FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

[Bill Godshall]

The leaked FDA Draft Guidance for PMTAs for Electronic Nicotine Delivery Systems at
http://tveca.com/tveca_docs/industry_guide_draft_tveca.pdf
confirms my previous analyses that FDA Deeming Regulation would:

- cost >$20 million to submit each ENDS PMTA (that FDA would actually accept for review) even though FDA estimated it would cost just $333,554 per PMTA,

- ban the sale of >99.9% of nicotine vapor products to adults,

- put >99% of estimated 10,000 vapor companies (incl. all vape shops) out of business,

- put 50,000+ vaping industry employees out of work,

- create a monopoly or oligopoly of just one or several legal (i.e. FDA approved) ENDS manufacturers and products (with large tobacco companies the most likely winners),

- create a multibillion dollar black market for totally unregulated vapor products, and

- force millions of vapers to go back to smoking cigarettes, switch to an FDA approved ENDS, or buy totally unregulated vapor products from newly created black markets, and

- protect cigarettes and threaten the lives of millions of vapers and smokers.

The leaked draft guidance also reveals that FDA decided to changed the term "e-cigarette" to Electronic Nicotine Delivery System (ENDS).


I recommend the weblinks below for more information about the deeming regulation (and what can be done by vapers). The reason I'm posting this thread is because other ECF threads on the leaked deeming reg (which FDA and/or the White House leaked to TVECA) provided little clarity.

Carl Phillips: FDA regulation of e-cigarettes would not actually be regulation, Godshall comments
FDA "regulation" of e-cigarettes would not actually be regulation

Mike Siegel – FDA is out of its mind: Deeming regulations should be called the “The cigarette protection act of 2015”; Regs are an embarrassment to public health and will decimate the vaping industry; Godshall comments
The Rest of the Story: Tobacco News Analysis and Commentary: FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

SFATA provides member guidance for requesting and attending OMB/OIRA meetings
SFATA Provides Member Guidance for Requesting and Attending OMB/OIRA Meetings - SFATA | Smoke Free Alternatives Trade Association

Jeff Stier webinar on FDA deeming regs and the OMB
Good Video about Deeming, The OMB/OIRA and what You can Do.

Dimitris Agrafiotis interviews Azim Chowdhury and Bill Godshall on FDA’s leaked Deeming Regulation, White House OMB/OIRA


Vape regulation is coming, and it might just kill the industry
Vape Regulation Is Coming, and It Just Might Kill the Industry

Mike Siegel: In reality, FDA deeming regulations are thinly veiled prohibition
The Rest of the Story: Tobacco News Analysis and Commentary: IN MY VIEW: In Reality, FDA Deeming Regulations are Thinly Veiled Prohibition


FDA “decision summary” for approving SM PMTA delineates how/why >99% of e-cig manufacturers cannot afford to submit a PMTA that FDA would actually review.
http://www.fda.gov/downloads/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/UCM472123.pdf

Mike Siegel: First PMTA approvals by FDA demonstrate why treating e-cigarettes like tobacco products makes no sense and will decimate industry
The Rest of the Story: Tobacco News Analysis and Commentary: First PMTA Approvals by FDA Demonstrate Why Treating E-Cigarettes Like Tobacco Products Makes No Sense and Will Decimate the Industry

Baptists, Bootleggers & Electronic Cigarettes (49 page article in Yale Journal on
Regulation by Jonathan Adler, Roger Meiners, Andrew Morris, and Bruce Yandel)
Baptists, Bootleggers & Electronic Cigarettes by Jonathan H. Adler, Andrew P. Morriss, Roger E. Meiners, Bruce Yandle :: SSRN

Jonathan Adler: E-cigarette regulations may increase teen smoking (and help Big Tobacco)
E-cigarette regulations may increase teen smoking (and help Big Tobacco)

And next week:

Free webinar November 18 at 8pm EST with Azim Chowdhury and VapeMentors:
How to Future-Proof Your Vape Shop or E-Liquid Company and Avoid FDA Shutdown
Knock, Knock. It's the FDA Calling!

 

[nicnik]

Dimitris Agrafiotis interviews Azim Chowdhury and Bill Godshall on FDA’s leaked Deeming Regulation, White House OMB/OIRA

You were really good in that interview, Bill!

 

[skoony]

Thanks Bill.
Mike

 

[Kent C]

- force millions of vapers to go back to smoking cigarettes

And, prevent millions who may have found the safer alternative of ecigs.

Thanks Bill.

 

[AndriaD]

Well, let's hear it for the black market then. If they're too stupid to avoid creating it, then they deserve to miss out on all that sales tax.

Andria

 

[Katya]

Thanks, Bill.

Is there anything we, vapers, can do now? How can we persuade the OMB/OIRA to send the deeming regs back to the FDA as too draconian?

 

[zoiDman]

Thank you Bill for Condensing all this into One Post.

 

[pennysmalls]

Where is the $20 million figure for PMTA coming from? Not doubting it, just wondering how that figure was arrived at.

 

[Jman8]

I wondered where the $330K figure came from. Compared to $20 million, that seems like it ought to be no brainer. But that $330K strikes me as astronomical. The $20 million strikes me as not credible for what one gets in return, UNLESS the market changes to only 2 to 5 companies will survive.

