7-Hydroxy-mitragynine (“7-OH”)—a naturally occurring alkaloid found in Mitragyna speciosa (kratom)—has become one of the fastest-growing and most controversial ingredients in the supplement and wellness markets. But is it legal?
As with most plant-derived compounds that affect the central nervous system, the answer is complex and depends heavily on evolving federal and state enforcement trends.
FDA Warning Letters and Federal Oversight
The U.S. Food and Drug Administration (FDA) has repeatedly stated that kratom and its alkaloids, including 7-OH, are not approved for any medical use. In July 2025, the agency announced multiple warning letters to firms marketing concentrated 7-OH products as supplements or drugs.
FDA Recommendation to Schedule 7-OH On July 29, 2025, the FDA announced it had recommended that the Drug Enforcement Administration (DEA) classify certain 7-OH products as Schedule I under the Controlled Substances Act, with additional detail via HHS. The FDA also published a consumer update and a public-health report, along with a Dear Colleague letter to clinicians highlighting risks of concentrated 7-OH products.
Scientific and Public Pushback
Not all stakeholders agree with scheduling. Researchers and public-health groups have urged regulators to preserve research access and consider a controlled retail framework. See the Reuters summary of objections and scientific pushback outlining concerns that a ban could chill research and push consumers toward unregulated alternatives.
State Laws and Enforcement Patterns
States are moving quickly on their own regulatory efforts. For example, Florida filed an emergency rule classifying concentrated 7-OH as Schedule I under state law; the Department of Agriculture later reported removing more than 17,000 packages from store shelves. Other jurisdictions have issued health alerts—see Texas DSHS—and are evaluating bans or tighter consumer-protection rules.
What Businesses Should Do Now
Retailers, distributors, and manufacturers of 7-OH products face mounting risk as both federal and state authorities ramp up enforcement. To stay compliant:
• Avoid unapproved medical claims on labeling, advertising, or social media.
• Verify supply-chain legality, including documentation of source material and manufacturing processes.
• Monitor FDA/DEA/state actions and participate in public-comment opportunities.
• Consult experienced regulatory counsel to evaluate exposure under FDA, DEA, and state consumer-protection laws.
In short, the legal environment for 7-OH is changing fast. Businesses that stay ahead of these developments—and proactively adjust their compliance strategies—will be best positioned to navigate enforcement and protect growth.
About Kennyhertz Perry’s Controlled Substances & Hemp Practice
Kennyhertz Perry advises clients on compliance, licensing, and enforcement matters involving hemp, kratom, cannabinoids, and other emerging natural compounds. Our attorneys have defended federal and state enforcement actions and routinely counsel manufacturers and retailers on risk management and regulatory compliance. To learn more about Kennyhertz Perry, LLC, please visit kennyhertzperry.com.
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