When asked about the availability of intoxicating products such as delta-8-THC, the U.S. Food and Drug Administration’s (FDA) head warned Tuesday that using cannabinoids could lead to psychosis and heart problems.
“I personally, in my writings, in my statements—and also the Department of Health and Human Services—have expressed serious concerns about people using these cannabis products,” FDA Commissioner Marty Makary said in response to a question from a Wall Street Journal reporter.
Makary responded, “We do not want children to use these drugs.” Makary replied, “We don’t want kids to use them.”
The FDA head’s remarks came during a press conference at which he announced, with federal health officials from other agencies, plans to act to regulate a distinct substance. This is 7-hydroxymitragynine. Also known as 7 OH-MIT (or simply 7 OH), this opioid-like substance produced by kratom in tiny amounts.
Makary described the plans for a 7-OH ban as “an entire separate public health initiative” that is not related to his remarks about cannabis.
The FDA has recommended that the Drug Enforcement Administration, or DEA, schedule this compound as a controlled substance under federal law.
In a planned press release, FDA stated that “there are no FDA approved 7-OH medications. 7-OH in supplements is illegal and 7-OH in conventional food products cannot be added legally.”
FDA states that the proposed schedule action will specifically target 7OH, which is described by the FDA as “a concentrated product of the kratom plants.”
It is stated that the “action” does not include natural kratom leaves, which have relatively low levels of 7-OH. The primary ingredient in botanical kratom is mitragynine.
Robert F. Kennedy Jr., Secretary of Health and Human Services said that “today we are taking action to combat opioid addiction.” We will safeguard the health of America’s young people as we work to achieve our goal, Make America Health Again.
FDA reported that it sent warning letters last month to seven firms that they claim were illegally selling 7-OH products. “These include tablets, gummies and drink mixes, as well as shots.” The agency
The officials released Tuesday new guidelines aimed at healthcare professionals, as well a warning for consumers to be aware of 7-OH product “hiding right in front of them.”
Consumer warning: “The time for action is now.” The consumer warning says, “We must and can stop the next wave of opioid crisis.”
The kratom market is applauding this new schedule.
In an email sent to its supporters, the American Kratom Association said that “this bold, scientifically-driven action is a crucial milestone in protecting consumer safety and public health.”
Mac Haddow is the senior fellow for public policy of this trade association. “These 7OH products aren’t kratom,” he said. These are chemically modified substances with potent effects similar to opioids and a threat for consumers. The move is a long overdue reminder that the American people’s safety comes first.
As for hemp-derived products, meanwhile, a Republican U.S. senator this week successfully blocked a proposed ban on hemp THC products that was included in a key spending bill, giving the industry a win amid contentious discussions around intoxicating cannabinoids.
Following intensive debates around the language—which would have prohibited hemp products with any quantifiable amount of THC—Sen. Rand Paul (R – KY) threatened to hold the Agriculture, Rural Development, Food and Drug Administration Appropriations Bill (Ag/FDA) up procedurally. To that end he was successful in getting this section removed.
Sen. Mitch McConnell (R-KY), who championed the federal legalization of hemp and its derivatives under the 2018 Farm Bill, wanted to see the hemp ban proceed through the process. On Tuesday, however, Senator John Hoeven, R-ND, chair of the appropriations committee of jurisdiction told reporters that the hemp ban was eventually removed from the bill.
Under the legislation that advanced through the Senate Appropriations Committee earlier this month, consumable hemp products with any “quantifiable” amount of THC would be banned.
Paul told MEDCAN24 late last month that the proposal—which largely mirrors provisions of a House version of the spending bill, championed by Rep. Andy Harris (R-MD)—would “completely destroy” the industry.
On the House side, while Harris amended report language attached to the chamber’s bill clarifying that it’s not the intent to stop people from accessing “industrial or non-intoxicating hemp-derived cannabinoid products with trace or insignificant amounts of THC,” the bill itself still says that products containing any “quantifiable” amounts of THC couldn’t be marketed. It’s hard to find CBD products without natural THC traces.
Paul recently filed a bill that would go in the opposite direction of Harris’s ban, proposing to triple the concentration of THC that the crop could legally contain, while addressing multiple other concerns the industry has expressed about federal regulations.
