Lawsuits mount against FDA regs on e-cigarettes

Status
Not open for further replies.

oplholik

ECF Guru
ECF Veteran
Verified Member
Mar 22, 2011
12,078
33,872
San Bernardino area, So. Cal.

DC2

Tootie Puffer
ECF Veteran
Verified Member
Jun 21, 2009
24,161
40,973
San Diego
I am slowly coming to appreciate the idea that...

The FDA went balls-to-the-wall on purpose.
To satisfy the alphabet soup and the anti-tobacco prohibitionists.

The FDA was basically in an untenable position.
Stuck between truth and money, yet being pushed to do something yesterday.

They moved forward while knowing full well they would find themselves in court.
And that's where things start getting interesting.

I think we will win, but I'm stocked up for a long time just in case.
Money is power, and power is money.
 

Racehorse

ECF Guru
ECF Veteran
Verified Member
Jul 12, 2012
11,230
28,272
USA midwest
I said 2 years ago "all this will be decided in a court of law" so I never got TOO upset about what might happen....

..what if, what if, what if, .......I think 30 and 40 year old's can live with constant thoughts of "what if's" but as you get older that is the kind of stress that predisposes people to high blood pressure, heart attacks, etc.

I have learned not to hold on to anger either, another "stress type killer". A dose of anger every day and you have a veritable......... health disaster.

Some of the stress I've seen on this board over the last 2 years would have a deleterious affect on most people's health. I quit smoking to be healthier. Adding a ton of stress is really as bad if not worse for one's health. That is a fact.

Stress isn't caused by events or circumstances.....it is how we handle events and circumstances.

It's okay to plan ahead and try to cover your bases, but you can never fully anticipate what will happen in life, and that tree I cut last month that looked like it was too close to the house......usually it's some other thing that you DIDN'T think about that goes awry. :lol:

I have learned not to be fearful, angry, or stressed about things beyond my control. It's pretty much a full time job just to take care of stuff that IS within my control.

Just a health message, if you will. :)
 

bigdancehawk

Ultra Member
ECF Veteran
Verified Member
Jan 27, 2010
1,462
5,477
Kansas City, Missouri
Well, the SFATA filed its amicus brief on Tuesday. You can read it HERE. Not a strong effort, IMO. It says:
“There is another significant segment within the vapor industry that produces e-liquids. Those e-Liquids are heated within the vaporizer to produce a flavored vapor without omitting the burned resins, chemicals, ash, and odor typically associated with combustible tobacco (e.g., cigarettes).”
"Emitting" is the word they were looking for.
Mistakes happen, but the primary flaw is that the brief consists mainly of assertions like these:
"SFATA’s own internal estimate for the number of e-Liquids on the market is significantly higher than FDA’s estimate."
"A study by Management Science Associates showed that vape shops sell a staggering number of products, on average selling 542 SKUs overall and 300 e-Liquid options. See Vape News Magazine, Vape Shop Owner Survey Results Revealed (Sept. 5, 2015)..."
"SFATA’s surveying shows that ninety-eight (98) percent of respondents operate a brick-and-mortar business, and almost seventy (70) percent of respondents are single-location owners."
"It has been estimated that micro businesses are the sole source of income for three-quarters of their proprietors. Association for Enterprise Opportunity, Opinion Poll: The Role of Micro Businesses In Our Economy, Oct. 9, 2012, at 3."
"A few example comments collected from SFATA’s member companies demonstrates the dire prospects for the industry under the Deeming Rule..." [grammar: a few comments demonstrate, not demonstrates]
And on, and on, and on.

These assertions, while undoubtedly true, are not supported by citations to the record. As I explained in an earlier post here, the time to submit evidence is before the regulation is adopted, not in the judicial review process. The judge will almost certainly ignore these assertions.

The main purpose of a legal brief is to cite law (cases and statutes) to support your position. Yet this brief contains no legal arguments or citations of any kind. Not one.

This is a missed opportunity to submit compelling legal arguments to this judge which have not yet been made. For example, millions of US citizens have invested goodly sums in vaping hardware. Hardware needs new parts from time to time. After 8/8/18 if you need replacement coils for your Nautilus, you might as well throw the thing away because new coils will probably be legally unobtainable. Or what if you need a new o-ring or drip tip? You'll be out of luck. This seems utterly arbitrary, unreasonable, and unjustifiable to protect public health, effectively rendering worthless things people have already paid good money for. Did the FDA take that into account--the economic, social and health consequences of it as they are required to do by law? Nope.

