FDA Deeming updates VTA issues FDA regulations calendar

[hcour]

"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.

 

[Robino1]

"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.

That was one of many that just made me throw up a little. Sickening what they are trying to get away with.

 

[Rickajho]

"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.

That was one of many that just made me throw up a little. Sickening what they are trying to get away with.

That's why I see Court challenges to potholes in the regulations it seems any hack lawyer could drive a bus through. It might be a regulation, but I ain't Alice and this still isn't Wonderland.

 

[Steamix]

"

So e-liquid with 0mg nicotine has to carry the label "'This product is made from tobacco"? This is beyond absurd.

Erm, good thing that there's currently no space shuttle around. Wouldn't put it past the FDA to fly to the moon and lay out a few thousand square miles of label ( 2o% surface for label, remember ? )

"This celestial body is made of green cheese"

 

[crxess]

"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.

Absurd.............and outright Fraud propagated by the FDA on behalf on Big Tobacco - (advertisement) If no Tobacco then NOT TOBACCO!!!
But what would one expect of a corrupt section of Government Dictating without Oversight.

 

[Kent C]

"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.

It's why they call it a 'deeming'. It's redefining something outside of the context of the concept. Has nothing to do with objective truth, only subjective mandates.

 

[Kent C]

What got my attention:

Substantial Equivalence Exemption Requests Due
–
Requests for exemption from SE requirements for a minor modification to an
additive for products on market as of August 8, 2016 must be filed with the FDA.

Notes:

Filing will allow your product to remain on the market until at least
August 8, 2018.

But, given the absence of any true predicate for ENDS products, most
companies will be unable to use this SE exemption application process.

Everything will require a 'new product application'

--------
Tobacco Health Documents Submission

Small-scale manufacturers must submit to the FDA documents developed after
June 22, 2009, that relate to “health, toxicological, behavioral, or physiologic
effects” of products, constituents (including smoke constituents), ingredients,
components and additives.

This is what kills small shops..... and costs hundreds of thousands to lose their jobs and cities and counties to lose revenue from income and sales (property?) tax losses.

 

[crxess]

What got my attention:

Substantial Equivalence Exemption Requests Due
–
Requests for exemption from SE requirements for a minor modification to an
additive for products on market as of August 8, 2016 must be filed with the FDA.

Notes:

Filing will allow your product to remain on the market until at least
August 8, 2018.

But, given the absence of any true predicate for ENDS products, most
companies will be unable to use this SE exemption application process.

Everything will require a 'new product application'

--------
Tobacco Health Documents Submission

Small-scale manufacturers must submit to the FDA documents developed after
June 22, 2009, that relate to “health, toxicological, behavioral, or physiologic
effects” of products, constituents (including smoke constituents), ingredients,
components and additives.

This is what kills small shops..... and costs hundreds of thousands to lose their jobs and cities and counties to lose revenue from income and sales (property?) tax losses.

Plus increased unemployment payouts
Increased State paid health care - no job, no insurance
Increased Food Stamps
Increased Family Financial Aid

However I'm sure someone has done the Calculations and this Cost would not come close to the Money being lost from the Drop in Tobacco Tax collection.
Checks and Balances

 

[Kent C]

Plus increased unemployment payouts
Increased State paid health care - no job, no insurance
Increased Food Stamps
Increased Family Financial Aid

However I'm sure someone has done the Calculations and this Cost would not come close to the Money being lost from the Drop in Tobacco Tax collection.
Checks and Balances

There will be some increase in jobs - DEA, ATF, FDA enforcement of the black market. Local Police for drive-bys, snitches, CI's, more prisons, prison guards, etc. etc. :- )

 

[hcour]

It's why they call it a 'deeming'. It's redefining something outside of the context of the concept. Has nothing to do with objective truth, only subjective mandates.

"The Deeming." Sounds like a cheesy horror movie.

 

[retired1]

Granted it was 6 years ago, but that is exactly what was required when I used to buy cigarettes online. Things may have changed now. No clue.

They kept a copy of my photo ID on file and I paid by electronic check since credit card companies did not allow purchase of tobacco.

Yeah... This is where the Lawyers enter from Stage Left.

Because does the Seller Need to see the Buyer's ID to be able to Make a "Tobacco Product" sale? Or is it Enough for a Delivery Company or the USPS to see an ID after the sale has been Made?

Exactly what I was thinking. The age may need to be verified at the P.O.S.

I would bet my money on it. Proving that you or someone at your residence is of legal age after the sale, will not count towards being in compliance at the time of sale.

Here's the problem with requiring that. We all know that point of sale compromises are on the rise. Some well known companies have been bit in the past as well. Trustwave has reported that there are still companies out there that are using e-commerce software that is still vulnerable and not patched.

There is no way on this green earth that I will permit ANY company to take a photocopy of my ID and keep it on file. We won't know how they'll store it, and if they plan on doing it electronically, it's even more at risk as now any server compromise could result in that information being released. And let's face it, a copy of someone's driver's license is an identity thief's wet dream.

Yes, there will be some that cheerfully comply with the request. Those are the people you see in the news claiming they have no earthly idea how their identity got stolen.

