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

[Bill Godshall]

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.
APNewsBreak: Firm Seeks to Say Tobacco Cuts Risk - ABC News

This would be the first MRTP application submitted to FDA, and if the agency accepts the MRTP application, the agency has 1 year to either approve or reject the application.

If the FDA issues a Final Rule for its proposed deeming regulation (for e-cigs and OTP), I expect all New tobacco Product applications that are accepted by FDA to be 100,000 pages long as well.

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. Although none of the eight SE approvals were for Swedish Match General snus, I strongly suspect that at least several of the 185 SE applications submitted by Swedish Match were for General snus.
http://www.snuscentral.org/snus-new...ight-swedish-match-smokeless-tobacco-products

Also please note that even if FDA accepts and subsequently approves a New tobacco Product application for one, two or several cigalike products (if/when FDA issues the Final Rule for the deeming regulation), those companies would have to submit an MRTP application (in addition to the New Product application) and FDA would have to approve it before the company could truthfully inform smokers that the cigalike product is a less hazardous alternative to cigarettes.

 

[Kent C]

Odd wording:

"The question remains whether smokers, which total about 42 million adults in the U.S., are willing to switch, even if it means saving their lives."

I'd drop the 'even'.

Also the 2007 date for US snus sales - wonder how much that had to do with the focus on ecigs and alternatives. I know I knew nothing about snus until I got here. But then I wasn't looking for alternatives at the time. My interest in ecigs was more along the lines of 'curious about how that would work'.

 

[Anjaffm]

Interesting.
Well, snus has been banned in the European Union except for Sweden (that's the influence of "public health" for you....) but in Sweden it is widely accepted. Sweden has the lowest rate of smoking and of smoking-related illness in the entire EU.

 

[sonicdsl]

Brad Rodu posted on his blog about this today: http://rodutobaccotruth.blogspot.com/2014/06/swedish-match-files-to-change-smokeless.html

 

[DrMA]

This is groundbreaking! Thanks for posting. If approved, it would be the world's first official endorsement of tobacco harm reduction ever.

 

[Jman8]

Curious what would take 100,000 pages to say that you couldn't say in the first 99,900 pages.

Us mere mortals may never know.

 

[Racehorse]

Looks like Swedish Match did their homework.

 

[DrMA]

Curious what would take 100,000 pages to say that you couldn't say in the first 99,900 pages.

Us mere mortals may never know.

The largest document I've ever seen (in fact contributed to writing) was 26,000 pages. It was a report about environmental investigations at a contaminated site. It's surprisingly easy to create page numbers when you include a lot of raw data, and detailed summary tables and graphics.

 

[MTFogger]

Curious what would take 100,000 pages to say that you couldn't say in the first 99,900 pages.

Us mere mortals may never know.

Maybe they submitted one word per page so it would sink in better.

 

[DeeLeeKay]

How many trees needed to die just for this one document?

 

[Bill Godshall]

Swedish Match has an excellent scientific and regulatory staff (as do Altria, Reynolds, Lorillard, PMI and BAT), and has had extensive experience in dealing with FDA tobacco regulations since 2009.

That's why those large tobacco companies have a huge advantage (over all e-cig companies) if/when the FDA issues a Final Rule for the deeming reg.

At the 2013 Food and Drug Law Institute's annual meeting, an FDA official said that the paperwork for just one New Drug application typically fills eight tractor trailer trucks, and she showed a picture of paperwork (for one New Drug application) stacked up in many rows taking up an entire corner of an FDA warehouse.

 

[Jman8]

And yet these drugs get recalled because of the harm that they inevitably cause. I'm unaware of any drug/substance on that planet that doesn't carry with it an unwanted side effect, and which attorneys may one day exploit for monetary benefit.

So, why not submit it in say 300 pages or less, when more than that leads to zero guarantee that approved product doesn't mean harm will result to users?

Sometimes scientist types are so full of themselves that they need to be called out on their gobblety-gunk, especially when the overwhelming evidence suggests that they do not have a corner on the market of Reason.

 

[Bill Godshall]

Jman inquired

So, why not submit it in say 300 pages or less,

Because doing so will most certainly result in the FDA refusing to accept the application.

 

[Vocalek]

If you want to understand why the MRTP application contains 100,000 pages, you might read this document.

http://www.fda.gov/downloads/Tobacco.../UCM297751.pdf

This is from the Table of Contents

V. Contents of an MRTPA 10

A. Contents of an MRTPA Required Under Section 911(d) 10

1. A Description of the Proposed Tobacco Product and Any Proposed Advertising and

Labeling 11

2. The Conditions for Using the Tobacco Product 12

3. The Formulation of the Tobacco Product 12

4. Sample Product Labels and Labeling 13

5. All Documents Relating to Research Findings 13

6. Data and Information on How Consumers Actually Use the Tobacco Product 14

B. Other Information 15

C. Environmental Impact Considerations 16

VI. Scientific Studies and Analyses in MRTPAs 16

A. Key Areas of Investigation Regarding the Effect of an MRTP 16

1. Health Risks of the Tobacco Product 17

2. Effect on Tobacco Use Behavior among Current Tobacco Users 19

3. Effect on Tobacco Use Initiation among Non-Users 20

4. Effect of Marketing on Consumer Understanding and Perceptions 20

5. Effect on the Population as a Whole 21


B. Detailed Considerations Regarding the Recommended Studies and Analyses 22

1. Product Analyses 23

2. Nonclinical Studies 24

3. Studies in Adult Human Subjects 24

4. Secondary Data Analyses and Computational Modeling 27

C. General Principles for Scientific Studies and Analyses 27

VII. Postmarket Surveillance and Studies 29

A. Postmarket Surveillance 30

B. Postmarket Studies 31

C. Outcomes Evaluated in Postmarket Surveillance and Studies 31

D. Design of Postmarket Studies and Active Surveillance 32

Brad Rodu wrote:

