Back on November 21st, I advanced the argument that while we were all so concerned about the impact of S.1147,  The PACT Act of 2009 legislation,  we were ignoring the larger threat:  FDA Tobacco Czar Lawrence Deyton's interpretation of The Tobacco Act and how that translated into real danger for Swedish Snus in America.  I opened the article, The PACT Act will Hurt, but FDA could Kill Snus Users, with the announcement by FDA that they were soliciting Public input on what they now call The Tobacco Act. I guess even FDA couldn't stomach calling it the 'Family Smoking Prevention and Tobacco Control Act' any longer....or maybe it's a reduction of paperwork thing.

If by some slim chance, you haven't read that article yet, do so now.  It foreshadows the taste and flavoring tampering FDA seems to have planned for smokeless tobacco including snus sold in the United States.  As ugly as the picture was that I painted using FDA and Dr. Deyton's own words, the situation has deteriorated even further with the release of more "clarifications" by FDA; in particular Modified Risk Tobacco Products (MRTP).

The MRTP Category will contain those products the FDA officially designates as Reduced Exposure and, in the glaring case of Swedish snus, Reduced Harm.  Once Swedish snus obtains the Reduced Harm designation, it will among other things, no longer have to carry the draconian warning labels which cigarettes do (and should).  Smokers will be no longer be confused by inaccurate cancer warnings on Swedish snus sold in the United States (the Swedish version of FDA already removed that requirement as scientifically unsound).

American  smokers will learn there is a 98% safer alternative which delivers taste and nicotine.  Maybe they'll even be curious enough to discover that only American snus is marketed as a complimentary product to cigarettes; Swedish snus is a viable and working alternative for the nicotine addicted.

Attached is the 2 1/2 page directive from FDA with their thoughts on how the MRTP will be implemented and the time-frame for certification.  The reason I'm attaching the directive is because you probably won't believe the synopsis I'm about to present.  I don't blame you.  Once you read it for yourself and combine it with the FDA quotes in The PACT Act will Hurt, but FDA could Kill Snus Users, you will be as stunned as I was.

This FDA Draft Guidance for the Industry on MRTP or Section 911 (aptly named....411 sure doesn't fit) states that once a manufacturer makes a MRTP application, there must be a Public Comment Period of an undefined length and the application goes to the Tobacco Products Scientific Advisory Committee who has 60 days to report back to FDA.  The sticking point here as that there is no Tobacco Products Scientific Advisory Committee.  FDA must create it under the Tobacco Act, but nothing can happen until they do.  Dr. Deyton has publicly stated that he hopes the first meeting of the Tobacco Products Advisory Committe will take place in February of 2010.  If so, they will have plenty of time to develop exactly what it is they are supposed to do and by what protocols.

The next number thrown in for a decision to be made by FDA on an MRTP application is 540 days as a result of a previous non-tobacco but related lawsuit FDA lost.  FDA goes on to say that since they never dealt with an MRTP application before, and Congress realizes that FDA usually fails in meeting deadlines, that a different 180 day guideline for drug approval should be ignored.

The reason FDA hasn't received any MRTP Applications is because the application doesn't exist! I'm quoting FDA now: "The Tobacco Control Act provides that within 2 Years and Nine months of its enactment, the Agency shall issue regulations or guidance regarding MRTP applications, and those regulations or guidance shall "establish a reasonable timetable for the Secretary to review an application under this section."

What is a "reasonable timetable"?  Two more years?  Five years?  Since FDA has never handled any now non-existent MRTP applications before, quoting FDA again, "It (FDA) therefore does not have experience in reviewing such applications, and has no information based on prior experience regarding the length of time...." "Moreover the MRTP application review process and approval criteria are new, and the Agency is likely to encounter a number of questions of first impression involving science, law, policy, and procedure.  Resolving questions of first impression may mean that the initial applications will require more time than later submitted ones." So how much longer will the initial applications take?  How long before FDA will figure it out?  Before the 22nd Century?

FDA pretty much states that until the first few applications go through their trial and error methodology of how to actually process an application, even reaching the 540 day milestone is an unknown until the first MRTP applications are submitted....after FDA creates them by June 2012.  Add to that the time the submitting manufacturers then have to take to study, complete, comply and submit whatever Version One of this applications turns out to be, the delays, additional information requests by FDA as they learn to create the process, computing the application fee, and of course politics.

So if you're keeping score, in a best case scenario (which the attached document doesn't seem to optimistic about hitting), FDA first has to actually create an MRTP application and guidelines Swedish snus manufacturers can use by June 2012. Then the hopefully two year old Tobacco Products Scientific Advisory Committee has 60 days to review each MRTP application after some unspecified period of public comment.  Then FDA has somewhere between 180 days and 540 days to rule on the application (much longer with the initial applications)...unless they miss the deadline as Congress acknowledges in Section 911 FDA usually does.

Inexperience is not holding FDA back when it comes flavors and ingredients, though. While not being able how to figure out MRTP implementation in our lifetimes, FDA has already banned flavored cigarettes as of September 22, 2009, claims they have the authority to do them same for any cigarillo or cigar they decide to classify as a cigarette, sent out warning letters to manufacturers and importers of same, and have most dastardly,  signaled they are planning to  "take a serious look" at smokeless tobacco...including Swedish Snus sold in the United States.

In the meantime, God help any manufacture who introduces or represents their product to be a modified risk tobacco product within the United States!  Much better to continue to equate snus with cigarettes when it comes to health risks.  Much better, that is,  for the cigarette manufacturers like Altria/PMUSA who helped write substantial sections of The Tobacco Act.

Much better for our elected officials who take campaign contributions, hard and soft, from Big American Tobacco.  Much better for the Anti-All-Tobacco Zealots in keeping them relevant, their names in the paper and the the money rolling into their organizations.  Why else would Matt Myers and the so-called Committee for Tobacco Free Kids have worked WITH Altria/PMUSA in writing the unworkable, unhealthy, and consumer un-friendly tangle now known as The Tobacco Act?

But much worse for 45MM+ current American nicotine-addicted cigarette smokers who will unnecessarily burden the American Health Care System, whatever that turns out to be, and will die before their time for no reason other than greed.  Not profits; not capitalism:  voracious obscene profits built on the graves of innocent nicotine-addicted cigarette smokers.

Friends, I'm sad to say this article and it's predecessor are but the tip of FDA iceburg/implementation of the Tobacco Control Act.  That's why it is so important to take FDA up on their invitation for public comment on The Tobacco Control Act. If we don't,  the Anti-All-Tobacco Zealots, Big Pharmaceutical, Big Cigarettes, and their paid-for lobbyists will be the only ones on the record.  The deadline is December 28th, 2009.

Merry Julesnus (for perhaps the last time),

Larry

LARRY WATERS
America's Leading Activist Snus Lord
Reporting From SnusCENTRAL.org

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