 

[retired1]

Here's some eye opening reading for you all.

Zero-day in Magmi database client for popular e-commerce platform Magento targeted in the wild

TWSL2016-006: Multiple XSS Vulnerabilities reported for Zen Cart

Now, tell me that all will be good when a company states they're storing that ID information electronically and it's totally secure.

Riiiiiiiiiiiiiiiiiiiiiiiiiiiight.

 

[Katmar]

Here's some eye opening reading for you all.

Zero-day in Magmi database client for popular e-commerce platform Magento targeted in the wild

TWSL2016-006: Multiple XSS Vulnerabilities reported for Zen Cart

And is there a way that we, as consumers, KNOW what is being used at various sites?

 

[retired1]

And is there a way that we, as consumers, KNOW what is being used at various sites?

Many times, you'll see what's being used at the very bottom of the page, especially if they're not going through a site like Shopify, Bigcommerce, etc.

Otherwise, you have to look at the source code for the page and see what's being used in the hand off for the transaction.

Magento I think you have to do some digging in the source code to see if it's being used. Zen Cart shows up at the bottom of the page on sites that use it.

And while the software companies are usually pretty good in getting the fixes pushed out to the public, there's no guarantee that the company using the software is aware of the vulnerability and has patched their servers. This is evident by the number of Magento sites that are still vulnerable.

 

[Eskie]

It is more likely an age verification service would be used, at least by larger companies. It avoids two problems. The first is eliminating the need for a person to actually review each drivers license to verify age (folks can get a license under the age of 18, so reading it for the birth date is required). Second, it avoids the liability of keeping something subject to abuse such as a drivers license on file. Businesses that are compromised by hackers can suffer major financial losses between penalties, customer notice, and picking up the expense of consumer credit checks for several years.

As for smaller companies whose volume is relatively low, drivers license review might be easier and cheaper to implement than paying for a service. But for the sake of security, all they have to do is store a paper record. If there's no electronic file, there's nothing to hack. Unless of course an employee exploits the information.

 

[retired1]

As for smaller companies whose volume is relatively low, drivers license review might be easier and cheaper to implement than paying for a service. But for the sake of security, all they have to do is store a paper record. If there's no electronic file, there's nothing to hack. Unless of course an employee exploits the information.

There's big bucks in the black market for personal information. There have been numerous cases of employees selling that kind of information.

 

[salemgold]

Here's the problem with requiring that. We all know that point of sale compromises are on the rise. Some well known companies have been bit in the past as well. Trustwave has reported that there are still companies out there that are using e-commerce software that is still vulnerable and not patched.

There is no way on this green earth that I will permit ANY company to take a photocopy of my ID and keep it on file. We won't know how they'll store it, and if they plan on doing it electronically, it's even more at risk as now any server compromise could result in that information being released. And let's face it, a copy of someone's driver's license is an identity thief's wet dream.

Yes, there will be some that cheerfully comply with the request. Those are the people you see in the news claiming they have no earthly idea how their identity got stolen.

I agree that it will indeed be an easy target. Heck, the state revenue department got hacked a few years back in my state and everyone in this state that filed state taxes had their identities stolen. It wasn't like we had a choice in them storing our info electronically in that case.

Could just end up that folks not willing to have their info stored by the vendor end up SOL. Good reason for so many of us to be well stocked and prepared for this.

Maybe they will be able to use an online age verification service now. I just don't know. But, I have serious doubt that having a delivery service check ID at the time of delivery will be acceptable.

 

[UnclePsyko]

Absurd.............and outright Fraud propagated by the FDA on behalf on Big Tobacco - (advertisement) If no Tobacco then NOT TOBACCO!!!
But what would one expect of a corrupt section of Government Dictating without Oversight.

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.

It's why they call it a 'deeming'. It's redefining something outside of the context of the concept. Has nothing to do with objective truth, only subjective mandates.

"The Deeming." Sounds like a cheesy horror movie.

I'm thinking it's time to start replacing "Deeming" with "Dooming" since that's what the regulations seek out to do, Doom the industry and nothing else.

 

[supertrunker]

It's why they call it a 'deeming'. It's redefining something outside of the context of the concept. Has nothing to do with objective truth, only subjective mandates.

That's the most concise explanation of this total nonsense i've ever read. Bravo.

T

 

[zoiDman]

Here's the problem with requiring that. We all know that point of sale compromises are on the rise. Some well known companies have been bit in the past as well. Trustwave has reported that there are still companies out there that are using e-commerce software that is still vulnerable and not patched.

There is no way on this green earth that I will permit ANY company to take a photocopy of my ID and keep it on file. We won't know how they'll store it, and if they plan on doing it electronically, it's even more at risk as now any server compromise could result in that information being released. And let's face it, a copy of someone's driver's license is an identity thief's wet dream.

Yes, there will be some that cheerfully comply with the request. Those are the people you see in the news claiming they have no earthly idea how their identity got stolen.

Yeah... If having a Photo ID on File Is what will be required, it is Almost like they Want to make things so that People will Not buy "Tobacco Products" in Non Face-2-Face transactions.