7-OH: who wants it scheduled, who does not, and what the record shows about the money

7-hydroxymitragynine, usually shortened to 7-OH, is one of the alkaloids in the kratom plant. The Drug Enforcement Administration describes its place in the leaf this way: “In its natural botanical form, 7-hydroxymitragynine makes up less than two percent of the total alkaloid content or occurs in trace amount in M. speciosa.”[1] The products the federal government has moved against are not leaf. They are the concentrated forms, which the FDA listed as “including tablets, gummies, drink mixes and shots” when it announced its position in July 2025.[2]

This page records who is pushing the federal action, who is resisting it, and what money each side has disclosed. Positions and finances can be documented from filings and primary records, and they are below. Motives cannot be documented. Where a named outlet or official has alleged one, it appears here as that person's allegation, with its date.

What the government has done, in order

July 15, 2025. The FDA said it had sent warning letters to seven companies for selling 7-OH products, in its words “seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH”.[3]

July 29, 2025. The FDA recommended that 7-OH be scheduled. Its release drew the line that every later document repeats: “The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products.”[2] Commissioner Marty Makary said that “7-OH is an opioid that can be more potent than morphine”.[2] Health Secretary Robert F. Kennedy Jr. described his own heroin use at the briefing and, per Axios, said of the past that he “had to go to the South Bronx or the Lower East Side. But now you can go to any gas station”.[4]

September 2, 2025. Ohio's governor paused a planned state kratom ban. The Ohio Statehouse News Bureau reported that “Gov. Mike DeWine is pausing his call for a ban on kratom after a conversation with Health and Human Services Secretary Robert F. Kennedy Jr.”[5] That call became part of a corruption allegation nine months later, below.

December 2, 2025. The FDA announced that the U.S. Marshals Service had “seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products” from three Missouri firms.[6]

March 2026. Eleven senators, led by Pete Ricketts and Richard Blumenthal, wrote to Makary asking for more than 7-OH: “However, we encourage you to consider scheduling the whole kratom leaf, given that some of the most accessible and addictive products contain whole kratom leaf, not 7OH.”[7] The next day Representative Gus Bilirakis introduced H.R. 8000, the END 7-OH Act, which would schedule synthetic 7-OH while exempting the compound as it occurs in the plant.[8] Senator Roger Marshall had been pressing DEA since October 2025 with a different comparison: “Its pharmacology more closely resembles that of fentanyl than any traditional botanical supplement, and its risk profile poses a grave threat to public health.”[9]

May 11, 2026. President Trump said the administration was “looking very seriously at natural 7-OH and getting that approved”.[10] Nobody agreed on what that meant. Pain News Network reported that “A HART news release said the president was endorsing all forms of 7-OH, even the concentrated products that contain as much as 96% 7-OH.”[10] The American Kratom Association read it as an endorsement of leaf.[10]

July 6, 2026. DEA published two notices of intent. The first, docket DEA-1570, proposes placing 7-OH in Schedule I only above a threshold. Leaf is covered when it “contains more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis”, and any other article when the compound is present at “greater than 0.050 percentage by weight/weight, weight/volume, or volume/volume or greater than 1.00 milligram of 7-hydroxymitragynine in the article”.[1] The notice records that HHS answered DEA on March 6, 2026, and that “there were currently no investigational new drug applications (IND) or approved new drug applications (NDA) for these substances.”[1] It said the order “will not be issued before August 5, 2026”.[1] The second notice, docket DEA-1644, covered three related compounds that do not occur in the plant: mitragynine pseudoindoxyl, MGM-15 and MGM-16.[11] HHS opened its own docket the same day, on the threshold alone: “Note that OASH is not soliciting comment on any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination for temporary scheduling.”[12] Kennedy's statement that week said “HHS reviewed the science and recommended this action.”[13] The same release said “These actions are not intended to regulate natural leaf kratom that does not contain enhanced levels of 7-OH.”[13]

August 26, 2026. DEA issued the order for the three derivatives. “This temporary order is effective August 26, 2026, until August 26, 2028.”[14] The Justice Department's release said “This action is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom.”[15] The order says nothing about 7-OH itself.[14] The same day, HHS extended its threshold docket and asked the public to “Submit either electronic or written comments, data, or information by September 10, 2026.”[16]

