least they are supposed to be and that used to be the way but since no one in government gets along anymore we often operate on the previous year's budgets (called continuing resolutions).

 

[markfm]

The bill has gone to the proper subcommittee. Here are the members of that group, if people want to nudge them on considering H.R. 2058:
Health (114th Congress)

 

[Train2]

Good for them!
You're up, ProVape.
Who else?

Nicopure Labs Challenges the FDA’s Deeming Rule - Nicopure Labs LLC.

Nicopure Labs Challenges the FDA’s Deeming Rule - Nicopure Labs LLC.

 

[Endor]

I don't think that is what was said. The sister to HR2058, which is buried in the Agriculture something or other budget thingamabobber, has passed out of committee and is set to be voted on by the House(?). If passed by the House, then goes to the Senate. If passed by the Senate, gets put on the President's desk to either be signed or vetoed.

Sorry for mangling all the technical/legal jargon.

It is an amendment to the Agriculture Appropriations Bill for 2017, and was introduced by Cole (author of HR2058). This bill appropriates money to various agencies, which includes the FDA.

Here's a link straight to the Appropriations Committee website that lists the amendments: Committee Approves the Fiscal Year 2017 Agriculture Appropriations Bill | Committee on Appropriations, U.S. House of Representatives

The Full Bill Report (last link on the page) is interesting when you do a search for the word "tobacco".

From what I'm hearing/reading, HR2058 is somewhat in a limbo state pending the amendment making it through the House and Senate as a rider on the Appropriations bill. I think it is common to attach these things to appropriations bills, because if they can make it through the entire process and to the President's desk, the lack of a line-item veto means that he'd have to reject the entire bill if he was really hell-bent on killing an amendment.

 

[StormFinch]

If they do not have enough horsepower behind their lawsuit and it fails it sets a legal precedence. Which can kill future lawsuits.

I'm not sure if it matters or not since I'm relatively unfamiliar with the group, but Nicopure is a founding member of VTA. In fact, their general counsel sits on the board.

 

[Pamawoman]

Can you post a Link to what you were Listening to?

Because as far as I know, this is the status of HR2058.

E-cig FDA deeming regulations explained by Dr. Michael Siegel. On YouTube.