Saturday, 31 December 2016 15:21

Swedish Match MRTPA denial shows FDA approval process is a Farce Featured

Written by  Larry Waters
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After 2 and a half years of fumbling the Swedish Match application for Modified Risk Tobacco Product (MRTP) status on their General Snus products sold in US convenience stores, the FDA announced on Dec 14th they had taken "action".

After a careful review of the entire MRTPA process concerning General Snus and FDA's eventual ruling, a fair-minded person can only conclude that NO tobacco product will ever win MRTP status, regardless of the merits, from this FDA Center for Tobacco Products. 

This begs the question, Congressional mandate notwithstanding, why does FDA perpetuate this cruel, expensive, and time consuming farce?  Simply make the MRTPA process a one page form, hold the required public comment period, and then deny the application.  That would save both the government and the manufacturer huge amounts of money while delivering the same outcome as the current process...minus the hypocrisy.

To refresh the memories of those who lost track of the process, here's a quick timeline:

  • In June of 2014, Swedish Match NA submitted an MRTP Application for the eight General Snus products sold over the counter (OTC) in US retail stores.
  • This application apparently sat in an FDA inbox collecting dust until August of 2014 when FDA "officially" logged it into the system.
  • Per the statute, the clock was now ticking giving FDA one year to reach a decision.
  • Two and a half years later after two 30 day public comment periods, a TPSAC hearing, a 120,000+ page application, an additional 1000 pages asked for by FDA, and a year's worth of "no comment" from the CTP Press Office, The General Snus MRTPA was partially denied outright while the can was kicked down the road by FDA on the remainder....if Swedish Match was willing to invest another 2 years of time and money into the process.

The Swedish Match MRTPA centered around the four warning labels required on all smokeless tobacco cans including the eight General Snus products sold over the counter in the US.

The warning labels in question are: 

WARNING:  This product is not a safe alternative to cigarettes.  Swedish Match wanted 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:  This product can cause gum disease and tooth loss.  Swedish Match wanted FDA to remove this label requirement for General Snus.

WARNING:  This product can cause mouth cancer.  Swedish Match wanted FDA to remove this label requirement for General Snus.

WARNING:  Smokeless tobacco is addictive.  Of course it is.  Any product containing nicotine is addictive.  Nicotine ranks with 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 didn't ask for any change to this warning label for General Snus.

FDA Denial Contradicts its own Premarket Authorization of General Snus

Thanks to the Tobacco Control Act, all tobacco products sold in US stores after February 15, 2007 requires premarket review and an order from FDA
authorizing the marketing of the product.  This includes any change to product recipe, content, flavoring, nicotine level among other things.

On Nov 3rd 2015, after only a short 8-month review, FDA approved the sale of the eight General Snus products being sold in US stores.  The PreMarket Tobacco Application (PMTA) approval was 67 pages long.  Here's a link to the General Snus PMTA if you care to read all of it.

It is important to recognize that a PMTA differs from an MRTPA in that the first concludes the product is not more harmful than other comparable products already on the market; an MRPTA states that a product(s) is less harmful than existing products.

Regardless, it is directly relevant to FDA's denial of the General Snus MRTPA to understand why they approved the PMTA in the first place.  The following is from page 6 of the PMTA executive summary.  I've bolded certain items as very significant and injected in red where I feel a comment is necessary.

On March 11, 2015, Swedish Match North America (SMNA) submitted eight General brand snus premarket tobacco product applications (PMTAs)
to FDA seeking authorization under Section 910(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Scientific review of these eight applications demonstrates that these eight products have the following qualities:

Produced with a voluntary, proprietary standard using acceptable manufacturing processes as confirmed by both application review and on-site inspections.

The applicant’s heat treatment process distinguishes Swedish snus from other types of smokeless tobacco (ST), including snus-like products sold in the US market.  i.e steam pasteurization.