 

[Rossum]

I wondered where the $330K figure came from. Compared to $20 million, that seems like it ought to be no brainer. But that $330K strikes me as astronomical. The $20 million strikes me as not credible for what one gets in return, UNLESS the market changes to only 2 to 5 companies will survive.

I think the FDA's estimate was that it would take 5000 man hours to prepare an acceptable PMTA. That's $66/hour, which seems rather low for someone competent to handle regulatory matters. Attorneys charge in the hundreds per hour.

 

[Stubby]

Where is the $20 million figure for PMTA coming from? Not doubting it, just wondering how that figure was arrived at.

It is not just a matter of filling out the forms by an army of lawyers. Many studies have to be done, not just on the health effects on an individual, but if there is a negative health effect on the population at large. As this is nearly an impossible goal to meet on a scientific level, in reality it is completely arbitrary as to if the FDA accepts the application or not.

The $300.000 something figure is actually the estimate for a substantial equivalent application. The new product application is many times more expensive.

FDA "regulation" of e-cigarettes would not actually be regulation

 

[Jman8]

I think the FDA's estimate was that it would take 5000 man hours to prepare an acceptable PMTA. That's $66/hour, which seems rather low for someone competent to handle regulatory matters. Attorneys charge in the hundreds per hour.

5000 hours = astronomical
More than $50 an hour for preparing PMTA = astronomical

 

[2coils]

As far as I understand this is per sku. 1 flavor @ 4 or 5 nic strengths etc - 4 to 5 skus.... Most manufacturers or vape shops in some cases, carry or make a minimum of 50 flavors.
And as stated above, the studies are nearly impossible to complete. There is nothing inexpensive or practical about this process. It was designed to stop the infiltration of new tobacco products to market.

 

[AndriaD]

As far as I understand this is per sku. 1 flavor @ 4 or 5 nic strengths etc - 4 to 5 skus.... Most manufacturers or vape shops in some cases, carry or make a minimum of 50 flavors.
And as stated above, the studies are nearly impossible to complete. There is nothing inexpensive or practical about this process. It was designed to stop the infiltration of new tobacco products to market.

Even those which really aren't tobacco products at all -- they seem to truly believe that just saying something is a thing, actually makes it that thing. Magical thinking, anyone? Or how about... gov't drunk with power and taxpayer money and run completely amok?

Andria

 

[Rossum]

5000 hours = astronomical
More than $50 an hour for preparing PMTA = astronomical

He has erected a multitude of New Offices, and sent hither swarms of Officers to harrass our people, and eat out their substance.

 

[Jman8]

He has erected a multitude of New Offices, and sent hither swarms of Officers to harrass our people, and eat out their substance.

If I were going to pay someone (even) $25 an hour for 5000 hours of work, it ought to return a result that is better than, "in section 7, on page 16, paragraph 11, line 8, you didn't dot an 'i' and therefore your application must be resubmitted. Have a nice day. This has not been a recording."

 

[MacTechVpr]

It is not just a matter of filling out the forms by an army of lawyers. Many studies have to be done, not just on the health effects on an individual, but if there is a negative health effect on the population at large. As this is nearly an impossible goal to meet on a scientific level, in reality it is completely arbitrary as to if the FDA accepts the application or not.

The $300.000 something figure is actually the estimate for a substantial equivalent application. The new product application is many times more expensive.

FDA "regulation" of e-cigarettes would not actually be regulation

No not regulation, nor even the selective development of monopoly…but the worst kind of governmental obsessive compulsion. They are the addicts of tobacco taxation and irrational perpetual incumbency.

Good luck all.

 

[edyle]

The FDA should be limited in power to merely APPROVE a product but not go so far as to disallow a product.

 

[Kent C]

premarket tobacco product application (PMTA)

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf

A. Full Reports of Investigations of Health Risks

Section 910(b)(1)(A) of the FD&C Act requires that a PMTA contain "full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products." FDA interprets the information required under this provision to include, not only investigations that support the application, but also any investigations that do not support, or are adverse to, the application. Information on both nonclinical and clinical investigations should be provided, including, but not limited to, any studies assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and consumer use profiles. Further, information on investigations concerning products with novel components, ingredients, additives or design features that are similar or related to those of the new tobacco product and investigations concerning products that share novel components, ingredients, additives or design features with the new tobacco product should also be provided so that FDA may adequately assess the health risks of the product. To the extent the information is available, you should indicate the source of funding for all studies provided.

FDA Cost estimates for applications:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

Table 21

20 products at $6,671,079 or $333,553.95 each.

 

[zoiDman]

I always liked this Paragraph...

"If electronic cigarettes are deemed to be subject to chapter IX of the FD&C Act, the cost of premarket applications would increase the cost of entering and remaining in the market. (It is uncertain whether there are any valid predicates for the electronic cigarette products currently on the market. If no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market.) In addition, warning labeling would serve as a negative signal to consumers and possibly discourage use. The combined effects of these two requirements would reduce consumption below levels that would be observed without regulation. It is important to note that this comparative reduction is a separate consideration from any general secular trend toward greater use of electronic cigarettes."

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf