7-HOPE Alliance Defends Legality and Safety of 7-OH, Challenges Kratom Association Claims

7-HOPE Alliance, a nonprofit focused on science and public education regarding 7-hydroxymitragynine (7-OH), has responded to the American Kratom Association's assertion that 7-OH products lack a lawful market entry basis. Legal experts confirm that 7-OH is not unlawful under the US Food, Drug, and Cosmetic Act (FDCA), and the FDA has not disputed this position. If FDCA provisions applied, many existing kratom products, including those with concentrated mitragynine sold by AKA members, would also be deemed unlawful, highlighting inconsistencies in the AKA's stance.

Leading researchers from institutions such as Johns Hopkins, Harvard, and UCLA have rejected safety claims by the FDA and AKA, finding no evidence of overdose deaths, respiratory depression, or widespread dependence associated with 7-OH. Toxicologists Dr. Michael Levine of UCLA and Dr. Andrew Monte of the Rocky Mountain Poison & Drug Center confirmed no safety signals in national poison control databases despite millions of adult exposures. Recent research highlighted in Pharmacy Times and published in Current Research in Structural Biology suggests 7-OH's potential as a HER2 inhibitor in breast cancer, indicating its promise for future pharmaceutical applications rather than being a reckless synthetic compound.

Jackie Subeck, Founder of 7-HOPE Alliance, criticized the AKA's campaign as fear-based and aimed at eliminating competition to protect market share, rather than consumer protection or science. The alliance emphasizes that banning 7-OH could harm individuals by pushing them toward unsafe opioids and illicit markets, advocating instead for evidence-based regulation. Through its Save7OH.org campaign, 7-HOPE is gathering real stories and science from consumers, healthcare providers, and policymakers, while hosting community meetings and supporting further research to ensure accurate information guides policy decisions.