At a recent press conference, secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. endorsed the Food and Drug Administration’s (FDA) recommendation to classify 7-hydroxymitragynine (7-OH) as a federally controlled substance. Despite political promises to forge a different path, the same tired Drug War tactics were on full display.
What Is 7-Hydroxymitragynine?
7-OH is one of many naturally occurring alkaloids found in the leaves of kratom trees. These leaves have been used for centuries as an herbal remedy. They contain a complex blend of alkaloids that interact with opioid, serotonin and alpha-adrenergic receptors. Around the world, people use kratom to help manage discomfort, enhance focus or relax.
In raw, dried kratom leaf, 7-OH exists only in trace amounts (typically less than 0.1 mg per gram of leaf). It’s formed when a more abundant alkaloid, mitragynine, degrades in the leaves.
But in recent years, manufacturers have begun converting large amounts of mitragynine into 7-OH to create extremely potent products. Some capsules and tablets contain 15–50 mg of 7-OH, hundreds of times more than what you’d find in a standard 2–5 gram serving of kratom leaves. 7-OH products produce stronger pain-killing effects than leaf kratom or kratom extract.
Yet potency, on its own, isn’t a problem. The problem is how these products are being manufactured, marketed and sold—with little to no safety testing, evidence for medical claims or manufacturing oversight.
7-OH manufacturing practices are often substandard, resulting in tablets that contain a range of unknown byproducts and impurities with substantial differences between batches. Oftentimes, manufacturers label them with kratom leaf imagery and terminology (such as “advanced kratom alkaloids,” “superior kratom alkaloids,” “premium kratom alkaloids” or “organic kratom extract full-spectrum 7-hydroxymitragynine”) with the clear intention to mislead consumers into thinking isolated 7-OH is similar to kratom.
Few come with clear dosage instructions, warnings about potential interactions or disclosures about dependency risks. And most are sold at gas stations and smoke shops, where employees typically have no education on the products or their potential risks.
What the Media and Government Get Wrong About 7OH
With growing popularity has come growing scrutiny. But government agencies and major media outlets aren’t focusing on the issues laid out above. Instead, the FDA, the Drug Enforcement Administration (DEA) and HHS are leaning on a familiar narrative predicated on fear: opioid = bad, synthetic = dangerous and availability = addiction.
None of these equations hold up under scrutiny. First, opioids have saved far more lives than they’ve taken—through pain management, trauma care and palliative medicine. The vast majority of opioid-related deaths involve combinations with other sedatives, not opioids alone.
Second, the natural vs. synthetic distinction tells us nothing meaningful about a drug’s safety. Consider nicotine (natural, widely available, highly addictive) versus naloxone (synthetic, life-saving, non-addictive).
And finally, while availability may shape patterns of use, it’s not what drives addiction. We don’t attribute alcoholism to the mere existence of alcohol—especially when younger generations are drinking less despite liquor stores on every corner. Nor do we assume that junk food availability is the sole cause of disordered eating. Addiction is about context, not presence.
So far, there is little evidence to support the HHS’s narrative that 7-OH is ruining lives. Many people do report issues with dependency and withdrawal, as well as financial issues from spending a lot of money on 7-OH products. But reports of severe 7-OH-related harms (like overdoses) are sparse. There’s currently no public record of a single verified death caused solely by 7-OH. At the same time, many individuals report success using 7-OH to manage conditions that they haven’t found any other viable treatment for.
Despite the lack of research into 7-OH and evidence of significant harm (and the nascent state of medical research), the FDA has formally recommended that 7-OH be added to Schedule I of the Controlled Substances Act. If approved, possession or production of 7-OH above a certain concentration would be a felony offense.
But placing a compound in Schedule I has historically done nothing to eliminate risk. In fact, we’ve often seen this categorization increase harm by pushing substances into the shadows, where they become harder to monitor, regulate, or use safely.
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