FDA Proposed regulation is available

[Dulce]

The statute establishes a "substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product," meaning a product commercially marketed in the United States as of February 15, 2007. FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date
is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months follo wing the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway.

It seems to me this has the potential to ban all of the post-2007 products that most of us use. We would have to see how they are interpreting "substantive equivalence" as the e-cigarette companies submit them for approval. Do chinese companies like Joyetech have to submit the eGo for US sale? Or do the third party sellers submit them? Is the FDA going to approve them or are they only going to approve cigalikes like the BluCig and Njoy? What about mods? Atomizers? Clearomizers? Tanks? Driptips? etc? Well I guess we have 2 years to find out.

 

[ClippinWings]

Just got a call from the Associated Press.

He gave me a synopsis.

Standard Equivalency
Minor Sales Ban
No restriction on Liquids

the equivalence issue the AP reporter didn't seem to think it would be a big deal... that most ecigs would be able to pass because they are functionally the same... even if the battery size or atomizer design has changed... the function is identical.

Not sure I buy that.

 

[DeeLeeKay]

Cigarettes now fall under the FDA are they now safer? So why would anyone truly believe the FDA will make e-cigs safer? If the FDA had won the court battle how many of us would still be smoking?

I know I would be still smoking. We just have to see how this all plays out. We just need to keep our eyes open for what will follow. From what I have read it looks like the regulations are not yet finished. They are just getting started. I suspect they will want to start limiting flavors.

 

[DeeLeeKay]

The statute establishes a "substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product," meaning a product commercially marketed in the United States as of February 15, 2007. FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date
is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months follo wing the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway.

It seems to me this has the potential to ban all of the post-2007 products that most of us use. We would have to see how they are interpreting "substantive equivalence" as the e-cigarette companies submit them for approval. Do chinese companies like Joyetech have to submit the eGo for US sale? Or do the third party sellers submit them? Is the FDA going to approve them or are they only going to approve cigalikes like the BluCig and Njoy? What about mods? Atomizers? Clearomizers? Tanks? Driptips? etc? Well I guess we have 2 years to find out.

Does this also apply to the e-juice? I am not even sure what was available in 2007 and how that would apply to the current market.

 

[Dulce]

edit: double post

Does this also apply to the e-juice? I am not even sure what was available in 2007 and how that would apply to the current market.

well they do use the word "products" versus the term "model". So once again I guess it's how the FDA wants to interpret that.

 

[ClippinWings]

How is this thread NOT on the home page?!

 

[hairball]

The future of internet sales(if we are lucky):

Mods=flashlights
Atomizers=incense burners
PG/VG/flavorings= incense
Nicotine=dietary supplement

Welcome to the grey market.

Pg/vg/flavorings are used in a wide array of items. The FDA won't touch those because they would be messing with a market that was already approved.

 

[aubergine]

This is all about giving the burgeoning e-cig biz to the tobacco companies; it's basically their bill. It's about money, not anyone's health. To those who want more regulation, you trust the careful and compassionate people who add thousands of chemicals to already-harmful cigarette tobacco to watch your back and bring you a healthy product? And bring you the sort of excellent concern, flexibility and quality that many of our fine small vendors do? Really?
The idea is to drive the little guys out of business or absorb them. "Basic ingredient approval", if big tobacco has its way, will entail enormously prohibitive fees and expenses and each vendor will need FDA approval: "Meeting such requirements includes the expenses of application costs, user fees that industry pays the agency, and assembling a scientific case to show that a product should be approved." (NYT, today) "Assembling a scientific case" would involve laboratories, I'd think. Philip Morris has piles of those, easy peasy. And so on.

Unlike some in here, I'm anti-tobacco big time and am fine with regulating cigarettes out of existence.* They killed both of my parents. What I love about ecigs is that they make cigarettes obsolete. I don't want to be forced to give my money to the highly untrustworthy cigarette industry, which has always been able to get around federal regs with their thousands of very harmful tobacco additives (addiction enhancers, mood enhancers, cough suppressors, etc etc etc) - "laboratory" items unavailable (and uninteresting) to small e-juice vendors, who only assemble nicotine, water, flavoring and glycol.
Can't imagine why anyone would do it in a bathtub; I'd find it simpler on a table.
It's true this could be more draconian, but they're seeing it as a "foundation" for further regulation - they'd love to prohibit flavorings, which of course is one thing that makes e-cigs an effective cigarette replacement; they reinforce.

* I know. Give 'em an inch (more cig regs) and they'll take a mile (more regs all over the freaking place). Don't remind me.

PS Don't argue "slippery slope"? That's absurd - when sweeping change is blocked, all activists move to "chipping away" strategies. Precedent is powerful.

 

[ClippinWings]

yeah... PG, VG, Flavorings, Batteries, Wick, Wire

Cannot be banned or even restricted due to their use in other products/markets.

Nicotine and bre-built mods & atomizers... those could be an issue.

 

[Schwiggiddy]

We all knew this was coming. It could be a lot worse, although I am interested to see what this means for e-liquid. Most of the e-liquid I've ever bought had ingredients and nicotine level on the label.

