Deeming Regulations have been released!!!!

[zoiDman]

What Zoid was saying in the first post was that in 2009/10 there were two things that occurred concurrently, or pretty close to.
1) The FDA tried to stop shipments of e-cigs by smokeeverywhere / njoy by saying that they were incorrectly classified drug products - being marketed and used as smoking cessation aid.

2) the TCA aka FSPTCA aka the Family Smoking Prevention and tobacco Control Act was passed giving the FDA the authority over tobacco products.

1) was stopped by injunction via judicial process. 2) still remains.

The TCA is what led to the current deeming that we see now, with the first draft being released in 2014 and now enacted with modifications. The TCA from 2009/2010, as far as I know, remains the same as it was when it was passed.

And what I'm trying to get to is that when the FDA Deemed e-Cigarettes/e-Liquids to be "Tobacco Products", it gave the FDA the Authority under the TCA to Regulate e-Cigarettes/e-Liquids as "Tobacco Products".

But the FDA's authority to Regulate e-Cigarettes/e-Liquids as a "Tobacco Product" does not, IMO, give the ATF/TTB any Legal Authority to Impose Requirements or Levy Fees/Taxes on e-Cigarettes/e-Liquids.

 

[crxess]

It's a simple problem: someone offers you a couple million bucks to do a study, and also hands you a fact slick stating that their position now is that vaping is not an effective cessation method. That grant (and the subsequent grants...) pays your mortgage on your new multi-million $ house, buys a $100K car for you, and sends your kids to the Ivy League college of your choice, and fully funds your retirement plan. And you know that if your study contradicts that "fact slick" this will be your last grant you ever get. Sell the house, the car, send your kids to a public college and work as a lab tech somewhere. Not many people would take Plan B.

Then this is an area that Does need a Legal definition of Full Disclosure to the Public including Grant Expectations, Limitations, Requirements of Compliance. Government should mane it clear to the American Public whether Grants are for Open or Orchestrated research.

Sorry, I have walked from every job that was contrary to my self respect and never been unemployed.

 

[choochoogranny]

Weren't several people replaced on the FSPTCA for "conflicts of interest"?........or am I confused.....again.

 

[zoiDman]

Weren't several people replaced on the FSPTCA for "conflicts of interest"?........or am I confused.....again.

Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia

 

[wiredlove]

And what I'm trying to get to is that when the FDA Deemed e-Cigarettes/e-Liquids to be "Tobacco Products", it gave the FDA the Authority under the TCA to Regulate e-Cigarettes/e-Liquids as "Tobacco Products".

But the FDA's authority to Regulate e-Cigarettes/e-Liquids as a "Tobacco Product" does not, IMO, give the ATF/TTB any Legal Authority to Impose Requirements or Levy Fees/Taxes on e-Cigarettes/e-Liquids.

I'm not a lawyer, and it sure hurts to read the TCA but you're probably right:

[*4] Sec. 4. SCOPE AND EFFECT.

<snipped>

(c) Revenue Activities.--The provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco products shall not be construed to affect any authority of the Secretary of the Treasury under chapter 52 of the Internal Revenue Code of 1986.

Family Smoking Prevention And Tobacco Control Act

And I'll just let you read through Chapter 52 of the Internal Revenue Code of 1986 ->

26 U.S. Code Subchapter A - Definitions; Rate and Payment of Tax; Exemption From Tax; and Refund and Drawback of Tax

but there's this :

(c)Tobacco products
“Tobacco products” means cigars, cigarettes, smokeless tobacco, pipe tobacco, and roll-your-own tobacco.

(d)Manufacturer of tobacco products“Manufacturer of tobacco products” means any person who manufactures cigars, cigarettes, smokeless tobacco, pipe tobacco, or roll-your-own tobacco, except that such term shall not include—
(1)
a person who produces cigars, cigarettes, smokeless tobacco, pipe tobacco, or roll-your-own tobacco solely for the person’s own personal consumption or use, and
(2)
a proprietor of a customs bonded manufacturing warehouse

 

[VNeil]

Then this is an area that Does need a Legal definition of Full Disclosure to the Public including Grant Expectations, Limitations, Requirements of Compliance. Government should mane it clear to the American Public whether Grants are for Open or Orchestrated research.

Sorry, I have walked from every job that was contrary to my self respect and never been unemployed.

Ever been in the business of submitting grant apps?

 

[crxess]

2) the TCA aka FSPTCA aka the Family Smoking Prevention and Tobacco Control Act was passed giving the FDA the authority over tobacco products.

This^^^^ The Original DEEMING Act.- Is 2016 Deeming a Re-Write or Appending?

 

[wiredlove]

This^^^^ The Original DEEMING Act.- Is 2016 Deeming a Re-Write or Appending?

