Deeming Regulations have been released!!!!

[Katya]

Hey y'all, they're picking on potato chips too:
Nanny State of the Week: FDA fries family's potato chip business with new cooking oil mandates - Watchdog.org

Yeah, those are the same scientists who told us years ago that margarine (and other partially hydrogenated fats) were better for us than butter and olive oil.

 

[zoiDman]

Can't really blame the flavoring companies, they had (and will still have) a thriving business without the vaping industry. This was the reason MOV has said they will discontinue their current line and put out a new line before the 8/8/16 deadline using only those flavorings from flavoring company(s) that they know will give their info to the FDA for use in eliquids so they can file for PMTAs

I just Don't even know what to say to that?

Because unless something Significantly changes in the Deeming and of PMTA for ENDS, I question how much that would matter?

Speaking of Change. Is there any New News on Anything? Like a Response from the FDA to the Oversight Committee?

Or some kinda of Organized State By State anything?

 

[zoiDman]

And they most likely better not mention whether or not there is diacetyl.

Not following you?

 

[Kent C]

Either way, I believe we'd be in the same boat, just years in the past. If they had succeeded in 2009/10, BP would have bought the rights / companies that were most successful and we'd have a BP controlled, prescription, closed-system device that was pushed through as a FDA drug / cessation aid.



Yeah, I don't think they wrote the deeming regs, I think they knew some of the contents, certainly. They were also given more weight in their comments than we were - since they 'play ball' on things that are advantageous to the FDA's mindset of a closed-system market. I wonder if BT's possibly supporting amendments to move the grandfather dates has to do with something in the 499 pages that spooked them, perhaps they thought that the modified risk advertising sections would be less stringent than it is since e-cigs are less harmful - or it could be that they're just hedging their bets and playing both sides to see what shakes out in the US market. In the meantime, they'll just keep earning money in other areas of the world.

IMHO, the biggest enemy is BP, the Robert Wood Johnson Foundation and their current neo-ANTZ who suck on that pseudo-scientific research teat with a particularly hate for for having been 'tricked' by us evil vapers, who continue to use nicotine in a manner that is not approved by their money-swollen overlord, which all aligns well with their FDA regulatory agency who continues to nurse a hefty amount of butthurt about the 2010 smack-down delivered by Judge Leon.

I tend to agree. I think Siegel summed up the tobacco company support well. The 3 and 4 letter agencies ALA, ACA, etc. all supported by RWJohnson Fdn. supply the junk science that has been debunked by many of our guys. Only thing is, they get better press on the fears, than we do on the solutions.

 

[Bronze]

I'm confused. A naturally curious 4-year-old went off somewhere he shouldn't have. Kids do that. A decision was made that because a child's life was in danger a gorilla had to be shot. That's protecting the children, right? Yet a petition titled Justice for Harambe has over 300,000 signatures, there's a facebook page with the same name and the parents are being investigated.

I'm not taking sides in the matter, just confused about why there aren't at least few people not involved in the vaping issue, with no first-hand knowledge of the situation, aren't giving us support. <sarcasm>

And death threats have been sent to the parents.

Just a sad tragedy. That's all it is. No one really did anything wrong including the silverback. I wouldn't believe anyone if they told me they never lost track of their child. It happens.

 

[The Ocelot]

My grand daughter brings in the mail after school.
She has gotten me twice in a week..........Handing me Packages of stuff I forgot I ordered.

I used to have a dog that brought me the newspaper everyday. It was kind of ripped up, since he had to crawl under the gate to get out of the yard, then drag the paper with him when he crawled back in. I don't know how he learned to do it, since I adopted him as an adult. It was really cool...especially since I didn't have a subscription.

 

[Lessifer]

I just Don't even know what to say to that?

Because unless something Significantly changes in the Deeming and of PMTA for ENDS, I question how much that would matter?

I seriously question the sanity of anyone planning to submit a PMTA for an e-liquid.

Speaking of Change. Is there any New News on Anything? Like a Response from the FDA to the Oversight Committee?

Or some kinda of Organized State By State anything?

Nothing to speak of. No public response to the Senator's letter that I've seen.

Larry Faircloth is fundraising to support his efforts.

Nothing concrete from anyone else afaik.

 

[DC2]

My understanding is the flavoring companies themselves do not have to file a PMTA, it is the eliquid manufacturers that when filing a PMTA would need all of the information on the flavoring used from flavoring companies to complete the PMTAs and many flavoring companies have already said they have no interest in supplying that info to the the eliquid manufacturers.
The FDA has said if flavoring companies want to file their flavorings information privately to the FDA so the eliquid manufacturer will not know the flavorings information but can use their flavorings in their eliquids the FDA will already know the information. Flavorart has said they will file their flavors privately with the FDA so eliquid manufacturers can use them when filing for their PMTA for finished eliquid products with the FDA.

My understanding is that flavor companies can submit information for Master Files. Then these Master Files can be referred to by eliquid manufacturers when registering their current products. That way they can have a method to show that a given product has not changed in any way, thereby becoming a "new" product which can not be sold. This is all done to avoid forcing the flavor companies to disclose their ingredients for any given flavor to the manufacturers. However, none of that would be of any use really when it comes to a PMTA application.

