Federal Agencies Seek Public Input Before Temporary Scheduling of Synthetic 7-OH Compounds
On July 13, 2026, federal health and law enforcement agencies provided an update on the ongoing effort to temporarily regulate 7-hydroxymitragynine (7-OH) and several related synthetic compounds under the Controlled Substances Act (CSA). The announcement builds upon actions first initiated on July 1, 2026, as the U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) continue evaluating how to address emerging synthetic opioid-like products while distinguishing them from naturally occurring kratom.
The agencies emphasized that the proposed action is specifically designed to target highly concentrated and synthetic 7-OH products, rather than traditional botanical kratom leaves that contain only naturally occurring trace amounts of the compound.
DEA Begins Temporary Scheduling Process
Earlier this month, the DEA formally initiated the temporary scheduling process by publishing a Notice of Intent (NOI) announcing plans to place certain 7-OH products into Schedule I of the Controlled Substances Act.
The proposal applies to:
- 7-hydroxymitragynine (7-OH) when present above a proposed concentration threshold.
- Mitragynine pseudoindoxyl (MP).
- MGM-15.
- MGM-16.
According to federal officials, the three latter compounds are synthetic derivatives that do not naturally occur in the kratom plant and are therefore treated separately from botanical kratom products.
If finalized, these substances would become subject to the criminal, civil, and administrative provisions that govern Schedule I controlled substances.
HHS Opens Public Comment Period
At the same time the DEA published its Notice of Intent, the Department of Health and Human Services (HHS) issued a separate Request for Information (RFI) inviting public participation in the decision-making process.
The agency opened a 30-day public comment period to gather scientific evidence and technical input regarding the concentration threshold proposed by the DEA.
Rather than requesting comments on whether the compounds should be regulated, HHS is specifically seeking data that could help determine the most appropriate threshold for temporary scheduling.
Key Questions Being Considered
Through the Request for Information, HHS is asking researchers, healthcare professionals, industry representatives, and other stakeholders to provide evidence addressing two primary questions.
First, the agency is seeking scientific data that supports either the DEA's proposed threshold or an alternative concentration level. Specifically, officials want to determine what amount of 7-hydroxymitragynine in a commercial product should be considered an imminent hazard to public safety.
Second, HHS is requesting information on whether different methods of measuring or expressing 7-OH concentrations may provide a more accurate or practical regulatory standard.
The goal is to ensure any future scheduling order is supported by the best available scientific evidence while providing clear guidance for manufacturers, retailers, laboratories, and enforcement agencies.
Focus Remains on Synthetic and Highly Concentrated Products
Federal agencies reiterated that the proposal is not intended to prohibit natural kratom leaf products that contain only naturally occurring trace levels of 7-OH.
Instead, regulators are directing their attention toward products containing synthetically produced or highly concentrated forms of the compound that are increasingly available through commercial channels.
Officials have expressed concern that many of these products contain significantly higher levels of 7-OH than would ever be found in the natural plant, potentially increasing the risk of misuse, dependence, overdose, and other serious health consequences.
By establishing a concentration threshold, regulators hope to distinguish traditional botanical products from manufactured products that may present substantially greater public health risks.
What Happens Next?
Under the Controlled Substances Act, the Attorney General may issue a temporary scheduling order no sooner than 30 days after publication of the Notice of Intent.
If the Attorney General determines that scheduling is necessary to prevent an imminent threat to public safety, qualifying 7-OH products exceeding the established threshold may be placed into Schedule I on a temporary basis.
Federal law allows a temporary scheduling order to remain in effect for up to two years, giving regulators time to complete additional scientific reviews and determine whether permanent scheduling is warranted.
Balancing Public Safety and Scientific Evidence
The current review represents another step in the federal government's broader effort to respond to emerging synthetic opioid-like substances while ensuring regulatory decisions are grounded in scientific evidence.
By inviting public input before establishing a final concentration threshold, the DEA and HHS aim to create a policy that targets synthetic and highly concentrated 7-OH products without unnecessarily affecting traditional botanical kratom products that naturally contain only trace amounts of the compound.
The outcome of the public comment period will help shape the final temporary scheduling order and may influence how these products are regulated in the United States moving forward.
Source: FDA