To the anti-government crowd, I'll ask: apart from the sanitation, the medicine, education, wine, public order, irrigation, roads, the fresh-water system, and public health, what have the Romans ever done for us?

 

[AgentAnia]

Mike Siegel's comment on the deemings: http://tobaccoanalysis.blogspot.com/2014/04/fdas-proposed-electronic-cigarette.html

 

[folkphys]

It's all about the New Product Review Submission and exactly what "tobacco products" or "covered tobacco products" this provision will apply to. They do mention an exemption however, which could be promising......but

 

[guambred]

Why should you or the FDA be the ones to decide if folks should be able to buy ejuice from folks mixing in their bath tubs if that is what they wish to do? Why do adults need others to make these decisions for them?

Most adults are quite capable of making their own decisions. the ones that are not should be under "other" supervision.

Call me an optimist, but with events in the last two weeks ie. Bundy ranch, the recent articles on our economy, Alabama Gov signing gun bill.... seem to indicate to me that as a country we are getting a bit fed up with the fed, and might just be starting to slowly take our country back.

 

[MorpheusPA]

We all knew this was coming. It could be a lot worse, although I am interested to see what this means for e-liquid. Most of the e-liquid I've ever bought had ingredients and nicotine level on the label.

To the anti-government crowd, I'll ask: apart from the sanitation, the medicine, education, wine, public order, irrigation, roads, the fresh-water system, and public health, what have the Romans ever done for us?

Hah! Civil defense, fire-fighting, legally defined rights, coinage stability...well, other than that, nothing at all. Useless Romans.

 

[AgentAnia]

The statute establishes a "substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product," meaning a product commercially marketed in the United States as of February 15, 2007. FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date
is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months follo wing the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway.

It seems to me this has the potential to ban all of the post-2007 products that most of us use. We would have to see how they are interpreting "substantive equivalence" as the e-cigarette companies submit them for approval. Do chinese companies like Joyetech have to submit the eGo for US sale? Or do the third party sellers submit them? Is the FDA going to approve them or are they only going to approve cigalikes like the BluCig and Njoy? What about mods? Atomizers? Clearomizers? Tanks? Driptips? etc? Well I guess we have 2 years to find out.

These are the details that contain the devil, IMO. The paperwork involved in submitting these applications is formidable, to say nothing of the person-hours involved at the manufacturer's level to prepare *each* application. And remember, *every* different flavor, at *every* different nic level, will be considered a *new product* requiring a separate application. (Unless, of course, FDA comes up with a different, more workable application process...)

ETA: And the question arises as to whether the FDA CTP, which already is buried under a mountainous backlog of Substantial Equivalence applications for existing tobacco products, is planning to add staff resources to process the further avalanche of SE and PMA applications that will result from this new rule.

 

[pianoguy]

Shouldn't we the people have the last say?

That would be nice, but:

America is an oligarchy, not a democracy or republic, university study finds - Washington Times

Along with the fact that the media has been doing such a nice job of spoon-feeding the public a load of BS about e-cigarettes.

 

[MorpheusPA]

Mike Siegel's comment on the deemings: http://tobaccoanalysis.blogspot.com/2014/04/fdas-proposed-electronic-cigarette.html

OK, the section 911 bit of is particular concern. On the other hand, we've done an extraordinarily good job telling our friends about quitting smoking, and e-cigs can't make that claim (and haven't been able to for years). It's not any more difficult to make the reduced risk argument stick.

So not optimal, but not an absolute killer.

Pre-approval for new and existing products is, as I mentioned earlier, sticky. But if they start blanket refusing, the lawsuits will start flying--that's what the courts are for. And I don't expect the FDA will win in that arena.

 

[klynnn]

I don't know why people have such a problem with home or basement mixers. It doesn't take a brain surgeon to add 2 drops of this, 1 ml of that, some pg and vg plus nic. Seems people think there is a whole lot more involved. If the same sentiment was applied to restaurants there wouldn't be any.

 

[Anjaffm]

That would be nice, but:

America is an oligarchy, not a democracy or republic, university study finds - Washington Times

Along with the fact that the media has been doing such a nice job of spoon-feeding the public a load of BS about e-cigarettes.

Excellent find, thank you very much for posting this!

 

[Dulce]

These are the details that contain the devil, IMO. The paperwork involved in submitting these applications is formidable, to say nothing of the person-hours involved at the manufacturer's level to prepare *each* application. And remember, *every* different flavor, at *every* different nic level, will be considered a *new product* requiring a separate application. (Unless, of course, FDA comes up with a different, more workable application process...)

ETA: And the question arises as to whether the FDA CTP, which already is buried under a mountainous backlog of Substantial Equivalence applications for existing tobacco products, is planning to add staff resources to process the further avalanche of SE and PMA applications that will result from this new rule.

Even with all that, I see no hint that the FDA will being approving these products. Quite the opposite, they mention they will "take comments" for those products that will not be passed. So they are already preparing for a backlash for when they refuse applications of things like eGo and their many variants. Effectively banning them and opening the door for raids on any online seller that continues to sell them. Ordering them from overseas may also be illegal, putting users at significant legal risk.