High urgency

Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

Detected July 5, 2026 · in Dietary-Supplement Labeling (FDA)

DEA proposes temporary Schedule I placement for 7-hydroxymitragynine above a specified threshold, making it illegal to manufacture, distribute, or possess without DEA registration. This directly impacts dietary supplement businesses using kratom-derived ingredients.

Aforeworn detected this change in the Dietary-Supplement Labeling (FDA) space on July 5, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Supplement brands, contract manufacturers, private-label sellers, and ingredient suppliers that handle kratom extracts or products containing 7-hydroxymitragynine above the threshold. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective upon publication in Federal Register (expected soon). Temporary order lasts up to 2 years, with possible extension.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Dietary-Supplement Labeling (FDA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

7-hydroxymitragynine above a specified threshold is temporarily placed in Schedule I, making it a controlled substance with no accepted medical use and high abuse potential.

Who it affects

Supplement brands, contract manufacturers, private-label sellers, and ingredient suppliers that handle kratom extracts or products containing 7-hydroxymitragynine above the threshold.

What you must do

Immediately cease manufacturing, distributing, or selling products containing 7-hydroxymitragynine above the threshold unless registered with DEA. Review inventory and supply chain for affected ingredients.

Deadline

Effective upon publication in Federal Register (expected soon). Temporary order lasts up to 2 years, with possible extension.

Source: https://www.federalregister.gov/documents/2026/07/06/2026-13580/schedules-of-controlled-substance-temporary-placement-of-7-hydroxymitragynine-above-a-specified

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