Deeming Regulations have been released!!!!

tidegirl

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"The PMTA (as I understand) is for a "Complete Product". And not a collection of Data based on Isolated Components."

BTW - This one of the Main Reason I believe that Open Systems are not going to be Approved.

Because I think that the FDA will just say that the PMTA Applicant did not show data on All Possible Combination and Permutations that a Vaper could use the Open System with.

And that there is No Prevention of an Open System from being "Adulterated".
Can you imagine how expensive the testing would be for them to even try to cover every possible use? Only to still be denied?? Crazy.
 

Mazinny

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Yeah... Now that is Problematic. And probably is something that he Wishes he could take back.

If FlavorArt is selling just to e-liquid Manufactures, no problem. But if FlavorArt is going to sell to the End User, well, that could be an Issue.

In the USA that is.
Flavorart would survive selling in Europe and Canada. They didn't sell to too many U.S. vendors anyway, prior to establishing their North American subsidiary in Canada. Many U.S. vendors claimed that they did not use FA flavorings because there was no easy way to buy the flavors in bulk ( also more expensive compared to other flavors ). When Molecule Labs was showing their facilities to PBusardo in one of his videos, the president of the company made sure to brag and point out to PB all the FA flavorings in their stock room.
 
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The Ocelot

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And the FDA shows their true colors once again... Candy Flavored Amphetamines... smh

Adzenys XR-ODT: New Chewable ADHD Medication For Children Sparks Worry

"Thousands of children are poisoned with iron every year, and iron poisoning is a leading cause of death by poisoning for children under the age of 6. The reason may be because we give our children "chewable vitamins with iron" every day."

ddb1b8b80995cfd239875ef991ad1a86.jpg


 

Lessifer

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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>

Well, its because we're smokers, of course.
Yup, we're smokers, smokers are horrible people and get what they deserve. The faster we all die, the better.
 

zoiDman

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Can you imagine how expensive the testing would be for them to even try to cover every possible use? Only to still be denied?? Crazy.

I don't see how a PMTA could be obtained? It can't be Done. It's a Ban thru Regulation. And of Course, the FDA knows this. Because they wrote it.

And where is the Friggin Public Health in all this? Just Scrap the Whole Concept of Harm Reduction.
 

Yiana

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"Thousands of children are poisoned with iron every year, and iron poisoning is a leading cause of death by poisoning for children under the age of 6. The reason may be because we give our children "chewable vitamins with iron" every day."

ddb1b8b80995cfd239875ef991ad1a86.jpg


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

YoursTruli

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If I am selling Flavorings. And I sell to someone who wants to do a PMTA for a Flavored e-Liquid. It is the person who is going to mix my Flavorings who is going to be Required to submit Testing. Not Me.

Now I can do it if I feel it would help me. But it would seem the Only people that I would want to do that for would be BT and a couple of BV.

And I don't see there being many Flavors that can get thru a PMTA. And States seem to be able to Ban Flavorings. So I would have to Think Long and Hard before I start cutting checks to Testing Labs.

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.
 

zoiDman

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Flavorart would survive selling in Europe and Canada. They didn't sell to too many U.S. vendors anyway, prior to establishing their North American subsidiary in Canada. Many U.S. vendors claimed that they did not use FA flavorings because there was no easy way to buy the flavors in bulk ( also more expensive compared to other flavors ). When Molecule Labs was showing their facilities to PBusardo in one of his videos, the president of the company made sure to brag and point out to PB all the FA flavorings in their stock room.

If I was FA, I would just Spin Off a New daughter company in the USA. Call it something like "Mom's Down Home Baking Flavors".

And never mention the "e" word in any Company Advertising and or Promotions.
 

Train2

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And we'll have to back them up that it's NOT INTENDED for use with any nicotine product.

I'm just partial to tobacco flavoring in my "Smokey Scones" and I drizzle RY4 on my ice cream sundaes!


If I was FA, I would just Spin Off a New daughter company in the USA. Call it something like "Mom's Down Home Baking Flavors".

And never mention the "e" word in any Company Advertising and or Promotions.
 

zoiDman

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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.

I kinda Applaud FA for what they say they want to do.

But on the Other side I kinda SMH. Why would I, as a Flavoring Company, want to put my Head into the Legal Lion's Mouth and set myself up for the Coming Tsunami of Flavoring Personal Injury Lawsuits?
 

The Ocelot

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In particular, Mr. Parrish believed that F.D.A. regulation could help push the industry to innovate — coming up with cigarettes, or cigarettelike products, that were less lethal. "

http://www.nytimes.com/2009/06/20/business/20nocera.html?pagewanted=2&_r=1

"In January 1964, the United States Surgeon General's Report on Smoking and Health likewise began suggesting the relationship between smoking and cancer.

"As scientific evidence mounted in the 1980s, tobacco companies claimed contributory negligence as the adverse health effects were previously unknown or lacked substantial credibility. Health authorities sided with these claims up until 1998, from which they reversed their position. The Tobacco Master Settlement Agreement, originally between the four largest US tobacco companies and the Attorneys General of 46 states, restricted certain types of tobacco advertisement and required payments for health compensation; which later amounted to the largest civil settlement in United States history."

Why hasn't BT come up with "cigarettes, or cigarettelike products, that were less lethal" yet? They've had lots of time to do so. I wonder how much time and money it cost to develop Camel Crush?
 

YoursTruli

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I kinda Applaud FA for what they say they want to do.

But on the Other side I kinda SMH. Why would I, as a Flavoring Company, want to put my Head into the Legal Lion's Mouth and set myself up for the Coming Tsunami of Flavoring Personal Injury Lawsuits?

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 (MOV) know will give their info to the FDA for use in eliquids so they (MOV) can file for PMTAs
 

The Ocelot

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Indeed you are correct and I was half asleep when I wrote that, Madam
I appreciate the correction, it was 100mg/ml Nude

Thanks for your attention.
Regards,
Hazy

You were half asleep and nude when you dripped nic on yourself? :blink:
 

Yiana

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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

That makes sense for them to do that.
 
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Lessifer

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"In January 1964, the United States Surgeon General's Report on Smoking and Health likewise began suggesting the relationship between smoking and cancer.

"As scientific evidence mounted in the 1980s, tobacco companies claimed contributory negligence as the adverse health effects were previously unknown or lacked substantial credibility. Health authorities sided with these claims up until 1998, from which they reversed their position. The Tobacco Master Settlement Agreement, originally between the four largest US tobacco companies and the Attorneys General of 46 states, restricted certain types of tobacco advertisement and required payments for health compensation; which later amounted to the largest civil settlement in United States history."

Why hasn't BT come up with "cigarettes, or cigarettelike products, that were less lethal" yet? They've had lots of time to do so. I wonder how much time and money it cost to develop Camel Crush?
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.
 
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