I was at the FDLI fall tobacco conference a couple of years ago when I met a gentleman from the FDA’s Center for Tobacco Products (CTP). He looked shocked when I told him, “you couldn’t pay me enough to work at the FDA.”
I went on to explain that no matter what they do, they will be assaulted with the outrage of people who think the FDA did the wrong thing. By “FDA,” I meant the CTP. They are under constant pressure to “do their job” from people who disagree about what that job entails. There is no “good enough.” And when they “do their job,” there are accusations by the people who don’t agree with their decisions that they’ve failed to “do their job.” (Yes, there have been times that I, too, was critical. Saint, I’m not.)
Since then, after meeting several more people from the FDA’s CTP, I found myself repeating to them what I said on that first encounter.
The pressure from organizations, industry, politicians, the media, and the public is constant. And so is the criticism. No thank-you! I am not thick-skinned enough to have a job where I would often be exposed to that kind of treatment. If you have a wish to be hated, I highly recommend you apply for a job at CTP.
I find the actions of organizations and individuals interesting, and it's been a learning experience to see what they’ve supported or opposed. It becomes even more interesting when people support an action only to oppose its results once it is taken. It goes to show how what we envision or expect can turn out very differently from the final result.
My use of nicotine (smoking) began in 1969. Discovering vaping and seeing both my family and myself stop smoking led me to advocacy in 2014. My main observation about this space is that there are multiple “sides” to this issue, and each side is filled with passionate, caring, knowledgeable individuals who strongly believe in their cause.
What is heartbreaking about this space is the millions of people who continue to die from smoking, how divided people in this space are—and how mean some of them are to others. It left me wondering: how did we end up with so many people trying to do a good thing, only to end up hating each other?
How did we get to where we are in the nicotine space?
I figured the answer was simple: the springboard would be the “Tobacco Control Act” (TCA). I intended to write a short 600 to 1000-word essay about it. And then I learned it was a long journey to get to the TCA and to get it passed. So, I got rid of the essay idea and went with a narrative timeline about what led to the TCA and how it was passed by Congress and signed by the President.
But as I began peeling back the layers of the TCA, I realized I couldn't look at the legislation in a vacuum. There was so much information on litigation that I decided it deserved its own timeline, which led to the bright idea of using two timelines instead of one. However, once my brain lit up on the investigative trail, it needed to know when our government began dealing with tobacco-related issues. Who had regulatory authority before the FDA?
That’s when it struck me that I would need a third timeline, one that went back in history. I knew that at one time, nicotine could be used as a pesticide, so I figured that any federal involvement with tobacco would go back to that time. I was so confident that that would be where the trail would begin that I decided to name the first timeline “Pesticide to NRT: A Regulatory History of Nicotine.”
I. Was. Wrong.
I’m going to leave that first timeline named as I originally intended. A little reminder to myself that one must never assume. A good lesson in this space. I shouldn’t assume I know the whole story any more than I should assume I know someone’s intentions.
I hated history in school, and the only time it became interesting to me was when I traced my family tree. That was my first project after my husband bought us our first computer. Once again, I find myself fascinated by history and our government’s involvement with, control of, and regulation of tobacco and nicotine.
While the first series is based on a narrative timeline, that timeline is the road our journey will follow. We will make several pit stops along the way to explore the stories of the people affected by that period of history. I’m hopeful that will bring the history to life for all of us.
The timeline for Part One of the first series kept growing. It kept going back farther in time as I explored the many ways tobacco has been on the radar of the U.S. Government. A few days of research quickly made it clear that the Part One timeline was too long and too confusing for a single blog post.
Chronological order was a mistake. It worked better to divide it into categories. Much easier to follow the story one topic at a time. My curiosity kept fertilizing that timeline, and I decided not to post Part One as a single post, but to divide it into chapters. I settled on five, then it grew to seven, and then I realized there is a whole topic I haven’t explored yet, so the current potential chapter count is eight!!
Then it hit me that the three parts of the first series can’t tell the whole story or help me answer how we got to where we are today. It means I will most likely have to add a fourth part to the first series and look at what has happened since the passage of the TCA. I have no idea why that wasn’t more obvious to me from the beginning!
Currently, my plan is to have the two series look like this:
Series #1: The Journey to FDA Regulation of “Tobacco Products”
Part One: From Pesticide to NRT: A Regulatory History of Nicotine
Chapter One: Tobacco & Nicotine History That Contributes to the Regulatory Landscape
Chapter Two: Federal Tobacco Taxation: Revenue, Regulation, and Public Health
Chapter Three: Indigenous Peoples, Tobacco, and Federal Authority
Chapter Four: From Tobacco Water to Nicotine Pesticide: Discovery, Commercialization & Federal Regulation
Chapter Five: Beyond FDA: Federal Tobacco Policy & Regulation Across the Federal Government
Chapter Six: Federal Tobacco Enforcement: Agencies, Authorities, and Enforcement Mechanisms
Chapter Seven: When Does Tobacco Become a Drug? Federal Drug Law and the Therapeutic Claims Boundary
Chapter Eight: Nicotine Becomes Medicine: The Development and Regulation of NRT
Part Two: Litigation: Foundations of FDA Tobacco Jurisdiction, 1974–2011
Part Three: History of the Family Smoking Prevention and Tobacco Control Act
Part Four: After the TCA (title to be determined)
Deeming Rule
Poor Man’s PMTA (Premarket Tobacco Product Application)
Tobacco 21
Other topics to be determined as project progresses
Series #2: Responses to FDA Tobacco Regulatory Actions
Organization and Individual Response Collection
Litigation
Policy, Rules, Guidance, and Oversight
Marketing Orders - PMTA & MRTP
Product and Action Specific Response Collections
None of this is written in stone, and all of it is subject to change. I won’t know the final result until I’m done. It is impossible for me to cover the full history of these topics; there are just too many things to include, so I am picking and choosing the ones that stand out to me.
So, before we can figure out how we got to where we are today and look at our current situation, we need to go back in time. I look forward to going on that journey with you.
As I complete sections of this project, I will update the Project Index with the links.
Until next time…
Notes:
This project is extensive. I am using ChatGPT, Gemini, and Perplexity to help me summarize the bills, articles, studies, and videos used to create the project’s entries. Several government websites and the tobacco industry document archives from UCSF have been very helpful as I investigated the historical content I’m sharing with my readers. Finding articles in newspaper archives was an additional and delightful way to learn the story behind the regulation.
I create these newsletters as a personal project. They are not affiliated with any current or past employers or groups with which I volunteer. I receive no financial compensation for my efforts to create these newsletters. I use AI to help with spelling, punctuation, grammar, and editing some of my work.