On July 29, 2025, the U.S. Food and Drug Administration (FDA) formally requested that the Drug Enforcement Administration (DEA) classify 7-hydroxy mitragynine (7-OH) as a Schedule I controlled substance. 7-OH is a powerful compound found in small quantities in the kratom plant. It is known to produce opioid-like effects and has no FDA-approved medical use.
Although it is still uncertain whether 7-OH will be scheduled, the FDA’s request signals increased federal scrutiny. Businesses involved in the sale, manufacture, or distribution of kratom products should stay informed and prepare for possible regulatory changes.
What Is 7-OH?
7-OH is a naturally occurring alkaloid in kratom. Scientific studies have shown that it interacts with opioid receptors in the brain and may be largely responsible for kratom’s pain-relieving properties. However, the FDA has raised concerns about its potency and abuse potential when isolated or concentrated.
In recent months, the FDA has tested products on the market and found some that contained elevated levels of 7-OH. In response, the agency issued warning letters to two companies for marketing these products as dietary supplements. The FDA warned that such marketing violates federal law and could result in enforcement actions.
What Happens if 7-OH Is Scheduled?
If the DEA agrees to schedule 7-OH under the Controlled Substances Act, the compound would be placed in Schedule I, alongside substances like heroin and LSD. This would make it illegal to manufacture, possess, or distribute 7-OH in any form.
While scheduling is not guaranteed, the possibility alone raises compliance risks for kratom-related businesses. Companies operating in this space should consider reviewing their business structures, formulations, and product claims.
What Kratom Businesses Should Do Now
The evolving regulatory landscape presents legal and operational challenges. Businesses that use kratom in their products, especially those involved in extraction or formulation, should take proactive steps.
One key area is corporate governance. Even if 7-OH is not scheduled immediately, companies should address the potential for scheduling in their corporate documents. Doing so may help protect the business, manage investor risk, and guide future decisions.
How LumaLex Supports the Kratom Industry
At LumaLex Law, we assist kratom-related businesses across the supply chain providing legal guidance on compliance, regulatory preparedness, and corporate structuring within the bounds of current law.
Our services include:
- Business formation and restructuring
- Risk assessments for kratom ingredients
- Labeling and marketing compliance
- Regulatory guidance tailored to the kratom industry
As the FDA and DEA continue to evaluate kratom compounds like 7-OH, we aim to help our clients take preventive legal steps with the goal of staying ahead of potential issues.
Staying Ahead of Federal Action
While the FDA’s request to schedule 7-OH is still under review, the agency’s actions show an increasing focus on kratom products. Companies that work with kratom should remain aware of these developments and be ready to adjust.
LumaLex is here to provide guidance as the regulatory landscape evolves. We assist kratom businesses in understanding their obligations and preparing for what’s next.
