Deeming Regulations have been released!!!!

[rothenbj]

I use distilled water in my DIY. Can they deem distilled water as a tobacco product? Or is it enough that one could show that something has other uses as well?

Now I refuse to read all these regulation, maybe someone here has. Since hardware has been deemed to be a tobacco product because it's used to vape e liquid, thus requiring FDA approval, have they done the same thing with pipes that can be used to smoke pipe tobacco as well as other things?

After all, pipes are made of wood and wood from different trees will have different characteristics. At a minimum, a new pipe would need to go through an SE review if they use the same thought process they're using for e cigarettes. I'm guessing they haven't made the same type demands.

 

[Coldrake]

The webinar with Cynthia Cabrera is up.


The webinar with Tony Abboud and Dimitris Agrafiotis was excellent. A lot of information about who and what VTA and Sevia USA are and what they are doing, the Cole-Bishop Amendment and other information we should all be aware of. The video should be up in 24-48 hours.

 

[nicnik]

Now I refuse to read all these regulation, maybe someone here has. Since hardware has been deemed to be a tobacco product because it's used to vape e liquid, thus requiring FDA approval, have they done the same thing with pipes that can be used to smoke pipe tobacco as well as other things?

I think they got deemed too, and goes into effect Aug. 8, 2016.

After all, pipes are made of wood and wood from different trees will have different characteristics. At a minimum, a new pipe would need to go through an SE review if they use the same thought process they're using for e cigarettes. I'm guessing they haven't made the same type demands.

I think they have, and mentioned reasons very much like what you wrote, above.

 

[HBcorpse]

www.august8th.org

 

[crxess]

Over the Next Several Years, LIES over the Tobacco Settlement start to be Exposed, As Highly Financed Health Lobbiest build Exposure Campaigns - still going today. Tons of money to be made supporting the people in need...

Nice Cover:
Broken Promises to Our Children

My Theory!
To Be Continued:

Now where was I?.......Oh yes, Public Out Cry......................Driven once again by HUGH Personally invested Non-Profit Organizations in the interest of Public Health(and nice Salaries)

Congressmen are Getting an Ear Full From these Lobbiest and in Concern for Public Out Cry over (SMOKING) and (FOR THE CHILDREN) and Let the FDA know of their Displeasure with Progress on Public awareness and Actions............Still nothing(or little) to do with e-cigarettes.
Progressing Forward - with unrelenting Demands for More action against Big Tobacco...........
We Arrive at 2013 and the Exit of the Former Director.
* Side Note, most cannot Name the Former director or his actions without Googling.
Dr. Lawrence Deyton Steps Down as Director of CTP
More Personnel Changes at FDA

He favored a science guided approach that respected the statute.

Job Opening!!!
Immediately, March 2013, Mitch Zeller was Positioned as the new Director of CTP.
Mitch Zeller was the Perfect Peoples Choice...... An Anti-Tobacco Activist(Health Organizations Pet choice), Heavily involved in the Tobacco Settlement and Years of FDA PHARMACEUTICAL Experience(Hmmm - There is that FAILED Attempt Insult)

What does any New Executive do when taking position of power?
Make Changes!!!

I do not even know, even at this point, if Vaping truly is a Concern for Mitch Zeller(personally). Never the less Zeller has become a Major concern for the Vaping industry.

In my opinion, Vapor Products have become an unacceptable Deflection from his Goal - Eventual Ending of Tobacco Use in America.
Health Advantages and Proof to the Contrary that Vaping is not something people should consider is Not of No Concern to him. Eliminating an Obstacle to Objective is.
Zeller Cannot Challenge the Very organizations that are Financing His Agenda. Why would anyone even make that consideration? However, as Director of the FDA he is obligated to act on Behalf of their creation of a possible Health threat.

Enter solution to the problem of Job Performance interference by outside Forces(Pharma/Health-Org's)

2013
So once again the Sword to Swipe away Vapor products is lifted. As in the First attempt, Based on NO SCIENTIFIC Reasoning or Documented HEALTH Threat, but as an appeasement to His Political and Financial Supporters and a Means to Get this Barrier to his Goal out of the way.
This time...........Contrary to popular thought that the FDA was Dragging their Feet, I see that with Guidance from a Director with understanding of LAW, the FDA started working a long and arduous plan in order to Gather as much knowledge of the Industry it had to Challenge due to Corporately motivated Out Cry, in order to ELIMINATE the obstacle.

2013-2016>>>> We have all been here and/or can first hand attest to Preparations, Deceptions and now - Actions of the FDA.

For the FDA, this is Business.
For Mitch Zeller this is Chess.

Seemingly in an attempt to Appease a Loud Out Cry from Smoking Prevention Lobbyist, Congress has:
Hired the Thief to Guard the Bank
This Thief must now accomplish Task much like Walking over Vapors Rights in order to Reach his Ultimate Goal of Cracking the Safe Door Big Tobacco has Been Safely Locked Behind since 2007.

