And neither does anyone else here, I don't bother reading every post either - quite repetitious. Predictions are like polls and Hillary is now President, you know.
Deeming Regulations have been released!!!!
- Thread starter Oliver
- Start date
- th_trl_thread_readers 0
And neither does anyone else here, I don't bother reading every post either - quite repetitious. Predictions are like polls and Hillary is now President, you know.
Laser is the cost per page way to go, now that should appeal to the Bronze I know.
Someone I know who is deep in the Industry, who was planning on filing a PMTA, says that this whole thing is a moving target, and being jerked around by the FDA is costing them a large fortune. The view may not be worth climb.
For example in the 2016 proposal "Environmental Impact" was one of the items the FDA wanted a full analysis and studies on in a PMTA. In the version dropped yesterday that section (and some others) was completely dropped. So the hundreds of manhours and many many thousands of dollars already spent on those studies, to meet the requirements in the 2016 PMTA proposal, is now down the toilet.
In yesterdays version, on page 41 it said that the FDA "proposed addition of 19 constituents to the established list of HPHCs". So it only proposed, in a separate document (this is the link), that they might be added to the PMTA proposal but applicants have no way of knowing if it will be added to the PMTA rules or not. Even if they started today, only an army of scientists could meet the testing protocols defined by the FDA by May 2020 on these 19 new chemicals. Not to mention that each one of these chemicals represents up to and in many cases over a $100K each to meet the FDA testing protocols as defined in yesterdays PMTA proposal. That is "IF" the feds decide to actually add them. Sure an applicant could start testing now, but if the feds dont add them then it is a half million $+++ down the drain.
Keep in mind that for each chemical proposed by the FDA in this separate (84 FR 38032) document, the protocol defined in the PMTA proposal is:
Bottom line, the whole PMTA process is a moving target, and represents millions of $$ to complete. And then there is no guarantee that it will be approved.
Only BT & BP can meet this financial burden, and perhaps some Chinese players who might be subsidized by their government. Everyone else is shut out............ It is even speculated that JUUL wont meet the burden, if nothing more than (and especially) for political reasons, the FDA will pick apart their application and deny it.
For example in the 2016 proposal "Environmental Impact" was one of the items the FDA wanted a full analysis and studies on in a PMTA. In the version dropped yesterday that section (and some others) was completely dropped. So the hundreds of manhours and many many thousands of dollars already spent on those studies, to meet the requirements in the 2016 PMTA proposal, is now down the toilet.
In yesterdays version, on page 41 it said that the FDA "proposed addition of 19 constituents to the established list of HPHCs". So it only proposed, in a separate document (this is the link), that they might be added to the PMTA proposal but applicants have no way of knowing if it will be added to the PMTA rules or not. Even if they started today, only an army of scientists could meet the testing protocols defined by the FDA by May 2020 on these 19 new chemicals. Not to mention that each one of these chemicals represents up to and in many cases over a $100K each to meet the FDA testing protocols as defined in yesterdays PMTA proposal. That is "IF" the feds decide to actually add them. Sure an applicant could start testing now, but if the feds dont add them then it is a half million $+++ down the drain.
Keep in mind that for each chemical proposed by the FDA in this separate (84 FR 38032) document, the protocol defined in the PMTA proposal is:
- Develop testing methods for each compound
- Validate those testing methods, preferably through external labs
- Receive external accreditation for these validated methods
- Test actual devices and juices for each compound
- Do a complete analysis of that data
- Determine toxicological, pharmacokinetics, pharmacodynamics, metabolism, and elimination profile consequences about the levels found in each device or juice
- Write up and submit a report on all of the above, in addition to the already established scope of work defined in the actual PMTA proposal.
Bottom line, the whole PMTA process is a moving target, and represents millions of $$ to complete. And then there is no guarantee that it will be approved.
Only BT & BP can meet this financial burden, and perhaps some Chinese players who might be subsidized by their government. Everyone else is shut out............ It is even speculated that JUUL wont meet the burden, if nothing more than (and especially) for political reasons, the FDA will pick apart their application and deny it.
Last edited:
And to firmly guarantee that it is like trying to pin Jello to a wall, the FDA said this in the separate (84 FR 38032) document
So they can add anything at any time.........
So they can add anything at any time.........
How convenient, saving the FDA a lot of time going through PMTA's. Just add one criteria nobody could have planned for and "poof", bulk application refusals.
BP and BT must be pleased that their hard work has paid off, with a little help.
BP and BT must be pleased that their hard work has paid off, with a little help.
Last edited:
If you read the pharmaceutical doctor's inserts, you will quickly learn that the exact mechanism of most if not all drugs is unknown.
