Overview

• The FDA sent seven warning letters on July 16 to firms illegally marketing products containing 7-hydroxymitragynine in supplements, foods and unapproved drugs
• Florida Senate Bill 1734’s failure in early 2025 left 7-OH unscheduled in the state, spurring a wave of lawsuits over its sale and safety claims
• Independent reviews of FDA Adverse Event Reporting System data found no confirmed deaths from 7-OH alone among over half a billion estimated doses and only five serious adverse events
• A 2025 pilot study in dogs given up to ten times typical human doses observed only mild, temporary drooling with full recovery and no lasting harm
• Scientists and industry advocates are calling for mandatory third-party testing, clear labeling and adult-only sales instead of outright prohibition