The FDA makes a planning recommendation for the KRATOM 7-OH by-product, warns dangers

Health officials take measures against a substance that some call “the heroine of the service station”. The FDA recommends that 7-hydroxymitragynine (also known as 7-OH)-a sub-product of the vegetable kratom-be classified as a medication of Annex I.

The secretary of HHS, RFK Jr., and the FDA commissioner, Dr. Marty Makary, stressed the importance of ahead of another wave of dependence before being able to sweep the country. Makary compared the distribution of 7-OH in the first days of opioid prescriptions, before doctors understand the addictive nature of pain relievers.

The American Secretary of Health and Social Services (HHS), Robert F. Kennedy, Jr., is expressed alongside the Commissioner of Food and Drug Administration (FDA), Dr. Marty Makary (L) from the sending of warning letters to companies for illegally marketing products containing 7-hydroxymitragynine opioids, also known under the name of 7-OH, as part of their actions, in combatants, during a press conference at the HHS at the HHS 29, 2025. (Saul Loeb / AFP via Getty Images)

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“Vape stores appear in all the districts of America, and many sell addictive products like the concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught,” said Makary in an FDA statement. “7-OH is an opioid that can be more powerful than morphine. We need regulation and public education to prevent another wave of the epidemic of opioids.”

At a press conference on Tuesday, Makary suggested that the public health community was often behind to act against dangerous substances due to “disconnection between the ivory towers and the streets”. He then thought out aloud if experts had gone to vape stores, as this “affects what we see in the operating room”.

According to the FDA, 7-OH begins to be recognized for its potential to abuse due to its ability to bind to opioid receptors. In addition, the substance is widely available and can be attractive for children and adolescents because they are sold in fruit cannons and even ice cream horn. The FDA also warns that 7-OH products “may not be clearly or precisely labeled as their 7-OH content and are sometimes disguised or marketed as Kratom”.

“I am in favor of this decision because of the relationship of 7-OH with opioid receptors. It is essentially an opioid. It is semi-synthetic and derived from the Kratom plant whose leaves make a stimulant. There are no approved 7-OH drugs,” said Dr. Marc Siegel, a senior medical analyst. “Bravo to the FDA for this decision – it must be listed as a controlled substance.”

Cannabis dispensary CBD Kratom, West 14th Street, New York, New York. (Plexi Images / Glasshouse Images / UCG / Universal Images Group via Getty Images)

The FDA says that the “dangerous” substance known as heroine of the service station presents a major risk for young people

Kennedy spoke of his own battle with heroin dependence. The secretary of the HHS described his “iron will” and how he abandoned candies and desserts for years, which gives him the impression of doing anything, until he gets his hands on the heroine.

“I felt that I could do everything with my will, but this constraint was absolutely waterproof to my will, and part of the problem was only availability. It was too easy to get this medication for me,” said Kennedy.

He also noted that President Donald Trump’s family also faced dependence. Although the president was sober all his life, his brother, Fred Trump Jr., fought against alcoholism for a large part of his life and died at the age of 43.

“I had a brother, Fred, a great guy,” said Trump about his brother in 2017. “But he had a problem. He had a problem with alcohol. And he said to me:” Don’t drink. Do not drink. “”

Trump said at the time that he listened to his brother because he “respected him”, adding “to this day, I have never drunk a drink”.

This file photo of September 27, 2017 shows Kratom capsules in Albany, NY (AP photo / Mary Esch, file)

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Senator Markwayne Mullin, R-Okla., Who attended the press conference, supported the recommendation based on his family experience with dependence, although he did not detail exactly to whom he was referring.

“It is a dependence that ruins lives,” said Mullin at a press conference on Tuesday. He then thanked Kennedy on behalf of his own family and “each family who treated this” for having acted against powerful drugs.

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The CDC reported In May, that the deaths of drug overdose in the country fell in 2024. The United States saw “80,391 drug overdose deaths in the United States in 2024-a decrease of 26.9% compared to the 110,037 deaths estimated in 2023. In addition, the CDC noted that” deaths by overdose involving opioids decreased compared to 83,140 estimated 2023 to 54,743 in 2024. “

Kratom, the plant of which 7-OH is derived, is a tropical tree from Southeast Asia. The FDA notes that Kratom is often used to treat a variety of conditions, such as pain, anxiety and depression. The agency notes that it has not approved any over-the-counter prescription or medication containing Kratom or its two main chemical components: Mitragynine and 7-OH.

Serafin Gómez de Fox News contributed to this report.