FDA Deeming updates VTA issues FDA regulations calendar

[Katdarling]

But what would one expect of a corrupt section of Government Dictating without Oversight.

Dunno, orange jumpsuits?

 

[element77]

MADE FROM tobacco

 

[skoony]

It was my Understanding that before a Major Rule, such as what the FDA is making, could be Finalized that it had to be Reviewed by BOTH Houses of Congress.

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

U.S.C. Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

I have brought this Up in a Few Threads. But No One seems to be Able to confirm this.

zoiD, are the required to review the regulations or only need to review them if they have issues
of concern? My thought is even if they have to give them some sort of perfunctory OK I would
consider that as doing nothing.

"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.

These sorts of contradictory statements were made in the proposed regulations too.

And where the FDA Crazy Train really goes "off the rails" is if you use unflavored, nicotine-free liquid in your device, it also instantly becomes a tobacco product as well since the hardware used is also deemed a "Tobacco Product"... If I'm incorrect in this observation, someone PLEASE correct me!
I'm losing my perspective on reality with these insane regulations.

Ditto,your interpretation is the same as mine.

Regards
Mike

 

[zoiDman]

zoiD, are the required to review the regulations or only need to review them if they have issues
of concern? My thought is even if they have to give them some sort of perfunctory OK I would
consider that as doing nothing.

It is My Understanding that the Purpose of the Congressional Review Act is to provided a Check and Balance in the Rule Making Progress. So a Federal Agency can Not just come up with Anything they want and there is No Vehicle for Opposition via Congress.

And that the Review Process is Not Instigated by a Request from Congress for Review. It is a Statutory Requirement that BOTH House of Congress are given a Copy of the Final Rule. And have the Option to Raise Opposition if they believe that the Rule is Not in Concordance to the Law(s) that gave the Agency Authority to Make the Rule.

The President also has the Power to Veto congressional Opposition to a Rule. And there is a Mechanism for Congress to Over-Ride a Presidential Veto.

It would be Nice if CASAA or SFATA or AMSEA or TVECA or anyone who has Lawyers could comment on this aspect of the Rule Making Progress.

 

[skoony]

@zioDman Thanks. So in the absence of any objections by any of the Houses nor the President
I would consider that as doing nothing as there is no yes or no vote. Only objections would
start any type of mitigating process.
Regards
Mike

 

[zoiDman]

@zioDman Thanks. So in the absence of any objections by any of the Houses nor the President
I would consider that as doing nothing as there is no yes or no vote. Only objections would
start any type of mitigating process.
Regards
Mike

I'm not I understand what you are Say'n?

 

[Robino1]

I'm not I understand what you are Say'n?

Inaction means approval. Only objections are noted then acted upon.

In other words, if there is no objection voiced, it is taken as an approval and things move forward.

At least that is what I am getting.

 

[skoony]

I'm not I understand what you are Say'n?

What @Robino1 said.
Mike

 

[zoiDman]

Inaction means approval. Only objections are noted then acted upon.

In other words, if there is no objection voiced, it is taken as an approval and things move forward.

At least that is what I am getting.

Once again, as I Understand it. It isn't an Issue of there being Opposition or Non-Opposition or Support of Congress. It is a Procedural Requirement. Just like there Had to be a Comment Period. Or it the Rule had to go to the OMB/OIRA.

Even if it was Optional, I would want to Force Congress to Review this Rule.

Not so much for the concept of Checks and Balances that this Government is Supposed to be Based On. But to Force Legislators to come out into the Light and go on the Public Record of whether they Support this type of Regulatory Over-Reach.

 

[Robino1]

Once again, as I Understand it. It isn't an Issue of there being Opposition or Non-Opposition or Support of Congress. It is a Procedural Requirement. Just like there Had to be a Comment Period. Or it the Rule had to go to the OMB/OIRA.

Even if it was Optional, I would want to Force Congress to Review this Rule.

