Gregory Conley

Donald Trump has been President for 40 minutes and he has not yet saved Flavored Vaping.

NEW from me and @jdawsey1 - Inside the downfall of FDA Commissioner Marty Makary gift link below

last smoker or drinker in the white house...going on ten straight years of teetotalers...

"It is perhaps not surprising that he resisted delivering on Trump's promise. But it is still hard to understand his reaction to the Glas approvals, which involved products designed to prevent underage use."

With FDA's Marty Makary resigning as FDA Commissioner, I wanted to share a few thoughts that I wrote about last night for AgencyIQ. 👇 - Acting Commissioner Kyle Diamantas is likely to remain in the position for quite a while. The logistics of getting a new commissioner confirmed prior to the midterms is daunting, and that's before you consider Senate politics. I can't imagine Bill Cassidy or Josh Hawley making the confirmation process easy for the next commissioner. - I suspect other officials in an acting capacity, like CBER's Katherine Szarama and CDER's Tracy Beth Hoeg, are likewise going to stick around in their current positions until a new commissioner is named (unless HHS's Chris Klomp steps in, that is). - I suspect most of the reforms that Makary enacted are likely to stick around, though they will probably be tightened up. There were lots of policies that were great in principle and deeply imperfect in execution and follow-through. - The big thing to watch is what happens to areas where Makary was leading reforms, but those reforms hadn't yet been announced. Nonprescription drug reforms are a good example: Makary wanted practically everything to be OTC. What happens to that? What about a rule to effectively ban DTC drug advertising? - What kind of leader is Diamantas? He's been a very effective foods leader (by which I mean focused, on-message, meets with stakeholders, etc). But the move from foods to leadership means he's going to need to handle some tough issues, including an upcoming decision by SCOTUS on mifepristone. He's already a Senior Counselor at HHS, meaning he might need to take a step back from his food portfolio in the coming months and lean more on other senior foods leaders. - The job of most acting commissioners is simple: Don't make bad headlines, don't rock the boat, and don't piss off stakeholders. That's going to be quite difficult for Diamantas due to the sheer number of issues facing the agency right now. He isn't exactly inheriting a stable agency with lots of experienced, tenured senior leaders. I suspect he's going to lean a lot on HHS Chief Counsel Chris Klomp for assistance and guidance in the coming months, which could include figuring out where he needs to clean house of some ineffective hires by Makary. - Who will be the next FDA commissioner? With the exception of Scott Gottlieb, Trump has a streak of hiring nonconventional commissioners. Both Stephen Hahn and Makary weren't active in FDA policy circles before they were selected. The question becomes whether Trump decides that was a mistake. It seems like the MAHA wing of Trump's coalition is losing political power, so perhaps we'll see a selection that is more conventional. Because Diamantas is a lawyer and not a medical doctor, I don't think he would have an easy path to Senate confirmation. - What are the narratives about why Makary left, and what takes hold? At present, there are a lot of stakeholder groups trying to argue that Makary was forced out due to mifepristone/tobacco/rare diseases/pharma/etc. While those arguments tend to do well on X, my best explanation is that Makary just wasn't a good executive in the managerial sense. (1) He didn't come to the job with management experience and wasn't a great manager of people or processes. (2) He frequently got in trouble with senior HHS and White House officials for things that should never have been problems in the first place; (3) His choice of senior executives in his orbit resulted in unrelenting bad headlines and he burned a lot of goodwill and political capital defending them; (4) his management of stakeholder relationships both inside of and outside of the FDA was not particularly good for the bulk of his tenure; and (5) he spent a *lot* of time appearing on podcasts and media, feeding perceptions that he wasn't actively involved in day-to-day management of his agency. - It seems likely that other senior officials at FDA will leave soon as well. Every FDA Commissioner has legions of senior advisors and executive hires brought in to help fulfill their mission. I don't know exactly who will be leaving, but I would bet that more than a few of them are updating their resumes this evening. I wouldn't expect FDA Chief of Staff Jim Traficant to stay in his position, for example, and Sanjula Jain-Nagpal and Acting Chief Medical Officer Mallika Mundkur might also be on the way out. (Pure speculation on my part, however.)

ABC News ran an entire article recapping the "concerns" anti-vaping organizations have about the authorization of Glas' flavors. Not once does the article mention the age-gating technology—the main reason why the products were approved. google.com/amp/s/abcnews.…

VTA statement notes they briefly met with Makary last week.

@olivialarinaldi @JenniferJJacobs @margbrennan Your report fails to mention that FDA scientific staff signed off on the age-gated vapes. That's a pretty substantial omission.

"We have been disappointed by the pace of nicotine product reviews at the Center for Tobacco Products,” said Laura Leigh Oyler (@RzbkRedMosquito) VP of Regulatory Affairs at @HayppGroup. “If recent reporting is accurate, Commissioner Makary’s removal should be treated as an opportunity to refocus the FDA on timely, evidence-based decision-making. Adult consumers, responsible manufacturers, and retailers need a regulatory process that produces decisions, not indefinite uncertainty." tobaccoreporter.com/2026/05/12/mak…

Blaming it all on vaping is the easiest path to respectability post-Trump. To say the least, I suspect there were greater issues. I wish we were powerful enough to sink a FDA Commissioner. I'm sorry, but whether you're talking about vape or tobacco companies, we just aren't.

@DrMakaryFDA resigned because he was forced to listen to his own scientists, who recommended authorizing a few fruit-flavored vapes that would help smokers quit. Makary claims he couldn't agree because of the youth appeal. He's wrong.

I would not be surprised if Makary felt pressure to go above and beyond Glas. That's a totally fair thing to report on. But all evidence suggests that zero politics were involved in the Glas authorization—until the political appointee got involved and overruled the scientists.

As Makary blames his departure on vaping, this quote from an FDA staffer to Politico last week seems apt: "He will not be missed by a single career person."

@SherylNYT @jrovner @By_CJewett Quite the omission: The flavored vapes Makary was so indignant about authorizing were age-gated and recommended by FDA career scientific staff.

BREAKING: Marty Makary has resigned under pressure as FDA commissioner. He came in a reformer, but ran afoul of Big Food, Big Pharma, Big Tobacco -- and eventually, the Trump White House. @By_CJewett has the scoop nytimes.com/2026/05/12/us/…

@By_CJewett @DrMakaryFDA @davidalim No mention that FDA career scientific staff recommended the Glas flavor authorizations and Makary overruled them for months. Trust the scientists—unless the scientists say something politically inconvenient.

Scoop on @DrMakaryFDA resignation goes to @davidalim & co. But we add: Dr. Makary ultimately resigned over concerns about the administration’s decision to authorize fruit-flavored e-cigarettes, an action he opposed. 🎁nytimes.com/2026/05/12/us/…

In my defense, I said "could."

@plopnl I never really objected to MRTP classification because there's no evidence anyone is going to want to use them for 50 years. By that metric, they'll harm far less people per 100,000 ever users than will real cigarettes per the same number of ever users.

@GregTHR Im still wondering that is the modified risk there as they only removed most of 1 of the least harmful ingredients. All the major dangerous stuff is unchanged

Got a notification that FDA CTP tweeted—maybe it's something big! Can't win 'em all. Moving on...

Here’s how one former bank employee managed to help the FDIC repo a jet in 1976: “I’m not really with the Kingston Trio. I’m with the FDIC.”

I will remember you as you were.