The proprietary quality standard for Swedish snus products was developed to ensure product quality. The principal components of this standard include constituent standards, manufacturing standards, manufacturing process requirements, and consumer package labeling with a “best before”
date.

The constituent standards set maximum levels that must not be exceeded for selected constituents in the finished products.

The proposed products contain significantly lower levels of NNN and NNK compared to over 97% the ST products currently on US market.
Since NNN and NNK are among the most carcinogenic constituents in tobacco products, reduction of NNN and NNK levels in ST products could reduce the cancer risk for consumers using ST products.

Assuming persons who would have used other US ST products use these product instead, an individual using these products with reduced
NNN levels could decrease the excess cancer risk by 90% compared to use of moist snuff (market share: 82%), 67% compared to use of chewing tobacco (market share: 15%), 38% compared to use of United States (US)-style snus, and 92% compared to use of dry snuff. Even further reductions in excess cancer risk could occur with the corresponding reductions in NNK; however, a quantitative contribution cannot be determined at this time due to the absence of a NNK cancer slope factor. NOTE:  on Apr 11 2016, six months after the PMTA was approved, Sweden issued new even tougher Food Product Regulations for Undesirable Substances (including NNK) in Swedish Snus.  Thus, the excess cancer risk will be even lower than percentages quoted above.

Levels of other harmful and potentially harmful constituents (HPHC)(including As, Cd, acetaldehyde, crotonaldehyde, formaldehyde, and
BaP) are similar to or lower than levels of ST products currently on the US market. Certain HPHCs (such as acrolein, acetaldehyde, cadmium, and nickel) have been identified as constituents of more toxic concern in the smoke of combusted products as compared to smokeless products.

When used as exclusively instead of other smokeless tobacco products or cigarettes on the US market, these products offer potential for reductions in oral cancer risk. NOTE:  Since 1971 when Swedish Snus became regulated as a food product, there are NO reported instances of oral cancer caused by Swedish Snus

When used as exclusively instead of combusted tobacco products, these products offer lower risk of developing respiratory diseases (i.e., chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis) and cancers (such as oral, esophageal, and lung) than smokers.  Since 1971, there are NO reported instances of cancers (oral, esophageal and lung).  Since snus is not burned when used, it of course wouldn't cause smoking-related diseases such as chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis.  Unless you sucked a huge number of snus pouches directly into your lungs, snus use has never been reported as a causal factor in lung cancer.

If nonusers were to initiate or users decrease cessation, there would be negative health consequences. Use of Swedish snus products is not risk-free and its use is associated with adverse health risks such adverse pregnancy outcomes, oral disease, increased risk of fatal cardiovascular events, pancreatic cancer, diabetes, and all-cause mortality.  VERY, VERY rarely associated beyond risk factors for nicotine or caffeine.  The risk of pancreatic cancer is half that of cigarettes which is already very small.  As to "all-cause mortality", I suppose if you dropped your snus can while driving and crashed into a tree trying to retrieve it would count...but it's more likely with a pack of cigarettes since a portion of snus lasts so much longer than a cigarette.

It is anticipated that the marketing of the proposed products, as described in the PMTAs, there is a low likelihood of nonuser uptake of these products, decreased or delayed cessation, or other significant shifts in user demographics. Information from national tobacco use studies and other studies submitted by the applicant indicate that migration of smokers to exclusive use of these proposed snus tobacco products while possible is expected to be limited. It is more likely that uptake of the proposed products occurs among current smokeless tobacco users.  NOTE:  this is more a supposition than fact.  It's largely based on overall lack of knowledge Americans have about Swedish snus.  Snus is not an American cultural norm like cigarettes and other smokeless tobacco products.  Lack of cigarette to snus conversion can also be caused by inaccurate warning labels General Snus cans are forced to display; hense the reason for the Modified Risk Tobacco Product Application by Swedish Match in the first place.