In June, the senator presented the Hemp Economic Mobilization Plan Act (HEMP). It mirrors versions he’s sponsored over the last several sessions.
Harris, for his part, told MEDCAN24 that he’s not concerned about any potential opposition in the Senate—and he also disputed reports about the scope of what his legislation would do to the industry.
The Congressional Research Service (CRS) released a report last month stating that the legislation would “effectively” prohibit hemp-derived cannabinoid products. The CRS originally stated that a similar ban would also prevent the sale CBD, but for unknown reasons the report has been updated to remove that specific language.
The hemp language is largely consistent with appropriations and agriculture legislation that was introduced, but not ultimately enacted, under the last Congress.
Hemp industry participants rallied to oppose that proposal. A previous version of it was included in last year’s base bill by the subcommittee. It’s virtually identical to a provision of the 2024 Farm Bill that was attached by a separate committee last May via an amendment from Rep. Mary Miller (R-IL), which was also not enacted into law.
A leading alcohol industry association, meanwhile, has called on Congress to dial back language in the House spending bill that would ban most consumable hemp products, instead proposing to maintain the legalization of naturally derived cannabinoids from the crop and only prohibit synthetic items.
Wine & Spirits Wholesalers of America (WSWA) President and CEO Francis Creighton said in a press release that “proponents and opponents alike have agreed that this language amounts to a ban.”
Separately, key GOP congressional lawmakers—including one member who supports marijuana legalization—don’t seem especially concerned about provisions in the bill despite concern from stakeholders that it would put much of the hemp industry in jeopardy by banning most consumable products derived from the plant.
Miller, of the U.S. Hemp Roundtable, told congressional lawmakers in April that the market is “begging” for federal regulations around cannabis products.
Rep. James Comer asked a sarcastic question at the hearing about FDA regulations.
A report from Bloomberg Intelligence (BI) last year called cannabis a “significant threat” to the alcohol industry, citing survey data that suggests more people are using cannabis as a substitute for alcoholic beverages such a beer and wine.
Last November, meanwhile, a beer industry trade group put out a statement of guiding principles to address what it called “the proliferation of largely unregulated intoxicating hemp and cannabis products,” warning of risks to consumers and communities resulting from THC consumption.
Regarding THC use and psychosis, meanwhile, some federal officials in the Trump administration have been playing up the apparent link—though experts say it’s unclear whether there’s any causal connection between the two.
DEA claimed in May that marijuana is more likely than methamphetamine to lead to psychosis. This was done by promoting a recently published article, where a psychiatrist said the jury has not yet been decided on this question.
The DEA is known for making sensationalized claims regarding the dangers of marijuana use. However, there appears to be a greater push by DEA to reinforce this message, especially among youth.
For example, DEA recently teamed up with an anti-marijuana organization to mark “National Prevention Week,” promoting a campaign that encourages people to share memes with dubious claims about the effects of cannabis—including the theory that it is a “gateway drug” to using other substances.
A 2023 American Medical Association study found that, despite an increase in adult cannabis consumption in the past few years, there was “no statistically meaningful” increase in diagnoses of psychosis in states with legal marijuana.
Separately earlier in the month, a Johns Hopkins University cannabis researcher said that there is a “questionable” causal relationship between marijuana and psychosis.
Ryan Vandry is an experimental psychologist who is a professor. He said that there is “no doubt” a correlation between cannabis and the onset and severity of psychosis. But “the causality for someone else, who wouldn’t otherwise have psychosis,” is questionable.
The deputy director of the advocacy group NORML wrote an op-ed in 2023 for MEDCAN24. He noted that the claims that cannabis could lead to “incurable sanity” date back almost a century and that they helped justify Congress’s prohibition on cannabis in 1938.
Paul Armentano wrote that acute cannabis-induced schizophrenia is rare. Those who have it tend to be either predisposed or already suffer from a psychiatric condition.
Armentano argued at the time that “the establishment of a regulated market designed to keep cannabis products away from young people, and that provides clear warnings to those specific populations who may be more vulnerable to its effects—coupled with a policy of consumer education—is the best way to protect public health and mitigate consumers’ risks.”