DEA Publishes Federal Register Notice of Intent to Schedule 7-OH Above 0.050% Threshold

Why it matters

The DEA's formal Federal Register filing sets a precise 0.050% by dry-weight threshold that will determine which kratom products are swept into Schedule I — affecting millions of consumers, hundreds of vendors, and future research pathways. The temporary order is expected to take effect around August 5, 2026.

The big picture

On July 6, 2026, the DEA published Docket No. DEA-1570, the formal Notice of Intent initiating temporary Schedule I placement for 7-hydroxymitragynine (7-OH) above a specified concentration. The action follows a March 2026 HHS endorsement and cites escalating poison control data, FDA adverse events, and DEA toxicology findings. Between 2020 and 2025, confirmed 7-OH detections in fatal overdose cases increased significantly, though nearly all involved polydrug combinations. A 30-day public comment period closes July 31, 2026, before a final temporary order publishes on or after August 5.

Key findings

• Products must contain more than 0.050% 7-OH by dry weight OR more than 1.00 mg per serving to fall under the scheduling threshold — natural whole-leaf kratom at approximately 0.01–0.02% falls below the Part A threshold
• DEA lab data identified 250 commercial 7-OH products between September 2024 and February 2025; single-dose concentrations ranged from 1 mg to 700 mg
• The DEA Toxicology Testing Program found 7-OH in 85 overdose cases since 2019 — 55 fatal, 30 non-fatal — with an average blood concentration of 463.23 ng/mL; most cases involved co-ingestion with fentanyl, benzodiazepines, or other opioids
• Poison control centers recorded 165 7-OH exposure cases in the first seven months of 2025; 35% of single-substance cases resulted in serious health outcomes; 67% required healthcare facility treatment
• Nine states had already prohibited 7-OH consumption before the federal action; 19 states have enacted the Kratom Consumer Protection Act model legislation

What they say

The DEA's filing states that 7-OH products "sold as dietary supplements pose significant health risks to users because information on their purity, identity, quantity and safety is unknown," and notes that "consumers of raw plant matrix may experience a modified or attenuated physiological effect due to the competitive, co-occurring alkaloids inherent to M. speciosa" — an acknowledgment that whole-leaf botanical kratom is pharmacologically distinct from isolated or concentrated 7-OH.

Bottom line

**The 1 mg per serving limit is the operative threshold for most concentrated products — and the public has until July 31, 2026 to file comments before the temporary Schedule I order takes effect around August 5.**