The agency sent its two notices of intent to the Federal Register. One addresses 7-OH above a specified threshold, while the second proposes moving the related substances to Schedule I. Those substances include mitragynine pseudoindoxyl, MGM-15 and MGM-16.
According to the DEA, the manufacture, distribution, sale and possession of the 7-OH substances will become subject to criminal, civil and administrative provisions of the Controlled Substances Act once the temporary scheduling orders take effect.
“Temporarily scheduling these substances underscores the emphasis this Administration has put on the safety, health and well-being of the American people,” DEA Administrator Terrance Cole shared in a statement. “This action gives law enforcement and public health partners the tools needed to address this emerging threat.”
A 30-day public comment period will allow for stakeholders to submit additional scientific data help determine what concentration or quantity of 7-OH in a product may constitute an imminent hazard. The comment period will also seek information on whether there is a more appropriate way to measure or express the threshold needed to prevent an immediate risk to public health or safety.
After the comment period, the U.S. attorney general may issue a temporary scheduling order placing products containing 7-OH above a specified threshold into Schedule I for two years.
“I commend the DEA for taking decisive action to address these addictive and harmful substances,” said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. following the announcement. “7-OH, MP, MGM-15 and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk. HHS reviewed the science and recommended this action. The Trump Administration will continue using every available authority to stop these deceptive products, hold bad actors accountable and protect American families.”
Running ‘roughshod’ over Americans?
The government has considered the science behind 7-OH for the last year, according to Bob Durkin, partner and co-chair of the regulatory group at law firm Amin Wasserman Gurnani. “They’ve determined the science and the data supports the scheduling of 7-OH,” he said. “That’s not up for debate with the DEA anymore.”
He added that the government’s three- and eight-factor analyses support the scheduling of the substance.
According to the Consumer Choice Center, a global consumer advocacy group, the DEA’s intent to place 7-OH into Schedule I invokes emergency powers that bypass the full scientific review Congress typically requires.
The organization said HHS simultaneously opened a public docket based on establishing a threshold but not on the science or safety of kratom-derived products themselves.
“The government is putting a plant alkaloid used by millions of Americans in the same legal category as heroin, and it’s doing so through an emergency loophole,” said Yaël Ossowski, deputy director of the Consumer Choice Center, in a statement. “Not only does this betray President Trump’s promise to legalize natural 7-OH, but it also uses a rushed emergency process that runs roughshod over Americans who rely on these products while using debunked science.”
Mac Haddow, senior fellow on public policy at the American Kratom Association, said it is misleading each time proponents of 7-OH argue the products are “natural.”
“It’s deception, and it needs to be penalized not only by the controlled substances act, but by the available marketing deception laws that are available to virtually every state attorney general,” he said.
At least a dozen states have banned 7-OH products, while other states have classified them as Schedule I controlled substances.
Distinguishing between traditional kratom and semi-synthetic 7-OH
Kratom originates from the leaves of a tropical evergreen tree, chewed or brewed for centuries to relieve pain and even act as a natural remedy to ease opium addiction. 7-Hydroxymitragynine (7-OH) is one of the more than 40 active alkaloids naturally present in kratom leaves. In contrast, semi-synthetic, concentrated and often clandestinely made 7-OH on the market is man-made, more potent and interacts mainly with the same receptor system targeted by morphine, heroin and prescription opioids.
Haddow said an important outcome of the federal actions is that they will provide state legislatures with greater clarity on the differences between 7-OH and kratom products. Legislatures that have banned both types of products because “they claim they can’t make the distinction between what they are” need to now revisit policies to allow for consumer access to safely formulated, properly labeled kratom that people can use for their health and wellness, he added.
Todd Underwood, president at MitWellness, a functional beverage company, wrote on LinkedIn that the DEA and HHS actions represented an important step toward distinguishing traditional kratom from highly concentrated and synthetic 7-OH products.
“For years, many of us have argued that these are not the same thing,” he said. “Traditional kratom leaf and responsibly manufactured kratom products should not be conflated with concentrated or chemically manufactured 7-OH products that present a fundamentally different risk profile.”
Underwood added that he was encouraged to see a regulatory approach that focuses on products presenting the greatest public health concerns while recognizing that traditional kratom is a separate issue.
Kevin Sabet, an American drug policy scholar who worked in the White House under several administrations, told The New York Times that 7-OH and mitragynine, a compound found in kratom, can both be lethal. He said signaling out 7-OH misleads the public into thinking kratom is benign.
Commenting on the recent developments, Daniel Fabricant, PhD, president and CEO of the Natural Products Association noted that “intoxicating products, or those that get a person ‘high,’ are not dietary supplements.”
“We remain consistent in our position that highly concentrated amounts of 7-OH are falsely marketed as kratom and have not demonstrated pre-market safety through FDA’s new dietary ingredient notification process,” he said.
Fabricant, who previously directed FDA’s Division of Dietary Supplement Programs, emphasized that all forms of kratom intended for the U.S. market must be supported by evidence of safety and comply with applicable regulatory requirements.
“Products with a high potential for abuse have no place in the dietary supplement marketplace,” he added.