There are faint IDEAS, and it is in fact true that like, drugs are tested. Sorta. And then you look at like, the side effects reported during drug trials and you see less than 0001.%-- pregnancy. Well, the drug makers have to report EVERY side effect reported so if some chick is 100% convinced a drug gave her pregnancy they have to report it as it is in the trial.
And, the process for approving new drugs, while it sometimes takes a DECADE is a LOT less complicated than the FDA vaping process. It really is.
While I am no fun of patent medicines (that is a lie, opium was an ingredient in many of them! Yay!) well you have to have SOME process. But the FDA's is both flawed and slow and irrational. I can't even IMAGINE trying to submit something to the FDA, even a complaint.
Anna
There are faint IDEAS, and it is in fact true that like, drugs are tested. Sorta. And then you look at like, the side effects reported during drug trials and you see less than 0001.%-- pregnancy. Well, the drug makers have to report EVERY side effect reported so if some chick is 100% convinced a drug gave her pregnancy they have to report it as it is in the trial.
And, the process for approving new drugs, while it sometimes takes a DECADE is a LOT less complicated than the FDA vaping process. It really is.
While I am no fun of patent medicines (that is a lie, opium was an ingredient in many of them! Yay!) well you have to have SOME process. But the FDA's is both flawed and slow and irrational. I can't even IMAGINE trying to submit something to the FDA, even a complaint.
Anna
This is a followup to this story. Lab Distances Itself From Lawmakers Claim That 84% of Vape Juices Tested Contain Illegal Drugs
Last edited:
Yeah... in 2016 much of the Talk was that PMTA's would be issued for Disposables/All-in-One type Cigalikes. Hence what would be Impact of Hundreds of Thousands of One Use batteries being chucked in the Trash?
Fast Forward to today and a Main Driver is going to be Teen Use prevention.
Yep.....
FDA is proposing to require information regarding likelihood of tobacco use initiation
and switching to potentially more harmful tobacco products, including among youth and young
adults, as part of its interpretation of the requirements of section 910(b)(1)(A) of the FD&C Act
because it will help FDA determine the number of current nonusers who will likely be exposed
to the health risks presented by the tobacco product, as well as the risks posed by potentially
more harmful products that individuals may go on to use. The information regarding initiation
and switching by current nonusers of tobacco products is also being required under section
910(b)(1)(G) because FDA must take into account the increased or decreased likelihood that
those who do not use tobacco products will start using tobacco products under section
910(c)(4)(A) of the FD&C Act. The types of studies that would likely fall into this category
include survey studies and focus groups. In order to assess whether permitting the marketing of
a proposed product would be APPH, FDA will need to understand how youth may use or intend
to use the proposed product because youth are a population of particular concern for initiating
tobacco use. However, FDA does not require research to be conducted on youth. Inferences
regarding youth may potentially be extrapolated from young adults, as well as derived from
existing sources of data, reviews of published scientific literature, and/or bridging information
obtained from other sources. Providing data from the published literature or marketing
information in your application with appropriate bridging information may be one useful
approach. If you take such an approach, FDA recommends that you clearly explain how such
data can be extrapolated to the target population or populations of interest, including youth, for
the product that is the subject of the PMTA.
If an applicant chooses to conduct a study in the United States using minors, they must
use appropriate parental consent procedures, as well as follow the requirements of the Children’s
Online Privacy and Protection Act (15 U.S.C. 6501-6505), the Pupil Rights Amendment (20
U.S.C. 1232h), and their implementing regulations (see 16 CFR part 312 and 34 CFR part 98,
respectively). FDA strongly recommends that any studies conducted outside of the United States
are designed so that the rights, safety, and welfare of human subjects, including minors, have
been protected in accordance with ethical principles acceptable to the international community,
such as those reflected in the ICH Good Clinical Practice standards.
This is just the blurb on one of many topics of FDA concern, there are many, and they are all worded in this same manner. This language is used throughout the document. They basically require you to include every known "published" study, whether the study was conducted realistically or not (think about the burning cartos). If no study exists then you must conduct your own "peer reviewed and published" study. Failure to do so means application denied.
