Deeming Regulations have been released!!!!
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It definitely seemed unusual to see such a bias in the comments. I'm used to seeing the other side where there is an anti vape article and the defense swarms in favor of vaping. This article was the opposite.
Not one single person chimed in to praise Johnson? Seems odd. Regardless, there are still way to many people who would post the same comments without political motivation.
People are too self serving nowadays with regulation vs true freedom. It's a lost virtue to root for true freedom regardless of opinion. If you only oppose restriction when it affects you directly and support it otherwise is dangerous and detrimental. Unfortunately it's a common theme now.
It is a bit unclear because he first puts it in context of Soterra and the continuation from that as 'tobacco products' instead of a drug. What I got on that was that he laid out how it should be, vs. how it will be - in the end, he says (paraphrasing) "because a device could be used with a tobacco product (nicotine), even if no nic, they'll capture everything under the sun". And he acknowledges even software updates to mods will also be covered ("as mind boggling as that sounds") as a tobacco product.
Without going back and re-reading the comments (yuk to that), it seems like a lot of them were attacking his ideolgy more broadly. I've not seen much of that before in response to vape-friendly speech, even when it's a conservative politician that's being vape-friendly.
I agree, except is it really more common than it already has been for a long time?
I don't remember seeing this letter before, but I spent a lot of time reading through it today. I know it is almost 2 years old and the FDA ignored a lot of the comments sent in response to the (proposed, at that time) deeming, but still, my shorts became twisted reading it.Appolagies in advance if this has already been posted. Thought I would drop this into the thread. It makes for some very very interesting reading and hopefully provides some of the core issues direct from one of the very best attorneys in the USA writing on behalf of SFATA.
Way back in 8/14 (may seem like a decade ago for the regulars) the attorneys sent the following letter to the FDA as part of their Deeming comments:
The SFATA letter to the FDA
The letter includes signatures of two attorneys (Counsel of record) for SFATA. These partner attorneys work for Venable LLP, one of the most highly regarded law firms in the nation. With over 600 attorneys, a century of existence, and an expertise in this very issue of regulatory authority and overreach. In a nut shell, these are very high powered attorneys who specialize in law suits against regulatory authorities.
Respectfully,
Senior Boy aka "Takin it to the Streets"
They apparently feel they are above the rules set in place for them, how did they even pull this off? I wonder if they changed anything before it went to OMB, or if the OMB even LOOKED at the thing before they said, um, ok?
From page 24:
Since the enactment of the proposed rule would have a substantial impact on business, consumers and the economy, it is what the Office of Management and Budget defines as a “significant” regulation. This means that the FDA is required to perform a regulatory impact analysis (RIA) under the guidelines set out under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Under these provisions the FDA must not only determine if the regulation is necessary but must assess all costs and benefits of available regulatory alternatives to select approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). It also requires the FDA to among other things analyze regulatory options that would minimize any significant impact of a rule on small entities.
From pages 27 and 28:
"According to the Office of Management and Budget, there are 16 key elements that every Regulatory Impact Analysis needs to address.......In addition to these 16 items, a proper RIA must examine a number of additional impacts including international effects and the effects on small businesses."
"Simply put, the RIA performed by the FDA staff for the proposed rule is significantly lacking in respect to the provisions outlined by the OMB. .......the analysis of the effect on small businesses was so inadequate as to encourage the Small Business Administration to offer its assistance to the FDA in completely redrafting the RIA. Looking just at the provisions outlined by the OMB, the RIA fails to perform 14 of the 16 checklist items."
I don't know why these particular details struck me harder than the rest of them, but I'm glad to know that SFATA has these experts working with/for them. Sorry for the long post, thanks for listening. I have been following the thread since day one and will continue to follow, but this makes me so angry!
