FDA has NOT killed the General Snus reduced harm application

To paraphrase Mark Twain, the reports of the death of the General Snus Reduced Harm Tobacco Product (MRTP) application have been greatly exaggerated.

Friday afternoon, the anti-all-tobacco crowd and media immediately began reporting that the FDA Tobacco Products Scientific Advisory Committee (TPSAC) had “turned down” the General Snus application; that “approval was denied”, that the MRTP application had been “voted down” and in the case of Matthew Myers of Tobacco Free Kids, the Swedish Match application was “poorly written” and “full of holes”.

As more information about the TPSAC deliberations began to trickle out, a different picture began emerging…..

FDA cleans house at TPSAC

Last month, in response to a District Court ruling in Washington DC, four members of TPSAC either resigned or were terminated for not meeting in particular the new conflict of interest rules for TPSAC members.

These TPSAC members were all anti-all-tobacco. Nothing makes this clearer than the statement issued by extremist Myers for Tobacco Free Kids which begins

“It is deeply troubling that the FDA today removed several extraordinarily qualified members of its Tobacco Products Scientific Advisory Committee (TPSAC) based on a misguided and overreaching court ruling that is under appeal. The FDA’s action demonstrates that the court decision and FDA’s overly cautious

interpretation of that decision will deprive the agency of advice from many of the nation’s foremost and most credible scientific experts and undermine the FDA’s ability to do its job. It is essential that the FDA both aggressively pursue its appeal of the court decision in question and, in the interim, apply that ruling in a way that does not impair its tobacco advisory committee.”

This statement by such an anti-tobacco extremist group as Committee for Tobacco Free Kids against FDA for eliminating the 4 TPSAC members with conflicts of interest underscores just how appropriate the Court’s and FDA’s response were.

Read FDA Tobacc Czar Mitch Zeller’s official statement on TPSAC decision and then (if you have a strong stomach) compare it to the rest of the Tobacco Free Kids statement in this obviously unbiased article; FDA further damages its credibilty by throwing highly qualified and respected scientists off TPSAC. (yes, they misspelled “credibility” )

The original news reports of TPSAC’s recommendation on 10 May made it sound like a unanimous slam dunk death blow against Swedish Match and the General Snus MRTP application.

The reality is that of the 8 TPSAC members, 3 voted for, 3 voted against, and 2 abstained.

The reality is that while FDA usually accepts the recommendations of its advisory boards, they are not obligated to, especially in a split decision like this one.

The reality is that past statements by Zeller on the levels of harm individual tobacco products cause and his swift action to remove the 4 offending TPSAC members before the Swedish Match decision are cause for optimism the truth could win out over ideology.

What comes next for General Snus?

Will General Snus gain MRTP status? In my opinion this is still the best opportunity for the public health to win out. What I do know is that if the 123K+ page General Snus application and testimony isn’t enough to win MRTP approval, then no other snus stands a chance.

When will FDA make their final decision on the General Snus MRTP application? By statute they have one year from the filing date to respond.

Since Swedish Match filed in June of 2014, you would think we would know the fate of the General Snus warning labels within the next two months.

In yet another twist, FDA has stated that since they did not begin processing Swedish Match’s application until August 2014, they technically have until this August to rule.

Either way, we will know soon enough. Either way, current snus users will not be impacted.

If FDA does grant General Snus sold over the counter in the USA MRTP status, the winners will be current smokers who don’t know about snus. They won’t be faced with the same cancer and mouth disease warning labels cigarettes and other tobacco products carry.

They won’t have to wonder “why should I switch from cigarettes to General Snus if I’m still going to get cancer?”.

Then they can take the next step to significantly improving their health, the health of those around them, and satisfying their nicotine addiction through the discreet wonder which is Swedish snus.

LARRY WATERS