FDA Big news coming out of FDA

[zoiDman]

...

So the FDA is now trying to INCLUDE in the deeming that which Judge Leon shot down.
In other words, they are trying to DEEM tobacco use to be a disease.

...

I just Don't see it that way.

What Judge Leon ruled on was the Authority of the FDA's actions at the Time of the Ruling.

I also don't see tobacco Use somehow being Pushed into some "Disease". And I believe that the right to "Recreational Use" of tobacco has been Upheld many times in court.

 

[SomeTexan]

Am I the only one that thinks every member of the FDA, and anyone that supports them, should be burned at the stake as a witch?

 

[YoursTruli]

I would be More Concerned about Hardware being considered a "Tobacco Product" than e-Liquids being considered a Drug.

Because not making any Safety or Quitting Smoking claims about an e-Liquids does not seem that hard.

But the Inclusion of Hardware into the Realm of Tobacco Products based of the wording of this FDA Clarification is Very Troubling.

strange we were just discussing modified risk tobacco and what it would mean to e liquid manufactures/retailers... personally I think the inclusion of hardware is a direct answer to the grandfather date for “deemed tobacco products” issue.

 

[DC2]

I just Don't see it that way.

What Judge Leon ruled on was the Authority of the FDA's actions at the Time of the Ruling.

I also don't see Tobacco Use somehow being Pushed into some "Disease". And I believe that the right to "Recreational Use" of Tobacco has been Upheld many times in court.

Then I still don't understand your take on what is different between now and then.
I'd take it to PM but I think it would be good to do it here.

 

[Completely Average]

Not sure what the problem here is.

It's exactly the same standards applied to herbal medicines and vitamins. They're limited on what claims they can make. They can say it MAY aid in weight loss, but if they say it WILL make you lose weight then they have to have the laboratory studies to prove it.

It's just a standard to prevent companies from making false claims. While most people may believe that ecigs help people stop smoking there is no definitive medical study that says so, so it's illegal to advertise ecigs as a proven stop-smoking method. Likewise you have to be able to show the medical and scientific proof that it's safer before you can make such claims in advertising. And that means long term studies on thousands of people using the specific product being sold, not just a few samples taken from random products.

This doesn't limit sales at all, it simply limits how the products are advertised. You can't make advertising claims without being able to prove with proper medical studies that your claims are true. It simply requires that ecigs conform to the FDA Bad Ad and mislabeling/misleading standards.

http://www.fda.gov/Drugs/GuidanceCo...ingAdvertisingandCommunications/ucm209384.htm

http://www.fda.gov/MedicalDevices/D...neralDeviceLabelingRequirements/ucm052190.htm

These same standards are applied to virtually all products being sold as health aids or having medicinal value.

 

[philoshop]

The FDA is trying to set the deeming up so that consumer testimonials can be seen as 'therapeutic claims' made by the manufacturers.
Holy end-around, Batman!

 

[DC2]

It's just a standard to prevent companies from making false claims. While most people may believe that ecigs help people stop smoking there is no definitive medical study that says so, so it's illegal to advertise ecigs as a proven stop-smoking method.

No, it has nothing to do with whether or not stop-smoking claims can be proven.

Making stop-smoking claims has always been viewed as being a health claim in and of itself.
And such claims take a product out of the "recreational tobacco use" category and into the drug realm.

Even Judge Leon, in his ruling, did not dispute that.

 

[zoiDman]

... personally I think the inclusion of hardware is a direct answer to the grandfather date for “deemed tobacco products” issue.

People may Hate the FDA. I for one Don't have them on my Christmas Card List.

But I never have felt that the FDA is Stupid. And they are going to Do whatever they feel they have the Legal Authority to do.

And if that means trying to Include All Hardware as a Tobacco Product so that it can Only be Sold in Face-2-Face transactions, or so Hardware can be Lumped into a Taxable Category, you can Bet that they will try.

 

[zoiDman]

Then I still don't understand your take on what is different between now and then.
I'd take it to PM but I think it would be good to do it here.

There is No Difference between Then and Now. The FDA has No More Authority to do Anything with e-Cigarettes than they did in 2009.

What I'm Talk'n about is AFTER Deeming.

