“Watching federal agencies repeat the same failed approach with 7-OH is disappointing, but unfortunately not surprising.”

By Caro Freinberg and Soren Shade, Top Tree Herbs

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.

What Prohibition Actually Does

Once banned, 7-OH will almost undoubtedly continue to be sold, but in the illicit market instead of the gray market. History makes this clear.

Illicit market substances are typically produced with even less quality control and less labeling. Alcohol prohibition in the early 20th century didn’t keep people from drinking; it led to bootlegging empires and deaths from methanol-tainted moonshine. Criminalizing cannabis didn’t stop its use; it fueled mass incarceration and made unregulated cannabis more hazardous.

Beyond that, every time one compound is banned, a dozen new analogs take its place. The bans on “spice” and “bath salts” in the last two decades led to waves of even more potent analogs hitting the unregulated market, making safe use even more challenging.

If 7-OH is outlawed, alternative kratom-derived substances and other novel compounds will very likely take its place. All of them will have even less evidence for safety than 7-OH currently does.

When one drug is criminalized and its availability is reduced, substance use and misuse do not end—because availability is not the driver of substance use issues.

The Real Drivers of Drug Use and Misuse

For the sake of argument, let’s assume the government is genuinely focused on helping drug users who meet the criteria for substance use disorder, a group that actually represents a minority of all users.

Prohibition doesn’t serve them, because the real drivers of addiction aren’t purely chemical; they’re rooted in socioeconomic conditions. People turn to drugs, legal or not, to cope with the everyday pressures and deeper pains of modern life. Our society is saturated with suffering: low-wage or purposeless work, housing instability, social disconnection, inaccessible healthcare, chronic anxiety, failing education systems…

These socioeconomic issues are the problem, and drug use is a common symptom.

We use coffee for burnout, wine for social anxiety, benzos and cannabis for sleepless nights and 7-OH for pain or relaxation.

7-OH is just one more option on a long list of temporary coping mechanisms people reach for when other systems have failed them. And targeting drug use—a mere symptom of that failure—won’t fix the problem.

The Prohibitionist Status Quo

Drug overdose deaths are a tragedy. But they’re not solely a pharmacological phenomenon, a moral failing or a consequence of “availability.” They’re the result of policy failure.

When people are forced to hide their drug use out of fear of prosecution, they lose access to harm reduction information and community support.

If, as all the evidence suggests, prohibition only amplifies drug-related harms, then why is it still the default policy approach?

Part of the answer lies in how prohibition has always served bureaucratic self-preservation. In the early 1930s, as alcohol prohibition was unraveling, federal agents and administrators needed a new justification for their roles. Harry Anslinger, the newly appointed head of the Federal Bureau of Narcotics, seized the opportunity. He helped manufacture a national panic around cannabis, exploiting racist fears, media sensationalism and support from industrial players threatened by hemp.

The “Reefer Madness” campaign fueled the criminalization of marijuana and ensured that the machinery of prohibition stayed in motion. The Bureau of Prohibition simply morphed into the Bureau of Narcotics—an early version of today’s DEA.

Today, prohibition isn’t just policy—it’s profit. It props up a multi-billion dollar ecosystem of law enforcement agencies, private prisons, court systems, rehabs, pharmaceutical giants and, of course, illicit drug markets. With so many stakeholders invested in maintaining the status quo, meaningful reform isn’t just resisted—it’s actively undermined.

Better Alternatives to Prohibition

Instead of criminalizing 7-OH, there are many other steps that the federal government can take to address the current issues with the 7-OH market.

The federal government should implement sensible regulations that ensure these products are clinically tested for safety, properly manufactured, sold only to adults, clearly labeled with accurate usage guidelines and warnings and distributed through well-informed vendors.

More broadly, we need to reframe how society approaches drug use.

Like driving or drinking alcohol, it should be treated as an adult activity that carries both risks and responsibilities. When misuse occurs, it should be addressed as a health issue—not a criminal one.

Countries like Switzerland have shown that heroin-assisted treatment can dramatically reduce overdose deaths and improve quality of life. Ultimately, we must stop pathologizing all drug use, broaden our definition of self-care and recognize that using drugs can, in many cases, be part of normal human behavior.

Same Playbook, Same Results

Watching federal agencies repeat the same failed approach with 7-OH is disappointing, but unfortunately not surprising.

We often hear that insanity is doing the same thing over and over and expecting a different result. If lawmakers keep passing prohibitionist drug laws while hoping to reduce drug-related harms, what does that say about their intentions? Are they unaware of prohibition’s history? Or are they willfully choosing punishment over progress, neglecting public health to preserve a broken status quo?

Soren Shade is the founder of Top Tree Herbs, a Colorado-based kratom tea bag company focused on reducing the stigma surrounding kratom. Caro Freinberg is Top Tree Herbs’ co-owner and graphic designer.

Photo courtesy of Caro Freinberg.