June 13, 2014 Larry Waters

Swedish Match, FDA, General Snus, and Modified Risk Tobacco Products: What does it mean?

UPDATED 27 Aug 2014: Two months ago, Swedish Snus giant Swedish Match presented FDA with a formal application that the General Snus products sold over-the-counter (OTC) in the United States be reclassified as Modified Risk Tobacco Products (MRTP).

I wrote an article back in February 2009 entitled The Tobacco Control Act: Wasted Taxpayer Dollars and the new Tobacco Black Market. In the article, I previewed the first view of snus can labeling with the four now-required smokeless tobacco warning labels.

I also went on something of a rant as to how 3 of the 4 warnings did not apply to Swedish snus and drove away cigarette smokers looking for a safer nicotine alternative. Ignoring my arguments, FDA went forward with enacting the inaccurate (for Swedish snus) smokeless tobacco warning labels effective 22 June 2010.

In their MRTP application to FDA, Swedish Match made the same case…in a 100,000 page long application. Such is the challenge of justifying General Snus to FDA as being deserving MRTP status.

What is the big deal about a smokeless tobacco product being reclassified as Modified Risk and why does it take 100,000 pages to make the case? Will all snus sold in the US; whether made in Sweden, Denmark, or the US, suddenly be classified as MRTP products?

Those are the questions this article is going to focus on.

Why is it critically important that American snus users and reduced harm tobacco products advocates understand what is going on here now?

Because later today; 27 August 2014, the FDA will publish the official Modified Risk Tobacco Product Applications: Swedish Match North America Inc. to the Federal Register. Once published, the Public Comment Period will begin. This is when Americans will have the opportunity to weigh in with FDA as to where you stand on the Swedish Match US application!

It is critically important that you do share your thoughts with FDA. You don’t have to be a scientist; just tell your own snus story.

If this MRTP application fails, then Swedish snus will continue to carry factually untrue cancer and oral health warnings.

If this MRTP application for General Snus fails, then no other manufacturer will invest the time and huge amounts of money to submit MRTP applications for their own products. Everyone is waiting to see what happens with this application; everyone including Reynolds American, Altria, and all the Swedish and Scandinavian snus manufactures.

If this MRTP application fails, 42 million US cigarette smokers will continue to sicken and die before their time because Swedish snus will continue to carry the same warning labels as deadly cigarettes. They won’t even know Swedish snus IS a considerably safer alternative to cigarettes while delivering more than enough nicotine satisfaction.

All Swedish snus is smokeless tobacco BUT not all smokeless tobacco is Swedish snus.

The Family Smoking Prevention and Tobacco Control Act 0f 2009, commonly referred to as the Tobacco Control Act initially dumped all smokeless tobacco products sold in the US into one big pot for the purposes of regulation… dip, chew, nasal snuff, snus; if you didn’t burn it then it was smokeless tobacco.

All smokeless tobacco products were required to have one of four warning labels printed on their containers. The warning labels were to be changed every quarter so that in the course of a year, a smokeless tobacco product (and any advertisements, promotional material and signage) would have displayed all four tobacco warnings.

Here is the 2009 graphic of the 4 smokeless tobacco warnings obscenely displayed on cans of Thunder Snus manufactured by V2 Tobacco of Denmark. They look normal today but back in 2009, they were jarring.

WARNING: This product can cause mouth cancer. In the case of Swedish snus; specifically addressed in the Swedish Match MRTP filing, the 8 General Snus products sold over-the-counter (OTC) in the US, this is scientifically, historically, clinically proven, and documented as being untrue.

General Snus does not and has not caused mouth cancer since the Swedish National Food Agency (Sweden’s version of the US FDA) began tracking and regulating snus in Sweden as a food product back in 1970.

Swedish Match wants FDA to remove this label requirement from General Snus.

WARNING: This product can cause gum disease and tooth loss. Same justification as above; additional reams of paper documenting it.

Swedish Match wants FDA to remove this label requirement for General Snus.

WARNING: This product is not a safe alternative to cigarettes. Not accurate in a way which negatively affects the public health.

Swedish Match wants to revise this label for General Snus to read: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

WARNING: Smokeless tobacco is addictive. Of course it is. Any product containing nicotine is addictive. Nicotine ranks above heroin when it comes to addiction. If you’re not already a nicotine addict, then you should stay away from any product containing nicotine including Swedish snus.

Swedish Match is not asking for any change to this warning label for General Snus.

Much of the 100,000 pages of the General Snus MRTP Application spells all this out in painstaking detail….but not all of it.

When the US Senate signed off (in the middle of the night) on The Tobacco Control Act of 2009 and sent it to President Obama (who signed it into law quietly with no publicity) it contained a section originally designed into the Master Settlement Agreement with between Big Tobacco and the US Government. As section 901 of the Tobacco Control Act, it gave tobacco product manufacturers a way out of the generic smokeless tobacco product bucket…. reclassification as a Modified Risk Tobacco Product.

The law requires that an applicant demonstrate that their product, as it is actually used by consumers, will:

1. Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; AND

2. Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

At first glance, that doesn’t seem like too high a hurdle; especially for Swedish snus, especially for Swedish Match AB with their GothiaTek standard.