I
Well, I had fun leaving a comment on the FDA's Facebook page. So apparently did many other vapers.
https://m.facebook.com/FDA/photos/a...0597299/?type=3&p=10&ref=m_notif¬if_t=like
https://m.facebook.com/FDA/photos/a...0597299/?type=3&p=10&ref=m_notif¬if_t=like
Imho- yes it has without question. Depends on what you mean irt a long time. 9/11 was the beginning of the big shift in sentiment and the financial crisis/recession closing the deal.
America got scared and then put unequivocal trust in the Government to do whatever they wanted to "protect us all". The reality is we gave up Constitutional freedoms left and right just to feel safe again and there is no turning back. Now we have 2 seriously devise parties that fight over which part of our lives they want to control.
There has been a huge power grab over the last 15 years. It was too easy. America became scared and weak and has entrusted the Government to "fix it all". And here we are. I'm not just talking single issue stuff either. We collectively bent over and gave so much away on the premise of protection. We have been protected from ourselves on so many issues that it's embarrassing.
I Honestly, I do not understand why the SBA is not hauling them in front of someone that can Force them to comply and Answer aligations.I don't remember seeing this letter before, but I spent a lot of time reading through it today. I know it is almost 2 years old and the FDA ignored a lot of the comments sent in response to the (proposed, at that time) deeming, but still, my shorts became twisted reading it.
They apparently feel they are above the rules set in place for them, how did they even pull this off? I wonder if they changed anything before it went to OMB, or if the OMB even LOOKED at the thing before they said, um, ok?
From page 24:
Since the enactment of the proposed rule would have a substantial impact on business, consumers and the economy, it is what the Office of Management and Budget defines as a “significant” regulation. This means that the FDA is required to perform a regulatory impact analysis (RIA) under the guidelines set out under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Under these provisions the FDA must not only determine if the regulation is necessary but must assess all costs and benefits of available regulatory alternatives to select approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). It also requires the FDA to among other things analyze regulatory options that would minimize any significant impact of a rule on small entities.
From pages 27 and 28:
"According to the Office of Management and Budget, there are 16 key elements that every Regulatory Impact Analysis needs to address.......In addition to these 16 items, a proper RIA must examine a number of additional impacts including international effects and the effects on small businesses."
"Simply put, the RIA performed by the FDA staff for the proposed rule is significantly lacking in respect to the provisions outlined by the OMB. .......the analysis of the effect on small businesses was so inadequate as to encourage the Small Business Administration to offer its assistance to the FDA in completely redrafting the RIA. Looking just at the provisions outlined by the OMB, the RIA fails to perform 14 of the 16 checklist items."
I don't know why these particular details struck me harder than the rest of them, but I'm glad to know that SFATA has these experts working with/for them. Sorry for the long post, thanks for listening. I have been following the thread since day one and will continue to follow, but this makes me so angry!
Greg Conley says the FDA admitted it expected to see Possibly 20 PMTA Applications.........TOTAL
How is this Not a De Facto Ban?
I'm sorry, but when you Over Regulate without Cause, it is Over Reach.
When you ignore Protocols and all Requested and received Data Confirming Less Regulation is reasonable - That is FRAUD .............on a Government level. If one of us did so, it would be a Felony against the Government.
No kidding! Your comment, Regulate without a Cause, oh, they have a cause all right, but it's nothing to do with what they say it's for, and Congress will give them a budget raise! I believe fraud is business as usual for government agencies. I am afraid my shorts will be twisted forever, I have a governmental wedgie!I Honestly, I do not understand why the SBA is not hauling them in front of someone that can Force them to comply and Answer aligations.
Greg Conley says the FDA admitted it expected to see Possibly 20 PMTA Applications.........TOTAL
How is this Not a De Facto Ban?
I'm sorry, but when you Over Regulate without Cause, it is Over Reach.
When you ignore Protocols and all Requested and received Data Confirming Less Regulation is reasonable - That is FRAUD .............on a Government level. If one of us did so, it would be a Felony against the Government.