Not so much for the concept of Checks and Balances that this Government is Supposed to be Based On. But to Force Legislators to come out into the Light and go on the Public Record of whether they Support this type of Regulatory Over-Reach.

I agree. I think that our legislators have gotten lazy over the years.

 

[zoiDman]

I agree. I think that our legislators have gotten lazy over the years.

And the Voters have gotten Lazy also by Not Demanding that things like this can Not just Blow thru Congress without Comment. Where is the Congressional Oversight to what the FDA wants to Do?

Were at the End of the Line Here. And I'm Not Saying that a Congressional Review could Prevent this Melt Down of the e-Cigarette Industry as we Know it.

But If Nothing Else happens, I would at Least want to see a Yeh or a Nay next to EVERY House and Senate Members Name as to Whether they Support what the FDA has Release.

And If I could Get only 1 Requirement Amended or Removed from Deeming or PMTA for ENDS, it would be 1 Less than we have Today.

 

[YoursTruli]

Sadly some decent business' may end up in States Mandating such record keeping.

I don't see that happening. Record keeping is one thing, requesting/storing a copy of someone's license is another.

Both... is already happening in Texas
Texas SB97 | 2015-2016 | 84th Legislature

One of the online stores I buy from is located in Texas and when I check out with my purchase I have to sign a legal written statement first...
(d)A retailer in this state that otherwise complies with
applicable laws relating to retail sales and primarily sells
e-cigarettes may comply with Subsection (c) by:
(1)verifying the age of the prospective purchaser
with a commercially available database or a photocopy or other
image of a government-issued identification bearing a photograph of
the prospective purchaser and stating the date of birth or age of
the prospective purchaser;
(2)obtaining a written statement signed by the
prospective purchaser, under penalty of law, certifying the
prospective purchaser's address and date of birth; and
(3)receiving payment for the delivery sale from the
prospective purchaser by a credit card or debit card that has been
issued in the prospective purchaser's name or by a check that is
associated with a bank account in the prospective purchaser's name.

 

[crxess]

It is My Understanding that the Purpose of the Congressional Review Act is to provided a Check and Balance in the Rule Making Progress. So a Federal Agency can Not just come up with Anything they want and there is No Vehicle for Opposition via Congress.

And that the Review Process is Not Instigated by a Request from Congress for Review. It is a Statutory Requirement that BOTH House of Congress are given a Copy of the Final Rule. And have the Option to Raise Opposition if they believe that the Rule is Not in Concordance to the Law(s) that gave the Agency Authority to Make the Rule.

The President also has the Power to Veto congressional Opposition to a Rule. And there is a Mechanism for Congress to Over-Ride a Presidential Veto.

It would be Nice if CASAA or SFATA or AMSEA or TVECA or anyone who has Lawyers could comment on this aspect of the Rule Making Progress.

The whole(and Major) problem with such action is the word LAW. Changes in Regulation supported By LAW as the only obligation - Takes the Freedom and Right of the people to decide what should be in their best interest - Completely out of consideration.
This equals Governing TO the people, Not For the people.
Congress has an Obligation(or once did) to Consider the effect of any law and its effect on those the law will be pressed upon. Not is it Legal, but is it JUST!
The FDA has scurried Far and away from the intended goal when enacted.

A Division of Government once Tasked with seeking out dangers in products made for Human consumption, Acting on those Dangers and making standardized practices(regulation) To prevent further illicit and dangerous practice for profit upon the people.
Even creating the Tobacco division was founded in Science on the Dangers of (Smoking) and (Chew) Tobacco........(but not -Pure Nicotine)

With the latest DEEMING Regulations - the FDA has placed the Cart squarely before the Horse.

1962

Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.

