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Health officials are taking action against a substance that some are calling “gas station heroin.” The FDA is recommending that 7-hydroxymitragynine (also known as 7-OH) — a byproduct of the plant kratom — be classified as a Schedule I drug.
HHS Secretary RFK Jr. and FDA Commissioner Dr. Marty Makary emphasized the importance of getting ahead of yet another wave of addiction before it can sweep across the country. Makary compared the distribution of 7-OH to the early days of opioid prescriptions, before doctors understood the addictive nature of painkillers.
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“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,” Makary said in an FDA statement. “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.”
During a news conference on Tuesday, Makary suggested that the public health community is often late to act against dangerous substances due to a “disconnect between the ivory towers and the streets.” He then pondered aloud if experts had been to vape stores, as it “affects what we see in the operating room.”
According to the FDA, 7-OH is beginning to be recognized for its potential to be abused because of its ability to bind to opioid receptors. Additionally, the substance is widely available and may be appealing to children and teens as it is sold in fruit-flavored gummies and even ice cream cones. The FDA is also warning that 7-OH products “may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom.”
“I am in favor of this move because of the relationship of the 7-OH to the opioid receptors. This is essentially an opioid. It is semisynthetic and derived from the kratom plant whose leaves make a stimulant. There are no approved 7-OH drugs or diet supplements,” FOX News Senior Medical Analyst Dr. Marc Siegel told Fox News Digital. “Bravo to the FDA for this move — it should be listed as a controlled substance.”
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Kennedy spoke about his own battle with heroin addiction. The HHS secretary described his “iron willpower” and how he gave up candy and desserts for years, making him feel as though he could do anything, until he got his hands on heroin.
“I felt that I could do anything with my willpower, but this compulsion was absolutely impervious to my will, and part of the problem was just the availability. It was too easy to get this drug for me,” Kennedy said.
He also noted that President Donald Trump’s family has also grappled with addiction. Though the president has been sober his entire life, his brother, Fred Trump Jr., struggled with alcoholism for much of his life and died at the age of 43.
“I had a brother, Fred, great guy,” Trump said about his brother in 2017. “But he had a problem. He had a problem with alcohol. And he would tell me, ‘Don’t drink. Don’t drink.’”
Trump said at the time that he listened to his brother because he “respected him,” adding that “to this day, I’ve never had a drink.”
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Sen. Markwayne Mullin, R-Okla., who attended the news conference, supported the recommendation based on his family’s experience with addiction, though he did not detail exactly to whom he was referring.
“It’s an addiction that is ruining lives,” Mullin said at a Tuesday news conference. He went on to thank Kennedy on behalf of his own family and “every single family that has dealt with this” for acting against the powerful drug.
The CDC reported in May that drug overdose deaths in the country dropped in 2024. The U.S. saw “80,391 drug overdose deaths in the United States during 2024 — a decrease of 26.9% from the 110,037 deaths estimated in 2023.” Additionally, the CDC found that “overdose deaths involving opioids decreased from an estimated 83,140 in 2023 to 54,743 in 2024.”
Kratom, the plant from which 7-OH is derived, is a tropical tree native to Southeast Asia. The FDA notes that kratom is often used to self-treat a variety of conditions, such as pain, anxiety and depression. The agency notes that it has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components: mitragynine and 7-OH.
FOX News’ Serafin Gómez contributed to this report.
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