Back then in 2009, I guessed 2000 pages or less with pie charts and attractively layed out data point graphs could make the case for MRTP status. This shouldn’t take more than a year to pull together; less if SMAB brought in enough temps to help out.

I expressed this opinion to Dr. Lars Erik Rudqvist, Senior Vice President for Scientific Affairs at Swedish Match AB, during a meeting we had in Sweden at the Swedish Match Gothenberg factory.

Dr. Rudqvist agreed that the first requirement could be quantified scientifically. The second requirement was the rub.

How do you prove that the health of the entire US population, tobacco users and non-tobacco users alike, would benefit from an MRT product? More specifically, how do you quantify how all the non-tobacco users in the United States would benefit?

He was right of course, especially since at the time since FDA had not even began formulating the fine print requirements to achieve MRTP status. I asked him how long it could take before any Swedish Match snus could be classified as a Modified Risk Tobacco Product.

Unfortunately, the MRT application and product approval process is also one of FDA’s “learning curve” challenges. Back in 2009, now former FDA Tobacco Czar Dr. Lawrence Dayton stated the approval process for the first MRT applications will move slowly as FDA “learns as it goes”.

Under Dr. Dayton, “slowly” was about the only speed the FDA Tobacco Directorate knew.

I revised my time estimate to five years for FDA to sort out the MRTP bureaucratic red tape. Dr. Rutqvist wasn’t as optimistic. He said that the first products to win FDA approval to be classified in the MRTP category could conceivably not occur in our lifetimes. To answer your unspoken question, he was serious.

Fortunately, Dr. Dayton (known to his friends as “Bopper”) was replaced at FDA by Mitch Zeller in March 2013. An attorney, Zeller had 30 years experience with tobacco regulation, although much of it made me initially apprehensive as to how he would view snus.

Mr. Zeller kicked the FDA Center for Tobacco Products into high gear which brings us to 10 June 2014 and the submission of the Swedish Match MRTP application for the eight General Snus products currently sold in the US.

The application took two years to complete. As previously stated, it is 100,000 pages long (give or take a page) and conclusively proves the MRTP case on both requirements in the Tobacco Control Act.

Whether Director Zeller agrees with myself and Swedish Match on this may take up to a year to find out.

When General Snus becomes a MRTP, what happens with snus next?

Internet Snus Stores in Sweden will continue selling to US consumers as regulated by The PACT Act. Moe Unz will still be there.

US cigarette smokers curious about snus will be able to pick up a can of General Snus without immediately fearing cancer or going toothless.

Essentially, nothing else changes except for eight versions of General Snus. Swedish Match will get a leg up in the US market being the only snus sold OTC that doesn’t have the smokeless tobacco warnings emblazoned on their cans…at least at first.

If SMUS markets the MRTP General Snus aggressively and quickly, Camel SNUS users as well as other American snus brands will start asking themselves “why am I using a snus that says on the can it can give me cancer, is as harmful as cigarettes, and will rot my teeth? Maybe I should try this General Snus“.

I have no doubt that Susan Cameron and Reynolds American are going to submit an MRTP application for Camel SNUS. Their market share has dropped over time, hovering at 75% or so for the past few years.

Timing is the only question. Will Reynolds wait to see how FDA rules on the General Snus application is or will they be submitting a Camel SNUS MRTP application Monday morning? How long will General Snus have the MRTP snus market to itself?

Meanwhile, this application is for the General Snus products already being sold OTC in the US and for those snuses only. When approved, nothing will change for any other snus sold in the US. They will still be regulated as smokeless tobacco.

Each manufacturer must submit their own MRTP applications for their own products with their own set of facts.

Theoretically, since this will be FDA’s first experience with an MRTP application, they should be able to move quicker with each new application they receive.

Similarly, Swedish Match will have gained insight into FDA’s thought process through their first MRTP application and should be able to assemble and submit any future MRTP applications more quickly as well. They may even be able to cut the next application down to 98,000 pages!

General Snus is manufactured under and to Swedish Match’s proprietary GothiaTek protocols. Reynolds American, for example, would have to demonstrate how their manufacturing, ingredients, and quality control measures for Camel SNUS would meet the first MRTP standard….and so on for all other American and Scandinavian snus manufacturers.

I don’t believe the MRTP applications ever become public so even generic information and existing published studies Swedish Match used would not be specifically known to other snus manufacturers.

The SnusCentral Intelligence Agency (SnusCIA) has learned from anonymous sources within Swedish Match that once the first eight General Snus products are approved sometime in 2015, SMAB has no plans to submit any other General Snus products or Swedish Match brands to FDA for MRTP status.

As (rather, if) enough other snus manufacturers begin filing their own MRTP applications AND if the US snus market volume expands significantly above its current 50 million cans per year (roughly the same as Norway), AND SMUS can boost the General Snus US market share out of the single digits….who knows what snus Americans will be able to find at their local gas stations over the next 3 to 7 years?

In the meantime, enjoy your REAL Swedish snus!