The FDA Takes A Wrong Turn

International policy on vaping could be very important for smokers and vapers in Australia.  As our politicians struggle with the requirements of sorting through the evidence they are presented with, how governments in other countries deal with the issues could be very influential.  It can have positive influences as we have seen the UK embrace tobacco harm reduction and are already seeing the benefits with plummeting smoking rates, or negative effects as we are seeing in the US.  While their smoking rates dropped rapidly as the popularity of vaping escalated (2% total population drop in 2015), more recent events including the introduction of the deeming regulations and a robust FUD campaign have seen both the uptake of vaping and the decline in smoking rates start to level out.

What is next for the US then, and can the FDA's new commissioner Scott Gottlieb steer the FDA towards a reasonable approach to regulation and tobacco harm reduction (THR)?  Apparently, the answer 'No', and a complete 'U' turn heading back towards medicalisation of THR, that will essentially make it an NRT product.  On Wednesday this week, the FDA released the statement paper by Gottlieb, Woodcock and Zeller Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA’s comprehensive approach to tobacco and nicotine.

This is in line with the formation of the new Nicotine Steering Committee of which Gottlieb states "The primary focus of the new Committee will be on these therapeutic nicotine products for combustible tobacco product cessation."

What?

Six years ago the FDA tried to medicalise vaping and were told it's not a medical product, and now the United States is back there again?  Among other ideas that seem to be coming from this steering committee is the plan to remove all or almost all of the nicotine from tobacco cigarettes.

The document linked above states in part:

When it comes to the discussion around transitioning current smokers to safer alternatives for the delivery of nicotine, a lot of public debate, to date, has been placed on the potential for modified risk tobacco products like electronic nicotine delivery systems and
e-cigarettes. FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that can be sold as new drugs, typically as over-the-counter pharmaceuticals.

If there are new kinds of NRTs — with different characteristics or routes of delivery – that can offer additional opportunities for smokers to quit combustible tobacco, we want to explore what steps we can take using our own regulatory policies to enable these opportunities, while
making sure these products are demonstrated to be safe and effective for their intended use.

 So I see them not looking at vaping as a consumer product, but trying to get pharmaceutical companies to produced an "FDA approved" alternative delivery system (ie vaping by another name).  Once that is achieved, no doubt the idea would be leave the deeming regs in place to eliminate most of the vapour market.   It's what they attempted to do in 2011, but now using the deeming regs and seemingly hoping for some products from the pharmaceutical industry to finally do it.

It seems to me that no matter what the intentions of the commissioner of the FDA when they come into the position, they rather quickly become hamstrung by the bureaucracy, politics and industry pressures and their stance on THR becomes watered down and pharma based.  I think we all know that one reason for the success of vaping is the ability to enjoy a personalised and tailored experience to make something that is as or more enjoyable than smoking.  A medicalised version would work for some people, but not everybody or even most, and not at all for current vapers used to an infinite flavour choice and nicotine levels that are effective.  I have no faith that pharma would produce something that is enjoyable to use (and therefore effective): they are not in the business of making recreational products, that is what the consumer market is for.

It has been suggested that this is a rather paranoid viewpoint, but on the contrary, there is absolutely no reason to think that the FDA is going to modify the deeming regulations or remove the requirement for a PMTA.  They appear to have not done one single thing that would give stability to the vapour market in the US.  It's still effectively frozen at August 2016, but mostly operating illegally because of that, and that's a situation that will get worse.  By August 2018 which was the original date for the final compliance for manufacturers and importers, there will be very little hardware on the market that was
being sold prior to August 2016.  This is an industry that reinvents itself almost completely every two years.

If there was any real will left to affect change for the better, the FDA would have openly
admitted that vapour products do not fit in the tobacco products category because of the nature of the innovation and the consumers.  No matter what they say, the only actions that have been taken are to extend deadlines they do not have the means to enforce, and which would be an obvious over-reach in ethical harm reduction terms.  The deadline
that really needs to be extended out of necessity is the one that says no new products can be brought to market after August 2016, because it means that almost all of the retail market is operating illegally out of necessity.  The FDA seem to be burying their heads in the sand on this matter, rather than recognising and dealing with the problem they
created.  It doesn't look good for the future.
 
It's a complete mess, and they seem to be hoping that medicalisation by default is going to solve the problem for them.  It's not clear at this stage whether pharmaceutical companies are even interested in manufacturing vapour products or "new and improved products that can be sold as new drugs".  So far they have indicated that they are not at all interested in entering the vapour market.
 
The only thing that appears to be obvious in all of this is that Scott Gottlieb does not and never did have a free hand to direct policy.  The difference between what he said about THR at the beginning and what the FDA has actually done is very wide.  What he is saying now is also quite different.
 
What he said then:
"We need to redouble efforts to help more smokers become tobacco-free.  And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether."
 
What he says now:
"...novel forms of nicotine delivery are being developed based on new technologies and innovations. These may develop into FDA-approved therapies that help more smokers quit."
 
This is along with reduced nicotine cigarettes to "protect the children" while throwing existing smokers squarely under the bus.  Coercive measures are never going to work, and I have a feeling that if Scott Gottlieb is as smart as I think he is, he knows that too.  Smokers given the only option of cigarettes with very little nicotine in them are much more likely to do one of two things: smoke a lot more and kill themselves faster, or turn to black market sources for unadulterated tobacco products.
 
The FDA's policies on vaping seem to have been entirely taken over by the Steering Committee on Nicotine, and yes this steering committee comes first and foremost from a medicalisation perspective.  That has been stated quite clearly.  This is what the FDA is going to use to literally "steer" policy on THR, and it's not going to include vaping
 
Medicalisation won't work because the vapour industry is made up of many small businesses and importers. It will stifle all innovation and eliminate from the market the most useful products for smoking cessation.
 
Following the mess that is developing in the US would be the worst possible outcome for Australia.  Rather than look to the FDA as we have done in the past with platitudes like "It's FDA approved" or "The FDA says..." we should be using this as an example of exactly what NOT to do.

 

In Summary:

I realise the above is a little long winded and is a complex issue that many will not be familiar with.  The concern is that the FDA is struggling to find a suitable framework within which to regulate vaping.  Regulation is certain almost everywhere, but it needs to protect consumers while maximising the benefits of harm reduction as much as possible and that means light touch regulation that allows the sale of products that are appealing to a wide range of smokers and vapers.

The FDA is heading directly for an outright prohibition on retail by means of requiring extensive paperwork and approval for sale (a PMTA) which most manufacturers and importers will be unable to to do, or for a medicalisation route which is even more difficult and expensive for vape shops and manufacturers.  Either way will be a complete disaster.  In addition classification as a tobacco product (the deeming rule) means that many states are applying, or trying to apply, tobacco excise taxes to vape products which is resulting in the failure of vape retailers in those states.

Australia should not be looking to the US for guidance or as an example in this matter.