Scientific and Legal Experts Challenge Claims Against 7-OH, Highlighting Potential Benefits and Regulatory Implications
TL;DR
7-HOPE Alliance counters AKA's misleading claims, protecting 7-OH market access and highlighting its competitive advantages over traditional kratom products for consumers.
Legal experts confirm 7-OH is lawful under FDCA, while researchers from top institutions find no evidence of overdose deaths or widespread dependence.
Preserving access to 7-OH supports harm reduction, offering safer alternatives to opioids and preventing a return to dangerous illicit markets for patients.
Research shows 7-OH demonstrates stable binding as potential HER2 inhibitors in breast cancer, suggesting future pharmaceutical breakthrough possibilities beyond current uses.
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Legal experts have confirmed that 7-hydroxymitragynine (7-OH) is not unlawful under the US Food, Drug, and Cosmetic Act (FDCA), and the FDA has not disagreed with this position, according to the 7-HOPE Alliance. This clarification comes in response to claims by the American Kratom Association (AKA) that 7-OH products lacked a lawful basis for market entry. Multiple industry legal teams have presented detailed arguments to the FDA supporting this stance, emphasizing that the provisions cited by AKA do not apply to 7-OH products.
If the FDCA provisions were applicable, which legal experts dispute, many kratom products already on the market would also be deemed unlawful, particularly those with concentrated levels of mitragynine sold by AKA members. This inconsistency undermines the AKA's position, suggesting their campaign may be motivated by competition rather than consumer protection. The alliance argues that if AKA truly believed 7-OH was unlawful, there would be no need to demand DEA scheduling, indicating an effort to eliminate market competition.
Leading researchers from institutions such as Johns Hopkins, Harvard, and UCLA have rejected safety claims made by the AKA and FDA regarding 7-OH. 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 no confirmed overdose deaths, evidence of respiratory depression, or widespread dependence linked to the compound. 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 estimated adult exposures.
Recent research highlights 7-OH's potential benefits, including findings published in Current Research in Structural Biology showing that 7-OH and mitragynine demonstrated stable binding and favorable drug-likeness as potential HER2 inhibitors in breast cancer. This early work suggests 7-OH is not a reckless synthetic compound but a natural alkaloid that could contribute to future pharmaceutical breakthroughs. Scheduling it as a Schedule 1 controlled substance would eliminate this promise, according to the alliance.
Jackie Subeck, Founder of 7-HOPE Alliance, stated that the AKA's campaign misrepresents both law and science, aiming to protect market share rather than consumers. The alliance emphasizes that 7-OH offers more predictable dosing, a ceiling effect that limits opioid-like risks, and no evidence of lethal overdose, unlike high-dose mitragynine products that stress the liver. Banning 7-OH could push individuals toward unsafe opioids and illicit markets, undermining harm reduction efforts.
Through its Save7OH.org campaign, the 7-HOPE Alliance is advocating for evidence-based regulation rather than fear-based prohibition. The organization is hosting community meetings and collaborating with researchers to expand studies, ensuring policymakers have access to accurate science. This effort aims to protect access for veterans, chronic pain patients, and others who rely on 7-OH as a safe alternative to dangerous painkillers and illegal drugs.
Curated from NewMediaWire