While proposed § 1114.7(k)(1)(ii)(c)-(f) would require a PMTA to contain only
information published, known to, which would reasonably be known to the applicant, as set forth
in proposed § 1114.27(b)(1)(ii), if a PMTA does not contain a threshold amount of information
regarding likelihood of changes to tobacco use behavior of current tobacco users, FDA intends to
refuse to file the application. This means where there is no published information regarding the
likelihood of changes in tobacco use behavior by current users of tobacco products or
information that is otherwise known to the applicant, including information from investigations
using other products that an applicant could bridge to its product, an applicant would need to
conduct its own investigations and include a full report of the results in its PMTA to meet this
requirement for application filing. And while the rule would not require an applicant address
each potential change in tobacco product use behavior for the purposes of filing, FDA must be
able to determine the potential risks and benefit to the population as a whole, including each of
the potential risks and benefits associated with changes in tobacco product use behavior by
current tobacco product users in order to issue a marketing order for the product. If a PMTA
lacks sufficient information needed for FDA to make these determinations, FDA intends to issue
a no marketing order for the new tobacco product.
While proposed § 1114.7(k)(1)(ii)(c)-(f) would require a PMTA to contain only
information published, known to, which would reasonably be known to the applicant, as set forth
in proposed § 1114.27(b)(1)(ii), if a PMTA does not contain a threshold amount of information
regarding likelihood of changes to tobacco use behavior of current tobacco users, FDA intends to
refuse to file the application. This means where there is no published information regarding the
likelihood of changes in tobacco use behavior by current users of tobacco products or
information that is otherwise known to the applicant, including information from investigations
using other products that an applicant could bridge to its product, an applicant would need to
conduct its own investigations and include a full report of the results in its PMTA to meet this
requirement for application filing. And while the rule would not require an applicant address
each potential change in tobacco product use behavior for the purposes of filing, FDA must be
able to determine the potential risks and benefit to the population as a whole, including each of
the potential risks and benefits associated with changes in tobacco product use behavior by
current tobacco product users in order to issue a marketing order for the product. If a PMTA
lacks sufficient information needed for FDA to make these determinations, FDA intends to issue
a no marketing order for the new tobacco product.
Ban flavor eliquid but then BT comes out with this 
!!! Wtf is going on!! Kids are gonna love this. 
!!! Wtf is going on!! Kids are gonna love this.
In the movie Tombstone, Doc Holliday first says "My hypocrisy only goes so far." And later says, "It appears my hypocrisy knows no bounds."
I suppose this is just fine in our emotionally driven times.
I suppose this is just fine in our emotionally driven times.
Ban flavor eliquid but then BT comes out with this
This is Sadly Ironic.
Because if Michigan or New York State Health Departments were held to the Same Standard, they would have No Legal Standing to Declare a Health Emergency over Flavored e-Liquids.
Because they have Present ZERO Published Study Data showing what the Reduction in Teen Use would be if Flavored e-Liquids are removed.
Or the Increase of Black Markets as a Result of their Actions.
Ban flavor eliquid but then BT comes out with this
I don't know what is IN that to make it do that, but it looks super not healthy at all. It looks like it would turn your lungs rainbow colored. Something.
Marlboro has always been the most unscrupulous tobacco dealer of them all if you ask me, I mean, as a brand name. I always like, used to judge smokers based on their brand like, "Lucky strike, trying to show off that I COULD be a prepper, but I'm not, actually." Marlboro lights, "Not to be trusted." (I smoked them for a while in my youth, I agree with myself."
I don't know how I would judge that smoker, probably "Needs ECT."
Anna
Baffled at the B.S. that is obfuscation.
(Not) In the news today:
"Multiple layers of complicated written documents have been found to deter 99% of a layman's ability to understand what meaning could have been expressed in a single sentence."
said no-one of any political significance.
/end rant
(Not) In the news today:
"Multiple layers of complicated written documents have been found to deter 99% of a layman's ability to understand what meaning could have been expressed in a single sentence."
said no-one of any political significance.
/end rant
The "Popcorn Lung" thing has come back to haunt us.
"The Centers for Disease Control said hundreds of people have been diagnosed with a bronchial disease linked to the chemical diacetyl, a chemical used to give butter-like flavors to popcorn and other foods.
The common name for that illness is popcorn lung.
"That same chemical has been found in some of the flavoring compounds that are used for flavoring vapes," Reed said."
2 Buncombe County people suffer consequences of latest smoking crazeThe common name for that illness is popcorn lung.
"That same chemical has been found in some of the flavoring compounds that are used for flavoring vapes," Reed said."
Last edited:
Oh, so THC vaping apparently causes "popcorn lung"....
(I know, I'm deliberately jumping to a conclusion here. But maybe....)
The article quoted that the Center for Disease Control said the "vaping associated illness" (new term) could be linked to diacetyl for causing "hundreds" of cases.
Is this poor reporting? From an old news story? New findings that the CDC hasn't previously announced? I don't know. I thought that our vaping industry stopped using diacetyl years ago.
Similar threads
- Locked
