HHS and FDA Formally Commend DEA's 7-OH Scheduling Action, Detail 30-Day Public Comment Period on Threshold Level

Why it matters

HHS and FDA's joint statement formalizes the inter-agency scientific basis for the DEA scheduling action and opens a 30-day public comment window on the specific 7-OH concentration threshold — giving researchers, manufacturers, and consumers an opportunity to submit data before final orders take effect.

The big picture

The HHS press release provides the regulatory roadmap behind the DEA's July 1, 2026 action. It clarifies that MP and the MGM compounds are synthetic derivatives that do not occur naturally in the kratom plant, and that scheduling does not intend to capture botanical leaf kratom. The statement also traces a two-year enforcement arc: FDA warning letters in July 2025, federal seizures in December 2025, and the HHS scientific recommendation to the DEA. The public RFI process now underway is the final step before temporary scheduling orders become legally binding.

Key findings

• HHS issued a Request for Information (RFI) concurrent with DEA's Notice of Intent, seeking public comment specifically on whether the proposed 7-OH threshold level is scientifically supported
• MP (mitragynine pseudoindoxyl) is a chemical rearrangement product of 7-OH; MGM-15 and MGM-16 are fully synthetic derivatives — none occur naturally in the kratom plant
• After the 30-day RFI comment period, OASH will forward submissions to the Attorney General, who may then issue a temporary scheduling order valid for up to two years
• FDA seized approximately $1 million in unlawful 7-OH dietary supplement products from three Missouri firms in December 2025
• HHS Secretary Kennedy stated that 7-OH, MP, MGM-15, and MGM-16 are "dangerous opioids that fuel addiction and put American lives at risk"

What they say

"I commend the DEA for taking decisive action to address these addictive and harmful substances," said HHS Secretary Robert F. Kennedy, Jr. "7-OH, MP, MGM-15, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk. HHS reviewed the science and recommended this action."

Bottom line

HHS and FDA have opened a 30-day public comment period on the 7-OH concentration threshold — stakeholders with scientific data on where the danger threshold lies should submit comments now before final scheduling orders take effect.