BTW - I don't see this FDA Clarification as having much to do with something being a "Drug". I don't think there needed to be much Clarifications for that.

What I do see this Clarification doing is What could be considered a "Tobacco Product."

 

[DC2]

There is No Difference between Then and Now. The FDA has No More Authority to do Anything with e-Cigarettes than they did in 2009.

What I'm Talk'n about is AFTER Deeming.

I know that, and I agree.
But it doesn't help me understand your position.

 

[Bad Ninja]

People may Hate the FDA. I for one Don't have them on my Christmas Card List.

But I never have felt that the FDA is Stupid. And they are going to Do whatever they feel they have the Legal Authority to do.

And if that means trying to Include All Hardware as a Tobacco Product so that it can Only be Sold in Face-2-Face transactions, or so Hardware can be Lumped into a Taxable Category, you can Bet that they will try.

It's simple labeling guidelines.
It's nothing new.
We actually NEED this.

I prefer to know exactly what's in my e juice.
I also prefer not to have a company make untested claims about any product.

I prefer honesty.

Don't all of you?

 

[nicnik]

Do we see them taxing sugar free alternatives for foods that provide questionable chemicals to satisfy the addiction to sugar? Should we see them declaring sugar free alternatives as medical substances just because they prevent users from going back to the real thing?

That's a great argument against this new FDA stupidity.

 

[zoiDman]

I know that, and I agree.
But it doesn't help me understand your position.

What I think the FDA is doing is putting Hardware Manufactures/Sellers on Notice that they feel they can Regulate Hardware even if a Hardware Manufacture/Seller markets their Products with No Intended Use. Or a use that is Not what the FDA believes people are buying the Product for.

 

[zoiDman]

It's simple labeling guidelines.
...

I Hope you are Right.

But I think there is a Little More going on here than what some might Perceive.

 

[DC2]

What I think the FDA is doing is putting Hardware Manufactures/Sellers on Notice that they feel they can Regulate Hardware even if a Hardware Manufacture/Seller markets their Products with No Intended Use. Or a use that is Not what the FDA believes people are buying the Product for.

I thought that was already the case in the previous FDA deeming proposals we've seen.

 

[YoursTruli]

People may Hate the FDA. I for one Don't have them on my Christmas Card List.

But I never have felt that the FDA is Stupid. And they are going to Do whatever they feel they have the Legal Authority to do.

And if that means trying to Include All Hardware as a Tobacco Product so that it can Only be Sold in Face-2-Face transactions, or so Hardware can be Lumped into a Taxable Category, you can Bet that they will try.

What I think the FDA is doing is putting Hardware Manufactures/Sellers on Notice that they feel they can Regulate Hardware even if a Hardware Manufacture/Seller markets their Products with No Intended Use. Or a use that is Not what the FDA believes people are buying the Product for.

...or regulated back to where closed system cigalikes are the only approved devices/hardware

 

[Wow1420]

I thought that was already the case in the previous FDA deeming proposals we've seen.

Except that this is the first I've seen the FDA assert that they can use "circumstantial evidence", not just direct marketing claims, in determining what category a product falls into. ( I wasn't following Zoid's thinking either at first, but now I think I understand, at least in part.)

 

[DC2]

Except that this is the first I've seen the FDA assert that they can use "circumstantial evidence", not just direct marketing claims, in determining what category a product falls into. ( I wasn't following Zoid's thinking either at first, but now I think I understand, at least in part.)

RIght, which would be trying to ignore/overstep the Judge Leon ruling.

Which could only be done by deeming Judge Leon's ruling to be no longer relevant.
Which could only be done by deeming tobacco use to be a disease.

 

[zoiDman]

I thought that was already the case in the previous FDA deeming proposals we've seen.

Like I said, I haven't seen Anything from the FDA with this type of Intended Use determination before. If you know of something, Please Post it. I would like to Read it.

 

[zoiDman]

Except that this is the first I've seen the FDA assert that they can use "circumstantial evidence", not just direct marketing claims, in determining what category a product falls into. ( I wasn't following Zoid's thinking either at first, but now I think I understand, at least in part.)

Ding Ding Ding.
Winner - Winner.
Chicken Dinner!