Nonprofit restates that evidence, not fear tactics or misinformation, must guide policy decisions in response to misleading claims by kratom advocacy organization 

Key Highlights: 

• Legal experts confirm 7-OH is not unlawful under the US Food Drug and Cosmetic Act (FDCA) and the FDA has not disagreed with this position.

• Leading researchers from Johns Hopkins, Harvard, and UCLA reject FDA and AKA claims, finding no evidence of overdose deaths, respiratory depression, or widespread dependence from 7-OH.

• If 7-OH were unlawful under the FDCA, the same provisions would apply to many kratom products on the market, and in that case there would be no reason for the DEA to schedule the substance.

LOS ANGELES, CA - August 26, 2025 (NEWMEDIAWIRE) - 7-HOPE Alliance, a nonprofit dedicated to science and public education on 7-hydroxymitragynine (7-OH), today issued a statement in response to the American Kratom Association’s (AKA) recent press release claiming that “7-OH products never had a lawful basis for market entry in the first place.”

Most importantly, this claim is incorrect per an analysis by numerous legal experts who have reviewed the facts. 7-OH is not unlawful under the US Food, Drug, and Cosmetic Act (FDCA). The provisions cited by AKA simply do not apply to 7-OH products. Multiple industry legal teams have already shared detailed arguments with the FDA expressing this point, and the agency has not indicated disagreement with our position.

Furthermore, if the FDCA provisions did apply, which they do not, the very same logic would render many kratom products already on the market unlawful, particularly those with concentrated levels of mitragynine, which most AKA members currently sell. It is inconsistent and disingenuous for the AKA to claim legal high ground while ignoring that their own members’ products would fail under the standard they now invoke.

Furthermore, if AKA truly believed 7-OH was already unlawful under the FDCA, there would be no reason for them to demand DEA scheduling. Their campaign is not about consumer protection, nor based in science, it is about eliminating competition so they can reclaim market share for their paid members.

The positive science of 7-OH was further illustrated last week by leading researchers at Johns Hopkins, Harvard, UCLA, and other top institutions who directly rejected the AKA and the FDA’s claims about 7-OH’s safety. Experts including Dr. Kirsten Smith (Johns Hopkins) and Dr. Edward Boyer (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 (UCLA) and Dr. Andrew Monte (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: a Pharmacy Times report highlighted findings published in Current Research in Structural Biology showing that 7-OH, along with mitragynine, demonstrated stable binding and favorable drug-likeness as potential HER2 inhibitors in breast cancer. This is early work, but it underscores that 7-OH is not a reckless “synthetic” compound as AKA suggests, it is a natural alkaloid that could play a role in future pharmaceutical breakthroughs, and scheduling it as Schedule 1 controlled substance eliminates this promise.

“The AKA continues to misrepresent both the law and the science,” said Jackie Subeck, Founder of 7-HOPE Alliance. “Their campaign of fear is not about protecting consumers, it’s about protecting their market share. They are attempting to create a false crisis that distracts from the real evidence: 7-OH is helping people in a variety of ways and is proving to be superior to high mitragynine concentrated products. The truth is simple. Banning 7-OH would cause harm to people, not prevent it.”

“It’s exciting to see other well-known independent kratom researchers confirming what our Scientific Advisory Board has said all along: the data are clear. 7-OH is not causing a public health crisis and does not meet the standard for scheduling based on what we know. Unlike high-dose mitragynine products that place stress on the liver, 7-OH offers more predictable dosing, a ceiling effect that limits opioid-like risks, and no evidence of lethal overdose. If regulators remove this option, people will be pushed back toward unsafe opioids and illicit markets. We should be advancing evidence-based regulation, not fear-based prohibition.”

The 7-HOPE Alliance is leading the fight to stop any bans and to protect access for the people who rely on the harm reduction 7-OH provides them with every day. Through its Save7OH.org campaign, the organization is bringing together consumers, scientists, healthcare providers, and policymakers to share real stories and real science. The group is hosting community meetings across the country, where veterans, chronic pain patients, hard working Americans, and people in recovery have spoken out about the fear of losing one of the few tools that works for them. At the same time, 7-HOPE is working with researchers to expand studies and ensure policymakers have access to the most accurate science, not the manufactured crisis narrative pushed by competitors.

About 7-HOPE Alliance

7-HOPE Alliance (7-Hydroxy Outreach for Public Education) is a nonprofit organization (501(c)(3) pending) dedicated to advancing public education, user support, and policy advocacy around 7-hydroxymitragynine (7-OH), a naturally occurring alkaloid in the kratom plant. Through a foundation of science, storytelling, and community, 7-HOPE empowers individuals, healthcare professionals, and policymakers with accurate, balanced information on 7-OH and its role in harm reduction, natural wellness, and safe, legal access to alternatives. The organization’s mission centers on four pillars: science, education, advocacy, and user support. By confronting misinformation, promoting responsible use, and providing uplifting real-life testimonials, 7-HOPE aims to ensure 7-OH remains available to the many individuals who find it to be a safe and effective alternative to dangerous painkillers and illegal drugs. For more information or to get involved, visit www.7hopealliance.org.

Media Contact
info@7hopealliance.org

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