Jim McDonald

@LanceChurchill It's the same.

@LanceChurchill Has this changed from what they published last week?

The final guidance document for the FDAs new "enforcement discretion" policy has now been published: "Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization" fda.gov/regulatory-inf… Download the document here: fda.gov/media/192403/d…

@jkelovuori @LanceChurchill @GregTHR @gopaulblair @jgitchell @JMacNYC @FDATobacco I don’t think it amounts to any kind of change, except for tobacco companies and the few vape manufacturers who can afford to produce PMTAs with comparative efficacy studies or age-gated products.

@LanceChurchill @GregTHR @gopaulblair @jgitchell @JMacNYC @whycherrywhy @FDATobacco Yeah, perhaps. But what I meant was what do you guys think of the statement itself? 🙂

The date on this news release is May 7th, but it hasn't been tweeted until now. Anyway, what do you reckon @GregTHR @gopaulblair @jgitchell @JMacNYC @LanceChurchill @whycherrywhy?

The notion that Makary resigned over the vaping policy is laughable. He was pushed out. Full stop. Anything saying otherwise is pure spin by his allies.

@joaniej0243 @AranenZen @jkelovuori @By_CJewett @DrMakaryFDA @davidalim @GregTHR @vapelawguy @ECIGattorney Tobacco control people say to ban them just in case, which is basically what the FDA has done. The truth is, there's no reason to believe flavors have any relation to youth vaping rates.

@AranenZen @jkelovuori @By_CJewett @DrMakaryFDA @davidalim @GregTHR @vapelawguy @ECIGattorney @whycherrywhy Well the scientists were correct and underage vaping is at an all time low, in fact the lowest ever. Flavors are still all over the market in most areas. These age-gated vapes, no one will want anyway. Do we need to ban all adult products just because a couple of teens use them?

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/…

@joaniej0243 @jkelovuori @By_CJewett @DrMakaryFDA @davidalim I doubt if an ultimatum was needed.

@whycherrywhy @jkelovuori @By_CJewett @DrMakaryFDA @davidalim Initially Makary overruled the panel of scientists that approved, then he got a call from Trump himself. Somehow he changed his mind. I would have liked to be a fly on the wall during that discussion. I wonder what the ultimatum was?🤔

@joaniej0243 @jkelovuori @By_CJewett @DrMakaryFDA @davidalim They were authorized by the FDA. Makary signed off on it.

@jkelovuori @By_CJewett @DrMakaryFDA @davidalim "But he authorized Glas Sapphire and Gold anyway, didn't he?" No he didn't, Trump overruled him.

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.)

FDA Commissioner Martin Makary has been forced to resign, following a clash with the White House over vaping regulation and numerous other issues. vaping360.com/vape-news/fda-…

Just what tobacco control needs -- a martyr.

Rhode Island is not banning menthol cigarettes, as they're so dependent on cigarette tax revenue that the tax gets hiked every other year. Best of luck to those in RI. There is an email to submit testimony in the below tweet.

No pharma board job for you. Back to Johns Hopkins, where everyone will praise your principled stance against those bad, bad vapes.

"Most doctors downplayed the impact." Worldwide, people living with HIV have very high rates of smoking; lung cancer is the leading cause of death in some populations. Tobacco harm reduction can and should be rolled into HIV care, reports @KiranSidhu51: filtermag.org/tobacco-harm-r…

For the first time, the FDA has authorized sale of fruit-flavored vaping products -- reportedly after pressure by President Trump on FDA Commissioner Makary. ow.ly/1Tja50YVPaP

📢 Last chance to make your voice heard this week. The government consultation on banning vaping and heated tobacco in public places closes on Friday. Read our briefing and submit your response today. ⬇️ nnalliance.org/nnanews/news/4…

If you're new to understanding Bloomberg's takeover of worldwide tobacco and nicotine policy, this piece neatly ties most of the threads together.

The only reason Hegseth and Trump promote this lie about Biden sending troops to polling places is because they plan to do it themselves, as I warned last year. It's an emergency; the other guys did it first; illegals are voting, etc.

Public health campaign referring to the eponymous “public”, the people they are nominally trying to help, as rats. Zero empathy or humility - sub-zero insight into nicotine use. Dehumanising and disgraceful.