HHS, RFK Jr. target synthetic opioid 7-OH aiming to avert the next national addiction crisis

The U.S. Food and Drug Administration published this slide in the report, "Preventing The Next Wave of the Opioid Epidemic: What You Need to Know About 7-OH."

Federal regulators will take action to ban the synthetic version of the opioid found in kratom, a herbal supplement sold in gas stations and convenience stores around the country.

The opioid 7-OH, short for 7-hydroxymitragynine, has become the target for new rules and expanded public attention to warn of the potential dangers of the drug. The U.S. Department of Health and Human Services (HHS) will ask the federal Drug Enforcement Agency to classify it as a Schedule 1 controlled substance, said Food and Drug Administration (FDA) Commissioner Marty Makary, MD, MPH.

FDA also is publishing a new report with scientific and layman details about 7-OH, along with a “Dear Colleague” letter to warn physicians about the risks of synthetic 7-OH. Along with stronger regulations, a goal is to spark a national conversation about the drug by starting conversations among parents and children, school boards, leaders of places of worship, and the medical community.

Getting ahead of a potential crisis

Martin Makary, MD, MPH
_{© U.S. Food and Drug Administration}

For years, American public health has been “asleep at the wheel,” reacting years to late to warn about health dangers of things like cigarettes, heroin, crack cocaine, other street drugs, OxyContin and fentanyl, Makary said. That ends now.

“Let's not get caught flat-footed again,” Makary said. “Public health is supposed to prevent disasters, not just clean them up after they killed thousands and thousands of people. Why do we get caught flat-footed, time and time again? In my opinion, it's because of a disconnect between the ivory towers and the streets.

“Have experts been to the vape stores? It affects what we see in the operating room,” he said, citing his own experience living and working in inner-city Baltimore, Maryland. He said he was surprised at the candies and gummies and drinks available with 7-OH.

The regulators are not targeting kratom leaves or ground up kratom, but the concentrated synthetic byproduct that is not like an opioid, but is an opioid, Makary said.

Keeping communities safe

DEA Assistant Administrator Tom Prevoznik said the agency will make the final scheduling decisions under CSA, consulting with the experts at FDA and HHS for rigorous, science-based evaluations. The legal rule-making process will include a public comment period, he said. An exact schedule for that process was unclear.

“DEA will do what we've always done: Follow science, follow the law and do what's right to keep our communities safe,” he said.

Get it off the shelves

The federal actions could inspire new interest in kratom, and the leaders emphasized the difference between the synthetic 7-OH and the natural substance. Marketing materials may blur the distinction and call 7-OH, kratom, when it is not.

That happened to Melody Woolf, of Kalamazoo, Michigan, a 20-year chronic pain patient, she said. Woolf described years of medical treatments and painkillers that did not work, and the strain that put on her family. Kratom, the powdered leaf only, saved her life, restoring her health so she could enjoy time with her husband, children and granddaughter, Woolf said.

Now she has experience asking store clerks about kratom products and getting 7-OH products. One clerk said he was glad to learn the distinction because customers said 7-OH “takes them back to their heroin days, and there is the big danger,” Woolf said. Synthetic “7-OH needs to be off of the shelves,” she said.

‘An addiction that’s ruining lives’

Sen. Markwayne Mullin (R-Oklahoma) described the cycle of someone addicted to opioids, going into recovery, then discovering a legal substance that creates the same high while allowing the person to pass a drug test and say they’re not doing anything illegal.

“And yet, it's a road to the same addiction. And you see the pattern, you see it in their face, you see it in their eyes, you see it in their words, you see it in their behavior. And you're going, oh my gosh, here we go again,” Mullin said. The industry has grown from nothing to worth billions of dollars, more than sales of opioids selling the street, he said.

“It's legal, but it's an addiction that's ruining lives,” Mullin said. “It's an addiction that's truly killing people because it leads them down a road that sometimes they'll never recover from. And we've known this.”