Given the above listed justifications based on information gathered from nonclinical and clinical product evaluations as well as substantial epidemiological studies, the totality of evidence provided in the applications support authorization of these products so that current ST product users will have additional options for less toxic tobacco products, thereby potentially decreasing the negative health impact from tobacco product use making the marketing of these proposed products appropriate for the protection of public health.

Lessons learned so far on General Snus from FDA

Cigarettes are the most dangerous form of tobacco product currently in use today.  Smokeless tobacco, either US smokeless or Swedish snus, contains less harm potential than cigarettes, if only by virtue of the fact toxic tobacco smoke is not inhaled into the lungs.

FDA states in the PMTA that General Snus reduces cancer risks over other smokeless tobacco products by up to a whopping 92%. Even users of Camel or other US made snus can lower their total cancer risk by 38% by switching to General Snus!!  FDA also recognizes Swedish Match's superior manufacturing and quality control processes versus other smokeless tobacco manufacturers.

General Snus contains significantly lower levels of NNN and NNK, the most carcinogenic substances in tobacco products, compared to 97% of all smokeless tobacco (I assume the other 3% wouldn't send FDA free samples to test?) and lit cigarettes contain significantly more NNN and NNK than any smokeless tobacco.

When compared to both cigarettes and other smokeless tobacco products, exclusive use of General Snus offers a lower risk (in practice, virtually none) to tobacco users.

FDA doesn't think smokers will switch to snus; the more likely target is current smokeless tobacco users.  This opinion ignores the 2.5MM ex-smokers who now use snus and the explosion (and subsequent destruction by FDA) of the vapor industry for nicotine-addicted smokers looking for less harmful alternatives. 

Meanwhile, nicotine gum in lots of tasty kid-friendly flavors are sitting openly on store shelves and the long-standing Black Box warning label FDA added to the drug Chantix indicating Chantix caused depression and suicide in patients using it to stop smoking who never exhibited such behavior before....vanished. 

Oh, depression and suicide are still listed as possible side effects on TV commercials but the Black Box label warning doctors of real risks was removed after a study by the manufacturer and aided by FDA was conducted.  Not only was the action very unusual but there are indication the study was tainted.  This is not a problem for FDA if Big Pharma is involved, apparently.

Why did the General Snus MRTP fail?

Why indeed?  According to those at Swedish Match putting together the General Snus MRTP, FDA seemed very cooperative and helpful.  FDA even gave them pointers on what items to include in the MRTPA.  Communication was open and (thought Swedish Match) very positive throughout the process....right up until the day they received the denial from FDA.

I read a redacted version of the FDA MRTP denial order on General Snus.  Even redacted, it's 115 pages long and plays every linguistic trick, twist of logic, contradiction, and declaring statements "fact" which were in fact, not fact at all. 

FDA dissected every single word of each Swedish Match request and used heroic of levels of semantics to justify a denial of two of the proposed warning label changes. Be aware that when FDA states "the population as a whole", they are talking about every single person in the United States regardless of whether they were tobacco users or not; whether they were new-born babies or peaple over 100 years of age.

WARNING:  This product can cause gum disease and tooth loss

After conducting a thorough assessment of the scientific substantiation for the claim that the eight General Snus products cannot cause gum disease or tooth loss, FDA determined that the claim is not substantiated. On the contrary, there is little biologically plausible reason to expect that outcomes related specifically to gum and teeth of users resulting from the use of the eight products would differ from those outcomes resulting from the use of other smokeless tobacco products.  Little biological plausiblity that the outcome would differ from other (already established by FDA to be far more dangerous than Swedish Snus) smokeless tobacco products?  Of course there would be a difference by the virtue of how General Snus manufacturing differs from all the other smokeless tobaccos in question, by the Swedish Food Agency's strict regulation of harmful substance levels allowed in Swedish snus, and all the other reasons the FDA PMTA of November 2015 clearly spelled out.

