On May 12, 2026, FDA Commissioner Marty Makary, MD, MPH, resigned after weeks of mounting pressure from the White House. The reporting from the New York Times, Axios, and the Associated Press makes clear this was not a graceful, voluntary departure — Makary's resignation came at the end of a 13-month tenure marked by repeated clashes with the President's allies and senior administration officials.

For an industry that spent the last ten months watching the FDA build the strongest federal case against concentrated 7-OH in the agency's history, the timing is not subtle. Makary stepped down roughly 24 hours after the President stood in the Oval Office and said, on camera, that his administration would "look very seriously at natural 7-OH and getting that approved." Read those two events back-to-back and the policy direction becomes hard to misread.

What the White House actually said

The President's public comments on Makary's exit have been brief. From his Truth Social post and subsequent remarks: "Marty's a terrific guy, but he's going to go on and he's going to lead a good life." When asked directly whether he had asked for the resignation, the President answered: "I don't want to say, but Marty is a great guy. He was having some difficulty."

The President confirmed that Kyle Diamantas, the FDA's deputy commissioner for foods, will serve as acting commissioner.

That replacement choice matters as much as the resignation itself. Diamantas runs the foods side of the FDA — not the drug or controlled-substances side. The agency is being temporarily led by someone whose institutional reflexes are about labeling, supply-chain safety, and consumer protection, not opioid scheduling. Whether the next permanent commissioner shares Makary's posture on 7-OH is the question the industry will be watching for the rest of the year.

What drove the resignation — and what didn't

Per the Times and Axios, 7-OH was not the singular driver of Makary's exit. The reported list of frictions is broader: abortion-pill regulation, flavored vape enforcement, vaccine policy, rejections of promising rare-disease drugs, and ongoing complaints from pharma CEOs and conservative allies who felt Makary was unpredictable. The industry should not flatter itself that Makary stepped down over kratom alone.

But the sequence still matters. The administration's "natural 7-OH" endorsement on May 11 was a direct rebuke of Makary's signature regulatory recommendation — the July 2025 push to schedule concentrated 7-OH under the Controlled Substances Act. Twenty-four hours later, Makary was out. Whether or not 7-OH was the deciding factor, it was clearly not a topic on which the President wanted continued public daylight between himself and his FDA chief.

What actually changes for 7-OH

We made this point in our May 9 piece and it remains the most important thing to understand: the FDA does not schedule controlled substances. The DEA does. Makary's recommendation went to the DEA, where it has been under review since last summer. His resignation does not retract that recommendation — only the DEA can decide whether to act on it, and the DEA does not answer to the FDA commissioner.

What changes is the political wind. The DEA is part of the executive branch. When the President of the United States stands in the Oval Office and publicly endorses approval for "natural 7-OH," and his FDA commissioner — the loudest federal voice for scheduling 7-OH — resigns the next day, the DEA hears that. Career officials at DEA are not going to be in a hurry to advance a Schedule I designation that the White House appears to be backing away from in real time.

The policy machine is still moving — but the driver has been replaced, and the new direction is unclear.

What it means for the "natural" question

The administration's "natural 7-OH" framing remains undefined. Does "natural" mean the trace amounts of 7-OH that exist in raw kratom leaf (typically less than 2% of total alkaloids)? Or does it include lab-isolated 7-OH that originates from the kratom plant — even when concentrated to 95%+? The administration has not said. The industry has not said. And Makary's resignation has, if anything, made the definitional fight more urgent because someone now has to define the term the President used.

Responsible operators — the ones who lab-test every batch, publish full COAs, restrict to 21+, and refuse to sell flavored gummies or ice-cream-cone formats designed to appeal to minors — should welcome that fight. A clear federal definition of "natural 7-OH," tied to plant origin and verifiable lab standards, is exactly the regulatory framework this category needs. The alternative — a permanent regulatory void where every state writes its own rules — is what we have today, and it is not working for consumers or operators.

What it doesn't change

Two things to keep in perspective:

First, the state-level patchwork is still tightening, not loosening. Kansas signed SB 497 (folded into HB 2365) on April 10, 2026, making kratom Schedule I effective July 1. Michigan's House passed HB 5537 in March (pending in the Senate) criminalizing manufacture, sale, and distribution. Spokane and Othello passed local bans in April and May. These are not waiting on FDA leadership. Federal turbulence does not stop state legislators from voting.

Second, a Schedule I recommendation already on the DEA's desk does not vanish because the recommender stepped down. The DEA review remains live. The agency could still act. The political cost of acting has gone up significantly — but the procedural runway exists, and a future administration could revive it.

Where this leaves Favor'd Alkz

Our position has not changed and will not change with the news cycle. Every batch we sell is verified by an ISO/IEC 17025 accredited lab. Every COA is published. We do not sell to anyone under 21. We do not market to children. We support the Kratom Consumer Protection Act framework and would welcome federal preemption tied to verifiable lab standards.

What changed on May 11 and 12 is that the policy door we have been pushing on for ten months is, for the first time, opening from the other side. We will keep operating the way we always have — and we will keep telling you the truth about what is happening in Washington, even when the news is good.

Sources

This post is the opinion of Favor'd Alkz and is provided for informational purposes only. It is not legal or medical advice. Federal and state laws regarding 7-hydroxymitragynine are evolving rapidly. Verify the legal status of any 7-OH product in your state before purchase.

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