FDA Sen Johnson (R-Wis) demands answers from FDA RE deeming

[Kent C]

You'll always need someone on the inside willing to bring to light what they don't want you to know.

Or from the 'outside' - Assange - but certain people were more concerned with the 'who' rather than the 'what'. lol...

 

[Lessifer]

Or from the 'outside' - Assange - but certain people were more concerned with the 'who' rather than the 'what'. lol...

Yeah, I'm not a fan of Assange as a person, but that's not really pertinent to the information he releases. It's a complicated subject though. I'd love to read any FDA internal correspondence regarding the deeming, but I'd hate to have the identities of operatives working abroad be compromised. Two vastly different situations there though.

 

[zoiDman]

Yeah, I'm not sure about that either, I think he just doesn't like the word.

My thoughts are, transparency in government is good, but you'll never achieve true transparency. You'll always need someone on the inside willing to bring to light what they don't want you to know.

I agree. But it brings things back to a Question I asked Earlier.

Why should the Public be Denied Access to the Information the FDA used to write the Deeming Rules?

I'm not calling for Complete Disclosure when National Security is in Question. Or when Disclosure of Information could Jeopardize someone's Life. That is Mis-Guided.

I'm questioning Why a Government Agency like the FDA would Feel that the Public (or the Scientific Community) should Not have Access to how they decided to Regulate e-Cigarettes?

And Why the FDA feels it does not have to Disclose such Information to a Senate Oversight Committee?

 

[Lessifer]

I agree. But it brings things back to a Question I asked Earlier.

Why should the Public be Denied Access to the Information the FDA used to write the Deeming Rules?

I'm not calling for Complete Disclosure when National Security is in Question. Or when Disclosure of Information could Jeopardize someone's Life. That is Mis-Guided.

I'm questioning Why a Government Agency like the FDA would Feel that the Public (or the Scientific Community) should Not have Access to how they decided to Regulate e-Cigarettes?

And Why the FDA feels it does not have to Disclose such Information to a Senate Oversight Committee?

No argument from me there. They don't even provide complete disclosure when they make a decision on a product. So, the rubric they use is unclear, undefined really, and their decisions are unexplained.

 

[zoiDman]

No argument from me there. They don't even provide complete disclosure when they make a decision on a product. So, the rubric they use is unclear, undefined really, and their decisions are unexplained.

I'm just Not Sure what justification could be used that the Public's Health is Better Served by having the FDA working "behind closed doors"?

But I'm sure some FDA Lawyer or some HSS Monarch could give me a Rambling, Vaguely Worded, Political Answer if they were backed into a corner and Forced to do so.

 

[Alexander Mundy]

Because they don't want to give anyone anything more than they absolutely have to that can be critiqued, one of the rules of politics. That is why the sunshine act only covers official "meetings" of agencies, wouldn't want the back room chatter out there for others to see. Everything else is a carefully drawn up response to avoid critique.

 

[zoiDman]

No argument from me there. They don't even provide complete disclosure when they make a decision on a product. So, the rubric they use is unclear, undefined really, and their decisions are unexplained.

BTW - Here is a Good Example of why I want More Transparency (or if someone Doesn't like the word "Transparency", substitute the word "Transparency" with "Information Disclosure") from the FDA.

"Mitch Zeller, director of the FDA’s Center for tobacco Products, acknowledged May 5 that there are “anecdotal studies” that show individuals weaning themselves from traditional cigarettes through e-cigs.

However, Zeller stressed that “there is no definitive support of e-cigs playing a cessation role.”

New FDA tobacco regulations stir help, harm debate

Perhaps if Someone knew what Study Data the FDA actually looked at, then one could make a Determination as to the Veracity of Mr. Zeller's conclusion about e-Cigarette cessation?

But then that might also Open Up a Can of Worms.

Because if the FDA Disclosed that they did Not Read any Independent Studies that did show that e-Cigarettes can aid in Smoking Cessation, and only Relied on the Tripe that the CDC spewes, well, that might not make the FDA look like an Unbiased Scientific Base agency who's Primary Goal is Public Health.

Better to just do it ALL in the Shadows and avoid any Pesky Accountability.