Indeed, given that these eight General snus products, like other smokeless tobacco products, cause delayed soft tissue wound healing, these products would not be expected to differ from other smokeless tobacco products with respect to these disease outcomes. Furthermore, the epidemiological evidence indicates that the use of these products, as actually used by consumers in Sweden and Norway, increases the risks of certain outcomes classified as gum disease or tooth loss, or precursors to gum disease and tooth loss.   Here we go yet again.  Did the epidemiological evidence take into account the difference in diet and lack of flouride in the water and most tooth pastes in Scandinavia?  The supposition, and it's no more than that, that General Snus allegedly causes delayed soft tissue wound healing means use of General Snus brings all the potential disease outcomes of EVERY other type of smokeless tobacco on the market in the US?  

FDA is saying that if ANY type of smokeless tobacco can cause tooth loss or gum disease, then the same MUST be true of General Snus.  Remember, this is the same General Snus touted as DECREASING the risk of cancer by up to 92% compared to other smokeless tobacco products!

Because the totality of the scientific evidence supports the statement that smokeless tobacco products in general and these products in particular "can cause gum disease and tooth loss," the proposed modified risk claim is not substantiated.   The totality of the scientific evidence does NOT support that General Snus IN PARTICULAR can cause gum disease and tooth loss.  Again, Swedish Match is being asked to prove a negative; that General Snus is incapable of ever, ever causing gum disease and tooth loss under any circumstances...including presumably if someone hit you in the mouth with a roll of snus hard enough to knock a tooth out.

Additionally, SMNA did not provide evidence regarding how the modified risk information (i.e., the removal of the gum disease and tooth loss warning) would impact consumer behavior or whether consumers would understand the modified risk information in the context of total health.  FDA is saying that Swedish Match can't prove the LACK of a warning label would change consumer behavior.  The lack of this warning label certainly didn't hurt sales of vapor and e-cigarettes...before FDA destroyed that market except for Big American Tobacco. We also DO know that an inaccurate warning label can change consumer behavior:  in this case they will continue using more dangerous tobacco products including cigarettes without giving General Snus a chance.  Why not, since the inaccurate can labels in effect state that snus will cause your gums to rot and teeth to fall out.

As a result, SMNA has not demonstrated that, as actually used by consumers, the products sold or distributed with the proposed modified risk information, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.  Accordingly, the request to omit the warning related to gum disease and tooth loss should be denied.  Since General Snus contains the inaccurate warning labels, how can Swedish Match demonstrate that by removing them, there WILL be a significant reduction in harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole if they are NOT allowed to remove them and measure the outcome?

IMPORTANT:  If FDA did approve any/all of the label changes for General Snus, they have the power to force Swedish Match to revert back to the old labels if upon review, FDA don't feel the amended labels worked in practice.  Instead, FDA is just assuming they won't which then leaves no opportunity to benefit tobacco users and the health of the population as a whole.

WARNING: This product can cause mouth cancer:

SMNA requests to omit from the label and advertising of the eight General Snus products "WARNING: This product can cause mouth cancer." This warning is currently required for smokeless tobacco products generally. Omission of this warning from a subset of smokeless tobacco products indicates that unlike other smokeless tobacco products, the eight General snus products cannot cause mouth cancer.  Here we go again.  FDA cannot prove that General Snus can cause mouth cancer.  That is just their hypothesis.  But because Swedish Match can not absolutely prove with 100% certainly despite the last 45+ years of data that General Snus WILL NEVER cause mouth cancer in anyone on the planet ever....well you can see what's coming.

Thus, the request is to market the products with an implied modified risk claim that the products, as compared to other smokeless tobacco products, cannot cause mouth cancer.  FDA continues to limit their focus on smokeless tobacco, now calling General Snus a "subset" of smokeless tobacco.  Their preconceived notion which is contradicted by the 1 million Swedish smokers who now snus exclusively that American cigarette smokers would never use General Snus to replace cigarettes is flawed.  With cigarette restrictions so tight in the US, why would a nicotine-addicted smoker be interested in a product which hides discreetly under the gum and involves no spitting?  BECAUSE General Snus, like FDA's beloved Big Pharma nicotine gum, is discreet, can be used anywhere, doesn't require a spit cup, and will satisfy their nicotine cravings.  The only difference is after a year, 92% of nicotine gum users returned to smoking.  

