The Regulatory Landscape and Legal Gray Areas of 7-OH Products

Unlike whole-leaf kratom, which remains in a patchwork of legality across U.S. states, 7-hydroxymitragynine (7-OH) sits in a more precarious smurph It’s a naturally occurring alkaloid in kratom but is present in very small amounts in the plant. The 7OH+ brand uses extracts that concentrate this alkaloid to levels far beyond what’s found in nature. This higher potency has put 7-OH under the microscope of both state and federal regulators.

FDA’s Position

The U.S. Food and Drug Administration (FDA) has publicly stated that 7-OH, especially in concentrated form, is not approved for use in dietary supplements or food products. The agency cites potential for abuse, addiction, and adverse health outcomes, and in 2025 it formally recommended placing 7-OH into Schedule I of the Controlled Substances Act.

Schedule I substances are defined as having no accepted medical use and a high potential for abuse, putting them alongside drugs like heroin and LSD if the classification is finalized.

DEA Involvement

While the Drug Enforcement Administration (DEA) has not yet officially scheduled 7-OH, it has signaled interest in reviewing the FDA’s recommendation. The DEA has authority to move quickly on such requests, sometimes in less than a year, particularly if public health concerns are documented.

State-Level Actions

Some states already ban synthetic kratom alkaloids or kratom derivatives by name, and depending on how legislation is worded, concentrated 7-OH could fall into that category. For example:

Alabama, Indiana, Vermont, and Wisconsin have strict kratom bans that may encompass derivatives like 7-OH.

States with Kratom Consumer Protection Acts (KCPA) may still allow 7-OH products, but labeling and age restrictions are often imposed.

The Loophole of “Naturally Occurring”

7OH+ and similar companies often point to the fact that 7-OH is a naturally occurring compound in kratom, even if it is being extracted and concentrated. This argument has been used to maintain legality in certain jurisdictions, but regulators are increasingly differentiating between “natural presence” and “highly concentrated, altered products.”

International Restrictions

Outside the U.S., countries like Australia, Denmark, Finland, Malaysia, and New Zealand have already banned 7-OH along with kratom. In many cases, the ban includes any derivatives or extracts containing alkaloids from the plant, regardless of concentration.

What This Means for Consumers

For someone purchasing a 7OH+ product, legality depends heavily on location and timing:

Today’s legality could change in a matter of months.

Ordering across state lines could become risky if regulations tighten mid-shipment.

Travelers may unknowingly cross into a jurisdiction where possession of 7-OH is treated as a criminal offense.

Final Thoughts

The legal landscape of 7-OH is shifting rapidly. While 7OH+ continues to operate in compliance with current laws, consumers need to stay informed. The FDA’s push toward Schedule I classification could fundamentally change access in the near future, and anyone using or selling 7-OH products should be prepared for sudden changes in availability and legality.