Key Reporting Points

• FDA has not established kratom as safe. In 2023, the FDA denied a New Dietary Ingredient application, stating it could not establish safety or even basic identity.
• Overdose deaths with kratom detected exceed 5,000 since 2020. CDC SUDORS data show more than 5,000 deaths with mitragynine present, and that count includes only participating jurisdictions.
• Poison control centers received 8,555 kratom-related calls from 2019-2024. In 2024 alone, there were more than 1,600 exposures, including 150 pediatric cases. Children under five are a fast-growing exposure group.
• Controlled studies do not mirror retail products. Industry-funded research often uses pure product in healthy adults for short periods, unlike variable products sold in gas stations and vape shops.
• Kratom Consumer Protection Acts are often drafted by industry advocates. These bills create an appearance of regulation but do not require warnings about dependence, withdrawal, or opioid-like effects.
• Law enforcement cannot currently perform routine roadside testing for 7-hydroxymitragynine, the more potent metabolite formed in the body, making impaired driving cases difficult to prosecute.

What to Verify

• FDA NDI denial: Johnson Foods' 2023 application was rejected because the agency could not establish identity or safety.
• CDC SUDORS definitions: SUDORS distinguishes between substances "detected" and substances "involved" in the cause of death. Both metrics are tracked separately.
• Poison control NPDS data: Annual reports from America's Poison Centers include case counts, severity, and pediatric exposures. These are verified reports, not projections.
• Adverse event reports: FAERS and CAERS contain more than 2,200 kratom-related reports, including nearly 1,000 deaths. These are spontaneous reports and signal potential risks.

Press Release Template

Use this template to announce local actions, events, or responses to industry announcements.

Backgrounder: Key Facts Every Journalist Should Know

• What is kratom? A tropical tree, Mitragyna speciosa, whose leaves contain mitragynine and 7-hydroxymitragynine, compounds that bind to mu-opioid receptors.
• Legal status: No FDA-approved kratom drug products. Not a lawful dietary ingredient. FDA has issued multiple import alerts.
• Industry lobbying: The American Kratom Association has promoted state-level KCPA bills that preempt bans but do not require warnings about dependence or withdrawal.
• Key data sources:
  • FDA CAERS/FAERS: more than 2,200 adverse event reports, nearly 1,000 deaths.
  • CDC SUDORS: more than 5,000 overdose deaths with mitragynine detected from 2020-2024.
  • Poison control: 8,555 exposures from 2019-2024, including 700+ pediatric cases.
• Human research: Clinical trials show dose-dependent increases in subjective drug effects, liver enzyme elevations, and adverse events requiring participant withdrawal.
• What consumers do not see: Kratom is metabolized into a more potent opioid-active metabolite, 7-OH. Retail products often lack quality control. Testing has found contamination with heavy metals, salmonella, synthetic substances, and high ethanol levels.