It's Spring at the CTP

And they turned the clock forward!

May 14, 2026

Spring is here! The season of renewal, change, and forward motion.

The last week and a half has been a busy one for the FDA’s Center for Tobacco Products. They are in moving forward mode.

Marty Makary, the head of the FDA, left the agency this week.

Last week, several CTP staff attended the Food & Drug Law Institute’s Annual Conference and the Nicotine Summit. Two weeks before that, they were at ATNF. I appreciate them attending conferences.

It has been a wonderful opportunity to meet many of them, tell them my story, and hear theirs. I got a little emotional during one of the sessions and impulsively walked up to the acting director of the CTP and gave him a hug!!! We should all share our stories more; I think we’d discover we have much more in common than we thought.

Three major announcements came out of the CTP offices last week: the authorization of the first fruit-flavored vapes (see reactions to that announcement here), new steps for product review (I haven’t dived into that one yet), and guidance on enforcement (which I’ll talk about below).

(Please forgive me, I’m going on a rant.)

What’s Good For The Goose…

There is a reason we say what’s good for the goose is good for the gander. It is a basic test of fairness.

If the Campaign for Tobacco-Free Kids and state Attorneys General want the FDA to enforce the Tobacco Control Act, they should consider the entire law, not just the part that supports enforcement against companies. The same statute that requires authorization before marketing also requires the FDA to act on PMTAs within 180 days. That part of the law is being ignored by the same folks who are outraged about enforcement.

This double standard is on full display after the US Food and Drug Administration (FDA) announced its new enforcement guidance. The agency is simply prioritizing its limited resources, focusing on bad actors while allowing products under active scientific review to remain in the pipeline. Within days, critics called the policy “a gift to Big Tobacco” and a “free pass”.

But acting as if enforcement discretion is a sudden, dangerous retreat is revisionist history. The FDA has relied on compliance periods, court-ordered timelines, and case-by-case discretion to manage the marketplace ever since the 2016 Deeming Rule. Regulatory prioritization isn’t a new scandal; it is standard operating procedure.

The deeper problem is the one-sided nature of the outrage. The Tobacco Control Act doesn’t just bind companies; it binds the FDA. The statute explicitly requires the agency to decide these applications within 180 days. Instead, law-abiding businesses of all sizes have been left waiting in regulatory limbo for more than five years.

The FDA has rightly acted against vapor products packaged like juice boxes, candy, cereal, toys, prescription bottles, phones, and gaming devices. Those serious cases should not be treated as representative of the millions of applications submitted to the agency. They are examples of irresponsible marketing, not the norm.

Given the FDA’s history, it is hard to imagine that a product using those tactics would pass even the initial acceptance-and-filing stages of PMTA review. And if one did, the May 8 guidance still preserves the FDA’s ability to prioritize enforcement against youth-appealing products.

When the FDA stalls, it doesn’t hurt everyone equally. Large legacy tobacco companies can survive years of bureaucratic limbo. They have endless revenue streams, massive legal teams, and diversified portfolios built to outlast any regulatory logjam.

Independent small businesses and their employees don’t have that luxury. For them, a five-year delay isn’t just an administrative footnote; it is a slow-motion execution. How is a local shop or a small manufacturer supposed to put its entire future, its payroll, and its investments on hold for half a decade while waiting for a government agency to do its job?

Even the day before the enforcement guidance announcement, the FDA acknowledged that efficient PMTA review can help make products that meet public health standards available to adults seeking to reduce their risk of premature death and chronic disease from smoking. But sometimes, it feels like certain groups prefer that no reduced-risk products make it through the very regulatory pathway those groups lobbied for.

The deepest irony of this entire debate is that the most dangerous nicotine product on earth, combustible cigarettes, remains available in practically every grocery store, gas station, and corner store. Yet, the very system meant to protect public health is keeping lower-risk, non-combustible alternatives locked in a state of permanent uncertainty. By continuing to ignore the FDA’s missed deadlines, critics aren’t hurting Big Tobacco. They are handing them a massive market advantage on a silver platter by crushing their independent competitors.

Behind every application are actual people. The millions of Americans who still smoke cigarettes are not pawns in a regulatory chess match. They are our parents, grandparents, coworkers, and neighbors. Many of them have tried to quit smoking more times than they can count. A system that keeps toxic cigarettes widely available while starving adults of less harmful alternatives isn’t protecting public health. It is a moral failure.

Protecting kids doesn’t require destroying adults’ options. We can and should aggressively target bad actors who market vapes as toys, candy, or games. We can stop counterfeit imports at the border. But using the FDA’s own bureaucratic backlog as an excuse to clear the market of products risks surrendering the market to chaos.

If public health advocates continue to cherry-pick the law to destroy the only pathway to science-based regulation, we cannot pretend to be shocked by the results. The ultimate irony is that the loudest critics of “Big Tobacco” are creating a reality where cigarette sales stay high, and life spans stay short. If we break the system meant to guide people toward safer alternatives, the only things left standing will be the combustible cigarettes on the shelves and the families grieving the people they lost to them.

As David Sweanor pointed out in his commentary, some health groups have fought the very things that can help people stop smoking, including nicotine replacement therapies, since they were invented. While I’m sure their intent is not to keep people smoking, I have to forcefully fight the intruding thoughts that that is exactly what they are up to. I have met many of them, and they are good people. They are not evil.

But it is really hard to sit here day after day, thinking of all the people who are going to die from smoking that day, and knowing that people with good, but misguided, intentions are contributing to those deaths.

Geese be damned, there is nothing fair about any of this.

Until next time….

Notes:

• 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. Thank you to those who have offered to fund this project and compensate me for my time and effort. This is my gift to those interested in nicotine. Community service is important to me. Volunteering is something I have done since I was a child.