FDA Commissioner Links Use Of Cannabis Products To Heart Problems And Psychosis

Asked about the widespread availability of intoxicating cannabinoid products, such as delta-8 THC, the head of the U.S. Food and Drug Administration (FDA) warned on Tuesday that the use of cannabinoids can lead to cardiac problems and psychosis.

“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.

“We don’t want kids to use them,” Makary replied. “Cannabis use disorder is a real thing, and as you appropriately mentioned, there are now studies linking it to psychosis and even cardiovascular problems.”

The FDA chief’s comments came at a press event at which he and other federal health officials announced plans to take action to restrict a separate substance: 7-hydroxymitragynine (known as 7-OH-MIT or simply 7-OH), an opioid-like compound that is produced in small amounts by the kratom plant.

Makary said the matter of reining in cannabis products is “an important issue” but described it “an entirely separate public health campaign” from plans to restrict 7-OH.

As for that substance, FDA is recommending that the Drug Enforcement Administration (DEA) schedule the compound under the federal Controlled Substances Act.

“There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods,” FDA said in a press release about the planned move.

FDA says the proposed scheduling action would specifically target 7-OH, which it described as “a concentrated byproduct of the kratom plant.”

The agency says the action “is not focused on natural kratom leaf products,” which contain relatively little 7-OH. In botanical kratom, the primary active ingredient in is another chemical, mitragynine.

“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said in a statement. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”

FDA noted that last month, it issued warning letters to seven companies that the agency claims was illegally distributing 7-OH products, “including tablets, gummies, drink mixes and shots.” The agency

Officials also unveiled new guidance for healthcare professionals on Tuesday as well as a warning to consumers about 7-OH products “hiding in plain sight.”

“The time to act is now,” the consumer warning says. “We can and must prevent the next wave of the opioid crisis.”

At least some in the kratom industry are applauding the newly announced scheduling action.

The American Kratom Association, for one, said in an email to supporters, that it “applauds this bold, science-driven action as a critical milestone in protecting public health and consumer safety.”

“These 7-OH products are not kratom,” said Mac Haddow, a senior fellow on public policy at the trade group. “They are chemically altered substances that carry potent opioid-like effects and pose an imminent threat to consumers. This move sends a clear and long-overdue message: the safety of the American public 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) stood his ground with a threat to procedurally hold up the appropriations bill covering Agriculture, Rural Development, Food and Drug Administration (Ag/FDA). And to that end, he prevailed in getting the 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. But on Tuesday, Sen. John Hoeven (R-ND), chair of the appropriations subcommittee of jurisdiction, told reporters it was ultimately stripped from the legislation.

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 Marijuana Moment 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. And it’s rare to find CBD items without any natural traces of THC.

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.

The senator introduced the legislation, titled the Hemp Economic Mobilization Plan (HEMP) Act, in June. It mirrors versions he’s sponsored over the last several sessions.

Harris, for his part, told Marijuana Moment 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. Initially it said that such a ban would prevent the sale of CBD as well, but the CRS report was updated to exclude that language for reasons that are unclear.

The hemp language is largely consistent with appropriations and agriculture legislation that was introduced, but not ultimately enacted, under the last Congress.

Hemp industry stakeholders rallied against that proposal, an earlier version of which was also included in the base bill from the subcommittee last year. 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.

At the hearing, Rep. James Comer (R-KY) also inquired about FDA inaction around regulations, sarcastically asking if it’d require “a gazillion bureaucrats that work from home” to regulate cannabinoids such as CBD.

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 in May claimed marijuana could be more likely to cause psychosis than is methamphetamine, promoting a recent article where a psychiatrist indicated that the jury is out on the question.

While DEA has long been known to promote sensational claims about the risks of cannabis use, it appears there’s been a stepped-up push to reinforce that message, particularly for 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.

Notably, a 2023 study published by the American Medical Association found that despite increases in cannabis consumption by adults in recent years, states where marijuana was legal experienced “no statistically significant increase” in psychosis-related diagnoses.

Separately, a cannabis researcher at Johns Hopkins University said on a federal Substances and Mental Health Services Administration (SAMHSA) earlier this month that the causal link between cannabis and developing psychosis is “questionable.”

There is “undoubtedly a strong correlation between heavy cannabis use and earlier onset of psychosis, and psychosis severity” said Ryan Vandry, an experimental psychologist and professor, but “the causality on someone who would not otherwise develop psychosis is still questionable.”

In a 2023 op-ed for Marijuana Moment, the deputy director for the advocacy group NORML noted that claims that marijuana could cause “incurable insanity” stretch back nearly a century in the U.S. and helped support Congress’s blanket ban on cannabis in 1937.

“In reality, acute cannabis-induced psychosis is rare, and those who experience it are typically either predisposed to psychosis or have a pre-existing psychiatric disorder,” wrote Paul Armentano, pointing to studies out of Europe and Canada.

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.”