Since then. As of October 5, 2026 the Federal Register holds five documents that mention 7-hydroxymitragynine, and none of them is a 7-OH scheduling order.[17] STAT reported on September 30 that the DEA had not acted “after an extended public comment period ended on Sept. 10 with nearly 36,000 submissions”.[18] No one has gone to court to stop the 7-OH notice. The Congressional Research Service explains why that would be hard: “Unlike permanent administrative scheduling, temporary scheduling is not subject to judicial review.”[19]

The sides, and what each discloses

Organisation	Legal form	Latest revenue on Form 990	Wants 7-OH concentrates scheduled	Wants leaf kept legal
American Kratom Association	501(c)(4)	Revenue $4,700,427 (year ending December 2024)[20]	yes[21]	yes[21]
Global Kratom Coalition	501(c)(6)	Revenue (2024): $3,431,756[22]	yes[23]	yes[23]
Holistic Alternative Recovery Trust (HART)	501(c)(4)	Revenue (2024): $406,300[24]	no[25]	not its issue
Stop Gas Station Heroin LLC	lobbying client	not a nonprofit; paid $750,000 to one firm[26]	yes[26]	yes[26]

The two largest kratom trade groups are on the government's side of the 7-OH question. Pain News Network summarised the American Kratom Association's position on the day of the DEA notice: “The AKA has been lobbying local governments to ban 7-OH, but keep kratom legal.”[21] Its lead lobbyist Mac Haddow, described by the Tampa Bay Times in 2023 as “a former Reagan administration official”,[27] put the group's view this way: “The 7-OH industry created this crisis. They manufactured or distributed high-potency opioid products, dressed them up as kratom, and then tried to force natural kratom consumers to pay the price for their recklessness.”[21] The association's nonprofit arm has also funded kratom research. ProPublica reported that “The AKA, through its nonprofit arm, the Center for Plant Science and Health, has donated more than $100,000 to the school.”[28] The school is the University of Florida.[28]

The association is the only party that has sued the federal government over any of this, and it sued from the pro-scheduling side. Its August 27 complaint asks that the order on the three derivatives not be applied to leaf carrying trace amounts of them: “The complaint names the Drug Enforcement Administration, DEA Administrator Terrance C. Cole, and the U.S. Department of Justice as defendants.”[29]

The Global Kratom Coalition takes the same position. NutraIngredients describes it as “an industry group founded by Ross in 2024 to advocate for traditional leaf kratom and against synthetic 7-OH”.[30] Ross is Jerry Ross of Botanic Tonics. A Florida Politics opinion column put it more sharply: “Ross, the founder of the Global Kratom Coalition, is best known as the founder of Botanic Tonics, manufacturer of the massively successful kava shot Feel Free.”[31] The coalition's executive director, Matthew Lowe, endorsed H.R. 8000 as a bill “which embraces existing federal health policy and widespread scientific consensus on the dangers posed by concentrated synthetic 7-OH opioid products”.[23] Its registered federal lobbying ended before the DEA notice. Legis1 reported that the coalition “terminated its lobbying relationship with BGR Government Affairs LLC effective May 1”.[32]

The larger lobbying spend ran through a differently named client. Lobbying Disclosure Act filings show Checkmate Government Relations reporting income from a client called Stop Gas Station Heroin LLC on kratom issues.[33] Legis1 added the quarters up as “totaling $750,000 across the engagement” and quoted the client's spokesperson: “Stop Gas Station Heroin advocates for stronger regulation of dangerous concentrated synthetic 7-hydroxymitragynine products”.[26] The New York Times reported that Ross backed the group.[34]

On the other side, HART is described by Pain News Network as “an advocacy group funded by 7-OH manufacturers”.[35] Its response to the DEA notice made two claims. The first is about evidence: “No confirmed deaths have been attributed solely to 7-OH.”[25] The second is about motive: “We are concerned this was never truly about public safety, but about market share.”[25] That second sentence is HART's allegation, made on July 2, 2026, by a party with a commercial interest in the outcome. HART organised a comment campaign and reported on July 30 that “more than 24,300 Americans have submitted public comments”.[36] A second consumer group, the 7-HOPE Alliance, reported “more than 30,000 comments submitted to the federal docket and more than 65,000 people signing a Change.org petition”.[37] The R Street Institute, which has no product to sell, filed a comment that accepted a problem and rejected the remedy: “It does not support temporary Schedule I placement at the proposed threshold.”[38]

The money, the allegations, and the pharmaceutical question

The documented financial interest in this fight belongs to a kratom company, not a drug company.

