FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
Read the FDA press release.
On July 29, 2025, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary held a press conference (watch video) to announce a major crackdown on 7-hydroxy mitragynine (7-OH), a concentrated, synthetic byproduct of the kratom plant, which they classified as a dangerous, high-potency opioid.
Key Points from the July 29, 2025 Press Conference:
Focus on 7-OH, Not Plain Leaf Kratom: The officials emphasized that the action targets synthetic 7-OH products—often sold as gummies or shots in gas stations and vape shops—rather than traditional, ground-up botanical kratom leaf.
7-OH Classed as Opioid: FDA officials described 7-OH as a “powerful opioid agonist” that is up to 13 times more potent than morphine, carrying a high risk of addiction.
Scheduling Recommendation: HHS formally recommended that the Drug Enforcement Administration (DEA) schedule 7-OH as an illegal, controlled substance.
Safety Concerns: The move is in response to a surge in overdoses, emergency room visits, and poisonings linked to these concentrated products.
HR8000 END 7-OH Act
The classifies 7-hydroxymitragynine as a schedule I drug.
This bill, as it currently stands, is only looking to ban 7oh.
The SENATOR’S LETTER requesting a FDA ban on plain leaf kratom. Also below, there is an email and contact for each of the senators that signed Senator Ricketts’ Letter. Please reach out to your senators as to the safety and efficacy of pure leaf kratom. Remember always be polite, courteous and respectful.
If you are unsure of what to say, how to say it, or what links and studies to include, please reach out and we can help you. Email us at info@botanicalae.org.
Senators on listed letter are below.
Pete Ricketts, Nebraska
Richard Blumenthal, Connecticut
Jeanne Shaheen, New Hampshire
Mike Crapo, Idaho
Marsha Blackburn, Tennessee
Steve Daines, Montana
James C. Justice, West Virginia
Alex Padilla, California
Katie Boyd Britt, Alabama
Ted Budd, North Carolina
John Boozman, Arkansas
STUDY
Pilot, Dose-Finding Study of Kratom Alkaloids: Study Design Updates – SEE STUDY