Preventing the marketing of modified risk tobacco products, which may be marketed withwithout an FDA order
unsubstantiated claims and may mislead consumers to initiate tobacco product use or to
continue using tobacco when they would otherwise quit,
The FDA can Order you not to Smoke or Vape?
Very poor writing indeed.
No joining facebook for me, but I had fun reading those comments, too.Oh that was fun, I left my 2 cents too
Yea great Facebook posts. About as worthless as all the posts here.
Yea, don't post my name here..............but I've made a lot of noise there and they haven't dared respond to any of my Post.
IMHO the FDA hasn't even gotten past the necessity part. This is not only the FDA. Every single
regulatory agency in the Federal government is watching this. If these regulations are not dropped
in their tracks they will become the template for countless regulatory adventures for the next
hundred years. This is why term limits will not work. The bureaucracy is a entity in and of itself
creating their own self fulfilling urge to expand and control. Our leaders had better start reigning
the growth and expansion of the bureaucratic monster they created. Unfortunately they are
under the illusion they are under control. The reality is their control amounts to no more than
a puppy leash around the tail of a whale.
Regards
Mike
+1. That's was my takeaway also. Their was a segment where Azim was talking about the content of web sites. My ears perked up when he was talking about "organization" web sites like CASAA etc. His first point was that if any of these organization web sites contain content that in some manner or fashion could be construed as a health claim "they should be very careful." I remember those 5 words I bolded but for the most part I'm paraphrasing.
His second point on this same issue was chilling to say the least. He used the words "Two Click Rule" and that means if a third party web site like mine or say ECF links to a site with non compliant health claims, this third party web site may be in violation with the FDA. I've not had a chance to research this issue in more detail and plan to find this segment and post back.
I almost feel like the ecig/vaping industry should just label their products
"This product may be really unhealthy. Maybe as bad as regular cigarettes. No one knows for sure. Use at your own risk. Only adults should decide what's best for them."
There. Done. Is that statement false and misleading? Sure. Is it worse than labeling a mixture of PG/VG "this is a tobacco product"? I don't think so.
Let's face it, the long term effects of vaping really are not known. They're only been around 7-8 years. No one yet knows what will happen with 30 years of use. The scientific and medical information about vaping to date, and the knowledge of the effects and toxicity of typical juice components, all point to a far lower risk to the user than burning tobacco. So let's put the burden where it's suppose to be, the individual choice of an adult to decide whether or not to use an otherwise legal substance, just like analog cigs, or alcohol. Unless you decide to make the use of tobacco in all forms illegal, do not limit the freedom the choice just because it MIGHT turn out to carry some risk.
If vaping MIGHT represent such a danger to public health that it needs to be regulated out of existence, apply the same standard to all other tobacco products which ARE known to be a danger to public health and eliminate all sales of tobacco products in the US (including all those cigars politicians love to smoke). And we all know the chances of that ever happening..............
"This product may be really unhealthy. Maybe as bad as regular cigarettes. No one knows for sure. Use at your own risk. Only adults should decide what's best for them."
There. Done. Is that statement false and misleading? Sure. Is it worse than labeling a mixture of PG/VG "this is a tobacco product"? I don't think so.
Let's face it, the long term effects of vaping really are not known. They're only been around 7-8 years. No one yet knows what will happen with 30 years of use. The scientific and medical information about vaping to date, and the knowledge of the effects and toxicity of typical juice components, all point to a far lower risk to the user than burning tobacco. So let's put the burden where it's suppose to be, the individual choice of an adult to decide whether or not to use an otherwise legal substance, just like analog cigs, or alcohol. Unless you decide to make the use of tobacco in all forms illegal, do not limit the freedom the choice just because it MIGHT turn out to carry some risk.
If vaping MIGHT represent such a danger to public health that it needs to be regulated out of existence, apply the same standard to all other tobacco products which ARE known to be a danger to public health and eliminate all sales of tobacco products in the US (including all those cigars politicians love to smoke). And we all know the chances of that ever happening..............
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