Wall Street Journal Article about FDA regulations to be relased Thursday 4/23/14

[Nate760]

It sounds a bit like the standard 2 year delay, plus the time for the lawsuits, which should be considerable

And the only people in the e-cig business who can afford to wage years-long court battles are the tobacco companies that own some of the cigalike brands, therefore the public perception that BT and the e-cig industry are one and the same will only become more ingrained.

 

[AgentAnia]

According to Felberbaum (on twitter just now), any product not on the market as of 2007 will have two years to obtain a "premarket approval."

But remember that all these articles are based on a press briefing yesterday (Wednesday) by Margaret Hamburg and Mitch Zeller. Until we have the actual text (to be released at 9AM, I believe, we can't know for sure how bad (or good) it's going to be. Rumor has it the regs are "hundreds of pages."

 

[Lessifer]

They will have a hard time making the argument for hardware, unless the hardware is part of a complete kit that includes liquid, like the disposables or cigalikes with pre-filled carts. I don't believe the FDA forces people to submit their designs for "water pipes," you know, the glass ones that are supposed to be used for tobacco smoking.

As for the liquid, unfortunately they will probably consider every flavor, every pg/vg ratio, and every nic content as an individual "product." So let's say your favorite vendor offers 0mg, 3mg, 6mg, 12mg, 18mg, 24mg and 100%pg, 80/20, 50/50, 30/70, 100%vg. That's 30 separate product applications per flavor, multiply that by someone like MBV with ~200 flavors and that's a lot of application fees. Depending on what the application process is like and what the fees are, I foresee our choices in liquid getting much much smaller.

 

[2coils]

Unfortunately this does nothing to slow down regulation at the local level.

TRUE, though we dont know the context of the regulations. If the climate has changed a bit and the FDA somewhat eases its stance, maybe things will calm down on the local level. I know this is wishful thinking on my part.

 

[Insignificance]

While there are a lot of hurdles ahead, in my opinion not banning internet sales would be a major victory. If they were banned, smaller companies like White Cloud and Halo would eventually go out of business as they would have a hard time finding space in retail stores and would get muscled out by the big boys (Logic, the Blu, NJoy).

 

[Eric A. Blair]

And therein lies the problem. An agency that's supposed to be about public health and consumer protection is driven 100% by politics, and by protecting the financial interests of its paymasters in the pharmaceutical industry.

Well, you are right. You are not exactly coming down off the mountain with the tablets with that. The FDA is funded by Big Pharma.

But we the people actually won one this time around. I'm not sure that big Pharma really fought this one hard. Global NRT is "only" a two billion-dollar business. Allegra does that in three weeks in the US.

 

[stevegmu]

And the only people in the e-cig business who can afford to wage years-long court battles are the tobacco companies that own some of the cigalike brands, therefore the public perception that BT and the e-cig industry are one and the same will only become more ingrained.

What lawsuits? If these are the regulations, who would have standing to sue? Children who can't get their BLU?

 

[AgentAnia]

TRUE, though we dont know the context of the regulations. If the climate has changed a bit and the FDA somewhat eases its stance, maybe things will calm down on the local level. I know this is wishful thinking on my part.

Other than restricting sales to minors (at the Federal level), these regs don't (AFAIK) address usage, so I don't see them as in any way slowing down the ANTZ army busily trying to get local govts. to tell us where/when we can or cannot vape. So yes, I think it's wishful thinking on your part. Right now I wish I could do the same!

 

[GaryInTexas]

You mean the cigalike business. There's no way they can construct a regulatory framework that will stamp out the PV business. They'll just wind up playing Whack-a-Mole for however many years until they finally give up.

No I mean that at the end of 2 years everything that could possibly be used as a vaporizer is going to have to be approved by the FDA. I suspect that the BT cigalikes will get approved quickly. The rest of our world can't afford to meet the requirements or the years in limbo that will be enforced by the FDA.

 

[cyclotron]

Obviously we don't have the regs to read yet but the article I read said that the products must be approved by the FDA if they make health claims. If that's true then it could be as simple as it has been in the past and sellers not making claims do not have to submit for approval. I expect the other regulations to apply to all things no matter the claim. Labeling and selling to minors that is.

Hey, I can hope can't I?

 

[salemgold]

Obviously we don't have the regs to read yet but the article I read said that the products must be approved by the FDA if they make health claims. If that's true then it could be as simple as it has been in the past and sellers not making claims do not have to submit for approval. I expect the other regulations to apply to all things no matter the claim. Labeling and selling to minors that is.

Hey, I can hope can't I?

You should read it again. It says that part will go into affect in 75 days. If they claim that it is healthier than cigs for use they will have to prove that.

At least this is what I think that you are speaking of

The FDA plans a 75-day comment period before the regulations become final. Some provisions, such as requiring evidence of health benefits, will go into effect at that point. The agency then will allow two years for all other provisions to be effective.

 

[Nate760]

No I mean that at the end of 2 years everything that could possibly be used as a vaporizer is going to have to be approved by the FDA.

This is not going to happen unless 1) E-cigs are classified as medical devices, or 2) the definition of "medical device" is expanded to include half the items at your local hardware store.

 

[GaryInTexas]

This is not going to happen unless 1) E-cigs are classified as medical devices, or 2) the definition of "medical device" is expanded to include half the items at your local hardware store.

I hope you are right and I am wrong. I don't think this will just cover liquids and nicotine though. We will see what surprises are in the other pages not yet seen.

 

[dr g]

What lawsuits? If these are the regulations, who would have standing to sue? Children who can't get their BLU?

So you're saying the ecigarette industry wouldn't have standing?

 

[Gato del Jugo]

You honestly think things will just stop here?


This is just the beginning -- not the end...

 

[Gato del Jugo]

Depending on what the application process is like and what the fees are, I foresee our choices in liquid getting much much smaller.

With some of the liquids out there, that's not necessarily a bad thing...

 

[Crunchy2k]

With some of the liquids out there, that's not necessarily a bad thing...

That was my first thought after the 'Unicorn's Milk' scandal and an Arizona nicotine vendor sending out a poorly mixed batch of diluted nicotine.

 

[Discord]

You mean the cigalike business. There's no way they can construct a regulatory framework that will stamp out the PV business. They'll just wind up playing Whack-a-Mole for however many years until they finally give up.

like the war on drugs? or the war on terror? lulz... once a law puts something into effect it takes an act of congress to remove it... and without political will (usually funded by special interests) that won't happen

 

[Neloish]

Considering how bad it could have been, this is freaking great. Sure its not perfect, but they did not ban internet sales, flavor, or even advertising. Hell we got it better than Europe, consider the alternative.

 

[-mj01-]

"Under its new rules, the FDA will require manufacturers to provide scientific evidence to substantiate any claims they make that e-cigarettes are safer than standard ones."

In order to do this, wouldn't tobacco companies need to release the exact ingredients contained in their cigarettes?