FDA Moves To Restrict 7-OH Opioid Products
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FDA Pushes For Drug Classification Of 7-OH Products
On Tuesday, July 29th, the U.S. Food & Drug Administration (FDA) made an official request to the Department of Justice and the Drug Enforcement Administration to classify over-the-counter products containing the opioid compound 7-hydroxymitragynine (7-OH) as illegal substances. This is part of the FDA’s larger plan for cracking down on the distribution and sale of dangerous 7-OH products, which have the potential to cause serious health consequences and addiction.
According to the FDA’s news release, a primary concern regarding these unregulated products is their widespread availability, as they can be easily purchased at gas stations, convenience stores, smoke shops, and online. Also included in the plan is a concentrated effort on public education and a push for vigilance among retailers.
What Is 7-OH?
7-OH is a psychoactive compound found in the leaves of the kratom plant. This compound interacts with the opioid receptors in the brain, producing opioid-like effects at high doses and stimulant-like effects at low doses. 7-OH has a high potential for abuse and toxicity and can lead to effects like sedation, respiratory depression, seizures, liver toxicity, and dependence.
Rising Concerns Over 7-OH Products
Lauded as a way to boost mood, gain energy, and alleviate pain, 7-OH products are available in various forms, including gummies, liquid shots, and capsules. Unlike FDA-approved opioids, these products are sold without clear dosage guidelines, quality control, or labeled health warnings. The FDA warns that the brightly colored and misleading packaging can be a specific risk for teens and adolescents who may accidentally use this dangerous product.
Public health experts further voice concern over the unregulated 7-OH and kratom market, highlighting that without drug classification of these products, they exist in a gray area that allows manufacturers and retailers to sell these addictive substances without the regulations applied to pharmaceutical opioids.
FDA Commissioner Marty Makary warned about the potency of 7-OH and pushed for stronger regulations, stating, “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”
As a result, the FDA has requested that the DEA classify 7-OH products as Schedule I controlled substances, putting them in the same category as heroin and LSD. Under the Controlled Substances Act, Schedule I substances are defined as having a high potential for abuse and no accepted medical use in the U.S. This classification would make the manufacture, distribution, and possession of 7-OH products illegal under federal law.
What’s Next?
As the FDA awaits the Department of Justice’s decision, it will continue to roll out educational and preventive initiatives to inform the public about the dangers of 7-OH. For now, the public is advised to avoid these products and consult a healthcare provider to discuss alternative options for pain treatment and mood regulation.
If you or a loved one is struggling with 7-OH or kratom misuse, help is available. Contact a treatment provider today to learn more about your treatment options.