Alert: Federal Regulatory Updates Impacting 7-OH and MGPI - Comment Period Extended, New Ban with Enforcement Discretion

The Office of the Assistant Secretary for Health (OASH) has extended the public comment period for the proposed Schedule I placement of 7-hydroxymitragynine (7-OH). The new deadline for comments is September 10, 2026. OASH is specifically seeking input on the allowable 7-OH threshold in kratom products, not broader policy questions or the general safety of kratom.

Separately, Mitragynine Pseudoindoxyl (MGPI), MGM-15, and MGM-16 are now officially banned as Schedule I controlled substances until August 26, 2028. While the Drug Enforcement Administration (DEA) has previously considered MGPI synthetic, they now acknowledge the possibility of its natural occurrence. The DEA has issued a statement confirming that this action targets 'deliberately manufactured and concentrated opioid products, not traditional botanical kratom.' They will exercise enforcement discretion for 'incidental trace amounts' of MGPI found in products otherwise consistent with botanical kratom, acknowledging unresolved scientific questions regarding its natural occurrence or presence due to processing. However, this policy does not create a legal exemption, leaving the determination of 'incidental trace amounts' to DEA discretion.

Source: Kratom Science via Sentinel Newsroom