Deeming Regulations have been released!!!!

[Robino1]

Tonight @10pm EST via via The VP Live Network
IV - EP049 - "Know Your Enemy"
*FDA Regulations - Product Classifications.
*The Cole - Bishop Amendment & HR 2058.
*Preliminary injunctions & Litigation.
*Timeline and enforcement.
*What will affect us in 90 days?
*Next steps for business owners.
*Next steps for consumers.
*Zeller’s “Bedrock Consumer Protection”
*Labeling requirements.
For live phones/chat join us every other Tuesday night at 10pm EST via The VP Live Network
If you would prefer to join us via YouTube the live event link is https://youtu.be/ftq0eQue40o

Thank you again, Mowgli

 

[skoony]

Something noted to me by Zoidman - the actual publication of the Federal Registry of the deeming today:

Federal Register | Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

(Comment 53) Comments stated the NPRM is a “major rule” according to the Office of Information and Regulatory Affairs, 5 U.S.C. 804(2) (1996), and the Congressional Review Act mandates that the rule cannot take effect until 60 days after the final rule is published in the Federal Register (5 U.S.C. 801(a)(3) (1996)). Therefore, they requested that FDA change the effective date for this rule and the compliance periods for parts 1100 and 1140 to at least 60 days following publication of the final rule.

(Response) FDA is providing a 90-day effective date for parts 1100 and 1140 with this final rule.

----
There's speculation as to whether such a Congressional review will happen.

I also noticed something in reading this - and I'm not sure whether it was in the original doc posted earlier this week (and didn't take the time to look :- ) ... but:


Also I found this interesting, since the Nicopure suit mentions it having problems with the definition of "tobacco products":

XV. Description of the Final Rule—Part 1140 Back to Top
Currently, part 1140 generally applies to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. FDA proposed additional provisions to apply to “covered tobacco products” (namely, the requirement to prohibit the sale and distribution of products to individuals under 18 years of age and the prohibition on vending machine sales except in adult-only facilities). As stated elsewhere in this document, “covered tobacco product” means any tobacco product deemed to be subject to the FD&C Act pursuant to § 1100.2, but excludes any component or part that is not made or derived from tobacco. FDA is finalizing these requirements without substantive change.

further down

We have slightly modified the definition of “covered tobacco products” from the notice of proposed rulemaking (NPRM) to clarify that components or parts that are “covered tobacco products” include not only those that contain tobacco or nicotine, but also those that contain any tobacco derivative.

Again, not sure if the context is right or if this was something they changed today.... just pointing it out.

i thought i had a grip on the whole derived from,derivative of mumbo jumbo.
I haven't a clue now.

Nicotine is a derivative of tobacco as it is made from tobacco in whole or in part.
E-liquid with nic is a derivative of tobacco becuase it is made in whole or in part of tobacco.
The part being the nicotine.
E-liquid with out nic is derived from tobacco as it substitutes for a derivative of tobacco the
tobacco leaf sans the nicotine. The FDA has said this is not under its regulation
because it contains no tobacco or nicotine.
The hardware in a assembled personal vaporizer is a derivative of a components
derived of a finished tobacco product the paper and or filter. The FDA considers this
under the purview of the regulations as a tobacco product if it is to be used with
a tobacco product as described in the regulation.even if no tobacco product is in it.
If not used for this purpose I haven't a clue what it is. The same for the individual parts.

Any part of this in whole or part can change with the phrase "reasonably expected to be used
with" at any time. Well, that was easier than I thought. (NOT!)
Regards
mike

 

[Sugar_and_Spice]

Hmmm...

I'm not sure when this was published, but it was after March 2011. It's anti-tobacco, but makes interesting points.

http://publichealthlawcenter.org/si...urces/tclc-fda-tobacco-products-apps-2015.pdf

"With its sophisticated knowledge of the Tobacco Control Act and instinct for profit-seeking at the expense of public health, the tobacco industry orchestrated a massive exploitation of this loophole in the new product authorization process.

"The industry flooded the FDA with Provisional SE reports just before the March 22, 2011 deadline, bringing the total number of Provisional SE reports to 3,517. This activity is striking considering that the industry filed only 959 Regular SE reports after March 22, 2011, and only 63 total product applications under the pathways that are entirely subject to premarket review (4 PMTAs and 59 SE Exemption requests).

"This means that 77% of the 4,539 applications that the FDA has received to allow new products to enter the market were submitted through the loophole that allows the industry to sell the products before they can be reviewed by the FDA."

As I previously posted:

A 2012 investigation by the Associated Press found that the FDA had received nearly 3,500 of these "substantial equivalence" applications since the law took effect in 2009. The agency was expected to rule on these applications within ninety days of receipt. At the end of 2012 it had issued zero rulings, with many applications lingering for years.

Link to AP article: http://bigstory.ap.org/article/fda-review-tobacco-products-grinds-halt

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

I am pretty sure this is what is going to happen to the ecig industry....even if the FDA receives any applications for approval they don't have the man power to cover the additional work. Even if they hire more people, it will take time to implement their training, etc. They are clearly over their heads and can't seem to provide good guidance to BT, let alone over see studies related to the public health. The message seems to be that push is coming to shove and is why FDA has taken so long for even get the deeming regs out.