Significant Dates in U.S. Food and Drug Law History

 

[skoony]

Both... is already happening in Texas
Texas SB97 | 2015-2016 | 84th Legislature

One of the online stores I buy from is located in Texas and when I check out with my purchase I have to sign a legal written statement first...
(d)A retailer in this state that otherwise complies with
applicable laws relating to retail sales and primarily sells
e-cigarettes may comply with Subsection (c) by:
(1)verifying the age of the prospective purchaser
with a commercially available database or a photocopy or other
image of a government-issued identification bearing a photograph of
the prospective purchaser and stating the date of birth or age of
the prospective purchaser;
(2)obtaining a written statement signed by the
prospective purchaser, under penalty of law, certifying the
prospective purchaser's address and date of birth; and
(3)receiving payment for the delivery sale from the
prospective purchaser by a credit card or debit card that has been
issued in the prospective purchaser's name or by a check that is
associated with a bank account in the prospective purchaser's name.

so only children that have the help of adult compliance checkers will have the
the ability to obtain these products in Texas.
Seems legit.
Mike

 

[crxess]

Inaction means approval. Only objections are noted then acted upon.

In other words, if there is no objection voiced, it is taken as an approval and things move forward.

At least that is what I am getting.

Agreed.......................However there Were Objections.
Cole, Cole-Bishop and noted objections by other members to recommendations and/or actions proposed by the FDA. No congressional action was brought on by/due to these objections.

 

[Robino1]

Agreed.......................However there Were Objections.
Cole, Cole-Bishop and noted objections by other members to recommendations and/or actions proposed by the FDA. No congressional action was brought on by/due to these objections.

 

[zoiDman]

The whole(and Major) problem with such action is the word LAW. Changes in Regulation supported By LAW as the only obligation - Takes the Freedom and Right of the people to decide what should be in their best interest - Completely out of consideration.
This equals Governing TO the people, Not For the people.
Congress has an Obligation(or once did) to Consider the effect of any law and its effect on those the law will be pressed upon. Not is it Legal, but is it JUST!
The FDA has scurried Far and away from the intended goal when enacted.

A Division of Government once Tasked with seeking out dangers in products made for Human consumption, Acting on those Dangers and making standardized practices(regulation) To prevent further illicit and dangerous practice for profit upon the people.
Even creating the Tobacco division was founded in Science on the Dangers of (Smoking) and (Chew) Tobacco........(but not -Pure Nicotine)

With the latest DEEMING Regulations - the FDA has placed the Cart squarely before the Horse.

1962


Significant Dates in U.S. Food and Drug Law History

The Problem with the System, and why there is such a High Level of Distrust in what the Government does, is that So Much of this is Done in the Shadows. And Many Times the 1st the average person hears about things is when some Majority Leader gives a Press Conference talking about what was Passed 24 Hours ago.

About the ONLY Way I could be More Disgusted by this Entire Deeming Sham (I mean "process") is if there is going to be some Congressional Review. But we don't hear about it until the 11th Hour.

 

[DoctorJ]

Aren't there a couple of age check services already in place that tie into public record information based on what you have to supply to the vendor anyway to complete a purchase?

How about the the netIDme site that ECF uses for verified members?

 

[espkh123]

Additional Label Requirements
–
All product labels must bear the following:

Name and
location of manufacturer, packer or distributor

Net quantity of contents by weight, measure or count

Percentage of tobacco used in the product that is domestic, percentage
foreign

“Sale only allowed in the United States” which must also appear on
packaging
and shipping cartons

...........

Now with point 2, would they basically have to post ALL their ingredients?

Lets look at some key issues - DIY juice will be HIGHLY used after the regulation wave hits. While I do sometimes clone juice, I do it based off taste and other methods. It would be rather silly. Imagine if they pointed this at cigarettes. The boxes would be A LOT bigger to fit all that s#it on there.

I would really hate to see companies go through all that work, post their recipe on the bottle, then have no one buy it because it will most likely cost 60 dollars for a 30ml and you could make it yourself for cheap.

 

[bnrkwest]

I am wondering, wouldn't it be easier for a supplier to get one level of nic plain approved say something low like 6 nic or 10 nic. If approved it only has one nic level and Pg and VG added. Then sell flavor shots of favorite recipes. The flavor shots would not have to be approved would they? Since the flavor shots are pure flavoring blends, wouldn't they be exempt??