Deeming Regulations have been released!!!!

[Lessifer]

That's how I understand it. This is why everyone's talking about a 2 year window before things get real hairy.

I still think we'll start seeing drop off way before then. But that's the deadline to file.

Ok, you're right. Didn't read the left column.... I'm not going to edit.... lol.... I was basically urging sky to stock up now :- )

See Bill G's post here:

White House OMB scrapped FDA plan to ban flavors

"Even worse, the deeming rule bans the manufacturing of any new tobacco product after August 8, 2016. It appears that FDA is planning to begin banning vape shops from mixing (i.e. manufacturing) e-liquids containing nicotine and/or flavorings. "

and the pdf posted May 27 at fda:

Regulations.gov

figured you just missed that part, easy to do on that chart.

Those who mix in-house should stop now and find someone to manufacture for them, if they plan to continue selling house liquid. There is no way that you can prove, to FDA standards, that the liquid you mixed by hand on August 9th is the same as the one you mixed on August 7th. I do think the FDA will take that part seriously, and will enforce, but that's just a guess from me.

 

[Mazinny]

Seems like it is by Design almost. Doesn't it?

---

So the FDA brings Harm Reduction thru e-Cigarette to it's Knees. All the while Cigarette keep on Killing People.

Good Job FDA! Way to Promote Public Health.

Of course its by design. Zeller has pretty much said it directly ! He has been talking about significant market consolidation ( read vendors going out of business ) for years now.

 

[VNeil]

Seems like it is by Design almost. Doesn't it?

---

So the FDA brings Harm Reduction thru e-Cigarette to it's Knees. All the while Cigarette keep on Killing People.

Good Job FDA! Way to Promote Public Health.

They are protecting public health. These small vendors may be killing vapers. Who knows what is in their juice?

Just because there are around 10 million US vapers and none have been harmed by these smaller vendors does not mean that mass death and destruction is not imminent. And we need to protect the chillren too. Don't forget that.

 

[Kent C]

Once Again. There is NO Guarantee of this Extra Year. If your PMTA is Denied, your are SOL at the time of the Denial.

I'm not saying that the FDA could not Extend the Time for review of you PMTA. Or to Request Additional Information from you. Or that there Isn't going to be some amount of Time that the FDA will need to Round File, I mean Review, your PMTA.

But that 1 Extra Year thing is Kinda a Red Herring is many ways.

From the revised pdf linked by Bill G in another thread. Here's the wording for PMTA products.

[the formatting with strikes, and font color didn't copy, but you can check it out at page 22]
Regulations.gov

For newly deemed tobacco products using the PMTA pathway, this continued compliance period will close 36 months after the effective date. (i.e., 12 months after the 24-month compliance period closes for submission and receipt of PMTAs). Any such non-flavored ornewly deemed tobacco-flavored product for which an application under one of the three marketing pathways has not been filedsubmitted within 24 months from the effective date of part 1100 of this final deeming rule will not benefit from this continued compliance policy, and the Agency intendswill be subject to begin enforcing the premarket review requirements against such a product on the market.enforcement as of that date. In addition, once the respective continued compliance period ends for products with applications submitted according to this policy, the Agency intends to begin enforcing the premarket requirements against products remaining on the market without premarket authorizations in effect, even if the product has a pending application that was originally submitted by its respective compliance deadline set forth aboveinitial compliance deadline set forth previously in this document, will be subject to enforcement. However, if at the time of the conclusion of the continued compliance period, the applicant has provided the needed information and review of a pending marketing application has made substantial progress toward completion, FDA may consider, on a case-by-case basis, whether to defer enforcement of the premarket authorization requirements for a reasonable time period.

My emphasis B/I/U speaking to your point that the "1 extra year may be a red herring"

 

[HazyShades]

Makes me wonder what ECF will be like if the FDA hammer strikes. I think consumer chit-chat will be ok but arranging for juice shipments from Viet Nam certainly won't.

Then again, without any advertisers ECF will most likely go away?

