FDA TVECA post table of contents for Deeming Final Rule

[navigator2011]

As the saying goes, "The road to Hell is paved with good intentions."

 

[StormFinch]

As the saying goes, "The road to Hell is paved with good intentions."

Or in this case, paid for intentions. Markey will swing whichever was the money flows. He was co-sponsor on the SANE Act and Co-President of Parliamentarians for Nuclear Non-proliferation and Disarmament, but after a considerable donation from the Iranian American Political Action Committee he decided to support the Iranian nuke deal. He's also been accused of using his position to manipulate the stock market; google Markey and Herbalife.

 

[Major Meatwad]

CASAA was started in 2009 in response to the FDA's first strike out at vaping. They realized that the Consumer had no voice, no leadership. It was members of ECF that decided that they needed to step up to the plate and formed this organization. They are NOT in bed with Big tobacco.
CASAA - The Consumer Advocates for Smoke-free Alternatives Association

I did not mean to offend others hard work at CASAA.

The legal interpretation of HR 2058 is Vague and extremely questionable. So I scrutinize all supporters of the HR 2058. It is very Related to current "Fda Deeming". Advocacy groups have historically fallen prey to Lobby money.

No, it doesn't. It says, in part:

“(A) to ‘February 15, 2007’, shall be considered to be a reference to ‘the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1)’; and

Which means that any *newly* deemed product will have an effective date after *it's* 'deeming'. i.e. if the final rule goes into effect in January of 2016, then products marketed up to Jan 2016 are grandfathered in.

You are wrong on most of what you are saying. To get a better handle of HR 2058 read this thread

https://www.e-cigarette-forum.com/f...007-to-2015-for-newly-deemed-products.670731/

HR 2058 changes the effective date of the deeming to the date the deeming is issued. This means that all products on the market before the deeming date are grandfathered.

I hope I am wrong about HR 2058.
Only "Bill Godshall" from smokefree america states it is the grandfathering in 21 months past deeming.

If you look closely at the Bill
"
SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO DEEMED TOBACCO PRODUCTS.

• 
  Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended--

• • 
    (1) by striking `This chapter shall apply' and inserting the following:

• • 
    `(1) IN GENERAL- This chapter shall apply'; and

• • 
    (2) by adding at the end the following new paragraph:

• • 
    `(2) DEEMED TOBACCO PRODUCTS- For each tobacco product deemed subject to the requirements of the Act pursuant to paragraph (1), each reference in sections 905(j) and 910(a)--

• • 
    `(A) to `February 15, 2007', shall be considered to be a reference to `the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1)'; and

• • 
    `(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'.'. "

Sections 905 (j) and 910(a) are only known due the release of the latest draft of .They are the Vape shop and E-cig ENDS regulations.

"http://vapers.org.uk/wp-content/upl...e-E-Liquid-PMTAs-Legitimacy-Not-Confirmed.pdf"

21 months after FSPTCA is March 2011.

The bill only specifies this and Not "21 months from Final Deeming"

Despite the championing of Tom Coleof for his bill. His speech for support sounds good but...
The Bill is suspect due to directly writing in sections 905 (j) and 910(a) making them exist before the FDA's Regulations have passed.

Many times Elected leaders champion bills they do not understand as the Lobby groups pay Lawyers to write Bills for Elected Leaders.
Let us not Forget about Earmarks and Revisions.
9 times out of 10 Bills become something totally different.

Laws and Regulations are not always Clear but there is a logic that can be deciphered.

The Real Fight should focus on challenging the "Deeming Authority" of the FDA not focused on writing Bills that only effectively reinforce it.

The exception being a bill that clearly states "e-cigs(vaping/nicotine delivery)" should not be regulated other than for basic product description ingredients , safety warnings and proper packaging that applies to all consumer devices.

Just because the industry isn't regulated doesn't mean companies are not liable selling you juice that isn't what they promised to sell you. Devices sold automatically still have a 90 day warranty for defective manufacture.

The Vape Manifest Project started by SmokeyJoe for B&M's(local vape shops) should be an excellent collective force to substantiate others effected by "Deeming" besides Big tobacco.

 

[Katya]

I hope I am wrong about HR 2058.
Only "Bill Godshall" from smokefree america states it is the grandfathering in 21 months past deeming.

I'm afraid you are.

http://halfwheel.com/rep-boehner-mccarthy-upton-ask-fda-move-grandfather-date

"Three of the most powerful members of the House of Representatives have requested the grandfather date used for the proposed regulations of tobacco products by the U.S. Food & Drug Administration (FDA) be moved to a date no earlier than April 25, 2014.

Speaker of the House, Rep. John Boehner, R-Ohio, House Majority Leader, Rep. Kevin McCarthy, R-Calif., and Fred Upton, R-Mich., the Chairman of the Committee on Energy and Commerce, co-authored a letter that will be welcome news to cigar smokers.

