HHS recommends revised 7-OH and MGPI thresholds for temporary scheduling

Why it matters

The revised recommendation would use both concentration and alkaloid ratios to distinguish concentrated 7-OH and mitragynine pseudoindoxyl (MGPI) products from botanical kratom. New DEA notices of intent start a further scheduling process; they do not themselves put the revised thresholds into effect.

The big picture

HHS issued its updated recommendation after reviewing scientific data and public comments. DOJ says the August 26 temporary controls on MGPI, MGM-15 and MGM-16 remain in effect during the new notice period and until a new order is issued. DOJ also states that DEA had not yet issued a temporary scheduling order for 7-OH.

Key findings

• HHS recommends control when 7-OH or MGPI alone, or their combined amount if both are present, exceeds 1 milligram per gram in solids or 1 milligram per milliliter in liquids.
• An alternative trigger is a mitragynine-to-7-OH, MGPI or combined 7-OH/MGPI mass ratio below 100 to 1; either test would trigger control.
• DEA is issuing new notices of intent, with revised thresholds for 7-OH and MGPI and an unchanged scheduling approach for MGM-15 and MGM-16.
• Existing temporary controls on MGPI, MGM-15 and MGM-16 remain in effect; the revised 7-OH/MGPI approach requires a later temporary order after the notice period.
• The DEA notice explicitly says below-threshold products have not been found safe; preclinical potency findings do not establish a safe human dose.

What they say

HHS says the recommendation is designed to target concentrated or chemically altered products while distinguishing them from botanical kratom containing trace amounts of 7-OH and MGPI.

Bottom line

The revised thresholds are a proposed basis for temporary scheduling, while existing derivative controls remain in place and below-threshold safety is unproven.