 

[Lessifer]

BTW - Here is a Good Example of why I want More Transparency (or if someone Doesn't like the word "Transparency", substitute the word "Transparency" with "Information Disclosure") from the FDA.

"Mitch Zeller, director of the FDA’s Center for tobacco Products, acknowledged May 5 that there are “anecdotal studies” that show individuals weaning themselves from traditional cigarettes through e-cigs.

However, Zeller stressed that “there is no definitive support of e-cigs playing a cessation role.”

New FDA tobacco regulations stir help, harm debate

Perhaps if Someone knew what Study Data the FDA actually looked at, then one could make a Determination as to the Veracity of Mr. Zeller's conclusion about e-Cigarette cessation?

But then that might also Open Up a Can of Worms.

Because if the FDA Disclosed that they did Not Read any Independent Studies that did show that e-Cigarettes can aid in Smoking Cessation, and only Relied on the Tripe that the CDC spewes, well, that might not make the FDA look like an Unbiased Scientific Base agency who's Primary Goal is Public Health.

Better to just do it ALL in the Shadows and avoid any Pesky Accountability.

Well, they do cite a bunch of different studies in the deeming, some of which they seem to consider valid, and some which are "anecdotal." The deciding factor appears to be, whether or not the study was funded by someone related to tobacco control.

I think what's truly telling is, in regards to cessation, this is the most scathing thing they could say:
the researchers could conclude no more than that
"among smokers wanting to quit, nicotine e-cigarettes might be as effective as patches for
achieving cessation at 6 months"

So, their evidence that vaping isn't a valid form of cessation is that it is NO MORE EFFECTIVE THAN TRADITIONAL NRT. Something isn't right there.

 

[zoiDman]

... Something isn't right there.

Yeah. Those 4 Words come to mind a Lot when I think of the FDA.

 

[Vandal]

NO MORE EFFECTIVE THAN TRADITIONAL NRT.

Big Pharma probably payed someone a million dollars a word to say it.

 

[Lessifer]

Big Pharma probably payed someone a million dollars a word to say it.

That's not the point though, the point is, the worst thing they could say is that some studies showed it to be no more effective than the pharma option that they say is the proper way to quit. They don't say it's ineffective, or they say it's ineffective, because it has the same rate of effectiveness as NRT. The articles never make the jump to then say "well, then, is FDA approved NRT effective?"

 

[Katdarling]

The "government" has slowly stolen it back again.
And that is in large part our fault for letting them.

We HAD the mechanisms in place to prevent this, to stop this.
It's called the Constitution.
Or at least it was.



America will never be destroyed from the outside.
If we falter and lose our freedoms, it will be because we destroyed ourselves.
--Abraham Lincoln

If the freedom of speech is taken away then dumb and silent we may be led...
Like sheep to the slaughter.
--George Washington

Freedom consists not in doing what we like, but in having the right to do what we ought.
--Pope John Paul II

Freedom is the right to tell people what they do not want to hear.
--George Orwell

Guard with jealous attention the public liberty.
Suspect everyone who approaches that jewel.
Unfortunately, nothing will preserve it but downright force.
Whenever you give up that force, you are inevitably ruined.
--Patrick Henry

Freedom is the oxygen of the soul.
--Moshe Dayan

Freedom is never more than one generation away from extinction.
We didn't pass it to our children in the bloodstream.
It must be fought for, protected, and handed on for them to do the same.
--Ronald Reagan

Some/many agree that we have the mechanisms in place to prevent this, to stop this.
It's called the Constitution, Article V.

Convention of States.

 

[skoony]

I think maybe what skoony is getting at is that transparency in government means they're showing you what they want you to see. If they tell you they're being transparent, they've just found a better way of hiding what they're really doing.

I have no problem with oversight in as much as there being a structured process
to monitor and manage institutions or business. However Transparency as a concept and,how it
is used in the modern lexicon is a bankrupt notion. It means to many things to to many
people and as such has no real defined definition.

The closest I can come to defining it goes as follows.

Tell me every thing I want to know,what you did or didn't do whether or not
I wanted or needed to know it and,even if has any relevance to anything I may
or may not find important. Stop everything and do it now because that's your
job because,I said so and, demand it. If you do not immediately acquiesce to my
demands you are being deceitful and or lying,ripping off voters or customers,
poisoning or ripping us off,yada,yada,yada.

