Deeming Regulations have been released!!!!

[AngiBe]

Gotta beef with the new regulations??? Voice your opinion here:

zlaikin@gmail.com

Senator.Alting@iga.in.gov

Indiana vape law shuts dozens of e-liquid makers out of industry

 

[rosesense]

100,000 pages????? Wow

 

[Kent C]

Good morning Girls and Boys

On the PMTA and SE issues. I pulled out a few of Bill Gs posts on ECF for your reading pleasure. All of his posts have source links and please note the dates of his posts.

FDA also issued 8 Not Substantially Equivalent (NSE) orders, 1 Refuse-to-Accept letter for SE, and companies withdrew 190 SE reports from the review process.”

See: FDA reports it issued 125 SE orders and rejected 199 SE reports in June

While FDA has approved 17 SE applications for tobacco products, the agency has refused to file 4 new tobacco product applications, has rejected 17 SE applications, and has demanded so much info that 247 SE applicants withdrew their SE application.

In sum, FDA has so far approved 17 tobacco products (mostly cigarettes), and has banned 268 tobacco products.

See: FDA refuses to file 4 new tobacco product applications, falsely portrays FDA approved cigarettes as safer than unapproved smokeless & e-cigs

Swedish Match is submitting a 100,000 page Modified Risk Tobacco Product application to the FDA to truthfully inform smokers that General Snus is a less hazardous alternative to cigarettes.
Please note that Swedish Match has already filed at least 185 Substantial Equivalence applications with the FDA, and that FDA approved 8 of them so far.

Source: Swedish Match submitting 100,000 page MRTP application for General Snus to FDA

Happy reading!

Stay Strong! Fight! Stock Up!

That's my basic understand from Bill's posts in the past. I reiterate the point in the lawsuit thread in 'Regulations' forum - a passage from the suit:

59. In fact, the only PMTAs that have been authorized by FDA to date are for eight
(8) smokeless tobacco (snus) products that have already been subject to extensive clinical and
long-term epidemiological studies.

[this is one reason why I have said that even the tobacco companies PMTA's may not be accepted. And there have been some SE applications accepted but not PMTAs which is what all* ENDS products will require. The FDA has said (as it says in the suit, there 'may be' one ecig grandfathered, where the possibility of SE is available, but that's a stretch, imo.]

 

[jm62]

Does anyone know for sure what FDA means by "commercially marketed"? Does it require for the product to be actually purchased by someone? Or is it enough if it has been produced, advertised and available for purchase?

 

[zoiDman]

Are we about to see every major vape hardware company out there be bought up by big tobacco? Is big tobacco going to bring out a rebranded Kangertech dripbox?


Sent from my iPhone using Tapatalk

If the Predicate Date is going to remain the Same, why would BT want to do something like that?

And if it going to Change, why would BT want to do something like that?

 

[VNeil]

This law sounds so idiotic that I can't get my head around the fact that our government is truly this stupid corrupt

Fixed it for ya

It's not stupidity. It's blatant corruption and cronyism.

 

[Kent C]

Does anyone know for sure what FDA means by "commercially marketed"? Does it require for the product to be actually purchased by someone? Or is it enough if it has been produced, advertised and available for purchase?

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

February 15, 2007. As stated in section II.D, we interpret “as of” to mean “on.” Accordingly, the information submitted should demonstrate (individually or collectively) that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007.

Examples of such information may include, but are not limited to, the following:
• dated copies of advertisements
• dated catalog pages
• dated promotional material
• dated trade publications
• dated bills of lading
• dated freight bills
• dated waybills
• dated invoices
• dated purchase orders
• dated customer receipts
• dated manufacturing documents
• dated distributor or retailer inventory lists
• any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007

FDA will consider and evaluate all of the information provided on a case-by-case basis.

 

[jm62]

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

February 15, 2007. As stated in section II.D, we interpret “as of” to mean “on.” Accordingly, the information submitted should demonstrate (individually or collectively) that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007.

Examples of such information may include, but are not limited to, the following:
• dated copies of advertisements
• dated catalog pages
• dated promotional material
• dated trade publications
• dated bills of lading
• dated freight bills
• dated waybills
• dated invoices
• dated purchase orders
• dated customer receipts
• dated manufacturing documents
• dated distributor or retailer inventory lists
• any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007

FDA will consider and evaluate all of the information provided on a case-by-case basis.

Thanks for the reply. I read this document and it still remains unclear whether it is required for the product to be actually purchased. If it was available for sale but unfortunately not bought by anyone, is it still considered commercially marketed?
Thank you!

 

[wiredlove]

Thanks for the reply. I read this document and it still remains unclear whether it is required for the product to be actually purchased. If it was available for sale but unfortunately not bought by anyone, is it still considered commercially marketed?
Thank you!

The issue is that what Kent gave you is what we have. Much like everything else involved in the FSPTCA, it's intentionally vague and up to interpretation by the powers that be.

What's the product that you're thinking of that was on the market pre-2007?

 

[Kent C]

Thanks for the reply. I read this document and it still remains unclear whether it is required for the product to be actually purchased. If it was available for sale but unfortunately not bought by anyone, is it still considered commercially marketed?
Thank you!

In the bulleted list - it doesn't have to include every item, (and may include others -"but are not limited to") ... so 'dated catalog pages, ads, promos, trade publications' still pass the test, as I read it.

Another 'guidance' doc:
Section 910 of the Federal Food, Drug, and Cosmetic Act - Application for Review of Certain Tobacco Products

The FDA almost always has a source for people who want clarifications, so if it's important to you, you might email them with specific questions.

