A powerful substance sold in gas stations and vape shops across America could trigger what health officials are calling the opioid crisis fourth wave, according to US Food and Drug Administration Commissioner Dr Marty Makary. The concentrated compound, derived from the kratom plant and known as 7-hydroxymitragynine (7-OH), is up to 13 times more potent than morphine.

The warning comes as regulatory bodies scramble to prevent another public health catastrophe following the devastating impacts of prescription opioids, heroin, and fentanyl that have claimed hundreds of thousands of American lives over the past two decades.

Easy Access, Deadly Consequences

“We can’t get caught flat-footed again,” Dr Makary recently cautioned. “We got burned with fentanyl, we got burned with prescription drugs. We cannot get behind the eightball again. This may be the fourth wave of the opioid epidemic.”

The accessibility of 7-OH products presents a particularly alarming aspect of this potential fourth opioid epidemic wave. Unlike traditional controlled substances, these products are readily available to purchase without prescriptions or age verification in many locations.

“7-OH, people need to know, is an opioid,” Dr Makary emphasised. “You can walk down the street in almost any neighbourhood in America and buy an opioid.”

Deceptive Marketing Targets Youth

The substance appears in various forms including powders, vapes, drinks, pills, and products designed to appeal to young people such as fruit-flavoured gummies and even ice cream cones. This marketing strategy bears disturbing similarities to tactics used in previous waves of the opioid crisis.

Products containing 7-OH are often inaccurately labelled regarding their content and may be disguised or marketed as merely the natural kratom plant. Whilst the kratom plant, native to Southeast Asia, has been used traditionally for medicinal purposes, the FDA has made clear its focus targets concentrated and synthetic forms that pose significantly greater risks.

The kratom industry in the US has grown into a billion-dollar market, with projections suggesting it will nearly double in size within just a few years. This rapid expansion occurs largely without federal age restrictions, though several states have begun implementing protective measures for minors.

Tragic Stories Emerge

New York mother Cari Scribner advocates for action following the death of her 27-year-old son, Nickolas, last year from what appears to have been a kratom-related fatality. She says her son began using the products to manage anxiety, depression, and insomnia, believing it was merely an “all natural herbal, energy and health supplement.”

In another heartbreaking account, Dr Makary shared a letter from a grieving stepfather whose young relative had finally overcome addiction, only to unknowingly purchase 7-OH from a vape shop.

“He called me on May 31 to tell me he had stopped at the vape shop to buy a vape and was offered a fruity pill, and was told that it was kratom,” Dr Makary read aloud. “He said that he took the pill and became addicted, and should have done his research. He died the night he took two 20 mg 7-OH pills. The wrapper was at his bedside. There were no other drugs or alcohol in the house.”

These personal tragedies underscore the urgent need for intervention before the opioid crisis fourth wave gains momentum.

Underreported Harm

Data regarding widespread harm, particularly to young Americans, remains mixed or potentially underreported. The Centers for Disease Control and Prevention acknowledges some overdose deaths associated with kratom products, though other substances were often involved. A recent Tampa Bay Times report linked kratom products to hundreds of deaths in Florida alone over the past decade.

Dr Alicia Tudor, a toxicologist and emergency physician from Albany Medical Center, believes kratom-related harms are significantly underreported, especially regarding overdoses.

“I’ll see it in the emergency department and then probably more often in the addiction clinic that I work at as well,” Dr Tudor explained. She noted that toxicology tests are not always administered when patients present with overdose symptoms, and by the time results return weeks later, patients have typically been discharged.

This gap in data collection may obscure the true scale of the problem, making it difficult to gauge whether the fourth opioid epidemic wave has already begun.

Regulatory Response Gains Momentum

At the end of July, the FDA recommended classifying 7-OH as a Schedule I controlled substance, making it illegal to sell or possess. The agency identifies it as an opioid carrying significant health risks, including addiction and overdose potential.

State-level action is accelerating as well. Florida leads the charge, with Attorney General James Uthmeier announcing an emergency rule to classify 7-OH as a Schedule I controlled substance. Republican Governor Mike DeWine has urged Ohio’s Board of Pharmacy to designate synthetic and natural kratom compounds as illegal drugs. Additional states have moved to implement age restrictions or concentration limitations on 7-OH products.

Lessons from Previous Waves

The potential opioid crisis fourth wave carries disturbing echoes of previous epidemics. Each wave has been characterised by a failure to recognise and respond to emerging threats before they spiralled out of control.

The first wave began with increased prescribing of opioid pain relievers in the 1990s. The second wave saw heroin deaths surge beginning in 2010. The third wave, dominated by synthetic opioids like fentanyl, commenced around 2013 and continues to claim tens of thousands of lives annually.

Whilst concentrated 7-OH has only risen in popularity within the last five years, the rapid growth trajectory and easy accessibility mirror patterns seen in previous opioid epidemics. Public health officials stress that early intervention represents the best opportunity to prevent another catastrophic wave of addiction and death.

A Race Against Time

The FDA’s move to classify 7-OH as a controlled substance represents an attempt to learn from past mistakes. Unlike previous opioid crises where regulatory responses lagged far behind the spread of addiction, authorities are working to implement restrictions before widespread harm becomes entrenched.

However, the kratom industry’s explosive growth and the substance’s current legal status in many jurisdictions present significant challenges. Advocates for stricter regulation emphasise that comprehensive federal action, combined with robust state-level enforcement, will be essential to prevent the fourth opioid epidemic wave from replicating the devastation of its predecessors.

As regulators race to implement protective measures, families who have lost loved ones to 7-OH serve as sobering reminders of what’s at stake. Their stories illustrate how quickly accessible substances, marketed as harmless natural products, can destroy lives.

The question now is whether lessons learned from previous waves will translate into swift, effective action, or whether another generation will fall victim to an opioid crisis that could have been prevented.

Source: Daily Wire