 

[Bronze]

Well, there's gotta be a level where you might need an emoji with earplugs and a blindfold.

I often wished ECF had an emoji with a gun to its head.

 

[nicnik]

I often wished ECF had an emoji with a gun to its head.

I was referring to a level of fat, as you know. Not the level of which a post makes you wish it hadn't been posted.

Anyway, correct me if I'm wrong, but i think people need to be aware that you shouldn't vape oils. I don't rule out the possibility that I might misunderstand the safety of vaping oils.

 

[The Ocelot]

So, surely the FDA will grant one or two uninspiring vaping devices...

I think APV devices are a gray area. A battery box and tank can be dual use. That's how head shops have stayed in business.

 

[The Ocelot]

Can you post a Link to what you were Listening to?

Because as far as I know, this is the status of HR2058.

Entertainment break.

 

[The Ocelot]

Good for them!
You're up, ProVape.
Who else?

I wouldn't push ProVape into that seat just yet.

 

[The Ocelot]

I'm not sure if it matters or not since I'm relatively unfamiliar with the group, but Nicopure is a founding member of VTA. In fact, their general counsel sits on the board.

What's VTA?

 

[Katya]

What's VTA?

Vapor Technology Association.

 

[wiredlove]

I was referring to a level of fat, as you know. Not the level of which a post makes you wish it hadn't been posted.

Anyway, correct me if I'm wrong, but i think people need to be aware that you shouldn't vape oils. I don't rule out the possibility that I might misunderstand the safety of vaping oils.

It's not a good idea, but I got my MD from Googlpedia.

 

[Robert Cromwell]

VG seems to be about 90W viscosity. Need to measure it.

 

[SeniorBoy]

BUT it's NOT about "intended use". NOT!

It's about this "clever" slice of verbiage which is used numerous time in the Final rule.

"...intended or reasonably expected..."

That's the catch all. A CYA by the desk killers. Arbitrary in nature. Intended to let them interpret anyway they wish BUT the context of the sale is critical. Think a Sony 18650 VCT5 sold by RTD Vapor verses the same bat sold by Amazon for use in flashlights. So you may say...RTD Vapor gets a PMTA or Sony does. A PMTA for every "skew". Slim to none IMHO.

EDIT: From the Final - Page 60 to illustrate:

"Also, as stated
earlier, nicotine-free e-liquid that is
intended or reasonably expected to be
used with or for the human
consumption of tobacco products in
most cases would be a component or
part of a tobacco product and, therefore,
within the scope of this rule. These
products will be evaluated on a case-by case
basis."

 

[ZeroedIn]

Where is that spelled out? It seems to me that if an application was duly filed, but failed because the FDA didn't get around to reviewing it, would open the door for litigation. Even a class-action suit if it happened to a number of manufacturers.

I don't think it is an automatic fail, just that the product must be taken off the market until such time that the application is approved or denied. Oh wait, right, there is no guarantee that ANY application will be approved - so yeah, basically a de-facto fail, probably.

 

[nicnik]

It's not a good idea, but I got my MD from Googlpedia.

Thanks Doctor Googly. I'll continue eating avacado, but I'll make sure not to vape the leftovers.

 

[Myrany]

Thanks Doctor Googly. I'll continue eating avacado, but I'll make sure not to vape the leftovers.

You are a sick sick person if there ARE any leftovers!

 

[Katya]

BUT it's NOT about "intended use". NOT!

It's about this "clever" slice of verbiage which is used numerous time in the Final rule.

"...intended or reasonably expected..."

That's the catch all. A CYA by the desk killers. Arbitrary in nature. Intended to let them interpret anyway they wish BUT the context of the sale is critical. Think a Sony 18650 VCT5 sold by RTD Vapor verses the same bat sold by Amazon for use in flashlights. So you may say...RTD Vapor gets a PMTA or Sony does. A PMTA for every "skew". Slim to none IMHO.

Dear friends, everything is a "covered tobacco product" as of today. Period. Everything and anything that FDA says (or might say in the future) is a tobacco product is a tobacco product. Really, don't bother.

 

[wiredlove]

Dear friends, everything is a "covered tobacco product" as of today. Period. Everything and anything that FDA says (or might say in the future) is a tobacco product is a tobacco product. Really, don't bother.

I think the moon is still safe. For the moment.

 

[Katya]

We have an ally with connections in WV, Larry Faircloth.

Fight the FDA » Larry W Faircloth; West Virginia State Treasurer

OK, so who is Larry Faircloth and are we signing this?

 

[YoursTruli]

Aspire has petitioned PayPal to disallow it's use as a payment gateway for non-authorized distributors of aspire products, it's been that way since last year, gift certificate is an easy work around for FT ..........

I understand that but my point was if a single company such as Aspire can get with paypal to disallow it's use as a payment I think the government/FDA could easily do the same along with other forms of payment processors.