FDA's Stance

[OnyF]

I live abroad and i'm new to Ecigs.

What''s the FDA's stance regarding the ecigs? If the FDA still has not approved the product, how can companies import them to the country?

I am opening an ecig business in my country and the biggest obstacle is getting our native FDA to approve the product. After they do, we are free to work. But that can take sooo long


ty in advance

 

[mamacat]

Where are you located?

 

[OnyF]

South America!

 

[Caesarea]

Hi Onyf,

From one of your other posts, you seem to be expecting success from a big marketing drive in Brazil.

http://www.e-cigarette-forum.com/fo...help-new-ecig-business-brazil.html#post276842

Coupled with the mention of Blu, I think you should first be wary of being overwhelmed by an imbalance between demand and supply, irrespective of legislative problems.

Best,

C.

 

[OnyF]

Don't worry about that, I am mentioning Blu simply because of their fame. I won't make the same mistakes that they did regarding supply and demand. I admire Blu, they made a solid marketing project (i've seen them advertising in loads of places) but they can't cope with the ascending demand. Too bad for them, they will surely lose clients because of this mistake.

I know Blu's manufacturer and I can assure you they made a HUGE order. I will not say how many because I can't trust the Chinese guy, but it's huge, and as soon as it arrives in America, customers will be happy again.


Anyways, can you give me some feedback on the FDA's stance? If its not approved, how can so many companies bring ecigs to the country? (Blu, smokeeverywhere, njoy, etc).

It's still not approved in my country and I can't start my business =[

 

[Caesarea]

Well, other countries as you know have imposed a ban. It looks as though that is where this is going too.

Best,


C.

 

[OnyF]

I understand. So the e-cigs actually go through american customs, but they can be subject to a ban at any moment by the FDA?

Here in Brazil, without the legit approval, the products won't even make it through when it arrives at the cargo airport.

 

[Caesarea]

I don't think anyone knows yet how this will play out, Onyf.

Best,

C.

 

[surbitonPete]

Oh dear.

 

[usamare]

So far I suppose they've been coming into country as tobacco products, which the FDA has little power over.
The only big seizures that I'm aware of were from large companies that the FDA perceived were making health claims about the products. Once health claims are made, they are considered drugs, and fall under the FDA control.

Very soon now, however, the FDA will have full jurisdiction over the products, and will almost certainly ban e-juice instantly. They will probably go after the e-cigs as well. IF the people selling the e-cigs bring a lawsuit over the vaporizers, they MIGHT win because the products don't HAVE to be filled with nicotine. That's a big IF though, as without nicotine, the market of buyers would be much smaller and may not be worth the money needed for lawsuits.

Well, that's more or less my take on the situation

 

[Surf Monkey]

I'd say that's a worst case scenario. Nothing happens quickly when it comes to the government, and if there are serious legal challenges to a proposed ban, that'll slow things down even more. A lot of people stand to make a lot of money off of e-smoking. I don't think they're going to want to go down without a fight.

 

[Sun Vaporer]

So far I suppose they've been coming into country as tobacco products, which the FDA has little power over.
The only big seizures that I'm aware of were from large companies that the FDA perceived were making health claims about the products. Once health claims are made, they are considered drugs, and fall under the FDA control.

Very soon now, however, the FDA will have full jurisdiction over the products, and will almost certainly ban e-juice instantly. They will probably go after the e-cigs as well. IF the people selling the e-cigs bring a lawsuit over the vaporizers, they MIGHT win because the products don't HAVE to be filled with nicotine. That's a big IF though, as without nicotine, the market of buyers would be much smaller and may not be worth the money needed for lawsuits.

Well, that's more or less my take on the situation

That is not quite on point---actually NJOY has never made a health claim and got their products seized. That is why they impleded them into the SE litigation with the FDA. SE did make health claims. As for it taking a long period of time---IMO not at all.

Once Judge Leon sees where this bill is headed, and if passed, he will have to rule on the pending Preliminary Injunction he has taken under review. If denied, the FDA will advance-------Sun

 

[Surf Monkey]

As for it taking a long period of time---IMO not at all.

Once Judge Leon sees where this bill is headed, and if passed, he will have to rule on the pending Preliminary Injunction he has taken under review. If denied, the FDA will advance-------Sun

And there will be an appeal process, and additional lawsuits, and more litigation...

 

[Sun Vaporer]

And there will be an appeal process, and additional lawsuits, and more litigation...

Surf--that maybe true about an appeal, but a stay is not likely and that really does not help us IMO-------Sun

 

[OnyF]

My question is how can companies sell a product which is inhaled by the consumer without FDA approval?

 

[yvilla]

Onyf, ecig suppliers started selling in the US having taken the position that FDA approval was not needed, because ecigs are not drug devices, but instead merely cigarette alternatives. The FDA regulates drugs and drug devices.

Cigarettes and other tobacco products have never been subject to FDA approval or regulation in the US to date (of course the pending legislation may change all that if it is passed). So, if ecigs are not categorized as smoking cessation devices or as drug devices, the argument goes, then as merely the functional equivalent of cigarettes they simply did not need FDA approval.

The FDA, after many months of ecigs being sold here under that premise, has decided it does not agree with that, so that's what the current litigation in federal court is about.

 

[Surf Monkey]

My question is how can companies sell a product which is inhaled by the consumer without FDA approval?

That question is exactly why H.R. 1256 exists.

 

[Surf Monkey]

The FDA, after many months of ecigs being sold here under that premise, has decided it does not agree with that, so that's what the current litigation in federal court is about.

Yes and no. The tobacco bill has been in the works for many years, not just the last few months.

 

[boxhead]

what did he say.( dodd ) ...ten years of one party or the other not (willing to lose the money tobacco brings to goverment and tobacco companys ) seeing how to work together on a simple idea, tobacco kills and fda regulation will stop the tobacco use...right...

 

[yvilla]

Yes and no. The tobacco bill has been in the works for many years, not just the last few months.

I said "litigation", Surf Monkey. The FDA's relatively recent stance on ecigs is what the litigation between SE and Njoy and the FDA is all about. And the lawsuit is based on current law, as the legislation is not in effect at the moment.