Availability can feed addiction

Robert F. Kennedy, Jr.
_{© U.S. Department of Health and Human Services}

Mullin credited HHS Secretary Robert F. Kennedy, Jr., for the backbone to do something about the situation. A 14-year heroin addict now 43 years in recovery, Kennedy said his own addiction was precipitated by availability. That happens at the national level as well, Kennedy said, citing historic availability, then regulation, of morphine, cocaine, heroin, crack cocaine, and oxycodone.

Three years ago, the nation lost 106,000 people to addiction. “It's two Vietnam Wars’ worth of casualties a year from this crisis,” Kennedy said. It touches many families, including the Kennedy political dynasty and the family of President Donald J. Trump, he added, so now is the time to stop another wave of addiction before it starts.

A recipe for disaster

In his introductory remarks, HHS Deputy Secretary Jim O’Neill said he has worked with people on the frontier of innovation. But not all innovation is positive, and dark innovations in chemistry have exacerbated the addiction crisis in the nation. Substances with 7-OH are often sold online or in convenience stores with no quality control, no dosage control, and no warnings, so people are misled, he said.

“This is a recipe for a public health disaster,” O’Neill said. “At HHS, we're committed to gold standard science, safety and compassion. We know people are looking for relief, but that relief must be grounded in reality. We owe it to the American people to act decisively, and that's what we're doing today.”

What about kratom?

During press questions, Makary said FDA and the federal regulators were not prepared to say kratom or any substance is 100% safe. He noted the scheduling recommendation will delineate trace amounts found in kratom leaves from synthetic, concentrated amounts.

FDA is focusing on items that concentrate the substance, such as tablets, gummies, drink mixes and shots. This month, FDA sent seven warning letters to companies that FDA said are illegally marketing products with 7-OH.

More evidence is needed

When asked if there was any evidence of 7-OH causing a fatal overdose, Makary acknowledged HHS needs better figures about use and injury. It’s possible physicians may not have heard about 7-OH. He compared it to the time when doctors prescribed opioids for minor surgical procedures.

“We would notice some people were coming back for refills at a very high rate, but we hadn't put the two together because we hadn't recognized the addictive nature,” Makary said. “So we need better statistics.”

The federal leaders also don’t want to wait until 50,000 lives are lost to take action, he said.

Where’s the evidence?

The HHS leaders discussed addiction in general, but offered no scientific evidence about how 7-OH is used by patients and why the substance could be dangerous, said a statement from Jeff Smith, national policy director of the Holistic Alternative Recovery Trust (HART). The organization formed to educate consumers, congressional leaders and state lawmakers about regulation of plant-based recovery products, according to its website.

“While stating that doctors don’t know what 7-OH is or how to check for it, HHS also claimed that there is an epidemic of people dying from 7-OH. Where is the data showing this?” Smith said. “Since (the) announcement did not reference any concrete public health data, we can only conclude that instead of public health being paramount, other interests may be driving policy decisions.”

The HART statement said preclinical studies show that 7-OH is less toxic than mitragynine, a substance found in pure leaf kratom, and that 7-OH does not cause respiratory depression at therapeutic doses, and has a lower dependence risk than opioids.

“Schedule I was suggested during the press conference. Schedule I is supposed to be reserved for substances with high abuse potential, no accepted medical use, and no safety margin,” Smith said. “The public needs to speak up to prevent dramatic regulatory overreach. A ban will push people back toward more dangerous substances, destroy responsible businesses, and cut off access to products that many rely on, as long as they are safe, tested, and clearly labeled.”

The HART statement did not distinguish or specify about natural or synthetic derivations of 7-OH, or how the substance is created or processed.

Kratom: a natural cure?

Kratom is a tropical tree native to southeast Asia and its leaves are used to make items sold online and in stores around the United States, said FDA’s official information sheet on it. As of 2021, an estimated 1.7 million people aged 12 years and older used kratom products to treat conditions such as pain, coughing, diarrhea, anxiety, depression, opioid use disorder, and opioid withdrawal. The estimate was generated by the National Survey on Drug Use and Health by the U.S. Substance Abuse and Mental Health Services Administration.

FDA has not approved kratom, 7-OH, or mitragynine, its other chemical component for use in any prescription or over-the-counter drugs. Until it is studied and shown to be safe and effective for medical use, FDA’s official policy is to warn people against using it.