FDA to Regulate Electronic Cigarettes as Tobacco Products

[Chief Rocka]

All kinds of news regarding this issue has come across the wire today. This may not be a surprise to some, but I guess it was recently updated on FDA website today.
FDA to Regulate Electronic Cigarettes as Tobacco Products - Bloomberg

Any insight to what this means?
more articles:
http://www.cleveland.com/business/index.ssf/2011/04/fda_to_regulate_e-cigs_as_toba.html
http://www.csnews.com/top-story-fda_rules_against_appeal_bid_in_electronic_cigarette_case-58582.html
http://www.mercurynews.com/business/ci_17924024?nclick_check=1

 

[yvilla]

Chief, the discussion has started one up, in the legislation news sub-forum. In short, it's hugely good news - for now - in that it is essentially the FDA's public announcement that it is conceding to njoy's victory in the lawsuit, and will NOT be filing a petition for review by the Supreme Court.

But, there are many battles ahead over the scope and substance of the new regulations the FDA intends to promulgate. Please see my much more lengthy post in this thread: http://www.e-cigarette-forum.com/forum/legislation-news/182522-fda-regulate-e-cig-tobacco.html

 

[PoliticallyIncorrect]

I don't like the sound of this: "The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act...The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products..."

User fee sounds like regulatory code for draconian taxation by an agency otherwise not empowered to levy taxes—and, as is virtually the case with cigarettes, de facto prohibition.

 

[krijmo]

It means we can't predict the future and at least the FDA had to suck our balls and concede. This is a political matter and once it's solved, I'm sure we will still be able to vape and the world will not stop turning. Maybe we might be taxed more, but nicotine is a vice and in my opinion, a taxation on vices is not unreasonable. So much of this stuff comes out of China I don't know how they're going to tax that, and DIY'ing will be like rolling your own. I highly doubt that there will be some draconian tax conspiracy against vapers... If you don't want to pay such high taxes, vote republican Not that I liked bush or that other ..... that ran against Obama... I would say tea party but I don't see ANY vapers throwing a precious ecig in the water. Lol.

 

[yvilla]

"User fees", in this context, means the fees the FDA imposes on industry parties - manufacturers, distributors, etc, for the privilege of being regulated by the FDA. That is, once the regulations for this new class of smoke-free tobacco products are all promulgated and finally settled upon (which could take up to about two years to get accomplished) fees paid for the privilege of having to register, to submit tons of paperwork, to undergo plant inspections, etc, etc.

 

[Grimloki]

I think in the big list of things the government thinks about taxing e-cigs are really close to the bottom.

 

[ukeman]

my hunch, purely elementary... "good thing i'm stocked up".

Prices will go up some due to regulatory fees on vendors/suppliers (licensing, taxes, etc)... it's a vice/luxury (imo).

I figure most juice will last a year... from fresh.
Some of the equiptment/gear/hardware/accessories' prices may never be the same.

No?

 

[simply me]

Can you ship tobacco though the ups? I thought you had to have a liences to receive tobacco. Wouldn't this be the same. So what about online sales.

 

[yvilla]

Can you ship tobacco though the ups? I thought you had to have a liences to receive tobacco. Wouldn't this be the same. So what about online sales.

"Tobacco product" is NOT the same as "tobacco", nor is it the same as "cigarettes". The PACT Act (that imposed new strict regulations on shipping), applies specifically and only to cigarettes and smokeless tobacco products (also specifically defined, which definition e-cigs do not fit within). It does not apply to cigars, or to pipe tobacco, and not to e-cigs now that they will be regulated eventually as an alternative "tobacco product".

This is not to say that if there is legislative support for changing the PACT Act, they cannot amend it to cover whatever they want it to cover. It is to say, though, that what it covers right now is very specifically limited.

So no, this decision by the FDA to concede that e-cigs are not illegal and unapproved drug products does not mean that online sales will be directly impacted in any way.

What it does mean, is that there will now be a probable two year period during which all the myriad possible and potential FDA regulations that could apply to this "new" class of tobacco products will be discussed and proposed and thrashed over - with opportunity for us to firmly and strongly give input - and eventually those that are settled upon will become official. Thus, we need to become more active and vocal than ever.

 

[Thulium]

“The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established” by the ruling, Lawrence Deyton, director of the agency’s Center for Tobacco Products, and Janet Woodcock, director of the Center for Drug Evaluation and Research, said in today’s letter.

Translation: I'll get you next time, gadget!!!

 

[rothenbj]

The big battle now is to get the hardware separated from the software. The E Cig is not a tobacco product, the liquid may be. If I'm in haling a 0 nic liquid I'm not using a tobacco product. We as a community have got to start selling that point. There have been some substantial changes to the hardware since 2007, but the tobacco product has remained pretty much the same- nic, PG/VG and flavoring. In my mind, this separation becomes extremely important. Think in terms of a pipe and pipe tobacco, one is a consumer item and one is an FDA controlled product.