 

[jm62]

In the bulleted list - it doesn't have to include every item, (and may include others -"but are not limited to") ... so 'dated catalog pages, ads, promos, trade publications' still pass the test, as I read it.

Another 'guidance' doc:
Section 910 of the Federal Food, Drug, and Cosmetic Act - Application for Review of Certain Tobacco Products

The FDA almost always has a source for people who want clarifications, so if it's important to you, you might email them with specific questions.

I supposed it does not have to include every item from the list, but I was hoping to find more accurate information.
I called and emailed FDA yesterday so I'm waiting for their reply. I suppose it will take a few days for them to get back to me so I am trying to research it as much as I can while I'm waiting.

 

[jm62]

The issue is that what Kent gave you is what we have. Much like everything else involved in the FSPTCA, it's intentionally vague and up to interpretation by the powers that be.

What's the product that you're thinking of that was on the market pre-2007?

True, we all have the documents released by FDA which are not very clear. Anyways, I hope I will receive the answer from them soon.

I am not thinking that way. I am asking to know this in case the date is changed from 2007 to August 2016. That could give a chance to new products to enter the market.

 

[wiredlove]

True, we all have the documents released by FDA which are not very clear. Anyways, I hope I will receive the answer from them soon.

I am not thinking that way. I am asking to know this in case the date is changed from 2007 to August 2016. That could give a chance to new products to enter the market.

LOL. Okay, yeah, that'd be a heck of a lot easier to provide proof for.

 

[crxess]

Personally haven't written to any politician outside of my state, but if writing might encourage him to not jettison this issue, then obviously it's a good thing

A Statement All should Consider - All Elected Officials are Obligated to listen to their Constituents.
Those Presiding in The U.S. House or U.S. Senate are Obligated to Listen to ALL Americans as they Make Law and Operate For All Americans in Accordance with the Constitution of the United States.

Government FOR THE PEOPLE

 

[Kent C]

I supposed it does not have to include every item from the list, but I was hoping to find more accurate information.
I called and emailed FDA yesterday so I'm waiting for their reply. I suppose it will take a few days for them to get back to me so I am trying to research it as much as I can while I'm waiting.

Well, you're not the only one questioning this :- ) Here's Altria's 'comment letter' that deals in the same area.

http://www.altria.com/About-Altria/...tobacco-product-was-commercially-marketed.pdf

They are contesting the 'test market' wording - iow, test marketing is part of the 'commercially marketing' process, and they think 'test marketing' should be also exempted. Their wording points to your point, though - in Section II - "evidence of marketing efforts" which wouldn't include actual sales.

 

[Wing]

A Statement All should Consider - All Elected Officials are Obligated to listen to their Constituents.
Those Presiding in The U.S. House or U.S. Senate are Obligated to Listen to ALL Americans as they Make Law and Operate For All Americans in Accordance with the Constitution of the United States.

Government FOR THE PEOPLE

lol That's so cute.

Study: Congress literally doesn't care what you think

Excerpt from link:
"Their study took data from nearly 2000 public opinion surveys and compared it to the policies that ended up becoming law. In other words, they compared what the public wanted to what the government actually did. What they found was extremely unsettling: The opinions of 90% of Americans have essentially no impact at all."

 

[skoony]

Does anyone know for sure what FDA means by "commercially marketed"? Does it require for the product to be actually purchased by someone? Or is it enough if it has been produced, advertised and available for purchase?

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

February 15, 2007. As stated in section II.D, we interpret “as of” to mean “on.” Accordingly, the information submitted should demonstrate (individually or collectively) that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007.

Examples of such information may include, but are not limited to, the following:
• dated copies of advertisements
• dated catalog pages
• dated promotional material
• dated trade publications
• dated bills of lading
• dated freight bills
• dated waybills
• dated invoices
• dated purchase orders
• dated customer receipts
• dated manufacturing documents
• dated distributor or retailer inventory lists
• any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007

FDA will consider and evaluate all of the information provided on a case-by-case basis.

IMHO reading the requirements of what would be considered eligible for SE
concerning the grand father date is the product had to be physically within
the borders of the United States available for purchase by someone else within
the borders of the United States. Though not specified I am assuming the purchaser
would have to be and end user buying ready made product.

As a side thought it just occurred to me This is why they are laying off the raw
materials for now. They were all on the market back then and are virtually unchanged
to this day. This very well might prevent them from doing anything about them.
Thoughts?

Regards
Mike

 

[crxess]

I know. It's lame. But it is what it is. One up them and figure out a way you can get around it.

Is anyone Read the Letter from RJR(?) to the FDA Back when this All started

They Laid out the Deeming Regulations down to a T for the FDA

How did I/we miss this?
http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-reg-ecigarettes-2015.pdf

 

[crxess]

lol That's so cute.

Study: Congress literally doesn't care what you think

Excerpt from link:
"Their study took data from nearly 2000 public opinion surveys and compared it to the policies that ended up becoming law. In other words, they compared what the public wanted to what the government actually did. What they found was extremely unsettling: The opinions of 90% of Americans have essentially no impact at all."

Possible difference being - Opinion vs. Action!

 

[mikepetro]

Is anyone Read the Letter from RJR(?) to the FDA Back when this All started

They Laid out the Deeming Regulations down to a T for the FDA

How did I/we miss this?
http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-reg-ecigarettes-2015.pdf

Damn, giving the States a roadmap....

Why is lobelia thrown in the same light as ecigs?
As in Minnesota "criminal penalties for the sale of nicotine or lobelia delivery products,"