FDA deeming rule could happen tomorrow
- Thread starter Oberon75
- Start date
- th_trl_thread_readers 0
- Status
So.................For all the chatter............It Regulations do as we always expected.
1) Open the Market to BT cig-a-likes
2) Destroy the Marketplace we now enjoy
Results:
1) Unemployment is about to take a Massive Jump
2) BT is about to see an increase in Adult tobacco Sales
3) Teen tobacco use will once again increase
4) A huge black market will open up. Juice makers will become the new moonshiners.
Comment 29. don't worry small business we're here to help you.
introduces a small business department in the FDa's tobacco agency.
Mike
introduces a small business department in the FDa's tobacco agency.
Mike
Only if it has a Rubber Stamp:
Exempt!
Exempt!
Exempt!
To keep enough Sell-able product on the shelves to keep the doors open
comment 31. The FDA will be the authority of what is or isn't valid scientific study.
"The FD&C Act states that determining whether a new product is appropriate for the protection of the public health shall be determined "when appropriate. . . on the basis of wellcontrolled investigations." (section 910(c)(5)(A)). However, section 910(c)(5)(B) of the FD&C Act also allows the Agency to consider other "valid scientific evidence" if found sufficient to 93 evaluate the tobacco product."
Mike
"The FD&C Act states that determining whether a new product is appropriate for the protection of the public health shall be determined "when appropriate. . . on the basis of wellcontrolled investigations." (section 910(c)(5)(A)). However, section 910(c)(5)(B) of the FD&C Act also allows the Agency to consider other "valid scientific evidence" if found sufficient to 93 evaluate the tobacco product."
Mike
Just ran the numbers.... 26 year supply in the deep freezer... if the worst I have to do is go back to winding coils I can live with that... The FDA can kiss my ....
Michael's Siegel's initial thoughts on this are on his blog: The Rest of the Story: Tobacco News Analysis and Commentary
"FDA E-Cigarette Deeming Regulations are a Disaster for Public Health"
"FDA E-Cigarette Deeming Regulations are a Disaster for Public Health"
Comment 32 validates what I have been saying for a long time.
We are tobacco users not vapers and again the chillin' and woman pregnant with chillin' card.
"(Response) An ENDS is a tobacco product as long as it meets the definition of "tobacco product" under section 201(rr) of the FD&C Act. Regardless of the type of tobacco product (and its potential risks and benefits), all tobacco products going through the PMTA pathway must meet all the requirements for a premarket authorization in section 910 of the FD&C Act before FDA can issue such an authorization. In addition, we note that, at this time, while there is general evidence of harm for all classes of newly deemed products, FDA has not yet obtained product-specific evidence regarding the various ENDS on the market. Since ENDS products contain nicotine, it is possible that such products may result in overall public health harm if individuals who would not have initiated tobacco use in the absence of ENDS ultimately graduate to combusted products (though scientific data regarding this hypothesis is unclear) or use them in conjunction with combusted products or if the users would never have initiated tobacco use absent the availability of ENDS. In addition, nicotine use in any form is of particular concern for youth and pregnant women."
Mike
We are tobacco users not vapers and again the chillin' and woman pregnant with chillin' card.
"(Response) An ENDS is a tobacco product as long as it meets the definition of "tobacco product" under section 201(rr) of the FD&C Act. Regardless of the type of tobacco product (and its potential risks and benefits), all tobacco products going through the PMTA pathway must meet all the requirements for a premarket authorization in section 910 of the FD&C Act before FDA can issue such an authorization. In addition, we note that, at this time, while there is general evidence of harm for all classes of newly deemed products, FDA has not yet obtained product-specific evidence regarding the various ENDS on the market. Since ENDS products contain nicotine, it is possible that such products may result in overall public health harm if individuals who would not have initiated tobacco use in the absence of ENDS ultimately graduate to combusted products (though scientific data regarding this hypothesis is unclear) or use them in conjunction with combusted products or if the users would never have initiated tobacco use absent the availability of ENDS. In addition, nicotine use in any form is of particular concern for youth and pregnant women."
Mike
Comment 33,the deeming regs will stifle innovation. The FDA we don't care the chillin".
Mike
Mike
Comment 34. The FDA is the sole arbitrator of what is or is not substantially
equivalent even if the product is.
Mike
equivalent even if the product is.
Mike
I LOVE My Country.........................
.........................I Despise the Machine that is relentlessly Chewing it up and Exhausting its waste upon the people.
* Not a thoughtless statement. Vaping is only a small portion of the Dictatorship of Rule and Control we have allowed Government to press upon us in the name of Peace, Protection(yea right) and Public Health.
The FDA Stands to collect Hundreds of Millions for increased research............and Personal Income through this action while putting MORE Americans on the Unemployment line, without one bit of Scientific Data dictating the need.