The original act rolled pre-existing products immediately under the authority of the FDA and gave the FDA the authority to deem future tobacco products as under their authority. The original Act remains unchanged by the deeming of e-cig products as a tobacco product. So - appending, in practice but really just them claiming authority over the products we consume.

"The Tobacco Control Act gave the FDA immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. For other kinds of tobacco products, the statute authorizes the FDA to issue regulations "deeming" them to be subject to such authorities."

Family Smoking Prevention and Tobacco Control Act | NIH Office of Disease Prevention (ODP)

 

[crxess]

Ever been in the business of submitting grant apps?

Fortunately no, my field was mechanical. (i.e. Minion in Society) My Business Retail Based and in 23 years I learned 2 things.
1)People appreciate and Value honesty.
2)An honest man may not realize all his Dreams....but can walk away with head held high.
My passion far exceeds my education.......something I will never apologize for.


Still, isn't Disclosure of Intent logical?(public concern)

 

[MyMagicMist]

Delivered price per liter, last bit of shopping around I did.

View attachment 563435

Thank you, thank you quite much.

 

[MyMagicMist]

Is nicotine labs a good company to order from?

Not sure. I have only been window shopping so as to know what to save nickels & dimes to buy. I am looking for the most affordable yet as best respectable to offer customs. "Let me find a cheap deal but not too cheap as to be risking my cookies."

 

[zoiDman]

I'm not a lawyer, and it sure hurts to read the TCA but you're probably right:


Family Smoking Prevention And Tobacco Control Act

And I'll just let you read through Chapter 52 of the Internal Revenue Code of 1986 ->

26 U.S. Code Subchapter A - Definitions; Rate and Payment of Tax; Exemption From Tax; and Refund and Drawback of Tax

but there's this :

I'm not a Lawyer either. And have Never even played one in an Off-Broadway Play.

But just like the FDA needed the FSPTCA to give them Authority over e-Cigarettes/e-Liquids via Deeming, it Wouldn't surprise me if the ATF/TTB needed to do something Also to include e-Cigarettes/e-Liquids into Their authority.

---

I have said Many Times that the 3 Things the ECF has always Needed are.

An On-Call Chemist.
A Friend in a Major Media Outlet.
And a pro bono Legislative Policy Lawyer

 

[Lessifer]

No, asking if the 2009 has been fully re-written to include 2016 or is this simply a Tag-on(amendment) to that Regulatory action.
As far as 2014 to 2016, the only changes I note are Hole Plugging actions..........Thanks to our Assistance.


FDA

It's an expansion/amendment, nothing in the original 2009 Act was changed.

 

[crxess]

Section 912 of the Federal Food, Drug, and Cosmetic Act - Judicial Review


Right to Review

1. In General. Not later than 30 days after
   1. the promulgation of a regulation under section 907 establishing, amending, or revoking a tobacco product standard; or
   2. a denial of an application under section 910(c),
   any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.

 

[Bronze]

Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia

I like how these regulators and lawmakers put "Family" in front of all their proposals. It's designed to make the idiot public think they actually care about families (whether their proposal has anything to do with families or not). And trust me, there are a lot of idiots in the general public who can and will be hoodwinked by such titles.

Remember the "Affordable Care Act"? It's anything BUT affordable. We Americans are suckers for marketing ploys.

 

[wiredlove]

It's an expansion/amendment, nothing in the original 2009 Act was changed.

I was trying to avoid the word 'amendment' which implies oversight.

 

[Lessifer]

I was trying to avoid the word 'amendment' which implies oversight.

o·ver·sight
ˈōvərˌsīt/
noun

1. 1.
   an unintentional failure to notice or do something.
   "he said his failure to pay for the tickets was an oversight"
   synonyms: mistake, error, omission, lapse, slip, blunder; More
   
   
   
2. 2.
   the action of overseeing something.
   "effective oversight of the financial reporting process"

We seem to only be using one of those definitions lately...

 

[Lessifer]

I was trying to avoid the word 'amendment' which implies oversight.

Also, who thought it was a good idea for Congress to grant authority to an agency, and then allow that agency the power to expand its own authority?

 

[crxess]

Okay, Next Question:

Will the 2016 Update Deeming include and effect All Producers of Nicotine?(Manufacturers/refiners)

i.e. are they now Required to register as Tobacco Manufacturers?
Are they now subject to PMTA policy?

 

[Lessifer]

Okay, Next Question:

Will the 2016 Update Deeming include and effect All Producers of Nicotine?(Manufacturers/refiners)

i.e. are they now Required to register as Tobacco Manufacturers?
Are they now subject to PMTA policy?

I'm curious about this too. My understand would be, if they ONLY sell to manufacturers then their product is a raw material and does not require a PMTA. However, if they sell directly to consumers, the product DOES require a PMTA. Whoever "finishes" the product, i.e. making it ready for sale directly to consumers, is the one who files the PMTA.