FDA Moves Against Concentrated 7-OH Kratom Products (2025)

Table of Contents

1. What the FDA Did in 2025
2. What 7-OH Is and How It Differs From Kratom Leaf
3. The July Warning Letters and the Legal Position They State
4. The Scheduling Recommendation and Who Decides
5. What the FDA’s 7-OH Report Found
6. The Letter to Health Care Professionals
7. The December 2025 Seizure
8. What the 2025 Actions Did Not Do
9. Dates and Legal Status as of 11 October 2026
10. How the 2025 Steps Fit Earlier Federal Kratom Actions
11. Primary Documents
12. Key Research Papers
13. Connections

1. What the FDA Did in 2025

The FDA’s 2025 action on 7-OH came in three announcements, each a news release from the agency:

• 15 July 2025 — warning letters. “FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine.” The FDA announced seven recent warning letters to companies “for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.” The release gives the compound’s other names as 7-OH-mitragynine, 7-OHMG and 7-HMG. It names the seven recipients; this page describes them only as seven companies.
• 29 July 2025 — scheduling recommendation, report and clinician letter. “FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers.” The FDA announced it was “recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA).” The same day it released a report, “7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat,” issued a letter to health care professionals, and published consumer materials on its page “Hiding in Plain Sight: 7-OH Products.”
• 2 December 2025 — seizure. “FDA Seizes 7-OH Opioids to Protect American Consumers.” In coordination with the Department of Justice, the U.S. Marshals Service seized about 73,000 units of 7-OH products, valued at roughly $1 million, from three firms in Missouri.

A warning letter is the FDA’s formal notice to a company that it considers the company to be violating federal law; it asks for a response and corrective steps but is not itself a court order or a fine. A seizure is an enforcement action in which federal officers take custody of products the government considers illegal.

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2. What 7-OH Is and How It Differs From Kratom Leaf

Kratom (Mitragyna speciosa) is a tropical evergreen tree from Southeast Asia. The FDA’s July 2025 report states that its leaves contain more than 50 alkaloids, with mitragynine and 7-OH the main psychoactive ones, and that the leaves have been used for centuries as a tea or dry leaf. It notes that there are no FDA-approved drugs containing kratom or kratom-derived substances such as 7-OH.

The report draws the line between leaf and concentrate with these figures:

• 7-OH is a minor constituent, making up less than 2 percent of the total alkaloid content of natural kratom leaves (about 1.6 percent in a 1994 analysis).
• In botanical kratom, 7-OH typically amounts to no more than about 0.01–0.04 percent of dry weight. In one study of 341 samples of kratom products that U.S. consumers were using, the 7-OH content ranged from below the measurable limit to a maximum of 0.21 percent, with a mean of 0.01 percent.
• Mitragynine, by contrast, accounts for about 66 percent of the total alkaloid content.
• The enhanced 7-OH in concentrated products is “likely synthetically derived through oxidate chemical conversion of mitragynine isolates or kratom extracts,” because extracting 7-OH directly from the leaf “would simply be unfeasible economically.”

The 29 July release calls 7-OH “a concentrated byproduct of the kratom plant.” The report cites an analysis of websites selling 7-OH products which found that most (82.2 percent) were chewable or sublingual tablets, shots or gummies, that 92 percent were marketed specifically as 7-OH-only products, and that the mean cost per recommended serving was $3.97. The 2026 DEA notice later set out a numerical threshold separating leaf from concentrate; that threshold is explained on the 2026 page.

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3. The July Warning Letters and the Legal Position They State

According to the 15 July release, the letters “specifically focus on products containing 7-OH as an added ingredient or enhanced levels of 7-OH,” such as tablets, gummies, drink mixes and shots, sold online and in smoke shops, gas stations and corner stores. The recipients were asked to respond within 15 business days. The 29 July release dates the letters to June 2025; the 15 July release calls them “recent.”

