FDA Big news coming out of FDA

[DaveP]

I don't really see a problem with the FDA reg in the bolded and underlined segment below. (1) Ecigs aren't intended for the diagnosis or treatment of a disease and (2) they aren't intended to affect the structure or function of the body in any way that is different from the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. So, given that initial statement of classification, ecigs don't meet the parameters for classification as a drug device, IMO.

Other than that, the only issue I see is that they just need to be considered as tobacco products and not pharmaceutical products, based on the statement below. This may be a step in a process that the FDA is using to incrementally build a case for moving them into the pharmaceutical realm. It's all a little too strange at this point. What is their ultimate goal?

If ecigs are sold with the statement that they may cure or mitigate the symptoms of a disease, they could be switched over from tobacco products to medical devices. If they are advertised to heal the lungs or some other part of the body, for instance, or are sold as a health aid, then they could be reclassified as drug devices.

Am I reading the clause correctly?

From the FDA link in the original post.

Conceptually, the proposed rule follows the disease prong and the structure/function
prong (with certain enumerated limitations) of the statutory definitions of “drug” and “device”
(section 201(g) and (h) of the FD&C Act). Under the proposed rule, a product made or derived
from tobacco and intended for human consumption would be regulated as a drug, device, or
combination product in two circumstances: (1) If the product is intended for use in the diagnosis
of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or
(2) if the product is intended to affect the structure or any function of the body in any way that is
different from effects of nicotine that were commonly and legally claimed in the marketing of
cigarettes and smokeless tobacco products prior to March 21, 2000. The proposed rule also
attempts to clarify remaining circumstances where a product would be or could be regulated as a
tobacco product.
In addition, FDA is proposing to amend its existing intended use regulations for drugs
and devices by inserting in §§ 201.128 and 801.4 a reference to the proposed rule to clarify the
interplay between these regulations and this proposed rule, and to conform §§ 201.128 and 801.4
to reflect how the Agency currently applies them to drugs and devices.

 

[Rossum]

I don't plan on fighting a war and don't want to spend all my time stockpiling for a zombie apocalypse. A boat can only carry so much weight; I just need enough to get to the boat...

Given that the CZ is land-locked, how will a boat get you there?

And do you really believe that they, a member of the EU, will someone exempt themselves from the European TPD?

Me, I've been all around this world and intend to stay here, where I have a freezer full of nic, and ammo to defend it.

 

[Bad Ninja]

Do Federal Laws Supersede State Laws under the Supremacy Clause?

The Key here is that Face-2-Face only sales of Tobacco Products could Never Happen.

Because they would have to Pass the FSPTCA first. And then the President would have to Sign It into Law.

And that is Never Going to Happen.

Yes, technically federal law super deeds most state law, but in reality Feds allow states to do their own thing.
Actually, they have increasingly done so on very controversial issues over the past 50 years.
Even with tobacco products and gun control, the Feds allow states to regulate themselves.

 

[stevegmu]

Given that the CZ is land-locked, how will a boat get you there?

And do you really believe that they, a member of the EU, will someone exempt themselves from the European TPD?

Me, I'll stay here, where I have a freezer full of nic, and ammo to defend it.

In CR I'd be in the mountains, on a boat in the US when the zombie hoard approaches. You really don't know CR if you think they will abide by EU TPD. TPD is enforced by member states, or not enforced. The nanny states will bend over backwards to apply and enforce it; others, not so much...

 

[Rossum]

You really don't know CR

Wrong. I was right next door in southern Germany when they failed to prepare for the obvious and then folded like a cheap suit in August of 1968.

 

[zoiDman]

Yes, technically federal law super deeds most state law, but in reality Feds allow states to do their own thing.
Actually, they have increasingly done so on very controversial issues over the past 50 years.
Even with tobacco products and gun control, the Feds allow states to regulate themselves.

Correct. The 10th Amendment is still part of the Constitution.

But this Only goes one way.

In that, a State may Chose to Raise the Age Limit to by a Tobacco Product to say 21+. But if there is a Federal Law that says the Minimum Age to buy a Tobacco Product is 18 Years Old, a State can Not Pass a Law to make buying a Tobacco Product Legal for a 16 year old.

So if there is a Federal Law that say that Tobacco Products can Only be Sold in Face-2-Face transactions, a State can Not Supersede this Law by Passing a Law in their State that say people can.

