When you spend a career in a particular industry, it can become difficult to separate the personal from the professional. Seismic changes don’t just impact policy structures and business models, they change the lives of real people, many of whom you hold in high regard. Even when downsizing is essential to the continued existence of an enterprise, these decisions come at a very human cost.
That is certainly the case with the significant changes announced this week at the Center for Tobacco Products (CTP). So today, I want to use this space to share both how I am thinking about what this means for the future of tobacco and nicotine policy in the United States, as well as how I am feeling about it as an individual who has spent much of my adult life in this space.
The only place to start is on a personal note. There is no question that the CTP has been dealt a significant blow and that a number of talented and dedicated government servants have lost their jobs. That is a hard process to go through, and my sincere hope is that they all find their professional footing quickly and find ways to continue advancing public health.
My next thought is this - so now what? Is CTP done? Should we “unregulate” the category? As someone who directly participated in the legislative process that led to the CTP’s creation, I have always believed in the core opportunity that it presents – to stop the death and disease caused by cigarette smoking. Even when it has most frustrated or disappointed me, I have been hopeful that FDA regulation serves as a force for good, helping lead our country toward a future in which cigarettes are obsolete and the nation is healthier for it. I retain that hope today, and while the path forward will be challenging, it is time to redouble efforts to make that opportunity a reality.
The CTP’s mission is as relevant as ever. Despite all the progress, far too many Americans still smoke and too many still start smoking cigarettes each year. That was always an unacceptable reality. It is all the more so given the fact that we now have more and better alternatives than ever to switch adults who smoke away from combustible cigarettes. We simply cannot go on losing nearly half a million Americans every year to premature death caused by smoking.
The CTP cannot sink into paralysis. Whether or not you agree, it has to do what is being asked of departments across the federal government and beyond in this era of efficiency in which we now live: do more with less.
That may feel like hollow words while the news of staff cuts is fresh. But I believe that the incoming leadership can actually fulfill the mandate, and I would urge them to think about three core strategic pillars for doing so:
First, regulate. It sounds simple, but far too often in prior years, and with all due respect, CTP has taken its eye off this ball. The essence of the Tobacco Control Act (TCA) is to regulate tobacco and nicotine products. As SCOTUS reminded us this week, the mandate is clear and unambiguous. More than fifteen years after the enactment of the TCA and nearly ten years after the Deeming Rule, the unassailable facts show that the current market is largely unregulated. Whether or not we agree with how the PMTA process has been executed (which I do not), there is no excuse for companies that flaunt the law, fail to register, fail to comply with basic regulatory requirements, and have the audacity to crow about business models designed to evade regulation. Regulating the vapor market and getting it under control, much as it did to address “bad actors” in the tobacco space, should be, without question, the top priority for CTP.
Second, prioritize. The marketplace is crying out for clarity and order. Provide it. Clear the backlog of applications for novel products and enforce the law. The good news is that both smoking overall and youth use of tobacco products are at all-time lows. Other initiatives, whether or not those you regulate agree, are still part of your mandate. Come back to them soon. But in the meantime, ruthlessly prioritize regulating the market.
Third, embrace the challenge. It is a truism in life that adversity creates opportunity. The CTP is diminished in size, but that does not translate to being diminished in stature or potential. History is full of examples of organizations of all types - from government offices, to businesses, to military units - that had their finest hours after being cut off from resources they thought they needed. The people who remain at CTP, and hopefully those who will join in the coming weeks and months, are talented, dedicated civil servants and they should feel inspired by the chance they have to leave their mark. If they can rally together and put a laser focus on the goal of making cigarettes obsolete, they can make progress toward it - perhaps even faster than they were able to when they were a larger group.
I don’t want to suggest that any of this is easy, nor am I expressing an opinion as to how these decisions have been made or executed. Rather, the decisions are a fact and there is no choice but to move on. In fact, I return to my first point - how we are feeling. No less a public health champion than Dean Ken Warner gave a talk some years ago where he remarked about how to “think,” not “feel,” about nicotine products. He acknowledged that a lot of what was going on, particularly as it related to vaping, was based on decades of distrust and anger. But, to paraphrase his remarks, the facts support the opportunity presented by vaping products, and appropriate solutions to manage potential risks can be found. While this week’s feelings are undoubtedly deep and raw, this is a time to “think.”
The CTP holds within its grasp all of the authority, capability, and incentive to fulfill the mission for which it was created. I say this as someone who was present at that creation and has been working closely with that office ever since. This is, undoubtedly, the CTP’s most challenging chapter, but I remain as hopeful as ever that it can step up, refocus itself on what matters most, and lead the way toward a healthier America free of cigarettes forever.
Joe, well stated. I could not agree with you more. Out of chaos let's hope sanity for a way forward from Dr. Makary who now must now decide how he wishes to pick up the pieces and lead FDA and CTP. The opportunity to accelerate the demise of combustible tobacco products and the associated harms needs to remain a priority.
These are painful and fraught times, and I feel like I understand things a bit better after reading this post.
And for those who want to read more about what @UMICHSPH's Ken Warner had to say about thinking and feeling, he had turned his @SRNT #SRNT 2017 plenary address in to an article in the society's journal, Nicotine & Tobacco Research.
https://doi.org/10.1093/ntr/nty084