7-HOPE Alliance Defends Legality and Safety of 7-OH, Challenges Kratom Association Claims
The 7-HOPE Alliance asserts that 7-hydroxymitragynine is lawful and scientifically supported, countering claims by kratom associations while highlighting potential medical benefits and harm reduction value.
Legal experts have confirmed that 7-hydroxymitragynine (7-OH) is not unlawful under the US Food, Drug and Cosmetic Act, according to the 7-HOPE Alliance, a nonprofit organization dedicated to science and public education on the compound. The organization issued this statement in response to recent claims by the American Kratom Association that 7-OH products never had a lawful basis for market entry.
Multiple industry legal teams have already shared detailed arguments with the FDA expressing this point, and the agency has not indicated disagreement with this position. The provisions cited by AKA simply do not apply to 7-OH products, according to legal analysis. Furthermore, if the FDCA provisions did apply, which they do not, the same logic would render many kratom products already on the market unlawful, particularly those with concentrated levels of mitragynine that most AKA members currently sell.
Leading researchers from Johns Hopkins, Harvard, UCLA, and other top institutions have directly rejected the AKA and FDA's claims about 7-OH's safety. Experts including Dr. Kirsten Smith of Johns Hopkins and Dr. Edward Boyer of Harvard emphasized that 7-OH should not be considered a public health crisis, noting there are no confirmed overdose deaths, no evidence of respiratory depression, and no widespread dependence linked to the compound.
Data reviewed by toxicologists Dr. Michael Levine of UCLA and Dr. Andrew Monte of Rocky Mountain Poison & Drug Center confirmed no safety signals in the national poison control databases, despite millions of estimated adult exposures. Recent research further underscores 7-OH's potential, with a Pharmacy Times report highlighting findings published in Current Research in Structural Biology showing that 7-OH demonstrated stable binding and favorable drug-likeness as potential HER2 inhibitors in breast cancer.
Jackie Subeck, Founder of 7-HOPE Alliance, stated that the AKA continues to misrepresent both the law and the science, suggesting their campaign is about protecting market share rather than consumer protection. Through its Save7OH.org campaign, the organization is bringing together consumers, scientists, healthcare providers, and policymakers to share real stories and science. The group is hosting community meetings across the country where veterans, chronic pain patients, and people in recovery have spoken about the fear of losing one of the few tools that works for them.
7-HOPE is working with researchers to expand studies and ensure policymakers have access to accurate science rather than what they describe as a manufactured crisis narrative pushed by competitors. The organization emphasizes that 7-OH offers more predictable dosing, a ceiling effect that limits opioid-like risks, and no evidence of lethal overdose, making it a valuable harm reduction tool that should remain available to those who rely on it as an alternative to dangerous painkillers and illegal drugs.