Should anyone consider this a negative Vaping Article, I'll just leave with this.
I am 100% Pro-Vaping and See no need, Beyond Reasonable Safety Regulation(Worked out with Industry leaders) and Age Restriction as Vaping was intended for Those that Are/Were Smokers.
* I am also Drawn to thought of a man with an agenda, once given to much power to control the will of the people and ultimately their Freedom......................as Citizens, in Germany.

 

[crxess]

I found it:

Economic Impact Analyses of FDA Regulations

The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.

Regulatory Impact Analysis

Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements (Final Rule) (PDF - 1,173KB)

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

ETA: I've only just skimmed the report, but I have a feeling the FDA will use it as a response to Sen Johnson's letter.

2012 Analysis is Worthless in 2016 Deeming Regulation of an industry that has grown exponentially

 

[The Ocelot]

What Drives Tobacco Control Policy?

April 26, 2016

1. Joel L. Nitzkin, MD

Corresponding Author: Joel L. Nitzkin, MD, JLN, MD Associates, LLC, 4039 Chestnut Street, New Orleans, LA 70115-2941, USA. Telephone: 504-899-7893; Fax: 504-899-7557; E-mail: jlnitzkin@gmail.com

"As published in Nicotine and Tobacco Research (NTR), and re-emphasized at the SRNT meeting, the FDA claims to be committed to a science-based regulatory agenda, rather than one based on political or special-interest concerns.

"Some question this FDA claim.

"It makes little sense to impose little or no regulatory burden on cigarettes currently on the market while attempting to remove far-lower-risk and less-addictive e-cigarettes and related vapor devices (e-cigs) from the market, and hesitating to grant Swedish Match’s snus products MRTP status. It makes even less sense to deal with pharmaceutical nicotine products (patches, gums, etc.) as if they have no nicotine.

"A major problem with the FDA Tobacco Law relates to the requirement that the manufacturer of a new or reduced risk product document that it will not harm nonusers of the product (ie, will not recruit nonusers to nicotine addiction). Unfortunately, FDA’s interpretation of this wording imposes a cost burden so substantial that, if unchanged, it will eliminate all of the smaller companies and all of the customizable products from the e-cig marketplace."

 

[The Ocelot]

This is from the Family Smoking Prevention and Tobacco Control. Act. June 22, 2009. [H.R. 1256]

Nowhere in the act is there any mention of electronic cigarettes (but we already knew that).

(a) DEFINITION OF TOBACCO PRODUCTS.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

‘‘(rr)(1) The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

"Component, part, or accessory" is not defined in the Act. The Deeming Final Rule goes into great detail defining what they consider components, parts and accessories, but it's not clear how they came up with the list.

While this notice in the FSP&TC is listed under SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE, even with ecigs not considered a drug it seems to me that at least some portions of the section would apply.

‘‘(b) REPORT ON INNOVATIVE PRODUCTS.—

‘‘(1) IN GENERAL.—Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine- based products and treatments) to better achieve, in a manner that best protects and promotes the public health—

‘‘(A) total abstinence from tobacco use;
‘‘(B) reductions in consumption of tobacco; and
‘‘(C) reductions in the harm associated with continued tobacco use.

 

[crxess]

shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine- based products and treatments) to better achieve, in a manner that best protects and promotes the public health—

E-cigarettes and Vapor Products?

 

[The Ocelot]

E-cigarettes and Vapor Products?

That is listed under the Family Smoking Prevention and Tobacco Control. Act. SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE

While the section is regarding NRTs, it seems the same language should be in the Deeming regs to include ecigs and vapor products that promote the public health by harm reduction.

 

[crxess]

it seems the same language should be in the Deeming regs to include ecigs and vapor products that promote the public health by harm reduction.

Or at least not to preclude individuals and industry form inventing advancing use of such harm reduction alternatives.

 

[The Ocelot]

Or at least not to preclude individuals and industry form inventing advancing use of such harm reduction alternatives.

Exactly.

From the Deeming regs:

"In a broad sense, because producers of ENDS products would need to incur sizable costs to be able to continue selling their products, we can expect the deeming rule to reduce the number of distinct ENDS products available on the market, relative to what would have been observed in the absence of the rule.

"However, chances are good that numbers of distinct ENDS products would fall anyway in years ahead, as competition causes consolidation of sales in the most popular product lines; as a result, the change caused by the rule has to be measured against an inherently dynamic counterfactual. For present purposes, an important point is that, although numbers of distinct ENDS products are expected to decline as the final rule takes effect, FDA expects that a range of delivery systems and e-liquids will remain available to consumers.

As small businesses shutdown or are "consolidated" by BT buyouts the "range of products" that remain available will be those of BT.

 

[The Ocelot]

Repost

I was looking for information on Robert Califf, M.D., the Commissioner of the FDA. Among other groups, he is a member of the Institute of Medicine. In March 2015, the IOM issued a report on the Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products.