Both July releases state the FDA’s legal position on 7-OH in the same three parts:

• Dietary supplements. 7-OH “is not lawful in dietary supplements.” A dietary supplement is a product sold under a separate set of federal rules that does not need FDA approval before sale, but whose ingredients have to meet a safety standard.
• Conventional foods. 7-OH “cannot be lawfully added to conventional foods.”
• Drugs. “There are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH.”

The release explains the two kinds of violation found. Some products were adulterated conventional foods or dietary supplements — the legal term for a food or supplement that fails a safety or quality standard — “because 7-OH does not meet the relevant safety standard.” Others were unapproved new drugs, meaning products sold with claims to treat a condition without the FDA approval a drug needs; the claims named were relieving pain and managing anxiety.

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4. The Scheduling Recommendation and Who Decides

The Controlled Substances Act is the federal law that sorts drugs and certain chemicals into five schedules. As the 29 July release puts it, substances are placed in a schedule “based upon their medical use, potential for abuse and safety or dependence liability.” Schedule I is the strictest; Schedule V the least strict.

The release states that the recommendation “follows a thorough medical and scientific analysis by the FDA” and that the FDA is “specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products.” Its stated reasons:

• 7-OH “is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors”;
• products with concentrated 7-OH are easy to buy online and in gas stations, corner stores and vape shops;
• some products, “such as fruit-flavored gummies and ice cream cones,” may be especially appealing to children and teenagers;
• products “may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom.”

The release quotes FDA Commissioner Marty Makary, M.D., M.P.H.: “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.” It quotes HHS Secretary Robert F. Kennedy, Jr.: “Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction.”

Who decides. The FDA recommends; it does not schedule. The release states that the Drug Enforcement Administration (DEA) “is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.” The text of the recommendation itself was not published in the FDA’s releases, so this page reports only what the releases say about it. The DEA’s July 2026 notice later recorded that HHS sent the DEA its scientific and medical evaluation, recommending Schedule I control of 7-OH above a specified threshold, by letter dated 28 July 2025 (see the 2026 page).

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5. What the FDA’s 7-OH Report Found

The report released on 29 July 2025 was written by staff of the FDA Center for Drug Evaluation and Research, including its Controlled Substance Staff. Its executive summary concludes that the data “indicate that 7-OH is a potent opioid that poses an emerging public health threat, especially when considering the increasing availability of enhanced or concentrated 7-OH products in the marketplace.” Its main findings:

• Opioid receptor action. Laboratory studies show 7-OH binds strongly to the mu-opioid receptor — the receptor through which morphine and fentanyl work — and switches it on (acts as an agonist). In isolated guinea-pig gut tissue, one study found 7-OH about 13 times more potent than morphine; the effect was reversed by naloxone, the opioid-overdose antidote.
• Abuse-potential tests in animals. Rodents self-administered 7-OH, developed a preference for places paired with it, and in drug-discrimination tests treated it like morphine. In these models the report states 7-OH “consistently demonstrated an increased potency relative to morphine.”
• Breathing. In rats, 7-OH caused significant respiratory depression (slowed, shallower breathing), reversed by naloxone. The report states that 7-OH produces respiratory depression “with more than 3-fold greater potency than morphine.”
• Tolerance and withdrawal. Mice given 7-OH twice daily for five days developed tolerance and, when given naloxone, opioid-type withdrawal signs.
• Human data are limited. To the FDA’s knowledge, no clinical studies have used isolated 7-OH; human pharmacokinetic data come from small studies of botanical kratom, in which 7-OH is also produced in the body from mitragynine.