Hypothetically, let's say some federal agency decides that in two years it will be illegal to sell any automobiles which don't have prior agency approval, even if those same automobiles have already been bought by millions who are currently driving them around with no known defect. And let's say the regulation also states that it will be illegal to sell any parts for those automobiles unless it has approved the entire automobile, bumper to bumper. Any court would hold that to be unreasonable. Likewise, who is going to submit a PMTPA for an o-ring or a drip tip?
 

bigdancehawk

Ultra Member
ECF Veteran
Verified Member
Jan 27, 2010
1,462
5,477
Kansas City, Missouri
Actually, there are plenty of words, but the moderators won't let me write them here.
I guess I don't see why this would be upsetting. This is an adversarial proceeding and FDA lawyers aren't going to wag their tails and roll over like Golden Retrievers.

My favorite part of the brief is their claim (in effect) that it's not arbitrary or an abuse of discretion for them them to rip an industry apart without doing a serious cost/benefit analysis.
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,050
NW Ohio US
Correct if I am wrong. Did the cigarette companies actually advertise their products
that were 'light' or 'low tar' were safer than than their regular (full strength brands).
(post regulatory restrictions)

Actually it was the Public Health Service (along with the FTC methods) that made that assertion:

S. Rept. 110-512 - TRUTH IN CIGARETTE LABELING ACT

In 1964, the U.S. Department of Health and Human Services
issued the first Surgeon General's report on the health risks
of smoking. The report concluded that cigarette smoking was a
cause of lung cancer in men. Two years later, the Public Health
Service announced that most scientific evidence suggested that
lower levels of tar and nicotine would produce a less harmful
effect on consumers.
In 1966, the FTC initiated two actions to
encourage manufacturers to disclose comparative tar and
nicotine yield information to consumers.
First, the Commission
lifted the ban on nicotine and tar advertising but made future
industry factual statements conditional: Statements would be
required to support tests conducted in keeping with the
Cambridge Filter method, and they could not include assertions
of reduced health hazards.
Second, the Commission authorized
the creation of a laboratory designed to analyze cigarette
smoke and sought public comment on suggested changes to the
Cambridge Filter method. Analysts often refer to the modified
Cambridge Filter method adopted by the Commission as the ``FTC
method.''

So some of the companies started to include tar ratings in their ads and labels, but no 'assertions of reduced health hazards' as above. It was the gov't that promoted that low tar was less harmful, not the cigarette companies. That changed... :)

When it was found that light cig smokers smoked more, then the hammer came down on lights and ultralights and the claim that the cigarette companies were "lying" when in fact it was the Public Health Service and the FTC who encouraged the cigarette companies to post the low tar figures.

The other thing was that while lowering tar, they also suggested lowering nicotine, which ended up being the cause of people smoking more, so when the cigarette companies maintained the low tar but increased the nicotine to prior levels, they were accused of making cigarettes "more addictive" :facepalm: ...when they were actually losing sales by returning to the original level of nicotine - meaning people smoked less cigarettes than they did with light and ultralight cigarettes.

I replied to you a while back:

22nd Century Launches New RED SUN® Extremely Nicotine Website

...on this citing this link:

http://cancercontrol.cancer.gov/brp/tcrb/monographs/13/m13_1.pdf

"Faced with the continuing exposure of large numbers of
smokers to the cancer-causing substances in tobacco smoke, public health
authorities made the valid conclusion that cigarettes that delivered less tar
to smokers would be likely to produce less cancer as well
(U.S. Congress,
1967
), and the effort to produce and market low-tar cigarettes began to
gather momentum."

"With the endorsement of lower tar cigarettes by public health authorities
in the 1960s (U.S. Congress, 1967),
cigarette marketing began to focus
on machine-measured tar deliveries. Tobacco industry research and engineering
efforts recognized that at least two directions were possible with the
development of either a health-image (health reassurance) cigarette or a cigarette
with minimal biological activity (one that would actually produce
less disease) (Green, 1968)."

All that said, you are not going to stop some people from saying that the tobacco companies "lied" and "made cigs more addictive", and convince them those steps were started by gov't entities, which the tobacco companies followed, then were attacked for following them. lol....
 