After conducting a thorough assessment of the scientific substantiation for the claim that the eight General Snus products cannot cause mouth cancer, FDA determined that the claim is not substantiated. Although the eight General snus products contain significantly lower levels of harmful carcinogens than other smokeless tobacco products currently in the U.S. market, the products contain nitrosamines, including nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) , which have been demonstrated to cause cancer, including cancers of the mouth. NNN, in particular, has been found to be a potent oral carcinogen, and since, according to the available toxicological evidence, there is no established threshold level for NNN carcinogenicity, the products pose an increased risk of mouth cancer compared to non-use.  Now FDA is stating because they don't know what a safe level of nitrosamines is in humans, then General Snus must be exceeding an unknown standard. How does Swedish Match prove General Snus meets or beats a standard FDA claims doesn't even exist?

Do you know what other products contain nitrosamines?  Eggplant, green peppers, French roast coffee, and any barbecued meat like hotdogs, hamburgers, and steak (just to name a few).  If FDA states there is currently NO safe threshold level for NNN and NNK, Why hasn't the FDA food department mandated big black cancer warning labels on these foods?  I'm afraid of Eggplant Parmesan giving me mouth cancer now.  I loved good Eggplant Parmesan.....  

In addition, although many of the epidemiological studies of Swedish snus may not have been statistically powered to detect moderate increases in oral cancer risk, the most recent published epidemiological study found a statistically significant increased risk (Roosaar et al., 2008). Accordingly, because the totality of the scientific evidence supports the statement that smokeless tobacco products in general and these products in particular "can cause mouth cancer," the proposed modified risk claim is not substantiated.  Of all the epidemiological studies FDA evaluated concerning the General Snus MRTPA, ONLY ONE, Roosaar et al., 2008, found a "statistically significant" increased risk.  Despite the questionable integrity of this single study (and the definition of "statistically significant"), FDA disregarded all the other reputable scientific studies and research in their possession as well as every Swedish study, opting for "if one study out of countless others raises a red flag, that translates to "the totality of the scientific evidence."

Additionally, SMNA did not provide evidence regarding how the modified risk information (i.e., the removal of the mouth cancer warning) would impact consumer behavior or whether consumers would understand the modified risk information in the context of total health.  Seriously?  While the current warning label would affect consumer behavior by scaring nicotine addicts away, how can Swedish Match prove a negative:  that the lack of a mouth cancer warning label would impact consumer behavior?  As to understanding the modified (Not "NO") risk in the context of total health, that is primarily the job of FDA to educate the public. 

As a result, in their present form, the applications do not contain sufficient evidence to demonstrate that, as actually used by consumers, the products sold or distributed with the proposed modified risk information, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. Accordingly, modified risk orders should not be issued for these products based on the proposed claim in its current form.  Again, FDA reiterates their ill-informed decision that "as actually used by consumers" excludes nicotine-addicted cigarette smokers.  Include smokers and second-hand smoke, General Snus would benefit the population as a whole.  Even if you limit the potential users to other smokeless tobacco products, FDA's own cancer numbers would signify significantly reduced harm and risk of tobacco-related disease to individual (smokeless) tobacco users.

However, the applications could be amended in several ways, for example by changing the proposed claims, supplementing the evidence, and conducting new studies, which could provide sufficient evidence to support issuance of modified risk orders relating to mouth cancer for these tobacco products.  Translation:  We know our argument is pretty weak here.  If Swedish Match wants to spend the enormous about of time and money to try again, it MAY be enough to change our minds in a couple of years.....or we could just say they didn't prove a negative again and have wasted everyone's time and money.

