What is DEA scheduling in simple terms?

DEA scheduling is the U.S. federal regulatory process for placing a substance into one of five schedules under the Controlled Substances Act, based on accepted medical use and potential for abuse. Schedule I is the most restrictive.

Has 7-OH been scheduled by the DEA?

As of May 2026, no. The FDA recommended Schedule I status for 7-hydroxymitragynine in July 2025; the DEA had not published a final scheduling rule by May 2026. The 2016 DEA notice of intent to schedule mitragynine and 7-OH was withdrawn after public response.

Has mitragynine been scheduled by the DEA?

No. The 2016 DEA notice of intent was withdrawn, and the FDA's 2025 recommendation specifically named 7-hydroxymitragynine, not mitragynine. Mitragynine and kratom remain federally legal in most U.S. states as of May 2026, though state-level restrictions apply in several jurisdictions.

What is the difference between Schedule I, II, and III?

Schedule I substances have no currently accepted medical use and a high potential for abuse. Schedule II substances have currently accepted medical use but high abuse potential. Schedule III substances have currently accepted medical use and lower (relative to II) abuse potential. Schedules IV and V are progressively less restrictive.

What is emergency scheduling?

Emergency scheduling under 21 U.S.C. § 811(h) allows the DEA to temporarily schedule a substance posing an imminent hazard, bypassing the standard public-comment process. Emergency scheduling is initially time-limited and can be made permanent through the standard process.

Regulatory & Compliance

DEA Scheduling

At-a-glance comparison

Spec	Value
Statutory framework	U.S. Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq.
Authority	U.S. Drug Enforcement Administration (DEA)
Schedules	Schedule I, II, III, IV, V (most to least restrictive)
Scheduling triggers	FDA scientific/medical recommendation; DEA-initiated investigation; international treaty obligation
Process steps	FDA evaluation → DEA proposed rule → public-comment period → DEA final rule
Emergency scheduling	Permitted under 21 U.S.C. § 811(h) for substances posing imminent hazard; can be made permanent
Kratom history	DEA notice of intent to emergency-schedule mitragynine and 7-OH (August 2016); withdrawn October 2016
7-OH status (May 2026)	FDA recommended Schedule I in July 2025; final DEA action pending

What is DEA scheduling?

DEA scheduling is the U.S. federal regulatory process by which the Drug Enforcement Administration places a substance into one of five schedules established by the Controlled Substances Act (CSA). The schedule a substance occupies determines the conditions under which it can be manufactured, distributed, prescribed, possessed, and researched. Schedule I is the most restrictive and is reserved for substances the DEA determines have no currently accepted medical use and a high potential for abuse. Schedule V is the least restrictive.

The CSA was enacted in 1970 and is codified at 21 U.S.C. § 801 et seq. The DEA administers scheduling decisions in coordination with the U.S. Food and Drug Administration, which provides the scientific and medical evaluation that informs DEA decisions.

How does the scheduling process work?

A substance can come to DEA's attention through several pathways: an FDA scientific/medical recommendation, a DEA-initiated investigation, or an international treaty obligation. When the FDA evaluates a substance for potential scheduling, the agency conducts an eight-factor analysis (codified at 21 U.S.C. § 811(c)) covering chemistry, pharmacology, abuse potential, public-health risk, and other factors. The FDA then submits a recommendation to the DEA.

If the DEA agrees with the recommendation, it issues a proposed rule placing the substance in a schedule, opens a public-comment period (typically thirty to sixty days), considers the comments received, and issues a final rule placing the substance in the recommended schedule. The final rule is published in the Federal Register and takes effect on a date specified in the rule. Substances posing an imminent hazard can be emergency-scheduled under 21 U.S.C. § 811(h), bypassing the standard process; such emergency scheduling is initially temporary and can be made permanent through the standard process.

DEA scheduling history of kratom alkaloids

In August 2016, the DEA published a notice of intent to emergency-schedule mitragynine and 7-hydroxymitragynine as Schedule I substances. The notice cited concerns about abuse potential and reports of adverse events. A substantial public response - including comments from researchers, public health organizations, and members of the U.S. Congress - led the DEA to formally withdraw the proposed scheduling in October 2016. The withdrawal cited the public response and a determination that more research was warranted.

In July 2025, the U.S. Food and Drug Administration formally recommended that the DEA place 7-hydroxymitragynine in Schedule I. The recommendation specifically targeted 7-OH as an isolated and concentrated form rather than kratom or mitragynine broadly. As of May 2026, no final DEA action on the 2025 recommendation had been published.

Common questions about dea scheduling

What is DEA scheduling in simple terms?: DEA scheduling is the U.S. federal regulatory process for placing a substance into one of five schedules under the Controlled Substances Act, based on accepted medical use and potential for abuse. Schedule I is the most restrictive.
Has 7-OH been scheduled by the DEA?: As of May 2026, no. The FDA recommended Schedule I status for 7-hydroxymitragynine in July 2025; the DEA had not published a final scheduling rule by May 2026. The 2016 DEA notice of intent to schedule mitragynine and 7-OH was withdrawn after public response.
Has mitragynine been scheduled by the DEA?: No. The 2016 DEA notice of intent was withdrawn, and the FDA's 2025 recommendation specifically named 7-hydroxymitragynine, not mitragynine. Mitragynine and kratom remain federally legal in most U.S. states as of May 2026, though state-level restrictions apply in several jurisdictions.
What is the difference between Schedule I, II, and III?: Schedule I substances have no currently accepted medical use and a high potential for abuse. Schedule II substances have currently accepted medical use but high abuse potential. Schedule III substances have currently accepted medical use and lower (relative to II) abuse potential. Schedules IV and V are progressively less restrictive.
What is emergency scheduling?: Emergency scheduling under 21 U.S.C. § 811(h) allows the DEA to temporarily schedule a substance posing an imminent hazard, bypassing the standard public-comment process. Emergency scheduling is initially time-limited and can be made permanent through the standard process.

References

U.S. Controlled Substances Act. 21 U.S.C. § 801 et seq.
U.S. Drug Enforcement Administration. 21 CFR Part 1308 - Schedules of Controlled Substances.
U.S. Drug Enforcement Administration. (2016). Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine into Schedule I. Federal Register, 81 FR 70652 (Oct. 12, 2016).
U.S. Food and Drug Administration. (2025, July). Recommendation to schedule 7-hydroxymitragynine.
American Kratom Association. AKA legislative resources. https://www.americankratom.org

Important safety information:

Products containing 7-hydroxymitragynine (7-OH) are sold for adult use only (21+). These statements have not been evaluated by the U.S. Food and Drug Administration. Products are not intended to diagnose, treat, cure, or prevent any disease. The FDA has raised safety concerns regarding concentrated 7-OH products; consult a qualified healthcare professional before use. Do not operate vehicles or machinery after use. Keep out of reach of children and pets. Laws vary by state, buyers are responsible for knowing applicable law.

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