what would happen if FDA regulates Ecigs?

[tattoogirl]

Sounds scary to me. In my moments of OMG I MUST DIY! freakouts i assume that our favorite vendors of ejuice would either have to get licensed or something else incredibly expensive or would have to close doors? Ordering through the internet would probably be restricted. Massive Taxes. Is that about right?

 

[BardicDruid]

Sounds like you've hit the nail pretty much right on the head.

 

[Eddie.Willers]

Yup - follow the money.

 

[rothenbj]

The massive tax proposal is on the table now via 14 Dem. Senators. The wording of the bill speaks of bringing the tax up to the same level as cigarettes which is rediculous especially in how they might determine the same level. Do yourself a favor and click the link in my signature to voice your opinion, vote no to the proposal and pass the link along to any of your social media groups. Your reps in Washington are notified of your comments.

 

[tattoogirl]

thats absolute bull.....

 

[Pamdane]

BTW, I did this POPVOX thing. I did chose to send a letter to my senator. He actually sent me a form letter back stating he got my e-mail. So, even if popvox doesnt hit the radar screen, our letters to our senators are getting there. Keep in mind that from the congressman's point of view, for ever one "letter" they get, they feel 200 constituents feel the same way. I suspect that in some cases they add more weight to the letters. I made sure I stated in the letter that I have been a campaign volunteer. Its true if they check it out.

 

[DC2]

Sounds scary to me. In my moments of OMG I MUST DIY! freakouts i assume that our favorite vendors of ejuice would either have to get licensed or something else incredibly expensive or would have to close doors? Ordering through the internet would probably be restricted. Massive Taxes. Is that about right?

The restriction of ordering through the internet could only be applied if the PACT Act is ammended to include electronic cigarettes.
At least that's how I understand it.

As written, I believe that the PACT Act specifically states what products it applies to.
And there is no blanket "tobacco products" definition included.

As for the massive taxes, that will require legislation to be passed, it does not happen automatically.
And there is a bill currently being introduced to do exactly that.
See the posts above for more information on that.

As for ejuice vendors needing to get licensed, I'm not sure how that works.
Someone else will have to answer on that score.

 

[VapahMan]

I'd think ALL vendors selling nic would need licensing to sell. You might see a few vendors stop offering just nic and leave that up to others. I'd hope the pact act wouldn't be revised, that'd make a big change on the internet. I'd think the number of PV products purchased on the net are far greater than in person. I think it's important that the industry plans ahead incase any bills were to be passed.

 

[rolygate]

The FDA does regulate e-cigarettes now that they have been classified as tobacco products in law.

However, there are no current regulations that can be applied. The FDA will start to bring in such regulations when it considers that it has sufficient reason to do so, sufficient support, and sufficient chance of being able to overcome resistance. It was strongly defeated in court when it tried to classify e-cigs as a drug and it now knows that there is enough funding in the opposing camp to defeat badly-planned moves.

We think that nothing / no one will be 'shut down', but instead a series of gradually more restrictive regulations will be attempted. The FDA's objective, as agents of the pharmaceutical industry, is to remove e-cigs. As they were prevented from doing this, another approach is necessary. The next-best plan would be to gradually reduce the attractiveness of e-cigs to consumers, thus limiting sales - so this seems an obvious approach to take.

For example they might try to introduce regulations limiting flavors or nicotine strength, or even restricting sales to pre-filled cartos only. These are all things that would hurt e-cig sales and so would help their agenda.

The question really is: what can they get away with? What can they attempt that would not be blocked by the industry in court? The answer to that seems to be that they should start gently, get a foot in the door, then gradually tighten the regs -so this is what can be expected to happen. The good news is, it won't happen overnight - they will take their time by preparing the ground first.

[edited - to add:]
The FDA have stated that their objectives, which are supported by law, will be as follows:

FDA regulation of e-cigarettes will subject them "to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for 'new tobacco products' and 'modified risk tobacco products'."

Such powers can be interpreted in many possible ways. For example, it has been suggested that they may try to ban any product that was not already on the market in 2006, as there appears to be some basis in law, subject to legal challenge, for them to be able to refuse it a sales license.

Because they have wide-raging powers over tobacco products, we can expect a series of protracted legal battles once they have their ducks in a row. This situation is almost certainly why the tobacco industry has not yet thrown their hat in the ring - at 2011 the situation is still risky for the required investment of millions of dollars that would be required. Anyone in the market will need to set aside sums for legal defense, and for the bigger players these sums might be substantial, in order to protect substantial investments.