The report’s surveillance figures, each with its own limits:

• Poison centers. Codes specific to 7-OH were added to the National Poison Data System only in February–May 2025. From 1 February to 30 April 2025 there were 53 exposure cases involving 7-OH, most for reasons classed as intentional abuse; 37 involved 7-OH alone. Most single-substance cases had minor or moderate outcomes, with several major outcomes.
• FDA Adverse Event Reporting System. 13 cases, including 2 deaths, were suspected to involve 7-OH; the report did not analyze them further because the role of 7-OH could not be separated from unknown products, other medicines and underlying disease.
• DEA toxicology testing. A query for mitragynine, 7-OH or mitragynine pseudoindoxyl from 2019 to 2025 found 103 fatal and non-fatal overdose cases. The report notes it generally cannot tell which compound was involved, but that fatal cases in 2023–2025 were about three times those of 2019–2022.

The report adds that because 7-OH is both a metabolite of mitragynine and present at low levels in the leaf, toxicology results alone make it “challenging” to identify 7-OH as the main cause in any human case, and that self-reported data likely undercount 7-OH use because people may not know a product contains it. Opioid overdose and its treatment are covered on the site’s Opioid Overdose page.

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6. The Letter to Health Care Professionals

The “Dear Colleague” letter of 29 July 2025, signed by Commissioner Makary, opens: “I am writing to warn you about an opioid that few physicians may be aware of.” It repeats the leaf-versus-concentrate distinction — “7-OH is found in trace amounts in the kratom plant leaf. But this is not our focus. Our primary concern is the concentrated form of 7-OH” — and lists other names clinicians may hear: 7-OHMG, 7-Hydroxy, 7-HMG, or 7.

The letter states that some kratom leaf products marketed as “spiked” or “enhanced” may contain 7-OH at a level 500 percent higher than would be expected naturally. It lists side effects besides addiction as withdrawal symptoms, insomnia and anxiety, seizures, and fatal respiratory depression, and says the FDA is “seeing increases in adverse events and related reports to poison control.” It refers readers to the FDA’s report and educational resources.

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7. The December 2025 Seizure

According to the 2 December 2025 release, the seizure of about 73,000 units from three Missouri firms “focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient.” The FDA considered the products adulterated “because 7-OH does not meet applicable safety standards,” and noted that it has not approved 7-OH for medical use. The agency worked with the Missouri Department of Health and Senior Services.

The release quotes Commissioner Makary calling the seizure “a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” and Kyle Diamantas, J.D., FDA Deputy Commissioner for Human Foods, stating that the rise of concentrated 7-OH “as an illegal ingredient in foods and dietary supplements is of particular concern for the FDA.” It describes the seizure as building on the July steps.

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8. What the 2025 Actions Did Not Do

• They did not target natural kratom leaf. The 29 July release states the FDA “is not focused on natural kratom leaf products,” and the clinician letter says trace 7-OH in the leaf “is not our focus.”
• They did not make 7-OH a controlled substance. The FDA’s recommendation is advice to the DEA. Scheduling is the DEA’s decision, made through its own process; none was made in 2025.
• They did not change the legal status of mitragynine or kratom generally. The 2025 documents address 7-OH. The report states that the FDA “still has concerns about the safety of kratom products more broadly,” but the 2025 actions were directed at 7-OH.
• The warning letters were not penalties. They asked for a response within 15 business days; the December seizure was a separate enforcement step against products held by three Missouri firms.

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9. Dates and Legal Status as of 11 October 2026

Update, filed 9 October 2026 (publication in the Federal Register scheduled for 14 October 2026): the DEA filed a new notice of intent to temporarily place 7-hydroxymitragynine and mitragynine pseudoindoxyl in Schedule I “when either substance alone, or their combined amount if both are present, is above a specified threshold” (Docket No. DEA-1570). It is based on an HHS letter of 8 October 2026 recommending a new threshold: more than 1 mg per gram for solid forms or more than 1 mg per milliliter for liquids, or a mass of mitragynine less than 100 times the mass of the controlled substance or substances present. The notice states that, in a separate document in the same issue, the DEA is withdrawing the July 2026 notice of intent for 7-OH. It also states that the 26 August 2026 order placing mitragynine pseudoindoxyl in Schedule I without a threshold “remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.” The DEA writes that “neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels.” A companion notice (FR Doc. 2026-20942) concerns MGM-15 and MGM-16. As of 11 October 2026 these are filed documents, not yet published, and no 7-OH temporary order exists.