After an administrative review for completeness, the agency must refer the application to the Tobacco Products Scientific Advisory Committee (TPSAC) and ask TPSAC to report its recommendations on the application to FDA within 60 days. The FDA will also make the application public and request comments. “FDA intends to act upon your MRTP application no later than 360 days after receipt…”

It would take one person reading for 40 hours per week nearly a year to read the document, assuming one page per minute.

I count nine people among the voting membership of TPSAC. If they divided the pages evenly, that's ~11,111 pages per person. Assuming 1 page per minute, each person could read their segment in 185 hours. It would be doable, within 60 days, but we need to keep in mind that each of the members has a full time job as well. Roster of the Tobacco Products Scientific Advisory Committee

 

[Bill Godshall]

While I'm very pleased that Swedish Match has submitted a MRTP application to FDA to truthfully inform smokers that General Snus is less hazardous than cigarettes, and even more pleased that Swedish Match has asked FDA to let it remove two of the three mandatory warnings and to change the third, Swedish Match's submission has pretty much confirmed my previous claim (made at several different FDA MRTP hearings and on several MRTP docket comments) that the FDA's MRTP regulations would be a "$10 million truth tax" on any company that submitted an application.

 

[Jman8]

Because doing so will most certainly result in the FDA refusing to accept the application.

And yet, you are saying 99% of all products will be disallowed. So either way, no application accepted.

And black market is then wide open for business. With person being able to claim that I did reasonably try to work with FDA, they refused. Here consumer is 300 pages of data to back up the safety of my products, in case you are concerned.

 

[Jman8]

If you want to understand why the MRTP application contains 100,000 pages, you might read this document.

http://www.fda.gov/downloads/Tobacco.../UCM297751.pdf

This is from the Table of Contents

I've reviewed this a few times. I see no justification for more than a few hundred pages.

 

[Bill Godshall]

Elaine wrote

I count nine people among the voting membership of TPSAC. If they divided the pages evenly, that's ~11,111 pages per person. Assuming 1 page per minute, each person could read their segment in 185 hours.

I pointed out that problem at one of TPSAC's MRTP meeting/hearing when they were discussing how TPSAC might be able to to efficiently and yet thoroughly evaluate and respond to an MRTP application in just 60 days.

The authors of the Tobacco Control Act (including Big Pharma funded CTFK's Matt Myers and GSK's Mitch Zeller) were far more interested getting Congress to enact the TCA (and telling everyone the TCA would protect the next generation of children from Big Tobacco) than drafting and negotiating (with Philip Morris lawyers) a rational or beneficial tobacco product regulatory scheme for FDA to implement.

 

[Alexander Mundy]

Maybe I am way off course here, but 100,000 pages is hard to even fathom. I don't know what the review time is, but an average time spent on a peer reviewed scientific paper is an hour per page per reviewer. Given that there is under 2000 work hours per year available per person, it would take 50 government employees over a year to review at the peer reviewed scientific paper rate. Best I can find is an average of $60K per year for persons in a regulatory branch of government. That would be $3 million just in wages of the reviewers to exam the document. I am just going to guess that another $2 million wages for co-ordination of the information. That brings us to $5 million. Now add (and again I am just guessing) another $5 million for document creation, transmittance, etc. and we are over $10 million. Add say $1 million for all the office space, heating, cooling, lighting, etc. so $11 million. That does not include any comparative lab work and I am sure a host of other things I am missing. I'll bet by the time it is all said and done that figure could easily be doubled to $22 million. Then add the overhead of collecting and distributing $22 million in tax dollars. Best I could come up with from the IRS website is for each dollar spent it collects $7. So to have $22 million available with tax dollars spent to collect is over $25 million. Now, what is the average cost from the collected for $25 million? Best I could find was an average of 30% more spent for preparation, filing, etc. So right at $33 million.

I'm just an electrical contractor guessing at this, so for those in the know how far off am I here?

Seems ridiculous our money would be used to that extent to allow a manufacturer to claim what decades of real world experience has already shown.

 

[Bill Godshall]

Jman wrote:

I've reviewed this a few times. I see no justification for more than a few hundred pages.

I submitted a few hundred pages of comments to FDA MRTP dockets (citing the scientific evidence comparing smokeless tobacco to cigarettes) when urging the FDA (and its TPSAC and its IOM Commissed Cmte) to simply inform smokers that all smokeless tobacco products are far less hazardous than cigarettes (and to not require any additional scientific evidence than I had already submitted).

But then CTP Director Lawrence Deyton instructed his commissioned IOM Cmte to NOT compare or contrast the risk differences between smokeless tobacco and cigarettes, and Deyton basically told (and paid) the TPSAC to do the same.