WARNING: This product is not a safe alternative to cigarettes

The rationale used by FDA for keeping this warning label instead of approving the Swedish Match alternative is particularly infuriating and indefensible.

SMNA requests to revise the currently required "WARNING: This product is not a safe alternative to cigarettes" on the label and advertising of the eight General Snus products, by replacing it with an express modified risk claim "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

Our review concluded that the claim that the eight General snus products present substantially lower risks to health may be substantiated, but only in part. That is, there is evidence to support that the eight General snus products, as actually used by consumers in Sweden and Norway, as compared to smoking cigarettes may substantially reduce the risks of some, but not all, tobacco-related diseases to individual tobacco users.

The scientific evidence is insufficient to support that substantial reductions would be observed across the full range of risks posed by tobacco products, as implied by a generalized statement about health risks as compared to smoking (i.e., "substantially lower risks than cigarettes"). The proposed new label doesn't state an absolute.  This is a Modified Risk application.  The new label states quite clearly that "No tobacco product is safe".  BUT General Snus presents substantially lower risks to health than cigarettes. 

In the broad sense, ANY smokeless tobacco product is potentially less harmful to smoking cigarettes but General Snus in particular has demonstrated and FDA even acknowledges that the "product has substantially lower risks to health than cigarettes."  Swedish Match does NOT state or imply that General Snus is "safe" or without risk. 

They is factually stating that the health risks are substantially lower compared to the health risks inherent in cigarettes.  A nicotine-addicted consumer would read this as General Snus is less harmful than cigarettes but still has a level of risk (of which FDA doesn't define). 

If "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes"  isn't a clear and accurate representation of a Modified Risk Tobacco Product, then what is?  How does this statement not fit the definition of what Congress had in mind when they wrote the MRTP classification into the Tobacco Act? 

FDA REALLY has to dance in denying this request...and does.

The evidence is also insufficient that U.S. consumers would use the products in the same manner as consumers in Sweden and Norway (e.g., frequency or
intensity of usage; exclusive snus use versus dual use with cigarettes); therefore, we cannot conclude that, as actually used by U.S. consumers, the products would substantially reduce the risks to smokers.  In the US Government and Anti-Cigarette group campaign material is the statement "every cigarette takes 5 minutes off a smoker's life"  If a smoker cuts his cigarette use only in half by using snus (most dual users cut down smoking by a much larger percentage), that's 5 minutes of life gained for every cigarette not smoked, how is that not substantially reducing the risks to smokers? 

How can FDA possibly know that given time, US consumers would indeed use the products in the same manner in Sweden and Norway....especially with the vapor market now virtually restricted to the inferior Big Tobacco e-cigarette monopoly?  Most importantly, how can Swedish Match possibly prove FDA's assumptions to be false unless their MRTPA had been approved?

In addition, FDA assessed the potential benefits and harms to the health of the population and concluded that the evidence is insufficient to determine that the products will benefit the population as a whole, taking into account, for example, smokers who switch completely to the General snus products, non-users who initiate use, and dual use by current tobacco users. What happened to the horror of Second Hand Smoke?  EVERY cigarette not smoked because of General Snus means less second hand smoke affecting the population as a whole.  That's just the most obvious reason; I could go on with many more as could current snus users in the US.  Against FDA's apparent pre-determined decision, it seems a futile effort.

Furthermore, the scientific evidence is not sufficient to conclude that the modified risk information would be comprehended by the public in the context of total health and in relation to all tobacco-related diseases, particularly in the context of a warning. As a result, in their present form, the applications do not contain sufficient evidence to demonstrate that, as actually used by consumers, the products sold or distributed with the proposed modified risk information, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.  What a low opinion FDA has of the intelligence of the average American!  How can one read "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes" and NOT understand it? 

They may have more questions but that's a good thing.  Since Swedish Snus is not a cultural norm in the US, education is the most important factor in ensuring that General Snus "as actually used by consumers" becomes a very visible and important method in lowering the risk of tobacco-related disease in both the nicotine-addicted users but the population as a whole.  Let's not forget the 2.5MM current US users of Swedish Snus either.

