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HomeMy WebLinkAboutAmerican Kratom Association Letter American Kratom Association + 13575 Heathcote Boulevard, Suite 320 + Gainesville, VA 20155 September 2025 1 AMERICAN KRATOM ASSOCIATION POLICY BRIEF A Legislator’s Guide to Natural Leaf Kratom (mitragynine) Versus 7-Hydroxymitragynine (7-OH) Background Kratom (Mitragyna speciosa) is a tropical tree na4ve to Southeast Asia, par4cularly Indonesia, Thailand, and Malaysia. For centuries, its leaves have been used by laborers in fields in Southeast Asia for an energy boost and for minor pain relief. In the United States, kratom is widely used as (1) a replacement for a cup of coffee for an energy boost and increased focus; (2) a natural alterna4ve to manage common aches and pain, anxiety, and; (3) to support individuals suffering from acute and chronic pain, and for those in that category who are trapped in opioid addic4ons, kratom has been found to help those addicted to opioids to wean off those highly addic4ve and poten4ally deadly opioids. 7-OH is not present in the natural kratom plant. It is a metabolite that occurs during the drying of the leaves aPer they are harvested from the kratom trees. That oxidiza4on during drying produces only trace amounts of 7-OH during this process and at those levels pose no safety risk to consumers. The Difference Between Natural Leaf Kratom and Chemically Manipulated 7-OH Products Natural leaf kratom products, whether pure leaf or properly manufactured extracts using naturally limi4ng food grade solvents, have as their main component the kratom plant alkaloid known as mitragynine. 7-OH products are deliberately manipulated to chemically flip the content of a product to be majority 7-OH and that product content is described by FDA Commissioner Makary as follows: “7-OH is an opioid that can be more potent than morphine. We need regula4on and public educa4on to prevent another wave of the opioid epidemic”.1 There are only trace amounts of mitragynine, if any, in these 7-OH products. Chemically Manipulated 7-OH Has Been Recommended to be Classified as a Schedule 1 Compound by HHS and the FDA While natural leaf products have a well-documented safety profile for consumer use with only trace amounts of 7-OH, chemically manipulated 7-OH products have been determined by HHS and FDA to pose an imminent threat to the safety of consumers. On July 29, 2025, the scheduling recommenda4on was transmi_ed to the Drug Enforcement Administra4on (DEA). 1 https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products- threatening-american-consumers American Kratom Association + 13575 Heathcote Boulevard, Suite 320 + Gainesville, VA 20155 September 2025 2 Is Natural Leaf Kratom Safe? Yes -- when manufactured responsibly with accurate labeling and age restric4ons on purchasing. Key evidence includes: § Na4onal Ins4tute on Drug Abuse (NIDA) has funded over $100 million in research that confirms kratom has a lower risk profile than opioids and has poten4al as a harm- reduc4on tool. § The FDA has acknowledged that kratom-related deaths are rare and typically involve adulterated or polydrug use. § Former HHS Assistant Secretary Bre_ Giroir, in 2018, rejected the FDA’s request to ban natural leaf kratom as a Schedule I substance, ci4ng "embarrassingly poor evidence" and "failure to consider overall public health." § Millions of Americans use kratom daily with no serious adverse effects, and 18 states have passed Kratom Consumer Protec4on Acts to ensure responsible regula4ons assure product safety through product formula4on standards, proper labeling and age restric4ons for purchase. Conclusion Kratom is a natural botanical that, when regulated for purity and serving sizes, is a safe and effec4ve product used by millions of Americans. The American Kratom Associa4on advocates for regula4ons on kratom products and 18 states have enacted Kratom Consumer Protec4on Act legisla4on. Chemically manipulated 7-OH products did not meet the federal requirements for market entry in 2023 when they were first introduced. The emerging threat to consumers of chemically manipulated 7-OH compounds compels states to act to remove these products from the marketplace today.