[edit]
Plus there are probably some US patent issues to resolve.

It may or may not be clear from the above, but nothing is going to happen for some time. No need for a freezer full of supplies yet.

 

[cookiebun]

Stock up on hardware.
Learn to make your own liquid. It's easy and FUN
Wean yourself off nicotine if you can. I'm down to 1mg per ml.
If you can't do that load up on liquid nic and store it in a freezer.

 

[Vocalek]

Let's hear it for freezers. And keep a cooler around and a large block of ice in your freezer. Be prepared to evalucate your stock to safety in case of hurricaine, earthquake, or other national disasters.

 

[txteatime]

Well, the suppliers are going to have to sue, either individually or in class action litigation. Totally Wicked sued the FDA for confiscating their product shipments to the US and got them to back down earlier this year:

Totally Wicked Settles Case Against FDA & Regulation Future

 

[rolygate]

Added some relevant material to Post #9.

 

[Vocalek]

The FDA does regulate e-cigarettes now that they have been classified as tobacco products in law.


Such powers can be interpreted in many possible ways. For example, it has been suggested that they may try to ban any product that was not already on the market in 2006, as there appears to be some basis in law, subject to legal challenge, for them to be able to refuse it a sales license.

Because they have wide-raging powers over tobacco products, we can expect a series of protracted legal battles once they have their ducks in a row. This situation is almost certainly why the tobacco industry has not yet thrown their hat in the ring - at 2011 the situation is still risky for the required investment of millions of dollars that would be required. Anyone in the market will need to set aside sums for legal defense, and for the bigger players these sums might be substantial, in order to protect substantial investments.

Actually, it is any product that was not sold prior to February 2007, and there were a few small vendors in business before then. All the other brands of e-cigarettes could come in under the "substantial equivalency" provision.... that the "new" product is just about the same as one that was previously sold. That provision would let tobacco companies get away with Camel orbs and Marlboro orbs because Star Scientific was selling quite similar products since 2000. The strips and sticks are another animal altogether. We will have to see. Wonder what tricks RJR and PM have up their sleeves to get those in the back door.

 

[MollieA]

It galls me that Big Brother is getting so down on nicotine products... meanwhile, here in California, one can walk into a "medicinal ........." shop and get a prescription for the stuff no problem. Sheesh!

 

[MiXoLoGiSt]

Sounds scary to me. In my moments of OMG I MUST DIY! freakouts i assume that our favorite vendors of ejuice would either have to get licensed or something else incredibly expensive or would have to close doors? Ordering through the internet would probably be restricted. Massive Taxes. Is that about right?

I would sure hope this doesnt happen. There are no local places for me to get supplies and such so i would have to drive 2 hours or so just to go get Atomizers, Cartomizers,Juice etc.

 

[Bill Godshall]

Instead of posting notes alleging that the sky is falling, I suggest that concerned individuals inform themselves of the facts (instead of spreading false rumors) and take appropriate action when legislative/regulatory/legal threats/opportunities occur.

Since the FDA's Center for Tobacco Products has (to date) only done what Congress required it to do in the FSPTCA, and since the FDA has had very little or no time or resources to research, evaluate or draft any new tobacco regulations (that weren't required by the FSPTCA), it is unlikely that the FDA will propose any new regulations for e-cigarettes for at least the next several years.

Besides, the FDA cannot legally regulate e-cigarettes until it first proposes regulations, allows for public comments, holds public hearings, probably asks the TPSAC to weigh in, and then (if it ever gets that far) approves final regulations - a process that could take one or two years.

If/when the FDA ever gets around to proposing new regulations for e-cigarettes, e-cigarette consumers and companies can and should widely expose, and aggressively oppose any regulatory provisions that are unwarranted.

Only US Congress (not the FDA) has the legal authority to impose federal taxes on e-cigarettes or to amend the PACT Act to include e-cigarettes, and it is highly unlikely that either of those will occuring during the next several years (and could only occur if Obama is reelected, Democrats take over the House, and Democrats pick up additional seats in the US Senate).

Anyone who claims that FDA regulation will cause e-cigarette taxation either is totally ignorant of the laws, or is intentionally attempting to mislead others, both of which only aid and abet the e-cigarette opponents.