On May 19, 2026 the Daily Beast reported, from a filing with the Office of Government Ethics, that Homeland Security Secretary Markwayne Mullin's disclosure “shows he holds between $500,000 and $1 million in Botanic Tonics LLC”.[39] A department spokesperson told the outlet that Mullin “acts to ensure full compliance with all ethics and conflict of interest rules”.[39]

On June 15, 2026 the New York Times, in an investigation by Kenneth P. Vogel and Christina Jewett, reported the same stake and connected it to policy: “In a disclosure statement, he listed an investment worth as much as $1 million in a kratom company, Botanic Tonics, that could benefit from the changes he has sought.”[34] The Times also reported the Ohio call and what followed it: “Kennedy, as health secretary, called the governor of Ohio to try to head off a state ban on kratom in the fall of 2025. Months later, Botanic Tonics donated $1 million to a political committee associated with Kennedy.”[34] The department said Mullin “follows all ethics and conflict of interest standards and has not lobbied for any individual or company”.[34] The Times noted that “The Health and Human Services Department and Kennedy did not respond to requests for comment, nor did Ross.”[34] These are the Times's findings, published on that date, and they have not been tested in any proceeding.

On August 3, 2026 Senator Ron Wyden, the ranking member of the Senate Finance Committee, wrote to Ross. The letter calls Mullin's position ‘This is corruption.’[40] It describes the DEA notice as the outcome Mullin wanted, one that would clear shelves “so that your products gain market share and his investment soars”, and adds “I am concerned that this announcement is grounded in politics rather than in science.”[40] That is a senator's allegation on committee letterhead, not a finding. The committee's release noted in passing that on May 12, 2026 “Dr. Marty Makary resigned from his role as FDA Commissioner after repeatedly arguing against FDA approval of flavored vapes.”[41]

Kennedy has answered once, when a reporter raised the donation at a Tampa event on August 26, 2026. The Daily Beast quoted him: “I don’t know anything about either of the things that you just said”.[42]

No named outlet has alleged kratom or pharmaceutical ties for Makary, for DEA Administrator Cole, or for White House staff. That is an absence in the record, not a clearance.

The claim that drug companies want 7-OH removed so a patented version can replace it circulates widely and has a documented substrate. The FDA's own kratom page says that “Drug companies that are interested in kratom-related drug development are encouraged to contact the relevant review division in the Center for Drug Evaluation and Research to answer questions related to their specific drug development program.”[43] A granted patent exists, titled “Mitragynine analogs for the treatment of pain, mood disorders and substance use disorders”, assigned to Columbia University, the Research Foundation for Mental Hygiene and Memorial Sloan Kettering Cancer Center.[44] DEA's own order says the three scheduled derivatives came out of research: “The chemical scaffolds of mitragynine or 7-hydroxymitragynine were used in scientific research to develop mitragynine pseudoindoxyl, MGM-15, or MGM-16 via chemical modifications of purified isolates.”[14] Of the two MGM compounds it says: “In 2014, as part of a drug discovery research, MGM-15 and MGM-16 were developed as potent opioid agonists, with potential therapeutic utility for pain.”[11]

What the record does not contain is a company. The one firm that took a kratom alkaloid derivative into people, Kures, ran a single Phase 1 trial of a modified mitragynine in New Zealand in 2022.[45] Its parent's annual report states that “In July 2024, the Board of Directors for Kures determined it was in the best interests of the company to wind up operations and dissolve Kures through a Plan of Liquidation and Dissolution”, and that “Kures assigned to Columbia all of Kures' intellectual property rights that were filed during the term of the License Agreement and agreed that all licenses granted to Kures by Columbia are terminated.”[46] One company, Sparian Biosciences, says it is developing a kratom-derived candidate called SBS-226 with federal grant money, at a stage before any human trial.[47] The only mitragynine drug entering human trials in the United States belongs to the government. The National Institutes of Health announced on June 1, 2026 that “The IND paves the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.”[48] The release says “Researchers at NIH and the University of Florida developed the purified formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.”[48] The registry entry, sponsored by the National Institute on Drug Abuse, describes the product: “MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal.”[49] And both DEA documents record HHS telling DEA that nobody held an investigational or approved application for the substances being scheduled.[1][14] The FDA page adds that “There are no FDA-approved kratom drug products or over-the-counter drugs containing kratom that are legally on the market in the U.S.”[43]

So the pharmaceutical allegation, as of this writing, has patents and an open regulatory door behind it. It has no documented company or licence in front of it, and no official connected to one. Every dated, attributable allegation about money in this fight runs between kratom sellers.

