The 7-HOPE Alliance, a nonprofit focused on scientific education regarding 7-hydroxymitragynine (7-OH), has countered recent assertions by the American Kratom Association (AKA) that 7-OH products lack a lawful market basis. Legal analysis confirms that 7-OH does not violate the US Food, Drug, and Cosmetic Act (FDCA), with the FDA not disputing this position. If the FDCA provisions cited by AKA were applicable, they would also render many kratom products currently sold by AKA members unlawful, particularly those with high mitragynine concentrations, highlighting inconsistencies in the association's stance.
Leading researchers from institutions including Johns Hopkins, Harvard, and UCLA have rejected safety concerns raised 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. This scientific backing challenges narratives portraying 7-OH as a public health crisis.
Emerging research underscores 7-OH's potential benefits, such as its role as a HER2 inhibitor in breast cancer studies, as highlighted in a Pharmacy Times report referencing findings in Current Research in Structural Biology. This positions 7-OH as a natural alkaloid with pharmaceutical promise, contrary to claims labeling it a synthetic hazard. Scheduling it as a Schedule I controlled substance could stifle this potential and harm individuals relying on it for harm reduction.
Jackie Subeck, Founder of 7-HOPE Alliance, emphasized that AKA's campaign is driven by market competition rather than consumer protection, aiming to eliminate 7-OH to reclaim market share for their members. The alliance advocates for evidence-based regulation, noting that 7-OH offers predictable dosing, a ceiling effect limiting opioid-like risks, and no lethal overdose evidence, making it a safer alternative to high-dose mitragynine products or illicit opioids. Through initiatives like Save7OH.org, 7-HOPE is gathering testimonials from veterans, chronic pain patients, and others who benefit from 7-OH, while collaborating with researchers to ensure policymakers receive accurate data. This effort aims to prevent regressive policies that could push users toward riskier options, underscoring the importance of science over fear in regulatory decisions.