I'm pretty sure Oliver isn't going anywhere
and the other Joe will likely go back to running a smut site.

I wanted to post about the danger of the FDA and the FCC getting in cahoots
to shut down this type of forum back when the FCC was getting ready to take over the internet..wanted to direct folks to an Electronic Frontier Foundation (EFF) campaign
but was told by moderators it would have to be posted in the "outside"
section of ECF because it wasn't vape related. (Remember, @Robino1?)

LOL..The guy from Viet Nam I was chatting with was looking to buy juice
from somebody that delivered to 'Nam...
actually, I think buying juice and nic from China may soon be easier
than buying in the states.

Regards,
Hazyy

 

[KODIAK (TM)]

So maybe 10 ~15% are Gone as of Aug 8th, 2016? Maybe More? Maybe Less.

Hard to say.

Yeah, I find it difficult to believe all these little vendors who are completely oblivious to the FDA regs, will be able to comply with all the other elements of the regs besides PMTA.

I'd expect those smaller vendors without a retail storefront (and no lease obligations) will most likely go first. Like the maker of Boba's (who strangely enough doesn't sell it anymore).

 

[Lessifer]

Very True.

As all this Evolves both with the FDA's Guidance and with Legal Challenges, it would seem to be a Very Poor Choice to be Locked into an Early PMTA.

It's not like you are going to want to New PMTA's if the Landscape changes.

I can think of one reason, it's the catch 22 of that one year. Remember it took YEARS for the FDA to sift through and START making decisions on all of the SE applications from 2009. If you think your PMTA has a chance of being approved, you'd better hope they have enough time to review it and make a decision before you're forced to pull your product from the market.

 

[Mazinny]

I still think we'll start seeing drop off way before then. But that's the deadline to file.
figured you just missed that part, easy to do on that chart.

Those who mix in-house should stop now and find someone to manufacture for them, if they plan to continue selling house liquid. There is no way that you can prove, to FDA standards, that the liquid you mixed by hand on August 9th is the same as the one you mixed on August 7th. I do think the FDA will take that part seriously, and will enforce, but that's just a guess from me.

Yup, that and the part about 'Product Adulteration' which kicks in on Aug 2016.

Product Adulteration
–
All manufacturers must operate their facilities in a sanitary manner such that no
products are manufactured or shipped that are contaminated in a manner that
might injure the public health beyond the risks that may be inherent in the
product.

 

[Kent C]

figured you just missed that part, easy to do on that chart.

Those who mix in-house should stop now and find someone to manufacture for them, if they plan to continue selling house liquid. There is no way that you can prove, to FDA standards, that the liquid you mixed by hand on August 9th is the same as the one you mixed on August 7th. I do think the FDA will take that part seriously, and will enforce, but that's just a guess from me.

Yep and see my reply to Zman on the revised doc - the part that says: even if the product has a pending application....

 

[KODIAK (TM)]

...actually, I think buying juice and nic from China may soon be easier
than buying in the states.

Indeed. There are Chinese vendors that will "discreetly" label and wrap it in such a way to avoid scrutiny.

Regardless, it will certainly be well steeped by the time you get it.

 

[Mazinny]

I'd expect those smaller vendors without a retail storefront (and no lease obligations) will most likely go first. Like the maker of Boba's (who strangely enough doesn't sell it anymore).

Yeah, some will exit the market, and some will continue to operate in the gray ( or black ) market.

 

[crxess]

Need another work around. cc, and name and address must match what is on file or will cancel......pp send$ to friend comes to mind.....

This is a NO GO - CC Number theft is already at an all time high. Adding a Vendor Database or Processing Data Base isolating Higher Gain Profits for theft targeting in not a good idea.
Replacement CC from theft = new numbers not in said DB and another verification process is required.

Ain't no simple alternatives...........and some AGE Verification Firm is looking to Profit From additional software licensing/Leasing.
There is always a promoted Added cost to the People to Regulation.

 

[Lessifer]

Yep and see my reply to Zman on the revised doc - the part that says: even if the product has a pending application....