The government has backed off before. In 2016 DEA announced it was “issuing this notice of intent to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine, which are the main active constituents of the plant kratom, into schedule I”, which would have covered the leaf.[50] Six weeks later it withdrew, saying “DEA received numerous comments from the public on mitragynine and 7-hydroxymitragynine, including comments offering their opinions regarding the pharmacological effects of these substances.”[51] In 2018 the Assistant Secretary for Health rescinded a recommendation to schedule, writing, in a letter published by an advocacy site in 2021: “I now conclude that while mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature.”[52] The 2026 action is narrower than the 2016 one. It names a threshold and leaves the leaf out.[1]

The death figures the government cites are its own, and both agencies attach qualifiers that the headlines drop. The FDA's July 2025 assessment, released with the scheduling recommendation, says this of its own case reports: “Although FDA's Adverse Event Reporting System (FAERS) has documented cases reporting adverse events (13 cases, including 2 deaths) suspected to involve 7-OH, ambiguity about the contributory role of 7-OH from uncharacterized products or concomitant medications and underlying disease limits interpretation. Therefore, we do not include further analysis of these FAERS cases here.”[53] Of the DEA's toxicology data it says “it generally cannot be discerned whether deaths are related to mitragynine, 7-OH, or mitragynine pseudoindoxyl, or some combination thereof”.[53] The Commissioner's letter to doctors the same day gave no death count. Its quantified claim was potency: “one study in the Journal of Medicinal Chemistry found 7-OH to be 13 times more potent than morphine”.[54] Seven months later the DEA's notice gave these figures. From the FDA adverse event database, queried February 27, 2026: “To date, 9 cases within the FAERS database have resulted in death.”[1] From DEA's toxicology programme, which “has identified 7-hydroxymitragynine in 85 cases since 2019”: “Of these, 55 were fatal and 30 were non-fatal cases.”[1] The next sentence is the one to read with those counts: “Samples often contained other related alkaloids (mitragynine and mitragynine pseudoindoxyl) or other drug classes, such as opioids (e.g. fentanyl), benzodiazepines (e.g. bromazolam), and ketamine.”[1] DEA also notes a measurement problem: “Public health assessment is further complicated because 7-hydroxymitragynine is a known metabolite of mitragynine, making it difficult to distinguish between the ingestion of M. speciosa and other isolated 7-hydroxymitragynine products.”[1] HART's sentence that “No confirmed deaths have been attributed solely to 7-OH” is consistent with those passages, and so is the government's count.[25][1]

One last thing about the label. ‘Gas station heroin’ is a phrase, not a pharmacology. The FDA used it in May 2025 for tianeptine, a drug that is, in the FDA's words, often called that “because of its availability in gas station stores, is not approved by the FDA for any use”.[55] Tianeptine is a different molecule from a different class. The FDA notes that “In some countries, tianeptine is licensed and marketed as an atypical antidepressant.”[55] DEA's proposed rule on it says “Tianeptine is structurally and pharmacologically referred to as a tricyclic antidepressant.”[56] Its opioid activity was established in 2014, when Gassaway and colleagues wrote: “Herein, we report the characterization of tianeptine as a μ-opioid receptor (MOR) agonist.”[57] 7-OH, by contrast, “is a psychoactive alkaloid found in Mitragyna speciosa” that DEA says “shares health risks similar to other mu-opioid receptor agonists, such as morphine (schedule II)”.[1] The same phrase has been applied to both, and the transfer is visible in the record. On the day of the announcement NBC News wrote of gas station products, not gas station heroin, and quoted Makary: “We are going after the killer first”.[58] The next day a Philadelphia station reported a poison-centre clinician's comparison: “He compared 7-OH to other unregulated substances like tianeptine, often referred to as "gas station heroin."”[59] The phrase still belonged to tianeptine. Neither Makary nor Kennedy used it in the six primary documents checked for this page.[2][54][13] Kennedy reached for the gas station image when announcing the 7-OH action.[4] The pro-scheduling lobbying client is named Stop Gas Station Heroin LLC.[33] The Daily Beast's headline on the Mullin disclosure called Botanic Tonics, a seller of leaf kratom drinks, a ‘Gas Station Heroin’ company.[39] A phrase that covers an antidepressant as readily as a kava drink is describing a shelf.