Accordingly, modified risk orders should not be issued for these products based on the proposed claim in its current form. However, the applications could be amended in several ways, for example by changing the proposed claims, supplementing the evidence, and conducting new studies, which could provide sufficient evidence to support issuance of modified risk orders relating to health risks compared to cigarettes for these tobacco products.

Again, FDA knows this is their weakest argument so far and is giving Swedish Match a chance to roll the dice again if they're willing to put up the time and money to make the bet.

Considering everything I've discussed about this particular warning label and how it clearly fits with the legislative definition of "modified risk", how is it possible to make this warning label any more appropriate, yet keep the modified risk message?  FDA has set a bar so high that if this label change wasn't approved, what change possibly could?

 Is the current FDA and their MRTP process just a sham by anti-all-tobacco extremists?

FDA's final decision on the SMNA General Snus MRTPA was a shock to Swedish Match, to me, and to the vast majority of reduced harm tobacco advocates who condemned it loudly and often.

Based on the ease in which the General Snus PMTA was approved and the positive language by FDA, it seemed under Mitch Zeller, the Center for Tobacco Products (CTP) had finally gotten their act together.

Swedish Match NA, prior to the decision, had nothing but nice things to say about what they considered a collaboration with FDA on getting the MRTPA on the right glide path to success.

Perhaps in hindsight, the Deeming Regulations on Vapor and e-cigarettes released prior to the MRTPA decision should have given everyone pause.

The question of why FDA issued such a negative and intellectually weak decision could be explained by a number of factors and/or a combination of factors.

The FDA employees who volunteered to work at CTP when it was formed didn't do so because they liked to smoke a good cigar at dinner.  They were by and large anti-all-tobacco, some to the point of being extremists.

This would certainly help explain why the bar for receiving MRTP status was set so impossibly high the chances of a positive decision were virtually impossible.

Since the Swedish Match application was the first to complete the process also may have worried them about the precedent they were setting.  The progressive political climate made marijuana legalization acceptable but the probable backlash from granting the General Snus MRTPA made them consider their personal interests and careers over those of the public health.

It may also be that the definition of "modified risk tobacco product" was never clearly defined by FDA to itself.  Obviously in this case, the changes they would allow to General Snus warning labels were not codified beforehand or communicated properly to Swedish Match.  Essentially, CTP had no idea what they were looking for, hoping to stumble upon it along this 2.5 year journey to nowhere.

I'm certain that if smokeless tobacco had originally been required to carry the cigarette warning "This product causes lung cancer" and Swedish Match had requested that label be removed from General Snus, FDA would have danced through hoops to justify denying that request too even though snus is not inhaled.

Or maybe FDA had already decided at the beginning no MRTP request would ever be approved and this was all for show.

Fortunately, we have a good indicator of what FDA's true stance is on MRTP.  Philip Morris International (PMI) is joining the "heat, not burn" cigarette product market with iQOS.   Unlike Reynolds with their Eclipse "heat, not burn" cigarette, PMI believes iQOS (which stands for 'I Quit Ordinary Smoking') to be so superior to conventional cigarettes that they submitted an MRTPA for it.

Rumored to be between 2-3 million pages long, PMI is attempting to justify a clearly more harmful alternative to Swedish snus, both to the user and public at large.

I'll be following the progress of the iQOS MRTP with interest.  If it is resolved quicker and/or with a positive decision by FDA, it is clear as with vapor, only Big Tobacco need apply.

I doubt Swedish Match will wait for the outcome of PMI's MRTPA in deciding whether or not to resubmit a modified General Snus MRTPA.  They have 45 days to signal their intentions to FDA and a 2 year period to resubmit.

At a minimum, I'm sure Swedish Match will want to discuss in detail with FDA where they feel General Snus application needs updating.  They will also ask FDA to clarify in no uncertain terms what FDA considers a modified risk tobacco product to be.