• June–July 2025: seven warning letters sent; announced 15 July 2025.
• 28 July 2025: HHS letter to the DEA with its evaluation and recommendation (date as recorded in the DEA’s 2026 notice).
• 29 July 2025: FDA announces its scheduling recommendation, report, clinician letter and consumer materials.
• 2 December 2025: seizure of about 73,000 units in Missouri announced.
• 6 July 2026: the DEA publishes a notice of intent to temporarily place 7-OH above a specified threshold in Schedule I (Docket No. DEA-1570), and HHS opens a request for information on that threshold.
• 26 August 2026: the DEA temporarily places three related compounds — mitragynine pseudoindoxyl, MGM-15 and MGM-16 — in Schedule I.

Status on 11 October 2026: the FDA’s 2025 recommendation has been acted on only in part. The DEA has published a notice of intent for 7-OH above a threshold but no temporary scheduling order for 7-OH itself, so 7-OH is proposed for control, not yet federally controlled under the Controlled Substances Act. The three related compounds are under a temporary order in effect until 26 August 2028. The FDA’s position that 7-OH is not lawful in foods, dietary supplements or drugs is unchanged. The details of the 2026 steps are on 7-OH Kratom Products: The 2026 Scheduling Steps.

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10. How the 2025 Steps Fit Earlier Federal Kratom Actions

The FDA’s July 2025 report summarizes the earlier history:

• 2012: the FDA issued its first import alert for kratom (an import alert lets border officials hold shipments without examining them), followed by further alerts in later years.
• 2016–2018: the DEA and HHS considered whether to control kratom and its constituents mitragynine and 7-OH under the Controlled Substances Act. The report states those actions were suspended in 2018, with the Assistant Secretary for Health at the time stating that “the science was incomplete, and the available data were not adequate to support a recommendation to control these substances.” The DEA’s August 2016 notice of intent covering both compounds, and its October 2016 withdrawal, are described on the 2026 page.
• 2025: the report states that “until now, 7-OH has not been the sole target of a regulatory response but has always been addressed alongside the kratom plant and mitragynine.”

The shift is the main point of the 2025 documents: earlier federal efforts aimed at the plant and its main alkaloid, while the 2025 recommendation, letters and seizure aimed at concentrated 7-OH. The 2026 DEA notice carried the same distinction into a concentration threshold. Other unsafe-supplement patterns the site covers are on Sedatives, Phenibut and Kratom, and the regulation of prescription opioids on Opioids for Chronic Non-Cancer Pain.

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11. Primary Documents

1. U.S. Food and Drug Administration (2025). FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine. FDA news release, 15 July 2025 — fda.gov news release
2. U.S. Food and Drug Administration (2025). FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. FDA news release, 29 July 2025 — fda.gov news release
3. FDA Center for Drug Evaluation and Research (2025). 7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat. Report released 29 July 2025 — fda.gov report (PDF)
4. Makary MA, Commissioner of Food and Drugs (2025). Letter to health care professionals on 7-hydroxymitragynine, 29 July 2025 — fda.gov letter (PDF)
5. U.S. Food and Drug Administration. Hiding in Plain Sight: 7-OH Products (program page; updated 13 July 2026) — fda.gov public health focus page
6. U.S. Food and Drug Administration (2025). FDA Seizes 7-OH Opioids to Protect American Consumers. FDA news release, 2 December 2025 — fda.gov news release
7. Later status: Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I (notice of intent). Federal Register 91:40917, 6 July 2026. Docket No. DEA-1570 — FR Doc. 2026-13580
8. Later status: Office of the Assistant Secretary for Health, HHS (2026). Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information. Federal Register 91:41049, 6 July 2026. Docket No. HHS-OASH-2026-0232 — FR Doc. 2026-13608
9. Later status: Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (temporary scheduling order). Federal Register 91:54948, 26 August 2026. Docket No. DEA-1644 — FR Doc. 2026-17429
10. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I (notice of intent). Filed for public inspection 9 October 2026; scheduled for publication 14 October 2026. Docket No. DEA-1570 — FR Doc. 2026-20943
11. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I (notice of intent). Filed for public inspection 9 October 2026; scheduled for publication 14 October 2026 — FR Doc. 2026-20942