It was addressed to Sylvia Burwell, secretary of the Department of Health and Human Services (HHS), Margaret Hamburg, commissioner of the FDA, and Mitch Zeller, director for the FDA’s Center for Tobacco Products. In it, they requested the date for the grandfathering of tobacco products be moved from Feb. 15, 2007 to April 25, 2014—the day the proposed regulations were announced—or the date in which is enacted, which will be in 2015 at the earliest."

 

[Katya]

Only "Bill Godshall" from smokefree america states it is the grandfathering in 21 months past deeming.

And speaking of @Bill Godshall (from Smokefree Pennsylvania ), I'm surprised we haven't heard from him yet...

 

[Kent C]

And speaking of @Bill Godshall (from Smokefree Pennsylvania ), I'm surprised we haven't heard from him yet...

niknic: (from the original hr 2058 thread)

"(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'."

But doesn't the 21 months only change the SE date to the end of 2008? Must be something I don't understand, here.

Bill Godshall:
"Please note that "effective date" refers to the date the Final Rule for the Deeming Regulation takes effect."

 

[Katya]

niknic: (from the original hr 2058 thread)

"(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'."

But doesn't the 21 months only change the SE date to the end of 2008? Must be something I don't understand, here.

Bill Godshall:
"Please note that "effective date" refers to the date the Final Rule for the Deeming Regulation takes effect."

Hi Kent! Right.

For the record--I meant to say why we haven't heard from BG on the subject of the leaked documents--he hasn't posted since Otober 23. I'd love to hear his take on the whole TVECA debacle...

 

[Kent C]

Hi Kent! Right.

For the record--I meant to say why we haven't heard from BG on the subject of the leaked documents--he hasn't posted since Otober 23. I'd love to hear his take on the whole TVECA debacle...

Understood. I had that (my posted) in the barrel (copied) so I thought I'd shoot it off when Bill was mentioned.

 

[Racehorse]

Has TVECA released any more of the documents? I thought they said they'd be releasing them all within 24-48 hrs, but the PMTA guidelines were all we got

Can somebody post a link to the "full document" promised by TVECA so I don't have to go looking for it?

 

[Robino1]

I did not mean to offend others hard work at CASAA.

The legal interpretation of HR 2058 is Vague and extremely questionable. So I scrutinize all supporters of the HR 2058. It is very Related to current "Fda Deeming". Advocacy groups have historically fallen prey to Lobby money.

Totally understood. Some that are newer to ECF, and the Advocacy that is going on, may not know the background of CASAA.

They hadn't been around for very long (relatively speaking) when I joined ECF and shortly after found out all about what is happening. At that time we were struggling to get to 10,000 members. I love that we are at 100,000. It gives us a stronger voice.

Oh, and they did have a chance to sit at the table with the FDA to present our side. That was about a year ago or so? Around the time we were called to action by CASAA to leave our comments for the first time with the FDA.

I doubt anyone is lobbying them Yet. CASAA isn't quite that powerful. I hope someday ...

 

[OldBatty]

I expect you're right that it would be extremely difficult to differentiate between different plant derived nicotines if they were sufficiently purified, but I also expect that synthetic nic would be relatively easy due to the presence of R-isomers. Plants have an an uncanny ability to produce just the L-isomer, whereas it's my understanding that synthetic methods produce both isomers in equal amounts and they're very difficult (read expensive) to separate. See also:
https://www.e-cigarette-forum.com/forum/threads/l-and-d-nicotine.92643/

Great, nicotine that is half as strong and give you ........! "Synthetic nicotine the Olestra of smoking cessation"

Might be worth it if it costs $100 verses $5,000 per liter.

 

[Kent C]

Can somebody post a link to the "full document" promised by TVECA so I don't have to go looking for it?

TVECA post table of contents for Deeming Final Rule

 

[Racehorse]

TVECA post table of contents for Deeming Final Rule

I was looking for the actual FDA document.

I see a table of contents, and then an "ecig industry guidance document".

Some of the cigar sites are noting the same thing, that instead of posting the entire FDA document at 2pm (as promised in one of the TVECA "tweets")


it appears that they opted instead to publish what they call an "e-cig industry guidance document."

To my mind, it's not the same thing? Just pointing that out. So TVECA hasn't really posted what was promised.

I am thinking the ecig guidance document looks more like "their interpretation" of what was in the actual document promised.

Or is it? Is this the actual "full document" from the FDA, guidance for the ecig industry" ?

I wanted to read the full document for myself.

 

[IanDVaypes]

While I

Please don't make me ignore this thread.
The prejudice against vapers existed for years before there were any cloud chasers. How about just defending *anybody's* right to engage in an enjoyable, harmless personal activity? Pointing fingers at fellow vapers who happen to be doing it in a way you apparently don't approve pretty much puts you in the same class as the ignoramuses who want to regulate it totally out of existence, in my opinion.

I support vaping and I don't mean to sound like I don't. I'm just trying to think outside of the box and putting my feet in other's shoes. I've seen a little arrogance here and there. In order to win this battle, the other point of views needs to be considered.

