Legality
The federal scheduling timeline for 7-OH, pseudoindoxyl and the MGM compounds
Dates, dockets and Federal Register citations from the July 2025 FDA recommendation to the October 14, 2026 notice, and what can happen from November 13, 2026.
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What is the status on 2026-10-20?
Mitragynine pseudoindoxyl, MGM-15 and MGM-16 have been federal Schedule I substances at any concentration since 2026-08-26 under a temporary order published at 91 FR 54948 that expires 2026-08-26 plus two years unless extended or made permanent (91 FR 54948). 7-OH is not yet scheduled; a reissued notice of intent published 2026-10-14 says a temporary order "will be published in the Federal Register on or after November 13, 2026" (91 FR 65370).
Kratom leaf and mitragynine are not federally controlled. The October notice uses mitragynine only inside a ratio test and does not propose to schedule it. Every date below is the Federal Register publication date unless stated.
2025: the FDA recommendation
On 2025-07-29 FDA recommended that concentrated 7-OH products be scheduled, a recommendation HHS described as targeting concentrated 7-OH rather than natural kratom leaf (HHS press room). In June and July 2025 FDA sent seven warning letters to marketers of 7-OH products, stating that 7-OH "is not an FDA-approved drug product" and that no food additive regulation authorizes it, and that as a new dietary ingredient with no pre-1994 marketing history, supplements containing it are adulterated under section 402(f)(1)(B); the letters are recounted in the October 2026 notice (91 FR 65370).
July 2026: two notices of intent
On 2026-07-01 DEA announced its intent to place 7-OH above a threshold, and three related substances, in Schedule I on a temporary basis (DEA press release). Two notices followed on 2026-07-06. Docket DEA-1570, 91 FR 40917, proposed control of botanical material containing "more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis" and of other articles with 7-OH "greater than 0.050 percentage ... or greater than 1.00 milligram of 7-hydroxymitragynine in the article," with no order before 2026-08-05 (91 FR 40917).
The companion notice, docket DEA-1644 at 91 FR 40909, covered mitragynine pseudoindoxyl, MGM-15 and MGM-16 with no threshold; its text is recounted in the August order (91 FR 54948). The July 7-OH notice also stated that natural 7-OH "makes up less than two percent of the total alkaloid content or occurs in trace amount" in the plant. HHS's request-for-information comment period closed 2026-07-31.
August 26, 2026: the first temporary order
On 2026-08-26 DEA published the temporary scheduling order for docket DEA-1644 at 91 FR 54948 (Vol. 91, No. 164, pp. 54948-54956), codified at 21 CFR 1308.11(h)(89) to (91): mitragynine pseudoindoxyl, MGM-15 (dihydro-7-hydroxymitragynine) and MGM-16 (9-fluoro-dihydro-7-hydroxymitragynine), with their isomers, esters, ethers and salts, in Schedule I with no quantity threshold, effective that day and expiring 2028-08-26 unless extended (91 FR 54948).
The order does not list Mitragyna speciosa, mitragynine or 7-OH. DEA described the three substances as "produced through synthetic modifications of purified isolates," and the order required anyone without a Schedule I registration to surrender held quantities, with 30 days for existing registrants to update inventory, labeling and records. The same day DEA extended the comment period on the 7-OH notice to 2026-09-10 (FR Doc. 2026-17409).
The lawsuit and its resolution
On 2026-08-27 the American Kratom Association announced a suit in the U.S. District Court for the District of Columbia, case 1:26-cv-02997, seeking a declaration that the August order does not reach botanical kratom whose pseudoindoxyl or MGM content is naturally occurring or trace-level, citing accredited-laboratory detection of trace pseudoindoxyl in unprocessed leaf (AKA release). No stay was reported. On 2026-10-09 the association said it had agreed to dismiss the suit conditioned on DEA publishing the revised order as submitted to the court (PNN, October 9, 2026). The docket itself was not retrieved by the research, so the dismissal is reported, not verified.
October 2026: the reissued notices
On 2026-10-09 the Department of Justice announced that DEA would reissue the 7-OH notice to reflect an updated HHS scientific recommendation, issue a new notice for mitragynine pseudoindoxyl with the same thresholds, and reissue the MGM-15 and MGM-16 notice without changing its approach; the August controls stay in effect meanwhile (DOJ release).
On 2026-10-14 the reissued DEA-1570 notice appeared at 91 FR 65370 (pp. 65370-65381), based on an HHS letter dated 2026-10-08. It proposes control of 7-OH and mitragynine pseudoindoxyl when a product exceeds "1 mg per gram (for solid powders, encapsulated material, or other solid forms) or greater than 1 mg per milliliter (for liquid preparations)," alone or combined, or when the mass of mitragynine divided by the mass of those compounds "is less than 100." It withdraws the July notice, keeps the August pseudoindoxyl control in force until the new order publishes or the old one expires, and says an order may issue "on or after November 13, 2026" for two years with a possible one-year extension (91 FR 65370).