Based on those discussions, Swedish Match will go back to the drawing board and decide if the time, effort, and money in revising the General Snus MRTPA is worth it or whether they would just be throwing good money after bad with no plausible change in outcome.

In the meantime, untold thousands of nicotine-addicted smokers will sicken and die before their time unnecessarily.  As to the rest of the general public, they will be footing the bill through higher health insurance premiums to cover the healthcare costs of sickening smokers.

From what I've been able to piece together about iQOS, if FDA does give them MRTP status, the same will be true.  Reynolds was honest with Eclipse.  They never said it was less harmful that regular cigarettes; to the contrary, Eclipse smoke was higher in carbon monoxide than conventional cigarettes. 

What RJRT did say at the time was that Eclipse smelled like burning paper, not cigarettes, meaning you would not reek of cigarette smoke....it was more discreet. 

Not having discovered Swedish snus yet, that's why I switched from Camel Lights to Eclipse.  Sure, the taste was terrible but it delivered nicotine.  Once you learned to tolerate the taste, people would not realize you were a smoker unless they saw you in the act. 

I am eternally grateful that a year later in 2007, I first heard about snus and that a knowledgeable tobacco store owner overcame my distrust of smokeless tobacco with a can of General Original Portion Snus.  I haven't looked back since...but I wish FDA would. 

Real Swedish snus, especially products made to Swedish Match GothiaTek standards, will have a positive impact on the American public: nicotine-addicted and nicotine-free alike.

LARRY WATERSOfficial Seal of the Swedish Snus Ambassador to the United States

Swedish Snus Ambassador to the United States
Reporting for SnusCENTRAL.org

 

Read 3640 times Last modified on Saturday, 31 December 2016 11:50

2 comments

  • Comment Link Freedom Luvr Friday, 24 February 2017 21:24 posted by Freedom Luvr

    I agree with Dan as an American myself. It is sad that the government doesn't work for the people anymore and citizens have to use a big chunk of time for thinking of ways to avoid the government, eg taxes. And the FDA probably worried it would have to do a lot of explaining to the antitobacco zealots when it hit the news that they approved it.

    I do respect General for making this huge effort as an outsider to play by the rules down to the letter. But money and power rule this land now.

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  • Comment Link Dan Thursday, 26 January 2017 11:01 posted by Dan

    As an american, I am used to this... maybe in Sweden you guys have some legitimate and reputable departments left in your government... in the US they can all be bought... almost every department in the Federal government has made at least one decision based on corporate interest rather than what is best for the people they supposedly serve... the FDA has a storied history of helping industries rather than being truthful... in the 1950's milk became the "perfect food" because the people in the FDA either were paid to say it or owned dairy farms... all Americans with average intelligence or better know info/decisions from DC are likely tainted by $$$$$$$....

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This was a disappointment to me.

Bryon R. , Tuesday, October 27, 2015 Skruf Original Portion Snus is nothing to brag to mom about....

An awesome los snus

Justin S. , Tuesday, October 27, 2015 Röda Lacket Loose Snus is just awesome. In the loose ...

I love the smell of chocolate in the morning

Bryon R. , Tuesday, October 27, 2015 Ettan Original Portion snus absolutely billows a dark ...

It's like Ettan portion’s weird half-brother.

Bryon R. , Tuesday, October 27, 2015 This snus has a good quality tobacco and portion material ...

Smells EXACTLY as one would expect

Bryon R. , Tuesday, October 27, 2015 Probe Whisky loose snus smells of tobacco and whiskey. Its ...

Really good snus!

Chris M. , Saturday, August 22, 2015 General Snus is the only real snus I can buy in American ...

A staple snus for me

Larry Waters , Saturday, August 15, 2015 This XRANGE snus is essentially Göteborgs Rapé Large White...

This is a great snus!

Teri S. , Friday, August 14, 2015 Olde Ving Fudge portion had a very different snus flavor for...

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