.........................I Despise the Machine that is relentlessly Chewing it up and Exhausting its waste upon the people.
* Not a thoughtless statement. Vaping is only a small portion of the Dictatorship of Rule and Control we have allowed Government to press upon us in the name of Peace, Protection(yea right) and Public Health.
The FDA Stands to collect Hundreds of Millions for increased research............and Personal Income through this action while putting MORE Americans on the Unemployment line, without one bit of Scientific Data dictating the need.
What we are seeing is the imminent destruction of vaping as we know it.
What no one seems to understand is the domino effect that this will have. This is literally going to kill every vape shop, their suppliers and inherently, people whether they vape or not. People will be out of work. Stores will close. Vaping will be stigmatized forever and I am very, very sad that things have come to this.
Now that the FDA has ruled, this provides ammunition to the anti-vape crowd and takes a huge chunk out of our community morale.
It seems simply that the world governments just want us to kill ourselves so they can line their pockets.
Sad, sad day.
What no one seems to understand is the domino effect that this will have. This is literally going to kill every vape shop, their suppliers and inherently, people whether they vape or not. People will be out of work. Stores will close. Vaping will be stigmatized forever and I am very, very sad that things have come to this.
Now that the FDA has ruled, this provides ammunition to the anti-vape crowd and takes a huge chunk out of our community morale.
It seems simply that the world governments just want us to kill ourselves so they can line their pockets.
Sad, sad day.
comment 35. Here it is. Proof the FDA doesn't care about the health issues at
all while saying out of one side of their mouth they are.
"(Comment 35) Comments suggested that the "appropriate for the protection of the public health" standard for PMTAs was meant for those products with well-established risks to consumers and should not apply to e-cigarettes. They suggested that FDA establish a different standard for issuing PMTA orders for e-cigarettes (i.e., that the product is no more hazardous than currently marketed tobacco products). (Response) FDA disagrees with comments suggesting the use of a different standard for e-cigarettes and other ENDS. Section 910(c)(4) specifies the standard FDA is to apply in deciding whether to issue a PMTA marketing authorization order. That section states that the product must be "appropriate for the protection of the public health" which "shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account--(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products." FDA is not authorized to deviate from this statutory standard."
Mike
all while saying out of one side of their mouth they are.
"(Comment 35) Comments suggested that the "appropriate for the protection of the public health" standard for PMTAs was meant for those products with well-established risks to consumers and should not apply to e-cigarettes. They suggested that FDA establish a different standard for issuing PMTA orders for e-cigarettes (i.e., that the product is no more hazardous than currently marketed tobacco products). (Response) FDA disagrees with comments suggesting the use of a different standard for e-cigarettes and other ENDS. Section 910(c)(4) specifies the standard FDA is to apply in deciding whether to issue a PMTA marketing authorization order. That section states that the product must be "appropriate for the protection of the public health" which "shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account--(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products." FDA is not authorized to deviate from this statutory standard."
Mike
Comment 37. The FDA has evidence of e-cigarette harm so again shut up already.
"FDA has data regarding health harms generally associated with all of the categories of tobacco products regulated under this rule (including ENDS)"
I would sure like to see it.
Mike
"FDA has data regarding health harms generally associated with all of the categories of tobacco products regulated under this rule (including ENDS)"
I would sure like to see it.
Mike
I don't know if this has been mentioned, but anyone notice the little dig they threw in? e-cigarettes are:
ENDS (as in, we are ending vaping as you know it)
ENDS (as in, we are ending vaping as you know it)
Comment 40. Can the FDA provide information of what it considers
what a substantially equivalent product is?
Why heck no! but,we'll know it when we see it.
Mike
what a substantially equivalent product is?
Why heck no! but,we'll know it when we see it.
Mike
Kinda seems a little strange to have our industry pay for individual study's and have them analyzed through the FDA for what they are going to call a pass or fail "review process" ? but the compounds in analogs that are know to kill people remain the same ..........
Meanwhile NICOTINE ( not pure nicotine, like the kind in "nicorette" that we use ) is addictive, that's what their advocating, without one single published scientific study ! If it's SO addictive how come patches / gum don't work for sheet.
How ? when it's dirived from the exact same product, is this so different to what where using and
The FDA has determined that there are no significant concerns with using NRT products like Nicorette at the same time as another nicotine-containing product like a cigarette FAQs on Nicorette | Does Nicorette Work | Nicorette
Meanwhile NICOTINE ( not pure nicotine, like the kind in "nicorette" that we use ) is addictive, that's what their advocating, without one single published scientific study ! If it's SO addictive how come patches / gum don't work for sheet.
How ? when it's dirived from the exact same product, is this so different to what where using and
The FDA has determined that there are no significant concerns with using NRT products like Nicorette at the same time as another nicotine-containing product like a cigarette FAQs on Nicorette | Does Nicorette Work | Nicorette
- Status
Similar threads