The same issue carried the reissued DEA-1644 notice for MGM-15 and MGM-16 at 91 FR 65381-65387, keeping the no-threshold approach; it cites an HHS letter dated 2026-10-06 and states that the August order remains in effect until the new order publishes or 2028-08-26 (91 FR 65381). The research could not retrieve the separate withdrawal document for the July notice, and notes that the two October documents cite HHS letters of different dates.
What can happen on or after November 13, 2026?
A temporary scheduling order may publish any day from 2026-11-13. If it does, any product over the thresholds becomes a Schedule I article nationally, non-mailable under the Controlled Substances Act regardless of carrier policy, for two years. DEA cautioned in the notice that people "should not infer" that below-threshold levels are "safe for consumption" (91 FR 65370).
This store's Federal Register watcher reads the DEA and FDA document feed daily and is seeded with docket DEA-1570 so that the first alert is this one. A final rule with an effective date schedules the matching product class for removal on that date; a leaf-derived extract whose report shows 7-OH not detected with a stated limit of quantitation is below both prongs. See what this store does not sell and the state policy.
What else is in motion?
H.R. 8000, the END 7-OH Act, introduced 2026-03-19, would permanently schedule synthetic 7-OH while excluding naturally occurring 7-OH in kratom; the research found no movement past committee (H.R. 8000). The Congressional Research Service has summarized the federal posture in Legal Sidebar LSB11457 (CRS). DEA has separately proposed placing tianeptine in Schedule I, a substance this store has never carried.
General information, not personalized guidance.
Sources
- HHS press room: FDA 7-OH scheduling recommendation (July 29, 2025) U.S. Department of Health and Human Services (accessed 2026-10-20)
- DEA to temporarily schedule 7-OH and related substances to protect public (press release, July 1, 2026) Drug Enforcement Administration (accessed 2026-10-20)
- 91 FR 40917, notice of intent, docket DEA-1570 (July 6, 2026), FR Doc. 2026-13580 Federal Register via GovInfo (accessed 2026-10-20)
- 91 FR 54948, temporary scheduling order, docket DEA-1644 (August 26, 2026), FR Doc. 2026-17429 Federal Register via GovInfo (accessed 2026-10-20)
- Extension of comment period on the 7-OH notice (August 26, 2026), FR Doc. 2026-17409 Federal Register (accessed 2026-10-20)
- Department of Justice announces updates to emergency scheduling actions on 7-OH and related substances (October 9, 2026) U.S. Department of Justice (accessed 2026-10-20)
- 91 FR 65370, notice of intent, docket DEA-1570 reissued (October 14, 2026), FR Doc. 2026-20943 Federal Register via GovInfo (accessed 2026-10-20)
- 91 FR 65381, notice of intent, docket DEA-1644 reissued for MGM-15 and MGM-16 (October 14, 2026), FR Doc. 2026-20942 Federal Register via GovInfo (accessed 2026-10-20)
- CRS Legal Sidebar LSB11457 Congressional Research Service (accessed 2026-10-20)
- H.R. 8000, END 7-OH Act (introduced March 19, 2026) Congress.gov (accessed 2026-10-20)
- American Kratom Association files federal suit (August 27, 2026) Yahoo Finance (press release distribution, secondary) (accessed 2026-10-20)
- DEA's 7-OH order amended; ban to take effect Nov 13 (October 9, 2026) Pain News Network (secondary) (accessed 2026-10-20)
Related questions
What happens on November 13, 2026?
Nothing automatically. November 13 is the earliest date DEA may publish a temporary order placing 7-hydroxymitragynine and mitragynine pseudoindoxyl above 1 mg per gram or...
Is kratom a federally controlled substance?
No, as of 2026-10-20. Kratom leaf and mitragynine are not scheduled; three related compounds (mitragynine pseudoindoxyl, MGM-15 and MGM-16) have been Schedule I since 2026-08-26...
What is the 1 mg per gram 7-OH threshold?
The line in DEA's October 14, 2026 notice: a product becomes a Schedule I article if it holds more than 1 mg of 7-OH or mitragynine pseudoindoxyl per gram (solid) or per...
Is 7-OH the same thing as kratom?
No. 7-OH is 7-hydroxymitragynine, one alkaloid that DEA says makes up "less than two percent of the total alkaloid content" of the plant; products sold as "7-OH" are concentrated...