The Food and Drug Administration pushed Tuesday to restrict a synthetic opioid found in tablets, gummies and drinkable shots commonly sold in convenience stores. Health officials announced they will seek to add 7-OH — a potent substance synthesized from a compound in the kratom leaf — to the tier of controlled substances reserved for the most addictive drugs, such as heroin and LSD.

The FDA, researchers and kratom companies have grown increasingly alarmed by the rise of 7-OH products they say are distinct from all-natural teas and powders derived from a leaf that grows on trees native to Southeast Asia.

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FDA Commissioner Marty Makary said at a news conference that the agency is not asking to restrict natural products made from kratom, which contains trace amount of the compound. In a report released Tuesday, the agency said it maintains concerns about kratom broadly but needed to act urgently on 7-OH because of its risk of sedation, nausea, breathing problems and addiction.

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“We think it’s night and day in terms of the public health risk,” Makary said of 7-OH products.

The agency is recommending to the Drug Enforcement Administration that 7-OH be classified as Schedule I, a tier designated to have no medical value and high risk of abuse. That tier still includes marijuana, which federal officials under the Biden administration sought to move to a less restrictive category. That issue remains undecided.

The law enforcement agency will review the 7-OH recommendation “expeditiously,” DEA Deputy Assistant Administrator Thomas Prevoznik said.

Federal health officials rolled out the campaign to stamp out 7-OH with the nation still in the throes of a drug crisis fueled by illicit fentanyl, methamphetamine and other synthetic compounds easily manufactured in clandestine labs. Overdose deaths have dropped dramatically during the past year but still topped a staggering 80,000 in 2024.

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Health and Human Services Secretary Robert F. Kennedy Jr., who himself battled a heroin addiction decades ago, said Tuesday that public health agencies have been “asleep at the wheel” on previous crises of addiction in the United States.

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The FDA’s report presented scientific studies on 7-OH and advisories to consumers and doctors warning them of “eye-catching” products sold as gummies, candies and even ice-cream cones meant to appeal to young people. This month, the FDA said it had sent warning letters to seven companies regarding allegations that they illegally marketed 7-OH products as dietary supplements or unapproved drugs that touted relief from pain or anxiety.

The scrutiny of 7-OH products adds another twist to the saga of kratom in the United States.

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Amid the nation’s drug crisis, kratom has become increasingly popular as users seek alternatives for pain or relief from opioid withdrawal symptoms. Smoke shops, gas stations, convenience stores and online retailers across the U.S. sell to devoted users who champion the health benefits of all-natural kratom products on social media.

Speaking at the news conference Tuesday, kratom advocate Melody Woolf drew a distinction between the powdered kratom leaf she takes to ease her chronic pain and 7-OH products.

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“7-OH is not what helped me get out of bed and get the quality of life I enjoy,” Woolf said.

Kratom acts as a mild stimulant when taken in small doses. Experts say that in higher doses, kratom’s compounds can induce euphoria similar to opioids, though with less potency than many legal painkillers.

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One of kratom’s many natural compounds is converted into the metabolite 7-OH, or 7-hydroxymitragynine, which produces an opioid-like effect in the brain. Though kratom contains trace amounts of the compound naturally, companies use semisynthetic 7-OH extracts to make an entirely new and potent product, said Christopher McCurdy, professor of medicinal chemistry at the University of Florida College of Pharmacy.

“This is essentially putting legal morphine at the gas station,” McCurdy said.

Retailers have been slapped with wrongful-death lawsuits from families of people who died with kratom compounds in their blood, usually in conjunction with illicit drugs. In 2016, the Drug Enforcement Administration announced plans to classify kratom compounds as controlled substances but shelved the idea after fierce backlash. More than a dozen states have passed laws regulating kratom, according to the American Kratom Association, a trade group representing the industry.

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The association casts companies selling “enhanced” 7-OH products as bad actors that offer “chemically manipulated” products — usually concentrated shots and tablets. The products distort the public’s understanding of kratom and provide ammunition to critics who seek to ban plant products, said Mac Haddow, a spokesman and lobbyist for the association.

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“We do not believe these products should be available over the counter,” Haddow said in an interview Monday.

An opposing trade association, the Holistic Alternative Recovery Trust, said the criticism is part of an “intra-industry turf war” between companies losing market share and those making better products.

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“Consumers find it more effective and safer,” Jeff Smith, the group’s national policy director, said of such 7-OH products.

Smith said the group supports measures such as warning labels, age restrictions and testing by third-party independent labs.

But he criticized the FDA’s proposals, saying officials presented no science to support the alleged dangers of 7-OH. He predicted a ban would push users to return to more dangerous substances and destroy responsible businesses.

“The public needs to speak up to prevent dramatic regulatory overreach,” Smith said.

correction A previous version of this article incorrectly referred to Christopher McCurdy’s title at the University of Florida College of Pharmacy. He is a professor of medicinal chemistry.

Robert F. Kennedy Jr. is cracking down on an opioid-like substance that has gone wildly viral for its addictive properties, misleading marketing and its wide availability.