The report goes into detail about the effects of tobacco on developing brains - yada, yada (in fact, some of the report was copied word-for-word into the Deeming Final Rule).

However, buried in the report it states, "In addition, the rapidly changing landscape of tobacco products—for example, e-cigarettes— provides unknowns and could affect the future of tobacco product use in ways that the committee was unable to anticipate due to lack of evidence."

It doesn't seem to me that a "lack of evidence" equals a negative. That's like saying there was a lack of evidence John committed the murder, but we are going to incarcerate him anyway since he might commit murder at some point.

 

[crxess]

although numbers of distinct ENDS products are expected to decline as the final rule takes effect, FDA expects that a range of delivery systems and e-liquids will remain available to consumers.

Damn Straight if WE have any Say!!!

Number 1 Consumer Priority - Support
COLE-BISHOP Amendment

 

[Qew]

.....However, chances are good......

For the FDA, 'chances are good' and 'lack of evidence' = unquestionably acceptable data. The FDA have NO scruples, none! I bet they all play poker since they know so much about chances.

Good job on hunting down the RIA, Ocelot, thank you. I haven't read much of it yet, I'm afraid I will sprain something.

 

[crxess]

Bits From the House Agricultural Bill Markup - FDA CTP Related

Harm Reduction.—It is the Committee recommendation that the
FDA consider the benefits of harm reduction as part of evaluations
under the Deeming regulations for tobacco products.

Given that there is very little mention of cigars throughout the TCA, it is clear Congress did not intend to focus on the unique sub-set of premium cigars.

in Budget increase - tobacco products; estimated $21,000,000

Not much, But reinforcing a Need for the FDA to stop ASSUMING Supremacy.

 

[Sugar_and_Spice]

Exactly.

From the Deeming regs:

"In a broad sense, because producers of ENDS products would need to incur sizable costs to be able to continue selling their products, we can expect the deeming rule to reduce the number of distinct ENDS products available on the market, relative to what would have been observed in the absence of the rule.

"However, chances are good that numbers of distinct ENDS products would fall anyway in years ahead, as competition causes consolidation of sales in the most popular product lines; as a result, the change caused by the rule has to be measured against an inherently dynamic counterfactual. For present purposes, an important point is that, although numbers of distinct ENDS products are expected to decline as the final rule takes effect, FDA expects that a range of delivery systems and e-liquids will remain available to consumers.

As small businesses shutdown or are "consolidated" by BT buyouts the range of products that remain available will be those of BT.

\

So, in other words, if your product is popular and BT makes an offer to buy you out, then the only other choice(currently) is to shut down.
Not much of a choice if you have family to feed.
And is BT going to employ all those thousands that will be out of work? Doubt it.
It feels like BT and FDA are saying........can't be ...... like a pup if you want to run with the big dogs.
Thanks for posting these last few posts. Last week, I too was pouring over the deeming regs, the US code as it pertains to tobacco, and Public Law. Came down with a migraine, so had to back off for a while.
We are in for a long hard road.

 

[frizzy_tyger]

Now I refuse to read all these regulation, maybe someone here has. Since hardware has been deemed to be a tobacco product because it's used to vape e liquid, thus requiring FDA approval, have they done the same thing with pipes that can be used to smoke pipe tobacco as well as other things?

After all, pipes are made of wood and wood from different trees will have different characteristics. At a minimum, a new pipe would need to go through an SE review if they use the same thought process they're using for e cigarettes. I'm guessing they haven't made the same type demands.

Yes pipes are also deemed as tobacco products under the new regulations. Any pipes not marketed before 2007 would have to file an SE or PMTA.

 

[The Ocelot]

For the FDA, 'chances are good' and 'lack of evidence' = unquestionably acceptable data. The FDA have NO scruples, none! I bet they all play poker since they know so much about chances.

Good job on hunting down the RIA, Ocelot, thank you. I haven't read much of it yet, I'm afraid I will sprain something.

Break something more likely. It is by far the most confusing report I have read so far. I think the worst part is that it combines statistics for cigars and other combustibles with ecigs and since they have more historical information on those products use it to support assertions, while ecigs get buried with not enough evidence.

Also, as @crxess pointed out, the studies cited are out of date; especially, when it comes to the estimated number of small businesses (referred to as "Entities"). It is also noted:

"We agree that product exit is likely to occur, but much of this may occur as a result of consolidation of similar products within product lines instead of through exit by manufacturers, although we expect most vape shops that currently mix e-liquids will convert to a retail model once the initial compliance period for submission of PMTAs ends."

Consolidation = BT
"Convert to a retail model" = Selling what? Consolidated products?

 

[The Ocelot]

Yes pipes are also deemed as tobacco products under the new regulations. Any pipes not marketed before 2007 would have to file an SE or PMTA.

Time to dig out granny's corncob pipe.