Last edited:

KY_Rob

Ultra Member
ECF Veteran
Verified Member
Feb 23, 2013
1,772
3,693
Kentucky
We Vapers "may" win, by being able to continue vaping using products we decide we like. However, look for product prices to skyrocket, due to taxation that is either equal to or greater than current tobacco taxes.
Plain and simple, it's all about the money. The very real and significant drops in smoking rates have put a big dent in the coffers of states. Those states will get their money.
 

bigdancehawk

Ultra Member
ECF Veteran
Verified Member
Jan 27, 2010
1,462
5,477
Kansas City, Missouri
Any lawyers want to decipher this for me?
Tobacco On Trial » Blog Archive » DOCKET for NICOPURE LABS v. FDA et al, Jul 29-Aug 2, 2016

If I'm reading it right, SFATA's testimony will be allowed, CASAA's, Clive Bates, and Vape A Vet will not?
By allowing SFATA, TechFreedom and the NCPPR to intervene, the judge is not saying they will be allowed to present "testimony." Rather, they will be allowed to present their legal arguments in briefs based on the existing FDA record.

A little background on this to better understand where the judge is coming from: the courts scrutinize federal regulations based on procedures established by federal statutes (principally the Administrative Procedure Act) and under certain provisions of the Bill of Rights, most notably due process.

Under those statutes and constitutional principles, it is the responsibility of the courts to review what the agency did based on the evidence which the agency had in front of it when it formulated the regulation in question. The courts do not start all over with the process and take in new evidence which was not presented to the agency. In this sense, the district court acts like an appeals court. An appeals court doesn't conduct a new trial and doesn't consider evidence which was not presented to the trial court. Instead, the appeals court reviews the record to assess whether the trial court screwed up one or more of its rulings and/or whether the judgment is supported by substantial evidence in the record.

Who is or isn't allowed to intervene is pretty much up to the discretion of the judge. The judge explained why CASAA would not be allowed to intervene: chiefly because it proposed to present evidence which was not presented to the FDA ("does not appear to be part of the existing record"). But nobody will be allowed to do that. Clive Bates' and Vape a Vet's motions were denied "without prejudice" because of technical deficiencies. "Without prejudice" means they can try to correct the deficiencies and refile.
 

Ipster

Ultra Member
Supporting Member
ECF Veteran
Nov 8, 2012
1,066
1,977
Hawaii, SAR,HongKong (Stanley)
I think that (at this point) the courts are our best chance of getting any relief from the FDA regulations
WELL I wish I could completely agree, but its one avenue only.
Im sure the FDA anticipated the vendors to respond, and compared to $BT$ its not enough.
We also need to advocate and fight.
The USA has one of the best grassroots campaign histories, and this is an election year...!!
So pls do everything you can to let your representatives know that vaping saved your life.
TYVM
 

Hightech Redneck

Vaping Master
ECF Veteran
Verified Member
Mar 27, 2015
3,922
23,731
N C
Haven't researched it yet but several youtube reviewers are reporting a small step in the right direction.
Apparently a federal judge is reported to have said the fda cannot make a manufacturer submit for juice approval multiple times or for label changes.
Basically it was originally understood if you sold a juice in 30, 60 and 120 bottles you would have to submit to have each size approved.
If reported correctly the judge said nope it's the same stuff in a different size bottle so only needs one approval.
I'm hopeful this trend will continue and these regs will be picked apart piece by piece.
As I mentioned it has been stated several places but I have not been able to confirm it yet.
 

squee

Super Member
ECF Veteran
Verified Member
Nov 12, 2013
478
815
Central CT
Judge Amy Berman Jackson gave FDA until Aug. 16 to respond to the lawsuits and scheduled a hearing for Oct. 19.

So no injunction prior to the August 8th cut-off date. Which means at the very least, no new products can be introduced to the US market (mods, tanks, liquids) from 8/8 until Nov/Dec at the earliest, assuming we get a positive outcome. If we don't.....??
 

Racehorse

ECF Guru
ECF Veteran
Verified Member
Jul 12, 2012
11,230
28,272
USA midwest
IF they took that same approach with EVERY consumer good they were an authority over, that would make sense, but they don't.