That is my understanding, and it is possible I could be wrong.

 

[DC2]

Not following you?

Intended use. If you advertise your flavor as being diacetyl-free then the FDA could consider it a tobacco product. There is no other reason to advertise it that way since diacetyl is only a concern with respect to inhalation. In other words, for vaping. Now if you were to sell it to manufacturers only I'm not sure how that would play out. But selling it directly to consumers would very possibly put you right in the tobacco product manufacturer category according to the FDA.

 

[Woofer]

Ain't it though? My old lady asked me why the FDA doesn't prohibit
Canola oil. With all due respect to our northern friends (LOL)
rape oil is bad for ya!

I guess you have credible science to back that up right.

 

[The Ocelot]

Those are yummy and I did get into them when I was a youngster cuz they tasted good. So I really can see that.

I have gummi vitamins and am ashamed to say that I probably eat more than I should.

 

[Kent C]

No argument here. So I guess, if you DIY and use flavourart flavorings, stock up now, because they may not be available to consumers in the future?

I bought from FlavourArt before they went into the specific ecig formulations. There was no mention of ecigs at first. Then when it became evident to them, most likely, they started to cater to the vaping community adding stuff - Vape Wizard, Magic Mask and other stuff. Before that it was just flavors and one nice thing is they had info on whether a flavor was water or oil soluble.

Frankly, now that they have 'developed' a vape market, the could return to their past ways and never mention anything about vaping at all - and not have to go through the PMTA process.

 

[The Ocelot]

Have you seen the MRTP process?

ETA: Here's just the initial bit

FDA can issue an order authorizing the marketing of a product only if the evidence submitted in the application meets the requirements of Section 911, including, among other things, showing that the product will or is expected to benefit the health of the population as a whole.

An order permitting the sale of an MRTP refers to a single specific product, not an entire class of tobacco products (e.g. all smokeless products). In addition, an FDA order permitting marketing of an MRTP is not permanent; it is for a fixed period of time that will be specified in the order. To continue to market a modified risk tobacco product after the set term, a company would need to seek renewal of the order and FDA would need to determine that the findings continue to be satisfied.

If, at any time, FDA determines that it can no longer make the determinations required for an MRTP order, FDA is required to withdraw the order. Before FDA withdraws an MRTP order, it will provide an opportunity for an informal hearing as required under the law.

I have read it, but when did that go into effect? The Surgeon General's Report came out in 1964.

 

[wiredlove]

I used to have a dog that brought me the newspaper everyday. It was kind of ripped up, since he had to crawl under the gate to get out of the yard, then drag the paper with him when he crawled back in. I don't know how he learned to do it, since I adopted him as an adult. It was really cool...especially since I didn't have a subscription.

Thank you. My dogs now think I'm crazy for how much I laughed at that.

 

[HazyShades]

I guess you have credible science to back that up right.

Google is your friend, Woofer.
I knew I'd tick off some Canadian..LOL. Do your own homework, man.
Believe me, I'd prefer that canola oil (Can-a-da Oil) not be harmful
'cause it's less expensive. & I understand Canada needs an industry.
But it's very bad for you, personal experience and I'm not easily
impressed or suggestible.
Start at Mercola..Google
I'm not gonna use it.
Peanut and olive oils are just fine with me.

 

[Lessifer]

I bought from FlavourArt before they went into the specific ecig formulations. There was no mention of ecigs at first. Then when it became evident to them, most likely, they started to cater to the vaping community adding stuff - Vape Wizard, Magic Mask and other stuff. Before that it was just flavors and one nice thing is they had info on whether a flavor was water or oil soluble.

Frankly, now that they have 'developed' a vape market, the could return to their past ways and never mention anything about vaping at all - and not have to go through the PMTA process.

I suppose that's possible.

I keep coming back, in my head, to the fact that if nothing is done about vapor products being subject to the FSPTCA, it's going to suck, big time. Any way you slice it.

 

[tidegirl]

I seriously question the sanity of anyone planning to submit a PMTA for an e-liquid.

I know. I just don't see how anyone smaller than BT could possible afford to submit for every flavor and every strength, not to mention not being able to meet the infinite possible use testing requirements. And you know BT isn't going to try to do anything that helps the consumer.

 

[zoiDman]

...

Nothing to speak of. No public response to the Senator's letter that I've seen.

...

Yeah... Imagine we'll hear something in the next Day or so.

BTW - It would have been Cool to have been able to sit in on some of the Face-2-Face meetings between the FDA/HSS Underlings and Sen. Johnson.

 

[Lessifer]

I have read it, but when did that go into effect? The Surgeon General's Report came out in 1964.

Well, they did come out with "lights" and "low tar" cigarettes, even heat not burn. However, since consumers just compensated by either modifying the products, or smoking more, or not using them the FDA decided they were just cheap tricks. Enter the FSPTCA.

 

[The Ocelot]

And death threats have been sent to the parents.

Just a sad tragedy. That's all it is. No one really did anything wrong including the silverback. I wouldn't believe anyone if they told me they never lost track of their child. It happens.

When I was little I slipped away from my mom at Marineland. There was no one around when I went to the back of the show area. I petted sea lions and dolphins for maybe 20 minutes before I got caught. It was really cool! Dolphins feel like plastic.