The Department of Health and Human Services recommended on Tuesday that the Drug Enforcement Administration schedule 7-hydroxymitragynine (7-OH) – a compound that appears in kratom leafs – as a class one illicit substance.

Kennedy says the hope is that scheduling it as a controlled substance will help ‘prevent the fourth wave of addiction’ in the U.S. and Food and Drug Commissioner Marty Makary says it’s 13 times more potent than morphine.

Currently, drinks, gummies and supplements with trace amounts of 7-OH from the kratom plant are widely available for purchase at smoke shops and convenience stores.

Some kratom plant products – like Feel Free botanical tonics – have recently gone viral with consumers claiming they quickly became addicted and dependent on the substance available at their local gas stations.

HHS recognizes the increase in reports of overdoses and emergency room visits linked to products containing 7-OH, many times from young people, veterans and people suffering from chronic pain.

Many who consume 7-OH claim they were not aware they were taking an addictive product. Others who bought it thought they were purchasing a product with the potency of an energy drink.

RFK Jr. and Makary warn that if 7-OH is allowed to remain on shelves, it will result in another opioid-crisis like in the 1990s and 2010s.

HHS Secretary Robert F. Kennedy Jr. is asking the DEA to schedule 7-hydroxymitragynine (7-OH) – a compound that appears in kratom leafs – as a class 1 drug to prevent the ‘fourth wave of opioid addiction’

Most known for appear in the Feel Free classic tonic shot, 7-OH is a highly addictive compound with opioid-like effects

During a Tuesday press conference, the two officials announced they are initiating the process to have the DEA classify 7-OH as an illegal controlled substance. They cited its opioid-like effects on the brain as justification for the scheduling.

It can take months and even years for drugs to get official scheduling by the DEA, but leadership at HHS and FDA make clear that this is a priority and suggest the process will be expedited.

The DEA must review the recommendation, which can take between two and six months. Then the rule must be opened for a public comment period, which is between 30 and 60 days.

During this time, advocates for the use of kratom leaf are likely to come out in opposition of the drug classification.

There are many kratom leaf products, like teas and other drinks, that do not fall in the same category as products that have trace amounts of 7-OH.

Makary made very clear that the FDA was not focusing on kratom leaf and only the 7-OH compound.

Companies that use kratom leaf with trace amounts of 7-OH in their products claim they help with relaxation and pain, as well as assist with productivity and focus.

Makary said: ‘7-OH is not just like an opioid, it does not just have opioid binding properties. 7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid.’

Products with 7-OH claim to help people with relaxation, pain management, productivity and focus. FDA Commissioner Marty Makary said at a press conference on Tuesday: ‘7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid’

‘And yet it is sold in vape stores, in smoke shops and convenience stores and gas stations that are popping up all over the United States, and nobody knows what it is,’ Markay lamented during a press conference at the HHS building on Tuesday.

‘It is a synthetic concentrated by-product of kratom. Our focus is not on kratom. Our focus is on 7-OH,’ he added.

Deputy HHS Secretary Jim O’Neill warned: ‘7-OH carries a high risk of addiction, on purpose. It is a powerful opioid agonist, many times more potent than morphine,’ sold online and in stores with no quality or dosage constraints.

‘Young people, veterans and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They are not,’ he concluded.

RFK Jr. (center) and FDA Commissioner Marty Makary (left) say that 7-OH is more potent than morphine

Kratom leaf – and trace amounts of 7-OH – appear in many products available at gas stations and smoke shops, including in gummies, drinks and tablets. They are often sold as a ‘dietary supplement’

RFK Jr. opened up about his years-long struggle with heroin addiction and said part of the HHS effort to schedule 7-OH is also to educate the American public about the threat it poses.

‘When there is availability that can become a crisis,’ Secretary Kennedy said. ‘And my addiction started because of, let me say this, it was precipitated by availability.’

Kennedy said that he met with Attorney General Pam Bondi this week regarding the action and that she showed the correlation between a high concentration of vape and smoke shops to areas where addiction-related deaths are happening in higher volumes.

‘Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH,’ Makary said. ‘After the last wave of the opioid epidemic, we cannot get caught flat-footed again.’

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.”

Secretary Robert F. Kennedy and FDA Commissioner Dr. Marty Makary took the bold and needed step today to protect consumers from chemically manipulated 7-OH products that pose an eminent threat to consumers. Specifically, HHS and FDA will schedule 7-OH as an “illicit substance.”… — Mac Haddow (@HaddowMac) July 29, 2025

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.”

WASHINGTON (AP) — U.S. health officials are warning Americans about the risks of an opioid-related ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban.

Watch U.S. health officials discuss kratom-related products in the player above.

The chemical, known as 7- hydroxymitragynine, is a component of kratom, a plant native to Southeast Asia that has gained popularity in the U.S. as an unapproved treatment for pain, anxiety and drug dependence.

In recent months, dietary supplement companies that sell kratom have been urging the Food and Drug Administration to crack down on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient.

The FDA action “is not focused on natural kratom leaf products,” according to a statement Tuesday by the U.S. Department of Health and Human Services.