 

[Bustastew]

Chief, the discussion has started one up, in the legislation news sub-forum. In short, it's hugely good news - for now - in that it is essentially the FDA's public announcement that it is conceding to Njoy's victory in the lawsuit, and will NOT be filing a petition for review by the Supreme Court.

But, there are many battles ahead over the scope and substance of the new regulations the FDA intends to promulgate. Please see my much more lengthy post in this thread: http://www.e-cigarette-forum.com/forum/legislation-news/182522-fda-regulate-e-cig-tobacco.html

They already tried to get the supreme court... They were denied on December 7th 2010. They spent these recent months trying to find a loop hole legally. The FDA's well paying customers (drug companies) are not going to be happy about this.

I believe I speak for everyone when I say "they can goto hell lol!!!"

 

[rons29445]

I seem to recall that during my cigar days. I sent and received packages of cigars all day long via USPS
Let's hope the e-juices falls with this realm as the atomizers and batteries would seem to fall into the electronics category

 

[Vocalek]

They already tried to get the supreme court... They were denied on December 7th 2010. They spent these recent months trying to find a loop hole legally. The FDA's well paying customers (drug companies) are not going to be happy about this.

I believe I speak for everyone when I say "they can goto hell lol!!!"

That was not the Supreme Court. There is an interim step in the Appeals Process between the hearing by the 3-Judge Panel and elevating to the Supreme Court. The FDA took that step by asking the Appeals Court to hear the case again with all 9 judges presiding. The Appeals Court turned down that request on December 7th. So the only recourse they had left was going to the Supreme Court. They had until yesterday, April 25, 2011 to decide whether they wanted to petition the Supreme Court. They decided to cut their losses and not go to the SC.

 

[Vapor Pete]

That was not the Supreme Court. There is an interim step in the Appeals Process between the hearing by the 3-Judge Panel and elevating to the Supreme Court. The FDA took that step by asking the Appeals Court to hear the case again with all 9 judges presiding. The Appeals Court turned down that request on December 7th. So the only recourse they had left was going to the Supreme Court. They had until yesterday, April 25, 2011 to decide whether they wanted to petition the Supreme Court. They decided to cut their losses and not go to the SC.

This seems to be the beginning of the end of our war, no? There is still a liteny of confusing and presumably false information being tossed around the ECF on this subject.

Some see this as a hands down win. Some say no, there are still battles yet to be fought. Some say all will be ok except internet sales. Some say internet sales will be fine... and the list goes on.

-VP

 

[Vocalek]

It isn't the end of the war, by any means, but it is a great victory. The FDA's stance was that e-cigarettes are unapproved drug delivery device combinations, which the agency claims that it could regulate under the Food, Drug, and Cosmetics Act. If the courts had agreed with FDA, the Agency could have commenced with a total ban on all products. The only way the products would have been allowed back on the market would have been if some company went through the entire drug approval process (which takes years and costs millions of dollars). And then, what we would have gotten out of the deal would very likely have been a product no more effective than the NRTs already on the market now.

This court victory keeps the products available for now. But we have our work cut out for us riding herd on the FDA to make sure that they don't try to hit is with regulations that will make the products ineffective for their intended use as a substitute for smoking. We also have to keep an eye on all the states and municipalities that want to outlaw sales and indoor use of the products or that might want to start levying taxes on tobacco products that are less harmful than smoking.

 

[The Wiz]

This all sounds pretty good to me. This has to be the largest victory for e-cig users to date. I personally think it will be quite some time before we see any changes to the status quo. Two years? Thats a good ways off. Thanks Vocalek for all the good work you do for the community.

Have a vape and celebrate!
Wiz!

 

[Bustastew]

That was not the Supreme Court. There is an interim step in the Appeals Process between the hearing by the 3-Judge Panel and elevating to the Supreme Court. The FDA took that step by asking the Appeals Court to hear the case again with all 9 judges presiding. The Appeals Court turned down that request on December 7th. So the only recourse they had left was going to the Supreme Court. They had until yesterday, April 25, 2011 to decide whether they wanted to petition the Supreme Court. They decided to cut their losses and not go to the SC.

I knew that =p

The word "to" was missing. They were denied to even get their propaganda to the supreme court lol

 

[Vocalek]

I knew that =p

The word "to" was missing. They were denied to even get their propaganda to the supreme court lol

Better yet, they decided not to try. Frankly, I feel they have wasted enough of my tax money on this case. They should have settled right after Judge Leon ruled.

 

[GMoney]

Translation: I'll get you next time, gadget!!!

LOL, that pretty much sums up my legal analysis of the memo!