Well they did on trans fats, (partially hydrogenated vegetable oils) and all the people here who eat that kind of stuff on a pretty regular basis were very "put out." And i mean VERY put out. [Personally I consider it poison for my arteries, because it is, and wouldn't touch it with a 10 foot pole. (thank god for food labels!) ]

Now the labelling I"ve seen on some peanut butter recently is "fractionated palm oil", which is really really bad for you. This is typical word tricks by the food industry.

I don't know if people are as unhealthy as the ones I see in arkansas, but I can't believe how big everybody is here. When I first moved here I found it very......startling......never having been around so much obesity. Then I lived here for 10 years and watched the eating patterns.......

look, trans fats kills people just as sure as cigarettes kill people.

I imagine the american landscape, when it comes to health, looks rather schizophrenic from the outside looking in. :lol: What would a space alien see? On the one hand, citizens BEGGING the FDA to "allow them to be healthy" by approving an alternative to smoking....but on the other hand, and equal amount of citizens kicking and screaming when anybody even suggests advice that may just bring them their wish? (taking hydrogenated vegetable oil out of foods is actually good for everybody).

It's all very strange........

then, you have the added perplexity and complexity of figuring out who is in who's back pocket.
.
 
Last edited:

bobwho77

Super Member
ECF Veteran
May 8, 2014
753
2,404
Ypsilanti mi

Opinionated

ECF Guru
ECF Veteran
Verified Member
Aug 19, 2015
11,168
59,365
55
My Mountain
It doesn't matter if they are or arent' cigarettes. You're missing the point. They could be moondrops or fountain of youth inhalers........my point was that the FDA is saying they already went thru all that "this is safe!" song and dance before, and it turned out very badly for everybody.

They are not going to make that mistake again.

IF you look at the Table of Authorities, Federal Cases, you can see where they are going.....

Section 918 of the FD&C act required the FDA to submit a report and examine how the FDA could regulate, promote and encourage development of innovative products which assist 1) total abstinence from tobacco products 2) reduction in consumption of tobacco and 3) reduction in harm from tobacco use.

Congress wanted the FDA not to hinder innovation and a market which went toward any of the above goals, but rather, create an environment where innovation was encouraged.

This is what and where vaping lies. (Specifically category 3) The FDA is not taking this directive seriously, and instead seeking to hinder innovation and market which goes toward those stated goals.

If the FDA is going this route, at best we are looking at 30 years of nearly a dead stop to this line of innovative products while they do enough studies to make them happy.

It shouldn't matter what happened in the past, what should matter is the spirit of the directive from Congress. I understand wanting some regulation, what I don't understand is literally trying to kill innovation dead, in light of what congress was asking the FDA to do.
 

choochoogranny

Vaping Master
ECF Veteran
Oct 21, 2013
9,091
35,782
chattanooga, tn, usa
What I would like to know IS how is a rogue regulatory agency reigned in? How does one get 40 some agencies to follow the original intent of their founding? How do we get our Congress to do their job instead of foisting their duties off to these agencies?

At this point in time I do feel those in the Fed. Gov. are working for themselves and not for the Republic.
 

retired1

Administrator
Admin
Supporting Member
ECF Veteran
Verified Member
Apr 5, 2013
50,735
45,046
Texas

Racehorse

ECF Guru
ECF Veteran
Verified Member
Jul 12, 2012
11,230
28,272
USA midwest
The other thing is that legal process is like politics in the sense that you have to be very astute and have the right words because it is very difficult to just change the opposition's mind(s).

I got a lot of insight into the process by reading and listening to audio tapes by Gerry Spence. There is a reason why he is in the Trial Lawyers Hall of Fame. "Spence has never lost a criminal case either as a prosecutor or a defense attorney. He has not lost a civil case since 1969...."

When you read about the way he thinks and responds you start to understand how to win. It's not about foot stomping and anger

There are other equally brilliant attorneys, but all of them have certain things in common, and that is that they really understand PEOPLE.

One of the audio books I had was How to Argue & Win Every Time: At Home, At Work, In Court, Everywhere, Everyday

Many politicians who huff and puff, as well as advocates for any cause, should read it. Beause huffing and puffing doesn't get the job done.....all it does is alienate. It takes actual compassion to understand other people and how they think and feel.....not hate and anger.
 
Status
Not open for further replies.

Users who are viewing this thread