FDA Proposed regulation is available

[SensesFailed]

Here is the issue that I think some of you are missing; a badly worded petition just doesn't look good. If you have claims in it that are unsubstantiated or even false, the petition will not look good going forward. Yes, I get that some people don't care, but at least in my opinion, you should care how a petition looks coming from the vaping community. A well worded, factual petition is actually better and looks good when it comes forward, especially when it contains evidence and links to the evidence to support the claim. If any petition is going to be signed and moved forward, that's what, in my opinion, people should want.

I know not everyone will agree with me on that stance, but in the long run, if you take the time to think about it, will actually be more beneficial for the vaping community.

 

[Myrany]

Guys I posted my thoughts on what we should all be doing in another thread. So I am just going to link to it.
http://www.e-cigarette-forum.com/fo...r-what-do-i-do-now-question.html#post12956590

We cannot let our internal squabbles form cracks to let the opposition break us. Sign the petition on or don't as your conscience dictates. Public argument over it serves nothing.

 

[Stosh]

What I don't get:
.....if any new "tobacco Product" is ever developed in the future... it will be illegal, because it didn't exist in 2007.

That includes any product that does not actually contain tobacco... all that is required is that the FDA decides its a "Tobacco Product"... and it's illegal.

The 2007 date was written into the law the FDA is operating under, so...all that is required is that the FDA decides its a "Tobacco Product"... and it's illegal.

It's politics not science...."common sense" has left the building...

 

[hoogie76]

People are saying these regulations are good news because they didn't see any outright ban in the document, but the ban is this: Submit an application, we'll never approve it, de facto ban.

I see this as a potential only products after the 2 year mark. Products submitted prior to the 2 year mark with have no action on them until either approved or not.

hoog

 

[skoony]

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.

this is what confuse's me.
"substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product,"
the predicate product.battery,check.container to hold the juice,check.
wick or other material to soak up said juice ,check.
coil to use the power from the battery to heat before mentioned juice into vapor,check.
broken down to the component level how are the newer products substantially different?
i have a ten speed bike.
i see some guy all the time on the bike path that has a recumbent bike.
neither looks any thing like the other but,they are still both bikes.

regards
mike

 

[drummerskey]

What I don't get:

eCigarettes were not deemed to be "tobacco products" until 2014. How on earth does that require them to meet the 2007 definition and rules related to tobacco products?

Think of it this way:

If eCigs were introduced TODAY, instead of 2006; The FDA with this Demeing Reg, would have banned all of them, outright.

Or further: if any new "tobacco Product" is ever developed in the future... it will be illegal, because it didn't exist in 2007.

That includes any product that does not actually contain tobacco... all that is required is that the FDA decides its a "Tobacco Product"... and it's illegal.

One could argue that the 2007 date is to make it fair for all products currently on the market. So that no one is really grandfathered in. If the date was 2013 and your product came out in 2014, that would be a little unfair too. I am not saying this is the case but this is what I assumed the case was.

 

[Myrany]

One could argue that the 2007 date is to make it fair for all products currently on the market. So that no one is really grandfathered in. If the date was 2013 and your product came out in 2014, that would be a little unfair too. I am not saying this is the case but this is what I assumed the case was.

Actually as I understand it the 2007 date is written into the law that put tobacco regulation under the FDAs jurisdiction. They have no standing to change it.

 

[drummerskey]

Actually as I understand it the 2007 date is written into the law that put tobacco regulation under the FDAs jurisdiction. They have no standing to change it.

That sounds valid

 

[ClippinWings]

The 2007 date was written into the law the FDA is operating under, so...all that is required is that the FDA decides its a "Tobacco Product"... and it's illegal.

It's politics not science...."common sense" has left the building...

right... so if i develop a new food product, that contains tomato... it could be banned outright because it contains nicotine and was not sold before 2007...

Crazy.

 

[ClippinWings]

this is what confuse's me.
"substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product,"
the predicate product.battery,check.container to hold the juice,check.
wick or other material to soak up said juice ,check.
coil to use the power from the battery to heat before mentioned juice into vapor,check.
broken down to the component level how are the newer products substantially different?
i have a ten speed bike.
i see some guy all the time on the bike path that has a recumbent bike.
neither looks any thing like the other but,they are still both bikes.

regards
mike

SE applications are required if they change the type of Glue used to seal the paper...

ANY change is a change and no product has received SE approval to date.