Now I'm sure that the FDA would Never Try to Include Hardware as a Tobacco Product. That wouldn't be Fair. LOL

But if they Could, then Bye-Bye net sales for Hardware. And I hope there are a Lot of Vape Shops in the Salton Sea area.

 

[stevegmu]

Wrong. I was right next door in southern Germany when they failed to prepare for the obvious and then folded like a cheap suit in August of 1968.

They also surrendered to the nazis, but a country of 10 million had no chance against nazi Germany or Soviet Russia...
The EU is spineless and has no enforcement power. CR doesn't even enforce it's own laws. Owning and operating brothels is technically illegal in CR-
For those who can't read Czech, there is a police station on the left and brothel on the right...

 

[Dan011z]

So if they regulate nicotine for vaping, what does that mean for us other than a price jump? If it doesn't affect my ability to buy the things I normally buy for my vaping, I see no problem.

Unless the prices are quadripled or something, then I would end up punching a baby.

 

[DaveP]

So if they regulate nicotine for vaping, what does that mean for us other than a price jump? If it doesn't affect my ability to buy the things I normally buy for my vaping, I see no problem.

Unless the prices are quadripled or something, then I would end up punching a baby.

As I posted a few posts back, the FDA won't touch ecigs (according to the document posted) unless the industry makes claims that vaping prevents some sort of disease or cures an ailment. It's still a touchy standoff, though. What if the FDA jumps on a claim that vaping is a cure for smoking. Then, it becomes equivalent to Nicorette, which is classified as a drug.

 

[Wow1420]

Well, if we knew for sure, this thread would be less than half the length it is.

One of the things we do know is that the FDA doesn't impose taxes, watch your friendly state and local governments for that angle.

If/when deeming goes through, depending on whether they keep the original grandfather date, manufacturers may have to comply with very costly testing and reporting requirements to have any product on the market, necessitating a price increase. Many smaller companies may go under due to not being able to afford the required testing at all. There's a two year lead time on enforcement of this aspect.

We could easily see sales restricted to face to face only, no more internet selling.

We know regulations will apply to e-liquids containing nicotine. They could try to include no-nic, although personally I don't see how that could possibly be justified. Regulations could include hardware, or maybe they won't. They could ban flavorings, or maybe they won't.

 

[Bad Ninja]

As I posted a few posts back, the FDA won't touch ecigs (according to the document posted) unless the industry makes claims that vaping prevents some sort of disease or cures an ailment. It's still a touchy standoff, though. What if the FDA jumps on a claim that vaping is a cure for smoking. Then, it becomes equivalent to Nicorette, which is classified as a drug.

As in the past, it will be used as a tool to shut down companies that continue to make claims.
Just like the vitamin and supplement indistry, they don't resort to it unless there is a violation.

Ironically, it'll protect us from shady juice companies and medical claims made by people who aren't doctors.

 

[DaveP]

Well, if we knew for sure, this thread would be less than half the length it is.

One of the things we do know is that the FDA doesn't impose taxes, watch your friendly state and local governments for that angle.

If/when deeming goes through, depending on whether they keep the original grandfather date, manufacturers may have to comply with very costly testing and reporting requirements to have any product on the market, necessitating a price increase. Many smaller companies may go under due to not being able to afford the required testing at all. There's a two year lead time on enforcement of this aspect.

We could easily see sales restricted to face to face only, no more internet selling.

We know regulations will apply to e-liquids containing nicotine. They could try to include no-nic, although personally I don't see how that could possibly be justified. Regulations could include hardware, or maybe they won't. They could ban flavorings, or maybe they won't.

That's the scary part. Eliquids having to be tested and approved would be a limiting factor for Mom and POP businesses. Footing the bill for FDA approval would be far greater in cost than any profit the could realize over many years of daily selling. Considering that a vendor might carry 50 to hundreds of juices, depending on the size of their operation, the cost would be astronomical. Only large manufacturers could afford to comply.

It's possible that components could be tested by the manufacturers and that approval would shift to the Mom and Pop dealers who use their components for juice mixing. FDA might just consider mixing from qualified components as creation rather than mixing. If that's true, then any company who uses ingredients to manufacture a food product would have to meet compliance on their final product.

 

[Dan011z]

As I posted a few posts back, the FDA won't touch ecigs (according to the document posted) unless the industry makes claims that vaping prevents some sort of disease or cures an ailment. It's still a touchy standoff, though. What if the FDA jumps on a claim that vaping is a cure for smoking. Then, it becomes equivalent to Nicorette, which is classified as a drug.

