By: Carl Schwartzbaum

Health Secretary Robert F. Kennedy Jr. on Tuesday announced a sweeping plan to restrict access to a powerful derivative of the kratom plant, signaling a decisive federal shift in how regulators approach a substance that has quietly gained millions of American users. The announcement, detailed in a report in The New York Times, focuses on 7-hydroxymitragynine, or 7-OH, a compound that binds to the brain’s opioid receptors and has raised fears of addiction.

The initiative marks the most significant federal intervention yet into the kratom market. For years, consumers have purchased kratom in powder or capsule form, often promoted as a natural supplement to ease pain, anxiety, and opioid withdrawal. But in recent years, manufacturers began isolating and amplifying 7-OH, producing far more potent products now found in smoke shops, convenience stores, and online markets. According to the information provided in The New York Times report, health officials see this development as a parallel to earlier public health crises where unregulated products evolved into widespread hazards.

Dr. Marty Makary, commissioner of the Food and Drug Administration, confirmed that his agency had begun the formal process of “scheduling” 7-OH, an action that will classify the compound under the Controlled Substances Act. The final scheduling decision will rest with the Drug Enforcement Administration. As reported by The New York Times, Dr. Makary described the move as an attempt to prevent a replay of the opioid epidemic, saying federal regulators could no longer afford to be “asleep at the wheel.”

In recent months, the F.D.A. has escalated its enforcement actions, issuing seven warning letters to manufacturers of 7-OH products. These letters, according to the report in The New York Times, are considered a precursor to harsher penalties, including fines, product seizures, and legal injunctions. Dr. Makary underscored the urgency of the situation: “This may be the calm before the storm. It may be the tip of the iceberg, but let’s be aggressive and proactive.”

The compound is typically sold in brightly packaged gummies, dissolvable tablets, or small drink vials, often labeled simply as “kratom 7” or “7-OH.” Federal officials emphasized that 7-OH has never been approved for medical use and is not permitted as an additive in foods or dietary supplements.

The announcement has sparked strong pushback from the kratom industry. Jeff Smith, national policy director of the Holistic Alternative Recovery Trust, argued that regulators had failed to provide evidence justifying emergency action. “If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented,” Smith said. His comments highlight a growing rift between federal health officials and industry groups that represent both kratom manufacturers and users who credit the substance with pain relief and improved mental health.

The American Kratom Association, which distinguishes between traditional kratom products and the concentrated 7-OH derivative, welcomed the announcement. Mac Haddow, the association’s senior public policy fellow, told The New York Times that his group has long warned about the dangers of 7-OH. “You can get addicted to 7-OH in a couple of days, and it’s a horrible situation to get off of it,” he said.

The move comes against the backdrop of a broader rethinking of U.S. drug policy. While the former Biden administration initiated a process to reschedule marijuana from Schedule I to Schedule III—reflecting its potential medical uses—Kennedy’s announcement charts the opposite course for 7-OH. The New York Times report noted that while cannabis rescheduling has stalled amid procedural obstacles, health agencies are now advising the D.E.A. to classify 7-OH as a Schedule I substance, a category reserved for drugs deemed to have no accepted medical use and high potential for abuse.

The F.D.A. will begin its analysis with an eight-factor evaluation, considering abuse potential, scientific knowledge, and risks to public health. This review will guide the D.E.A.’s ultimate determination.

The debate over 7-OH is complicated by a lack of comprehensive data. Kirsten Elin Smith, an assistant professor at Johns Hopkins University who has studied kratom extensively, told The New York Times that she was initially alarmed when 7-OH products appeared two years ago, fearing a wave of adverse reports. “If you had asked me a year ago, I would have said this is evil,” she remarked. But so far, she noted, widespread reports of harm have not materialized—possibly because there are no standard tests to detect 7-OH in the bloodstream.

Dr. Smith said her research indicates a mixed picture: some users describe improved mood and quality of life, while others acknowledge that the compound is habit-forming. Roughly 15 percent of survey participants in her studies favored stricter regulation. “Both kratom products and 7-OH products have a benefit-risk profile,” she concluded, stressing the need for more scientific research before definitive conclusions can be drawn.

The crackdown on 7-OH comes amid a wave of federal interventions against unregulated psychoactive products that have proliferated in convenience outlets. Last summer, more than 160 people became ill and three died after consuming Diamond Shruumz candy bars, which contained unauthorized psychedelic substances. These incidents prompted federal authorities to intensify monitoring of “gas station drugs” ranging from tianeptine-based products, nicknamed “gas-station heroin,” to unauthorized THC edibles.

Health Secretary Kennedy pointed to these recent tragedies as cautionary examples, emphasizing that the government’s proactive response to 7-OH was intended to forestall a similar crisis. “This is about averting another opioid epidemic,” Kennedy said.

As federal agencies move forward, the proposed restrictions on 7-OH raise questions about the future of kratom regulation more broadly. Kratom itself remains legal in most states, though it is banned in several jurisdictions. With millions of Americans relying on the plant for pain and anxiety relief, The New York Times reported that public health officials will face ongoing challenges in distinguishing between traditional kratom use and newer, more potent derivatives.

For now, the decision to move toward scheduling 7-OH reflects a broader tension in U.S. drug policy: balancing harm reduction with concerns about potential abuse. While the F.D.A. and D.E.A. prepare to act, researchers, industry advocates, and consumers are bracing for a regulatory battle that could reshape the landscape of alternative pain management in America.https://youtu.be/DhG85Cu7JCI