When I was 22, I watched my grandpa wheeled out of his home in a body bag. Aged 53, I sat in the dark with my mom as she breathed her last breath. My family tree is filled with people who died too soon from cancer, heart disease and other ailments linked to combustible tobacco use. All of them smoked, and all were unable or unwilling to quit.
So, like millions of others in the United States, I have a deeply personal stake in legislation around smoking.
It was 15 years ago, on June 22, 2009, that President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (TCA) into law. “More than 400,000 Americans now die of tobacco-related illnesses each year,” said the president, no stranger to cigarettes himself, as he signed it. But this law would “save American lives and make Americans healthier.”
Families like mine are painfully aware of how this promise is yet to be realized. On April 11, 2024, during a House Committee on Oversight and Accountability hearing, US Food and Drug Administration Commissioner Dr. Robert Califf pointed out that 460,000 of us die annually from smoking-related diseases.
What could have gone so wrong?
The TCA established the Center for Tobacco Products (CTP) as the newest branch of the US Food and Drug Administration (FDA), granting the FDA regulatory authority over tobacco products. “Tobacco products,” in TCA and FDA parlance, include those that contain nicotine but no tobacco. It is the CTP’s job to determine which are “appropriate for the protection of public health.”
When I think of my lost loved ones who couldn’t quit smoking, my grief is heightened by the knowledge that we now have a range of options that might have spared them, if only they’d existed at the time.
These include vapes, which provide people with the nicotine they want or need, but with far less harm than cigarettes. Millions of people worldwide have switched, likely extending their lives, and evidence indicates that vapes are more effective smoking cessation tools than nicotine replacement therapies (NRT), like patches or gum.
I quit smoking with vapes; it was the only way I could quit. The same goes for my son. We’ve benefited from an option that past generations of my family didn’t have. So I watched the April 11 hearing closely.
Califf spoke at length about youth experiencing nicotine dependence, which he defined as a “brutal, fierce addiction which is almost impossible to shake.”
I could relate to Dr. Califf when he told lawmakers how, as a cardiologist, he “saw many, many people die from the ravages of tobacco.” But after that, he didn’t talk much about the adults who will die from smoking.
He had much more to say about youth vaping. He spoke at length about youth experiencing nicotine dependence, which he defined as a “brutal, fierce addiction which is almost impossible to shake.”
That’s a frightening but subjective assessment. What is objectively true is that nicotine does not, in itself, cause the diseases that kill millions of people who smoke.
The TCA was discussed several times during the committee’s questioning of Califf. The TCA states that new products must “benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.” But nowhere does it mention that one group should take priority over the other.
Califf stated that new vaping products must demonstrate that their benefits for people who smoke outweigh the risk of youth becoming dependent on nicotine. But he offered no details on how such a calculation should be made, or how non-lethal dependency could ever be deemed to outweigh the prevention of deaths.
As I listened to the hearing, Califf referred to the fact that the CTP is under pressure from watchdog and pediatric groups to address youth vaping. There is political pressure, too. On the same day as the hearing, Senator Dick Durbin (D-IL) held a meeting with CTP Director Dr. Brian King and other officials about enforcement around unauthorized vaping products.
Where is the equivalent pressure to reduce smoking? While Califf could cite the number of premarket tobacco product applications (PMTA) his agency has denied for products far less harmful than the cigarettes they can replace, he could not provide any information about the large number of combustible products that have been authorized, under a different FDA pathway, on his watch.
I was left with the impression that the FDA’s efforts to determine what is appropriate for the protection of public health are egregiously unbalanced.
Of course, that’s an impression I held already. The FDA, to date, has authorized just a handful of vaping products—none of them in the flavors most adults prefer. And the agency has never loudly and wholeheartedly endorsed vaping as a smoking cessation strategy.
Our system is broken when it is faster, easier and cheaper to get lethal combustible cigarettes to market than it is for massively less harmful alternatives. Whose fault is this?
FDA officials say their hands are tied as they implement the TCA. But the TCA doesn’t force them to focus messaging on grossly exaggerated risks to youth who vape.
FDA officials—whether Califf, or Dr. King, speaking for example at the E-Cigarette Summit in May—like to parry criticisms by saying their hands are tied as they follow the science and implement the TCA.
The TCA tells the FDA to balance the risks and benefits to nicotine users and non-users, a sensible principle. It was passed before the significance of vapes and other harm reduction options, and their evidential support, had become so widely known. Its specifics are clearly flawed if they permit our current situation.
But the TCA doesn’t force the FDA to focus its messaging on grossly exaggerated risks to youth who might vape. The TCA didn’t make the CTP overrule its own scientists’ recommendation to authorize menthol vapes. The TCA didn’t require the agency to send manufacturers of flavored vapes on a “wild goose chase”—pulling “regulatory switcheroos” in order to deny, without even reading them, PMTA applications for millions of products that might have made a lifesaving difference to someone who smokes.
The FDA should change its message, rethink its PMTA process and learn from how other countries, like the United Kingdom and New Zealand, have allowed vapes to replace deadly cigarettes in millions of people’s lives.
In its failure to do this—and in the words of its leaders—it is evident that the FDA is not hearing the voices of adults who smoke or used to smoke. It needs to do its job, and quickly, to save millions of lives. But politicians, public health groups and media continue to push the agency in the wrong direction.
On June 12, days before the TCA anniversary, the FDA was called to another hearing—this time ordered by the Senate Judiciary Committee, led by Durbin, who has been on an anti-vape campaign for years.
The hearing was titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” While the FDA has abandoned the term “epidemic” amid falling youth use, Durbin sticks with it as a means of maintaining moral panic.
We must give all impacted people an equal voice in the process—including the people who are going to die from smoking if we don’t find better ways to help them.
Those invited to testify included King, a representative from the Department of Justice, public health advocates who want to see vaping products banned, trade group representatives, and a 17-year-old who said she vaped and became addicted.
Once again, the adults who used these products to stop smoking were silenced. None were invited to testify.
We are in the midst of a contentious battle, ostensibly forced to choose between preventing youth vaping and saving the lives of adults who smoke. If we step away from a polarized debate and start working together, there’s no reason we can’t do both. But first, we must give all impacted people an equal voice in the process—including the people who are going to die from smoking if we don’t find better ways to help them.
So far, the FDA is failing them. Only if its focus becomes balanced, in proportion to risks and benefits, will the US move as fast as possible to a point where we no longer have to witness our loved ones’ suffering and death from smoking.
I don’t want people to have to do what I do. Most of my family members have already died from smoking. The only way I can spend time with them is to visit their tombstones.
Photograph (cropped) by Santeri Viinamäki via Wikimedia Commons/Creative Commons 4.0
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