References

1. Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I (notice of intent, 91 FR 40917, Docket DEA-1570) — Drug Enforcement Administration, Federal Register, 2026-07-06
2. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers — US Food and Drug Administration, 2025-07-29
3. FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine — US Food and Drug Administration, 2025-07-15
4. Feds launch crackdown on kratom byproduct — Axios, 2025-07-29 (Wayback Machine copy)
5. Meeting on kratom canceled after call from HHS Secretary RFK Jr., but DeWine still wants Ohio ban — Ohio Statehouse News Bureau, 2025-09-02
6. FDA Seizes 7-OH Opioids to Protect American Consumers — US Food and Drug Administration, 2025-12-02
7. Letter from eleven senators to FDA Commissioner Makary on kratom scheduling — Office of Senator Pete Ricketts, 2026-03-18
8. H.R. 8000, END 7-OH Act, 119th Congress, as introduced — US Government Publishing Office, 2026-03-19
9. Senator Marshall Urges Immediate DEA Action on 7-OH Substances — Office of Senator Roger Marshall, 2025-12
10. Trump's Endorsement of 'Natural 7-OH' Stirs Debate in Kratom Industry — Pain News Network, 2026-05-13
11. Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (notice of intent, 91 FR 40909, Docket DEA-1644) — Drug Enforcement Administration, Federal Register, 2026-07-06
12. Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information (91 FR 41049, Docket HHS-OASH-2026-0232) — HHS Office of the Assistant Secretary for Health, Federal Register, 2026-07-06
13. HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products — US Department of Health and Human Services, 2026-07-01 (Wayback Machine copy; hhs.gov refuses automated readers)
14. Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (temporary scheduling order, 91 FR 54948) — Drug Enforcement Administration, Federal Register, 2026-08-26
15. Justice Department Announces Emergency Scheduling of Three Potent Opioid Compounds — US Department of Justice, Office of Public Affairs, 2026-08-25
16. Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period (91 FR 55104) — HHS Office of the Assistant Secretary for Health, Federal Register, 2026-08-26
17. Federal Register search: documents containing the term 7-hydroxymitragynine — Office of the Federal Register, queried 2026-10-05
18. Kratom and 7-OH should be regulated, experts agree. They're split on how — STAT, 2026-09-30 (Wayback Machine copy)
19. Temporary Control of 7-Hydroxymitragynine (7-OH) and Related Substances Under the Controlled Substances Act (LSB11457) — Congressional Research Service, 2026-07-17
20. American Kratom Association, EIN 47-2208981, Form 990 data — ProPublica Nonprofit Explorer
21. DEA Will Classify 7-OH as Illegal Drug — Pain News Network, 2026-07-01
22. Global Kratom Coalition Inc, Form 990 data — ProPublica Nonprofit Explorer
23. Global Kratom Coalition Endorses Rep. Bilirakis' Bill to Schedule Concentrated Synthetic 7-OH — Global Kratom Coalition via EZ Newswire, 2026-03-26
24. Holistic Alternative Recovery Trust Inc, Form 990 data — ProPublica Nonprofit Explorer
25. HART Responds to DEA Notice of Intent to Temporarily Schedule 7-OH — Holistic Alternative Recovery Trust, 2026-07-02
26. Kratom Lobby Fights FDA Regulation Push — Legis1, 2026-07
27. As dangerous kratom products go unregulated, lobbyists write the laws — Tampa Bay Times, Deadly Dose investigation, 2023
28. The Scientist Trying to Keep Kratom Legal Has Not Disclosed Longstanding Ties to Kratom Lobbyists — ProPublica, 2025
29. American Kratom Association Files Federal Lawsuit to Protect Natural Kratom Consumers from Misapplication of DEA Temporary Scheduling Order — American Kratom Association, 2026-08-27
30. Senator’s inquiry questions kratom industry’s influence on Trump administrations — NutraIngredients, 2026-08-26
31. Conflicts abound in new Florida push against kratom compound (opinion) — Florida Politics, Peter Schorsch, 2025-02
32. Global Kratom Coalition Ends BGR Government Affairs Contract — Legis1, 2026-06-16