The agency said it was releasing a report to educate about the risks of “7-OH and its distinction from the kratom plant leaf.” Regulators are also recommending that the ingredient be placed on the federal government’s most restrictive list of illegal drugs, which includes LSD and heroin.

“7-OH is an opioid that can be more potent than morphine,” said FDA Commissioner Marty Makary. “We need regulation and public education to prevent another wave of the opioid epidemic.”

READ MORE: What happens if kratom becomes illegal?

The agency’s recommendation will be reviewed by the Drug Enforcement Administration, which sets federal rules for high-risk drugs including prescription medicines and illicit substances. A national ban wouldn’t take effect until the agency drafts and finalizes new rules governing the ingredient.

Federal regulators have been scrutinizing kratom for about a decade after reports of addiction, injury and overdose. But users and distributors have long opposed efforts to regulate it, saying kratom could be a safer alternative to opioid painkillers that sparked the ongoing drug addiction epidemic.

Last month, the FDA issued warning letters to seven companies selling drinks, gummies and powders infused with 7-OH. Regulators said the products violated FDA rules because they have not been evaluated for safety and, in some cases, claimed to treat medical conditions, including pain, arthritis and anxiety.

Supplement executives quickly applauded the move.

The FDA “demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.,” said Ryan Niddel of Diversified Botanics, a Utah-based company that sells kratom supplements.

An industry group, the American Kratom Association, has lobbied Congress for years against restrictions on the plant. Legislation supported by the group would prohibit the FDA from regulating kratom more strictly than food and dietary supplements

Nearly a decade ago, the federal government came close to banning the substance.

In 2016, the DEA announced plans to add kratom to the government’s most restrictive schedule 1, reserved for drugs that have no medial use and a high potential for abuse. But the plan stalled after a flood of public complaints, including a letter signed by more than 60 members of Congress.

The FDA then began studying the ingredient, concluding in 2018 that kratom contains many of the same chemicals as opioids, the addictive class of drugs that includes painkillers like OxyContin as well as heroin and fentanyl.

Since then, FDA regulators have continued to issue warnings about cases of injury, addiction and death with kratom supplements, which are usually sold in capsules or powders.

In recent months, the FDA has also issued warnings on other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. Sometimes referred to collectively as “gas station heroin,” the drugs have been restricted by several states, but they are not scheduled at the federal level.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.

Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content.

Kratom‑derived 7‑hydroxymitragynine (7‑OH) is at the center of a sweeping Food and Drug Administration crackdown announced on Tuesday. The FDA sent seven formal warning letters to companies illegally marketing concentrated 7‑OH products such as gummies, tablets, and drink mixes often sold in gas stations, smoke shops and online.

Why It Matters

The FDA emphasized that 7‑OH is a potent, unapproved opioid-like compound not permitted in dietary supplements or conventional foods. Officials also called for federal scheduling of the substance due to its risks, distinguishing it from the natural kratom plant.

The availability of 7-OH products is a “major concern” to the FDA, the agency said in a news release.

President Donald Trump (L) and Health and Human Services Secretary Robert F. Kennedy Jr. speak at a White House event on May 12, 2025. President Donald Trump (L) and Health and Human Services Secretary Robert F. Kennedy Jr. speak at a White House event on May 12, 2025. Associated Press

What To Know

The FDA said the recommendation follows medical and scientific analysis by the agency, which is particularly concerned about a growing market of 7-OH products that may appeal to juveniles, including gummies and ice cream cones.

“These products may not be clearly or accurately labeled to their 7-OH content and are sometimes disguised or marketed as kratom,” the FDA said.

The agency said it has sent warning letters to seven companies for allegedly illegally distributing 7-OH products. The agency also issued a letter to health care professionals about the risks associated with these products.

What Is 7-OH?

7-OH is a psychoactive compound that occurs naturally in small amounts in the kratom plant.

The FDA said the substance can cause respiratory depression, physical dependence and withdrawal symptoms similar to common opioids, like morphine, fentanyl, oxycodone and hydrocodone.

File photo: Kratom capsules seen in Albany, New York, on September 27, 2017. File photo: Kratom capsules seen in Albany, New York, on September 27, 2017. AP Photo/Mary Esch, File

What Is Kratom?

Kratom refers to Mitragyna speciosa, a tree native to Southeast Asia, and products derived from its leaves marketed as herbal supplements, according to the National Institute on Drug Abuse. The most well-studied compounds related to kratom are mitragynine and 7-OH, according to the institute.

The FDA has not approved Kratom and its related products for any medical use. Some people have reported using kratom products for pain, anxiety and drug withdrawal symptoms and cravings. The National Institute on Drug Abuse said much is still unknown about the long-term and short-term effects of kratom use.

What People Are Saying

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

FDA Commissioner Marty Makary, in a statement: “Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again. 7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

What Happens Next

The Drug Enforcement Agency is reviewing the FDA’s recommendation and will have final authority on the scheduling of the substance. Under the Controlled Substances Act, drugs are placed into one of five different schedules based on various factors, including medical use and potential for abuse.

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Update 7/29/25, 12:56 p.m. ET: This article was updated with additional information.