Ah I get it.
Classified as drug but sold over the counter right?
Lets just hope they don't touch mess with flavorings.
Nicolette already has multiple flavorings.

 

[Oliver]

@DaveP I think the issue with the "structure/function prong" is that it means that even if you don't consider smoking a disease, if a product (any product) is marketed as being an alternative to smoking, it is making a medical claim: after all, there's nothing quite like smoking in terms of disease burden on the body, even if the behavior of smoking itself isn't a disease.

Under this reading, if I say "beer enables you to stop drinking whisky", I'm making a medical claim for beer because there will be differences in the metabolic effects of both whisky and beer. It's a hyper-legalistic interpretation of the medicines law.

My principal concern with this rule is that, in my mind, vape stores have a unique role and opportunity in helping people migrate from smoking to vaping. As I see it, anyone who's opened a vape store with this in mind is going to have to be extremely careful in how they run their business. I think this is a huge public-health own goal.

Consider: in the UK now we have our National Smoking Cessation Services queueing up to partner with e-cig companies to help educate smokers properly on e-cigs and how to use them. I think this is probably unique in the world. What a damned shame this won't happen in the USA, where there are 4 times as many smokers in need of such advise.

Also, it's absolutely canonical that replacing nicotine helps people to stop smoking. This has been known for a long time. Why on earth this can't just be accepted with e-cigs is, I must say, beyond me.

 

[Bad Ninja]

That's the scary part. Eliquids having to be tested and approved would be a limiting factor for Mom and POP businesses. Footing the bill for FDA approval would be far greater in cost than any profit the could realize over many years of daily selling. Considering that a vendor might carry 50 to hundreds of juices, depending on the size of their operation, the cost would be astronomical. Only large manufacturers could afford to comply.

It's possible that components could be tested by the manufacturers and that approval would shift to the Mom and Pop dealers who use their components for juice mixing. FDA might just consider mixing from qualified components as creation rather than mixing. If that's true, then any company who uses ingredients to manufacture a food product would have to meet compliance on their final product.

You don't need FDA approv to sell herbal extracts, goat weed supplements, vitamins or ejuice.

You must, however, follow their marketing and packaging guidelines.

 

[Dan011z]

@DaveP I think the issue with the "structure/function prong" is that it means that even if you don't consider smoking a disease, if a product (any product) is marketed as being an alternative to smoking, it is making a medical claim: after all, there's nothing quite like smoking in terms of disease burden on the body, even if the behavior of smoking itself isn't a disease.

Under this reading, if I say "beer enables you to stop drinking whisky", I'm making a medical claim for beer because there will be differences in the metabolic effects of both whisky and beer. It's a hyper-legalistic interpretation of the medicines law.

My principal concern with this rule is that, in my mind, vape stores have a unique role and opportunity in helping people migrate from smoking to vaping. As I see it, anyone who's opened a vape store with this in mind is going to have to be extremely careful in how they run their business. I think this is a huge public-health own goal.

Consider: in the UK now we have our National Smoking Cessation Services queueing up to partner with e-cig companies to help educate smokers properly on e-cigs and how to use them. I think this is probably unique in the world. What a damned shame this won't happen in the USA, where there are 4 times as many smokers in need of such advise.

Also, it's absolutely canonical that replacing nicotine helps people to stop smoking. This has been known for a long time. Why on earth this can't just be accepted with e-cigs is, I must say, beyond me.

We can never have nice things..

 

[Oliver]

We can never have nice things..

Well, in reality nor can we: In May next year 90% of the products currently on the market will be banned under the stupid EU TPD rule which was signed into law last year.

 

[Dan011z]

Well, in reality nor can we: In May next year 90% of the products currently on the market will be banned under the stupid EU TPD rule which was signed into law last year.

Banned, like illegal to buy/sell?

 

[Oliver]

Yup - 90% of the products currently on the market will be illegal to sell. RDAs, RBAs, Tanks more than 2ml capacity. Bottles over 10ml. All tanks must have a "leak free refilling mechanism" which has not yet been defined.

 

[Dan011z]

Yup - 90% of the products currently on the market will be illegal to sell. RDAs, RBAs, Tanks more than 2ml capacity. Bottles over 10ml. All tanks must have a "leak free refilling mechanism" which has not yet been defined.

..........wow