US Moves to Tighten Controls on Kratom-Related Opioid Substances

The US Department of Justice has announced revised emergency scheduling actions targeting four potent opioid substances associated with kratom, introducing new concentration thresholds to distinguish naturally occurring compounds from products in which they have been enhanced or concentrated.

The measures cover 7-hydroxymitragynine (7-OH), mitragynine pseudoindoxyl (MGPI), MGM-15 and MGM-16. The Drug Enforcement Administration (DEA) will issue two new notices of intent, drawing on updated scientific assessments and recommendations from the Department of Health and Human Services (HHS).

For 7-OH and MGPI, the revised approach would apply Schedule I controls when either substance individually, or their combined amount when both are present, exceeds one milligram per gram in solid products or one milligram per millilitre in liquid products. The threshold would also apply when the ratio of mitragynine to 7-OH, MGPI or their combined amount falls below 100 to one.

The thresholds are intended to distinguish products containing concentrated amounts of the substances from botanical kratom, which naturally contains relatively low levels of 7-OH. HHS said emerging scientific evidence also suggests that MGPI may occur in trace amounts in some botanical or kratom-derived products, although research on its presence remains ongoing.

Attorney General Todd Blanche said the measures were intended to restrict access to potentially harmful substances and hold drug traffickers accountable.

"Dangerous and addictive opioids do not belong behind convenience store counters," Blanche said.

The DEA will reissue its notice of intent for MGM-15 and MGM-16 without changing the existing scheduling approach for those substances. A separate notice covering 7-OH and MGPI will incorporate the revised concentration and ratio thresholds recommended by HHS.

The four substances are subject to different scheduling considerations under the updated process. The DEA temporarily placed MGPI, MGM-15 and MGM-16 in Schedule I on August 26, 2026. Those controls will remain in place during the new 30-day notice period and until the agency issues a replacement temporary scheduling order.

The latest actions follow an updated scientific review intended to refine how kratom-related substances are regulated. The distinction is significant because the revised approach seeks to target concentrated formulations while accounting for trace amounts of naturally occurring compounds in botanical products.

The notices of intent will begin new 30-day periods for the scheduling process. The Justice Department has not said in the supplied announcement when the revised controls will be finalised.

Source: FSX Business News