That's after August 8, 2019 if I'm reading it correctly. Meaning you have to submit your PMTA by 2018, for your product that was on the market by 2016, and if you still haven't received a response by 2019 you have to pull your product from the market, unless the FDA decides to grant you an extension on a case by case basis.

 

[zoiDman]

They are protecting public health. These small vendors may be killing vapers. Who knows what is in their juice?

Just because there are around 10 million US vapers and none have been harmed by these smaller vendors does not mean that mass death and destruction is not imminent. And we need to protect the chillren too. Don't forget that.

The Key wording in all this should be "Harm Reduction". And Not what the FDA seems to want to set the Bar at with "Harm Elimination".

 

[wiredlove]

Indeed. There are Chinese vendors that will "discreetly" label and wrap it in such a way to avoid scrutiny.

Regardless, it will certainly be well steeped by the time you get it.

It depends on the carrier. DHL Express took 4 days from Shanghai to my door, including customs pre-approval, which I believe happened in air.

 

[VNeil]

Yep and see my reply to Zman on the revised doc - the part that says: even if the product has a pending application....

So let me get this straight... I'm not terribly bright. The FDA can sit on the PMTA's, that might have cost $millions to produce, past the 3rd year deadline, and then demand the products be taken off the market because FDA did not review the PMTA's in a timely manner? Unless of course, they do you a favor and grant an extension which they are under no obligation to provide?

Seems imminently fair to me... never forget the chillren....

 

[zoiDman]

From the revised pdf linked by Bill G in another thread. Here's the wording for PMTA products.

[the formatting with strikes, and font color didn't copy, but you can check it out at page 22]
Regulations.gov

For newly deemed tobacco products using the PMTA pathway, this continued compliance period will close 36 months after the effective date. (i.e., 12 months after the 24-month compliance period closes for submission and receipt of PMTAs). Any such non-flavored ornewly deemed tobacco-flavored product for which an application under one of the three marketing pathways has not been filedsubmitted within 24 months from the effective date of part 1100 of this final deeming rule will not benefit from this continued compliance policy, and the Agency intendswill be subject to begin enforcing the premarket review requirements against such a product on the market.enforcement as of that date. In addition, once the respective continued compliance period ends for products with applications submitted according to this policy, the Agency intends to begin enforcing the premarket requirements against products remaining on the market without premarket authorizations in effect, even if the product has a pending application that was originally submitted by its respective compliance deadline set forth aboveinitial compliance deadline set forth previously in this document, will be subject to enforcement. However, if at the time of the conclusion of the continued compliance period, the applicant has provided the needed information and review of a pending marketing application has made substantial progress toward completion, FDA may consider, on a case-by-case basis, whether to defer enforcement of the premarket authorization requirements for a reasonable time period.

My emphasis B/I/U speaking to your point that the "1 extra year may be a red herring"

And all this is Inline with I and just about Everyone in this thread have been saying.

 

[VNeil]

Why do I have this strange feeling that the BT apps will be at the top of the review pile as the 8/2019 deadline looms?

 

[Train2]

Let's break this down to some simple predictions....

1 - Pretty much nobody we buy from is going to submit a PMTA.
2 - The FDA will begin 8/9/16 looking for people violating rules in effect as of that time - specifically, they'll start going into vape shops, just like the go into cigarette stores. They'll send in a minor and try to buy juice. And check labels. And start the long slow process (warning letter, fine, fine, fine...big fine...).
3 - We'll have 2 years to either change the regs, or see all the juice and mod vendors go black market, because by 2018, the only people who'll be able to market their product officially will be a couple of the very biggest vendors (those who've applied) like NJoy, and Vuse and Blu...and that's IT.

I'm mostly curious whether direct consumer nicotine sales will be targeted, and what kind of attempts they will make to "inspect" online purchasing - both in August and then also in 2018.

 

[Train2]

They're already looking them over...

Why do I have this strange feeling that the BT apps will be at the top of the review pile as the 8/2019 looms?