Questions for the FDA nominee on 7-OH

The Senate Committee on Health, Education, Labor and Pensions holds the confirmation hearing for Dr. Heidi Overton, nominee for Commissioner of Food and Drugs, on Thursday, September 24, at 10:30 AM Eastern. Today we called committee offices to ask that senators raise the proposed federal scheduling of 7-OH with her. This is what we asked, and why.

Senate HELP CommitteeHearing September 24, 2026, 10:30 AM ETQuestions for the record due September 25, 5 PM ETRe: HHS-OASH-2026-0232-0001

Update, September 24: The hearing has taken place. At its close, senators were told to submit written questions for the record by 5 PM Eastern on Friday, September 25. If you want an office to submit one of the questions below, contact them before then. In her opening statement, Dr. Overton listed “continuing to tackle the opioid crisis, and the new dangers of synthetic 7-OH” among FDA’s public health priorities.

Why the FDA nominee

FDA recommended scheduling 7-hydroxymitragynine in July 2025 and published the scientific assessment behind that recommendation. That assessment also states that “surveillance systems do not provide estimates for the prevalence of 7-OH use.” The comment period on HHS’s proposed threshold closed September 10, and DEA may now issue a temporary Schedule I order at any time.

The next commissioner will shape what FDA does after that, including whether the research that could answer the open questions stays possible.

Who uses 7-OH, according to the record

We analyzed the public comments on the HHS docket. About 60% of commenters mention pain. One in five mention mental health, and more than a thousand mention it without mentioning pain at all.

The care pathway problem

This week we attended a continuing-education training for clinicians on kratom and 7-OH. It described people using these products for severe pain, anxiety and depression, and then recommended treating all of it as opioid use disorder, with buprenorphine as the recommended first-line treatment.

Buprenorphine is already FDA-approved for pain, at lower doses usually taken two or more times a day, while addiction treatment is typically a single daily dose. Research protocols for suicidal ideation use 5 to 10% of addiction doses. So people who do get buprenorphine may still get the wrong dose for their actual condition. And most people with opioid use disorder don’t get medication at all: of the 4.0 million people with opioid use disorder in 2025, 15.7% received medications for it (SAMHSA, 2025 NSDUH). Most pain patients already can’t get good pain management, and there is no care pathway for people using 7-OH for their mental health.

We are not suggesting that anyone using 7-OH switch to buprenorphine. The point is that the only prescribed route on offer is built for a different condition, and most people can’t reach it.

The threshold has no human data behind it

The medical organizations commenting on this docket, including those that support scheduling, told HHS there is no human dose-response study or established lethal level to support the proposed 1 mg threshold, or any other threshold:

• American Society of Addiction Medicine: “Current evidence is insufficient to validate 0.050%, 1mg, or any alternative human harm threshold at present.”
• American Psychiatric Association, which said it was “encouraged” that DEA is taking steps to schedule 7-OH: “There are no controlled human dose-response studies that would allow identification of a precise human toxicity threshold for 7-OH.”
• FED UP! Coalition, which supports scheduling: “There is no established human therapeutic range, toxic range, or lethal blood concentration that would allow a scientifically confident determination that a particular consumer dose […] is below the level associated with imminent hazard.”

In the docket’s own comments, the median dose people report taking is 30 mg. About 3% report taking 1 mg or less.

What we asked senators to raise

We asked offices to raise these with Dr. Overton at the hearing, or to submit them as written questions for the record:

1. FDA’s own assessment says surveillance can’t estimate how many people use 7-OH or why. Before FDA supports a Schedule I threshold, what evidence would it need to see that the threshold is set at the right level?
2. If 7-OH is scheduled, what care pathway will FDA make sure is available for people using it for pain, anxiety, or depression without an opioid use disorder diagnosis?
3. Some people are using 7-OH as over-the-counter self-treatment for opioid addiction, and only 15.7% of people with opioid use disorder received medications for it in 2025. If 7-OH is scheduled, how does FDA plan to address access to self-treatment?

If you want to do the same

Video of the hearing will be posted on the committee’s website. Committee members can submit written questions for the record until 5 PM Eastern on Friday, September 25, so contact their offices before then. If you call, it helps to mention the hearing and the document ID above.

Our full comment on the proposed threshold, with the method behind the figures here, is on this site.