The 7-HOPE Alliance, a nonprofit organization focused on science and public education regarding 7-hydroxymitragynine (7-OH), has issued a comprehensive response to recent claims by the American Kratom Association (AKA) questioning the legality of 7-OH products. Legal experts have confirmed that 7-OH is not unlawful under the US Food, Drug, and Cosmetic Act (FDCA), and the FDA has not indicated disagreement with this position. This legal standing challenges the AKA's assertion that these products never had a lawful basis for market entry.
Researchers from prestigious 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. Experts such as Dr. Kirsten Smith of Johns Hopkins and Dr. Edward Boyer of Harvard emphasized that 7-OH should not be considered a public health crisis. 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.
The implications of this debate extend beyond legal technicalities to consumer access and medical research. Recent research highlighted in Pharmacy Times shows that 7-OH, along with mitragynine, demonstrated stable binding and favorable drug-likeness as potential HER2 inhibitors in breast cancer treatment. This early research, published in Current Research in Structural Biology, suggests that 7-OH could play a role in future pharmaceutical breakthroughs, a potential that would be eliminated if the substance were scheduled as a controlled substance.
Jackie Subeck, Founder of 7-HOPE Alliance, stated that the AKA's campaign represents a protectionist market strategy rather than genuine consumer protection concerns. The organization argues that banning 7-OH would harm people who rely on it for harm reduction and push them toward unsafe opioids and illicit markets. Through its Save7OH.org campaign, 7-HOPE Alliance is gathering real stories and scientific evidence to support evidence-based regulation rather than fear-based prohibition.
The outcome of this regulatory debate carries significant implications for public health policy, consumer choice, and scientific research. If 7-OH remains accessible, it could provide a safer alternative to traditional opioids for pain management and substance use disorder treatment. However, if scheduled, it would eliminate both consumer access and research opportunities while potentially driving users to more dangerous alternatives. The organization continues to work with researchers to expand studies and ensure policymakers have access to accurate scientific information rather than what they describe as manufactured crisis narratives pushed by competitors.