 

[Jman8]

Kinda feel like responding to individual posts in last 12 hours, but rather just say my own thing.

I continue to wonder what 'best case' scenario ECF people were expecting.... from the FDA. For years leading up to yesterday, it was doomsday predictions galore, and people visibly expressing expectations of the worst. Now we have a document that we can all quote from, and it is nowhere near those doomsday predictions, but people spin like it is, and yet don't have the intellectual courage, it would seem, to quote from the document about where they are getting their 'feelings of this being a really bad thing.'

So, as I continue to see it, they base this entirely on FDA track record and general disdain for government (intrusion). That will continue to play well, given FDA track record, but I see it as out of step with what this proposal is saying (and can quote it, already have), plus what was said in CASAA teleconference call, which was posted in this thread, or one just like it (thus available to all). I see FDA not really having full understanding of eCigs and, more importantly, admitting to that publicly, and most importantly seeking comments for how to regulate this new, innovative, product.

Best/ideal case scenario is FDA doesn't regulate eCigs at all because eCigs/PVs aren't really a tobacco product. But that ship has long sailed and it would take a good 5 million+ signatures for current WH admin to even consider going in that direction. 5 million sigs in next 74 days. Good luck with that! Plus, if not regulated by FDA, there are likely umpteen other organizations, in federal government, that would fill the void when it comes to regulating. Main point of this paragraph is that vaping is going to be regulated, and unless you were just born yesterday, you already knew this. Now we have FDA proposal for regulations plus ability to comment on that.

And so best advice I think that can be given is to encourage every vaper to comment to the FDA on how you truly feel eCigs ought to be regulated and that you think has a reasonable chance of working. If you want to word something that is akin to ideal scenario, I say go for it. But, I can't sign a petition calling for that, cause I see it as unrealistic, and would really like to know from people that created such a petition who they see as being likely government organization that is fit for administering regulations of eCigs, and what we ought to expect/plan for in dealing with them.

I say comment, comment, comment to FDA. Hopefully do a thoughtful letter. Hopefully it is an organized letter, with lots of people saying the same thing. I know CASAA will help with that and I look forward to adopting some of what CASAA suggests we put into our comments into my letter. But unless CASAA is willing to back off of a 'ban it from kids' position, I simply can't be on same page for what I feel absolutely needs to be said to FDA when it comes to a 'reasonable response' with regards to their proposed regulations.

 

[DanFromRioRancho]

this is what confuse's me.
"substantial equivalence" (SE) pathway for a new tobacco product to
enter the market if it is substantially equivalent to a "predicate product,"
the predicate product.battery,check.container to hold the juice,check.
wick or other material to soak up said juice ,check.
coil to use the power from the battery to heat before mentioned juice into vapor,check.
broken down to the component level how are the newer products substantially different?
i have a ten speed bike.
i see some guy all the time on the bike path that has a recumbent bike.
neither looks any thing like the other but,they are still both bikes.

regards
mike

Silly, silly man -- we're talking about a government agency here. In the case of Hestia Tobacco, they had to do a detailed and precise predicate comparison of the length and diameter of the paper tube, the filter paper, the composition of the paper, composition of the filter, design of the filter, composition of the glue, gluing process, manufacturing process of the paper, manufacturing process of the filter, tobacco sourcing, aging and curing processes, grinding process, blending process, rolling process blah blah blah.......all the way up to (not kidding here) "heating source" -- i.e. how, exactly, is it lit? Do a Google search for Hestia Tobacco for all the dirty details. I would not expect the FDA to take a different approach for e-cigs.

 

[Sdh]

I just obtained this from a petition I signed last year. Hopefully, you guys can comment on the proposed ruling.

https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd

Or use this link.
http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0189-0001


Personally, I am taking my time on evaluating this proposal. I will be responding to it eventually. I will not sign any petitions that are misconstrued.

 

[skoony]

SE applications are required if they change the type of Glue used to seal the paper...

ANY change is a change and no product has received SE approval to date.

but the glue is being combusted. the smoke has to pass through the filter if used.
the battery, wick,coil,or tank isn't being combusted or ingested,the vapor is.
regards
mike

 

[Jman8]

Guys I posted my thoughts on what we should all be doing in another thread. So I am just going to link to it.
http://www.e-cigarette-forum.com/fo...r-what-do-i-do-now-question.html#post12956590

Very good thread. Thanks for posting link of it here.