 

[mirinuh]

Bill . . . you are correct- formal regulation and federal taxation will take a while to get established. Biggest concern in the near term will be what individual states do with respect to taxation. That's where e-cigarette proponents will need to be vigilant. A number of suppliers are no longer selling to Minnesota addresses as a result of a 2010 OTP tax on the products that was passed without anyone noticing.

 

[Bill Godshall]

Vocalek wrote

Actually, it is any product that was not sold prior to February 2007, and there were a few small vendors in business before then. All the other brands of e-cigarettes could come in under the "substantial equivalency" provision.... that the "new" product is just about the same as one that was previously sold. That provision would let tobacco companies get away with Camel orbs and Marlboro orbs because Star Scientific was selling quite similar products since 2000. The strips and sticks are another animal altogether. We will have to see. Wonder what tricks RJR and PM have up their sleeves to get those in the back door.

Please note that the MRTP provision (Section 911) and the banning of new products provision (Section 910) unless/until approved by FDA as "substantially equivalent" only apply to cigarettes and smokeless tobacco products (not to e-cigarettes, e-liquid, cigars, pipe tobacco, nicotine water, nicotine skin cream, at least two dissolvable tobacco products [Star's Ariva BDL and Stonewall BDL], and to other smokefree nicotine products that are not currently on the market).

Even if FDA does propose applying Chapter IX of the FSPTCA to the previously cited unregulated tobacco products), it would be very difficult for the FDA to justify applying all Chapter IX provisions retroactively to currently unregulated tobacco products (e.g. they might extend the Feb. 2007 new product deadline until 2011 or 2012).

It remains unknown how the FDA will deal with "substantial equivalence" applications for cigarettes and smokeless tobacco products (as several thousand applications were already filed). If the FDA denies some/many/most substantial equivalence applications for cigarettes and smokeless products, they would be likely to similarly interpret that clause with e-cigarettes (if/when the FDA proposes and subsequently approves a regulation applying Chapter IX regs to e-cigarettes and e-liquid).

However, if FDA denies some/many/most substantial equivalence applications for cigarettes and smokeless, we will need to aggressively oppose any proposed regulation to apply Chapter IX (or at least Section 910) to e-cigarettes, e-liquid and other smokefree nicotine alternatives.

I also strongly urge all e-cigarette advocates to oppose any proposed regulation by the FDA (in the future) to apply Section 911 (the MRTP provision that currently prohibits smokeless tobacco products from truthfully claiming they are less hazardous than cigarettes) to e-cigarettes, e-liquid and other currently unregulated smokefree tobacco/nicotine alternatives.

 

[Bill Godshall]

Here's one of the ways the National Association of Tobacco Outlets and the Pipe Tobacco Council has responded to the FDA's statement of intent to propose a regulation to apply Chapter IX of the FSPTCA to at least some currently unregulated tobacco products.

NATO and Pipe Tobacco Council Request FDA Meeting
NATO and Pipe Tobacco Council Request FDA Meeting | CSP Daily News / Magazine | Tobacco - CSP Information Group, Inc. - news for convenience & petroleum retailing.

Tobacco E-News August 30, 2011

NATO and Pipe Tobacco Council Request FDA Meeting
Organizations submit letter to FDA Center for Tobacco Products director
By Thomas Briant, NATO Executive Director

With the announcement that the FDA's Center for Tobacco Products (CTP) is considering the extension of certain tobacco regulations to other tobacco products, NATO and the Pipe Tobacco Council have sent a letter to Dr. Lawrence Deyton, the director of the CTP, requesting that the CTP staff meet with representatives of NATO and the Pipe Tobacco Council to be briefed on the distinctive characteristics of pipe tobacco and other tobacco products.

As was noted in the letter sent to Deyton, the FDA may consider extending to other tobacco products various regulations including manufacturer registration, product listing, ingredient listing, good manufacturing practices, user fees for products, adulteration and misbranding provisions, pre-market review standards for new products and modified risk tobacco product rules.

Please recall that the FDA currently regulates cigarettes, roll-your-own tobacco and smokeless tobacco products and the FDA law passed by Congress in 2009 grants the agency the authority to regulate other tobacco products as well.

NATO is in the process of setting up a meeting with FDA staff to discuss this possible extension of regulations to pipe tobacco and other tobacco products.