 

[LouisLeBeau]

Personally, in the absence of good sense, I'm an advocate for civil disobedience. Problem is, there is so little sense, and so much civil disobedience, it's tough to know what is wrongful, and what is rightful anymore.

 

[inspects]

@pennysmalls It really is crazy, right? But I do understand why it's happened. Put simply, our side of the industry is invisible - the only tracked data on sales comes, via Nielsen, from the C-Store sector which is dominated by the tobacco industry.

That's why I started Vape Manifest project with SFATA/ECigintelligence/Roebling, and we now have data from a properly representative sample of B&Ms which we will be submitting to OIRA once it's been fully analysed. This is big news - we're putting the vape sector on the map, finally.

Once we've got this in from of a few people (financial analysts in particular), it will no longer be possible to claim Big Tobacco ownership of the sector, and it will no longer be possible to ignore the size of the independent industry.

Thanks for everything, SJ...!

 

[roxynoodle]

I wish I could get an hour on the Senate floor. My students felt I was calm and reasonable, and I managed to keep 180 teenagers focused and excited about math every year. If 180 teenagers can be rational, some of those senators must be as well.

 

[Dan011z]

I can't believe this is happening.
This is unbelievable.

 

[The Houdini]

I think this is a fight no one will be able to fight unless you got money and political opponents in your pocket.
I will say a big thanks to those public cloud makers for making this possible.
Just today in a amusement park I seen a guy in the crowd puffing away like he did not care.
Me I vape in public but no ones sees the vapor.
Outta site outta mind.

 

[Stubby]

I did not mean to offend others hard work at CASAA.

The legal interpretation of HR 2058 is Vague and extremely questionable. So I scrutinize all supporters of the HR 2058. It is very Related to current "Fda Deeming". Advocacy groups have historically fallen prey to Lobby money.





I hope I am wrong about HR 2058.
Only "Bill Godshall" from smokefree america states it is the grandfathering in 21 months past deeming.

If you look closely at the Bill
"
SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO DEEMED TOBACCO PRODUCTS.

• 
  Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended--

• • 
    (1) by striking `This chapter shall apply' and inserting the following:

• • 
    `(1) IN GENERAL- This chapter shall apply'; and

• • 
    (2) by adding at the end the following new paragraph:

• • 
    `(2) DEEMED TOBACCO PRODUCTS- For each tobacco product deemed subject to the requirements of the Act pursuant to paragraph (1), each reference in sections 905(j) and 910(a)--

• • 
    `(A) to `February 15, 2007', shall be considered to be a reference to `the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1)'; and

• • 
    `(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'.'. "

Sections 905 (j) and 910(a) are only known due the release of the latest draft of .They are the Vape shop and E-cig ENDS regulations.

"http://vapers.org.uk/wp-content/upl...e-E-Liquid-PMTAs-Legitimacy-Not-Confirmed.pdf"

21 months after FSPTCA is March 2011.

The bill only specifies this and Not "21 months from Final Deeming"

Despite the championing of Tom Coleof for his bill. His speech for support sounds good but...
The Bill is suspect due to directly writing in sections 905 (j) and 910(a) making them exist before the FDA's Regulations have passed.

Many times Elected leaders champion bills they do not understand as the Lobby groups pay Lawyers to write Bills for Elected Leaders.
Let us not Forget about Earmarks and Revisions.
9 times out of 10 Bills become something totally different.

Laws and Regulations are not always Clear but there is a logic that can be deciphered.

The Real Fight should focus on challenging the "Deeming Authority" of the FDA not focused on writing Bills that only effectively reinforce it.

The exception being a bill that clearly states "e-cigs(vaping/nicotine delivery)" should not be regulated other than for basic product description ingredients , safety warnings and proper packaging that applies to all consumer devices.

Just because the industry isn't regulated doesn't mean companies are not liable selling you juice that isn't what they promised to sell you. Devices sold automatically still have a 90 day warranty for defective manufacture.

The Vape Manifest Project started by SmokeyJoe for B&M's(local vape shops) should be an excellent collective force to substantiate others effected by "Deeming" besides Big tobacco.

You are getting hung up on the 21 months. It is not at all vague if you understand what is meant by effective date. Effective date means the date the deeming goes into effect. The 21 months refers to what could be called a grace period for companies to comply as manufactures would still have to register there products with the FDA, even though they are grandfathered. Of course they wouldn't have to go through the essentially impossible new product stuff. I't is a very straight forward bill.

What may make it appear vague is that the term effective date is used as opposed to an actual date. The reason for that is because we don't know what the date of the deeming will be.

As for your statement that "challenging the "Deeming Authority of the FDA is the real fight", perhaps in an ideal world, but we are a long ways from that. The problem with that approach, even though it sounds ethically superior, is that it is a sure way to lose everything. In its current incarnation with the grandfather date of February 15, 2007, within a few years nothing will be available in the US. It is the end of the road. With a change in the grandfather date we live to fight another day. It may not be ideal, but it is far better then what is currently on the table.