FDA Announces Intent to Add 7-Hydroxymitragynine to Schedule I
FDA ANNOUNCES INTENT TO ADD 7-HYDROXYMITRAGYNINE TO SCHEDULE I
In the past decade, the Food and Drug Administration (FDA) has gone from opposing natural kratom to supporting early studies on the safety profile of the plant.
Now it’s taking the next step, and putting the “bad actors” that are using kratom as a smokescreen to target dangerous products masquerading as natural supplements.
In a press conference on July 29, the FDA announced plans to pursue the process of scheduling 7-hydroxymitragynine (7-OH), an alkaloid found in natural kratom leaves, but only in trace amounts. As lawmakers across the country have gone back and forth over the best way to regulate kratom products, advocates for access to natural kratom products now have the backing of federal regulators in their quest to make a clear differentiation between kratom and 7-OH products.
When it comes to the science surrounding kratom’s alkaloids, the past few years have cleared up questions about the difference between natural kratom and synthetically produced 7-OH products.
Most kratom products have higher concentrations of mitragynine, the most abundant natural alkaloid found in the plant, while 7-OH occurs in trace amounts as the kratom leaves dry. To enhance the opioid-like effects of their products, some producers have instead begun artificially enhancing the concentration of 7-OH found in products, which caused researchers to sound the alarm about these bad actors in the industry. Want to dive deeper into its chemistry? Learn what mitragynine is and how it compares to 7-OH.
Backed by Science
Dr. Christopher McCurdy has been among the group of researchers speaking out against 7-OH, and presented that information in a Congressional briefing in September of 2024. McCurdy is also part of the group behind a website to help consumers understand the difference between kratom and these “enhanced” products.
As part of a presentation put on by the American Kratom Association earlier this year, McCurdy made his stance clear on 7-OH.
“In my opinion, the maximum dose of purified 7-OH is zero,” McCurdy said. “I will state this from a scientific perspective…the concerns that we have is that this molecule, purified and out is an opioid. It’s not going to get FDA approval to be an over-the-counter medication regardless of what the story is.”
McCurdy, who also conducted a dosage study on natural kratom products for the FDA, was speaking of his own accord after a formal presentation by the AKA, and made it clear: 7-OH products have a completely different profile from natural kratom products.
“If you really want to protect consumers, you don’t want to put a product into the marketplace that you know causes addiction from the start,” McCurdy said.
With the announcement from the FDA, it appears federal regulators have started to listen to the science.
How 7-OH Differs From Regulated Kratom Products
The first speaker at the press conference was Deputy Secretary Jim O’Neill, who painted a picture of how 7-OH has taken advantage of the lack of kratom regulation to carve out a place in the market. Whereas responsible kratom brands have been willing to adhere to regulatory structures and safe manufacturing processes, O’Neill said 7-OH products have exploited the patchwork of kratom laws around the country.
“These substances are often sold online or in convenience stores with no quality control, no dosage control, no warnings,” O’Neill said. “This is a recipe for public health disaster.”
Because of those regulatory loopholes, the companies behind these products have found ways to artificially enhance the amount of 7-OH to dangerous levels. Due to these products, O’Neill said the FDA’s reports of deaths and adverse effects from products labeled as kratom have grown to alarming levels–but these products are not natural, and are far different from the kratom products offered by responsible actors in the industry.
“Not all innovation is positive. Dark innovations in chemistry have exacerbated the addiction crisis in this country…7-OH carries a high risk of addiction, on purpose. It is a powerful opioid agonist and is many times more potent than morphine,” O’Neill said.
That position was echoed by FDA Commisioner Marty Makary, who used his background as a medical practitioner to expand on the dangers posed by 7-OH products.
“7-OH is not just ‘like an opioid’ it does not just have ‘opioid-like binding properties’, 7-OH binds to the mu-opioid receptor, which means scientifically by definition it is an opioid. Yet it is sold in vape stores, smoke shops and convenience stores and gas stations that are popping up all over the United States,” Makary said. Here’s a guide on how to shop safe kratom online and avoid risky products.
Makary also made it clear: Attempting to schedule 7-OH does not change the FDA’s position on kratom. The agency is in the early stages of studying natural kratom products, and clearly understands the difference between lab-created 7-OH products and the natural kratom products available in teas, capsules and extracts.
“(7-OH) is a synthetic, concentrated byproduct of kratom–our focus is not on kratom, our focus is on 7-OH,” Makary said. “We’re not targeting the kratom leaf or ground up kratom; we’re targeting the synthetic byproduct that is an opioid.”
Due to those differences, Makary said the FDA’s action is to schedule 7-OH as Schedule I and leave a carve-out for the trace amounts of the alkaloid that are found in naturally occurring kratom products.
“We think it’s night and day in terms of the public health risk,” Makary said.
The presentation also included a pair of politicians, starting with Sen. Markwayne Mullin from Oklahoma. Mullin offered the support of the legislative branch and said that the bad actors in the kratom industry “know the loopholes they’re targeting” before sharing his personal experience of helping family members overcome addiction.
To close the presentation, Secretary of Health Roberty Kennedy Jr. took to the podium to explain how the Department of Health and Human Services has a history of addressing addiction issues after the fact. With the action to schedule 7-OH, Kennedy said he is hoping that HHS can flip the script and help consumers recognize the threat posed by these synthetic products.
“Our agency has been asleep at the wheel for all of these other crises,” Kennedy said. “Now we’re going to wake up and stop this before it starts.”
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