 

[salemgold]

The 2007 date was written into the law the FDA is operating under, so...all that is required is that the FDA decides its a "Tobacco Product"... and it's illegal.

It's politics not science...."common sense" has left the building...

The thing is that the FDA did not decide that ecigs are a tobacco product. They wanted them classified as pharmaceutical. The ruling that ecigs be classified as a tobacco product was made by Judge Leon back in 2010.

http://www.e-cigarette-forum.com/fo...e-njoy-vs-fda-discussion-211.html#post3086105

US Supreme Court means that e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams and nasal sprays are now unregulate tobacco products according to federal law (as long as no therapeutic claim is made by the manufacturer/importer).

These nicotine products now join cigars and pipe tobacco as unregulated tobacco products under the Family Smoking Prevention Tobacco Control Act. Currently regulated tobacco products include cigarettes, roll-your-own and smokeless tobacco.

right... so if i develop a new food product, that contains tomato... it could be banned outright because it contains nicotine and was not sold before 2007...

Crazy.

No. Not unless your recipe was ruled to be classified as a tobacco product.

 

[patkin]

The main thing I see as the problem is hardware. During the 75 days, I intend to write the FDA and all my reps along the lines of ecig hardware not being subjected to standards beyond those already in place for other hand-held, battery-containing, consumer-product safety... IE: cell phones, fire-starters, electric razors, etc.... simply because they are used for other, in this case vapor delivery, purposes. The hardware issue, including individual components and kits to build various setups, along with complete ecigs "substantial equivalency" is the main one I feared. It looks to me those fears were well founded unless CASAA reads differently than I do. I will await CASAA's input before I write but, as of now, I see it as FDA over-reach and intent to destroy the industry as it exists and potential consumer shift from smoking to vaping with or without the use of nicotine (non-tobacco usage) or at least only being able to obtain completed setups from a handful of mfgs. If they insist on it, my hope is that it will be legally challenged.

 

[Kent C]

Here's CASAA's "rosy scenario".

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

"The rules would eliminate the small businesses that provide the high-quality e-cigarette products that experienced vapers prefer."

"FDA is aggressively soliciting reasons to ban e-cigarette flavors and there are several hints that they intend to take this step. Buried in the middle of a nondescript paragraph is the observation that they would gain the authority to impose whatever unspecified restrictions on additives and constituents they want. Reading between the lines indicates they would be inclined to ban any product variation that appears to be slightly higher risk than an alternative (but still very low risk compared to smoking), regardless of whether consumers preferred it."

 

[salemgold]

The main thing I see as the problem is hardware. During the 75 days, I intend to write the FDA and all my reps along the lines of ecig hardware not being subjected to standards beyond those already in place for other hand-held, battery-containing, consumer-product safety... IE: cell phones, fire-starters, electric razors, etc.... simply because they are used for other, in this case vapor delivery, purposes. The hardware issue, including individual components and kits to build various setups, along with complete ecigs "substantial equivalency" is the main one I feared. It looks to me those fears were well founded unless CASAA reads differently than I do. I will await CASAA's input before I write but, as of now, I see it as FDA over-reach and intent to destroy the industry as it exists and potential consumer shift from smoking to vaping with or without the use of nicotine (non-tobacco usage) or at least only being able to obtain completed setups from a handful of mfgs. If they insist on it, my hope is that it will be legally challenged.

Here you go.

It is our current assessment that these proposed regulations are not in the best interests of consumers. They include some good provisions, but do far more harm than good. They are based on arbitrary claims and rationalizations. Should the regulations be finalized as currently formulated and implied, we are prepared to marshal our resources to file a lawsuit on behalf of consumers.

 

[Roger_Lafayette]

What I don't get:

eCigarettes were not deemed to be "tobacco products" until 2014. How on earth does that require them to meet the 2007 definition and rules related to tobacco products?

Basically anything derived from tobacco is considered a tobacco product. There are a few other details such as it has to be for consumer use (not a fertilizer for ex.) and not an approved therapy such as NRT.

You can blame the FDA for a lot of things (and you'll be able to blame them for a lot more in the future) ... but this was Congress' doing, because it drafted the statute to cover tobacco cigarettes. Now it's being put to a use (at least as far as the '07 date goes) that Congress clearly didn't intend. That will likely be one of the bases for challenging the regulation, as soon as the FDA decides to enforce it.