33. Lobbying report, Checkmate Government Relations for client Stop Gas Station Heroin LLC, 4th quarter 2025 — US Senate Office of Public Records, Lobbying Disclosure Act filing
34. How an addictive gas station drug found allies in Trump's cabinet (New York Times, Kenneth P. Vogel and Christina Jewett, 2026-06-15; syndicated copy) — The Philadelphia Inquirer, 2026-06-16
35. 'Enormous Confusion' as Deadline Nears for 7-OH Kratom Ban — Pain News Network, 2026-08-03
36. More than 24,300 Americans urge DEA to reject 7-OH ban — Holistic Alternative Recovery Trust, 2026-07-30
37. 7-HOPE Alliance Applauds 7-OH Comment Extension, Calls on HHS and DEA to Reconsider and Review Emerging Science — 7-HOPE Alliance via EZ Newswire, 2026-09-03
38. R Street Comments on Placement of 7-OH on Schedule I — R Street Institute, 2026-07-31
39. ICE Barbie Successor Has Up to $1M in Shares of 'Gas Station Heroin' Company — The Daily Beast, 2026-05-19
40. Letter from Senator Ron Wyden to Jerry Ross, Botanic Tonics — US Senate Committee on Finance, 2026-08-03
41. Wyden Investigates Trump and RFK Jr. Corruption Favoring Big Tobacco and Kratom Companies — US Senate Committee on Finance, Ranking Member, 2026-08-05
42. RFK Jr. Bails on MAHA Event With MAGA Senator Ashley Moody After Being Cornered on Kratom — The Daily Beast, 2026-08-26
43. FDA and Kratom — US Food and Drug Administration, public health focus page
44. US20210179619A1 / US11760758B2, Mitragynine analogs for the treatment of pain, mood disorders and substance use disorders — Google Patents (assignees Columbia University, Research Foundation for Mental Hygiene, Memorial Sloan Kettering Cancer Center)
45. NCT05114265: Safety, Tolerability, Pharmacokinetics, Analgesic and Respiratory Effect of KUR-101 in Healthy Adult Participants — ClinicalTrials.gov, sponsor Kures, Inc.
46. ATAI Life Sciences N.V., Form 10-K for the fiscal year ended December 31, 2024 — US Securities and Exchange Commission, EDGAR, filed 2025-03-17
47. Sparian Biosciences Awarded $19.5 Million Five-Year NIH/NIDA Grant to Fund Development of SBS-226 for Opiate Use Disorder/Opiate Withdrawal Syndrome Through Phase 1 Clinical Development — Sparian Biosciences via GlobeNewswire, 2024-11-14
48. NIH research clears way for study of experimental treatment for opioid use disorder — National Institutes of Health, 2026-06-01 (Wayback Machine copy; nih.gov refuses automated readers)
49. NCT07204171: Phase 1 Study of Oral MG001 — ClinicalTrials.gov, sponsor National Institute on Drug Abuse
50. Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I (notice of intent, 81 FR 59929) — Drug Enforcement Administration, Federal Register, 2016-08-31
51. Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I (81 FR 70652) — Drug Enforcement Administration, Federal Register, 2016-10-13
52. Letter from Assistant Secretary for Health Brett P. Giroir to DEA Acting Administrator Uttam Dhillon, 2018-08-16, rescinding the 2017 scheduling recommendation (transcription) — Kratom Science, transcription published 2021-02-12
53. 7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat — US Food and Drug Administration, Center for Drug Evaluation and Research, July 2025 (Wayback Machine copy of the PDF)
54. Letter to health care professionals on 7-hydroxymitragynine (7-OH), signed by Commissioner Martin A. Makary — US Food and Drug Administration, 2025-07-29 (Wayback Machine copy of the PDF)
55. New “Gas Station Heroin” Tianeptine Product Trend (letter to health care professionals) — US Food and Drug Administration, 2025-05-08
56. Schedules of Controlled Substances: Placement of Tianeptine in Schedule I (notice of proposed rulemaking, 91 FR 42150) — Drug Enforcement Administration, Federal Register, 2026-07-08
57. The atypical antidepressant and neurorestorative agent tianeptine is a μ-opioid receptor agonist — Translational Psychiatry, 2014, via PubMed Central
58. FDA asks Justice Department to classify gas station products with opioid-like effects as illicit substances — NBC News, 2025-07-29
59. FDA urges crackdown on 7-OH, a potent opioid-like substance sold in gas stations — 6abc Philadelphia (WPVI), 2025-07-30