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Key Research Papers

1. Matsumoto K, Horie S, Ishikawa H, Takayama H, Aimi N, Ponglux D, Watanabe K (2004). Antinociceptive effect of 7-hydroxymitragynine in mice: Discovery of an orally active opioid analgesic from the Thai medicinal herb Mitragyna speciosa. Life Sciences 2004;74(17):2143-2155 — PubMed PMID: 14969718
2. Matsumoto K, Horie S, Takayama H, Ishikawa H, Aimi N, Ponglux D, Murayama T, Watanabe K (2005). Antinociception, tolerance and withdrawal symptoms induced by 7-hydroxymitragynine, an alkaloid from the Thai medicinal herb Mitragyna speciosa. Life Sciences 2005;78(1):2-7 — PubMed PMID: 16169018
3. Kruegel AC, Gassaway MM, Kapoor A, Váradi A, Majumdar S, Filizola M, Javitch JA, Sames D (2016). Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atypical Molecular Framework for Opioid Receptor Modulators. Journal of the American Chemical Society 2016;138(21):6754-6764 — PubMed PMID: 27192616
4. Obeng S, Wilkerson JL, León F, Reeves ME, Restrepo LF, Gamez-Jimenez LR, Patel A, Pennington AE, Taylor VA, Ho NP, Braun T, Fortner JD, Crowley ML, Williamson MR, Pallares VLC, Mottinelli M, Lopera-Londoño C, McCurdy CR, McMahon LR, Hiranita T (2021). Pharmacological Comparison of Mitragynine and 7-Hydroxymitragynine: In Vitro Affinity and Efficacy for μ-Opioid Receptor and Opioid-Like Behavioral Effects in Rats. Journal of Pharmacology and Experimental Therapeutics 2021;376(3):410-427 — PubMed PMID: 33384303
5. Chear NJ, León F, Sharma A, Kanumuri SRR, Zwolinski G, Abboud KA, Singh D, Restrepo LF, Patel A, Hiranita T, Ramanathan S, Hampson AJ, McMahon LR, McCurdy CR (2021). Exploring the Chemistry of Alkaloids from Malaysian Mitragyna speciosa (Kratom) and the Role of Oxindoles on Human Opioid Receptors. Journal of Natural Products 2021;84(4):1034-1043 — PubMed PMID: 33635670
6. Hill K, Boyer EW, Grundmann O, Smith KE (2025). De facto opioids: Characterization of novel 7-hydroxymitragynine and mitragynine pseudoindoxyl product marketing. Drug and Alcohol Dependence 2025;272:112701 — PubMed PMID: 40373645

All six papers are cited in the FDA’s July 2025 report on 7-OH.

PubMed Topic Searches

1. PubMed: 7-hydroxymitragynine
2. PubMed: 7-hydroxymitragynine and the mu-opioid receptor
3. PubMed: kratom alkaloid content

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Connections

• FDA Actions of 2025
• FDA and Regulation
• 7-OH Kratom Products: The 2026 Scheduling Steps
• Sedatives, Phenibut and Kratom
• Dangerous Supplements
• Opioids for Chronic Non-Cancer Pain
• Opioid Overdose
• Addiction and Substance Use Disorders
• FDA Requires New Opioid Labeling on Long-Term Use (2025)
• FDA Reverses Course: NMN Allowed in Dietary Supplements (2025)
• FDA Public Meeting on What Counts as a Dietary Ingredient (2026)

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