Health and Human Services (HHS) Secretary Robert F. Kennedy Jr has announced a federal effort to crack down on a derivative of Kratom. Worries over addiction to synthetic Kratom, known better as 7-OH or 7-hydroxymitragynine, have grown due to its ability to bind to the brain’s opioid receptors.

Kratom is commonly promoted as a natural pain reliever and energy enhancer, often sold in eye-catching packaging at gas stations, smoke shops and liquor stores.

In recent years, however, manufacturers have intensified the strength of a compound in Kratom known as 7-hydroxymitragynine, or 7-OH, which binds to the brain’s opioid receptors and may heighten dependency risks.

7-OH not Kratom under spotlight

7-hydroxymitragynine (7-OH or 7-OH-MIT) is a naturally occurring alkaloid found in all Kratom leaves, though only in very small amounts - typically around 0.6% to 0.7%, depending on the strain. However, through oxidation, manufacturers have developed methods to drastically increase its concentration, producing compounds with up to 98% 7-OH.

In contrast to the trace levels found in natural Kratom, these synthetic 7-OH products contain highly concentrated doses. Experts caution that these are not natural extracts, but rather pharmaceutical-grade substances. Because of its efficiency in binding to the body's opiod receptors, there is a viable case for 7-OH in the treatment of chronic pain. However it's the unscrupulous way in which 7-OH products are being sold and marketed alongside less-potent natural Kratom products that's put them both in the spotlight.

“I became an addict because [heroin] was so available, but I had to go to the South Bronx or the Lower East Side,” Kennedy said during a press conference on July 29. “But now you can go to any gas station.”

Standing alongside Food and Drug Administration (FDA) Commissioner Dr Marty Makary, Kennedy revealed that the FDA will begin proceedings to classify 7-OH as a controlled substance.

“7-OH isn’t just ‘similar to’ an opioid, it is an opioid,” said Makary.

“It’s 13 times stronger than morphine. And yet, it’s sold in vape shops, convenience stores, and gas stations across the country. Most people don’t even realize what it is.”

The FDA notes that 7-OH is not legally recognized as a dietary supplement or food additive, despite misleading marketing by some companies.

“Consumers using 7-OH products are exposing themselves to items that haven’t been proven safe or effective for any purpose,” the FDA cautioned last month.

According to the Mayo Clinic, side effects can include rapid weight loss, liver injury, high blood pressure, dizziness, depression, seizures and even death.

Between 2011 and 2017, poison control centers across the US received 1,807 reports related to Kratom exposure. More recently, concerns about Kratom addiction have gone viral on platforms like TikTok and Instagram.

Kratom legality in the US

While Kratom remains legal at the federal level, state attitudes toward it vary wildly across the United States. It is legal in some states, outlawed in others and regulated in many more.

Eighteen states have adopted the Kratom Consumer Protection Act (KCPA), a regulatory framework developed by the American Kratom Association (AKA) which aims to protect both Kratom sellers and consumers by regulating products, manufacturing proccesses and marketing methods.

Currently, only seven states have outright bans on Kratom. Additionally, the FDA has not approved Kratom for use in any medications.

What next?

The agency recently sent warning letters to several companies marketing products containing 7-OH. Failure tohidnued, “There’s still a lot we don’t know. This could be the calm before the storm. It might just be the tip of the iceberg. But we have to be proactive.”

Once that step is taken, the Drug Enforcement Administration (DEA) will evaluate whether the compound should be officially designated as an illegal drug.