Like I said before it's just a pet peeve of mine.
I also do not like the word synergy for much the same reason.

Regards
Mike

 

[MacTechVpr]

The lack of transparency is an act of hostility against those to which it is directed. An inward expression of malevolence. Like war it may only be justified by the aggression or criminality of others. When it becomes a matter of practice or policy it is therefore likely to be criminal in its objectives or to become so with time.

Deception is the lifeblood of the antisocial.

Good luck.

 

[jdrewry]

Well, here we are, the day before the FDA Deeming regs go into effect. Is it safe to say that, at this point, there's nothing Sen. Johnson can do to stop this? I'm finding it hard to believe he can do anything at the last minute that would prevent the regs from going into effect...

 

[MacTechVpr]

It would seem we live in impossible times.

Good luck all.

 

[Alexander Mundy]

Well, here we are, the day before the FDA Deeming regs go into effect. Is it safe to say that, at this point, there's nothing Sen. Johnson can do to stop this? I'm finding it hard to believe he can do anything at the last minute that would prevent the regs from going into effect...

The 8/8 date is just the start and isn't by any stretch of the imagination the worst date in the future of the regulation. The Judicial branch, Congress, or POTUS could stop this before the ship sinks. That isn't likely to happen with the later two unless there is more general public dissent or a personal freedom POTUS is installed.

 

[sonicdsl]

Well, here we are, the day before the FDA Deeming regs go into effect. Is it safe to say that, at this point, there's nothing Sen. Johnson can do to stop this? I'm finding it hard to believe he can do anything at the last minute that would prevent the regs from going into effect...

Remember, even though it's "the date", it's only the stop date for introducing new products without a PMTA. Everything on the market now should be ok for a minimum of two years (during which they will ostensibly go through the PMTA process to continue selling after the two years, or a third year if they do submit the PMTA, and the answer is not yet received by the two years time period). This means no new devices, flavors, strengths, PG/VG blends, coil-building, etc. But what's on the market already as of 8/8/16 should be ok for now.

 

[Lessifer]

No update on the FDA's response, but Senator Johnson did post a statement about today: Majority Media | Homeland Security & Governmental Affairs Committee | Homeland Security & Governmental Affairs Committee

 

[Downgraded286]

A while ago I said I sent an e-mail to Senator Johnson commending his actions. Today I got a response:

Thank you for contacting me about the regulations of e-cigarettes recently announced by the Food and Drug Administration (FDA).

One of the greatest costs to consumers and the economy comes when a regulation is so burdensome and overreaching that it threatens to wipe out an entire product or industry. The FDA’s decision to expand its own authority over e-cigarettes could threaten a whole class of businesses and the people who work at them, and it could harm public health by making it harder for consumers to buy products that serve as an alternative to smoking. The regulation forces e-cigarette manufacturers to complete prohibitively costly and time-consuming applications to sell e-cigarette products. As a result, many e-cigarette manufacturers—many of which are small businesses—could be forced to shut down.

As chairman of the Senate Homeland Security and Governmental Affairs Committee, which has broad jurisdiction over federal agencies’ operations, I am committed to holding the FDA accountable. I have sent multiple requests for information about the FDA’s e-cigarette regulation so the committee and the American public may fully understand the FDA’s rulemaking and its consequences for small businesses and the public’s health. As of July 15, 2016, the agency’s responses have been inadequate.

I asked the FDA how many e-cigarette businesses it expects will be affected by the rule. The FDA gave an inadequate response that lacked the necessary details. The FDA said it did not possess some important information about the economic effects of the rule, writing that ‘[t]he baseline number of manufacturers and importers of [e-cigarette] products is uncertain.’ Without such basic information, it is impossible for the agency to weigh costs and benefits as it is required to do.

I will continue to fight on behalf of Wisconsinites and the American people in order to get complete answers from the FDA and to ensure that the agency remains transparent in its rulemaking.



Sincerely,

Ron Johnson
United States Senator

It becomes increasingly apparent that the FDA doesn't appear to know what it's doing regarding e-cig regulations. It seems they're just 'out to get us'.