The Food and Drug Administration has launched steps to regulate a substance that has quietly flooded U.S. shelves in recent years: 7‑hydroxymitragynine, or 7‑OH, a chemical extracted from kratom.
It’s not the kratom plant itself but a high‑strength byproduct—isolated, processed and far more potent—that acts on the brain like opioids.
Across America, you can already find it in the form of gummy candies, drinks, dissolvable sachets and even fruit‑flavored ice creams, often with no clear labels. Some brands market it as “natural” kratom. The FDA now wants it off the market.
What kratom is and why 7‑OH stands apart
Kratom comes from a tree native to Southeast Asia. Locals chew its leaves or brew them into tea to ease pain, boost energy or unwind, depending on how much they use. It remains legal in parts of the U.S.
But 7‑OH hardly exists in the raw leaf. In labs, it’s pulled out, refined and concentrated until its effects and strength diverge sharply from the plant.
“7‑OH is an opioid. It can out‑power morphine. After the last opioid wave, we can’t be unprepared,” said FDA Commissioner Marty Makary. “We need firm rules and clear public warnings.”
Disguised as snacks, sold without warnings
The alarm bell rang when 7‑OH started appearing in products wrapped in bright, kid‑friendly packaging—gummy bears, popsicles, instant powder sachets.
Often, the pack doesn’t list 7‑OH at all or hides it under vague names like “kratom extract” or “herbal blend.”
“In the U.S., these items pop up online, at gas stations, convenience stores and vape shops,” notes the FDA statement. “Many lack any clear 7‑OH label, posing as harmless supplements.”
No approval. No safe use.
7‑OH carries no FDA approval. No medicine contains it. It can’t legally go into supplements or foods.
The FDA stresses its action targets only these lab‑made derivatives, not the raw kratom leaf, since those “pose a clear public‑health risk.”
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
Seven companies warned for illegal sales
In June, the FDA sent warning letters to seven U.S. firms caught selling 7‑OH products—tablets, candies, drink mixes and “energy shots.”
Today, it also alerted doctors and health workers about 7‑OH’s risks. The goal: halt unregulated sales before a new front opens in the opioid crisis.
Next step: DEA decision
With its scientific review done, the FDA has formally asked the Drug Enforcement Administration (DEA) to list 7‑OH as a controlled substance under U.S. law.
The DEA must now hold a public comment period. Only after that will it decide on the final scheduling and any new restrictions.
Glossary
- 7-hydroxymitragynine (7-OH): Chemical substance derived from kratom. It is not found in pure form in the plant but can be produced through extraction and concentration processes. It has an effect similar to opioids and can be stronger than morphine. It is not approved for medical use nor can it be used in supplements or foods.
- 7-OH gummy candies: Sweet products, often fruit-flavored, containing the synthetic 7-OH derivative. They are sold similarly to snacks or supplements, sometimes without clear labels. Some packages are designed to attract young people.
- Controlled Substances Act (CSA): U.S. federal law regulating the control of potentially dangerous drugs and substances. It provides five “schedules” or tables, depending on abuse risk, recognized medical use and dependency potential.
- DEA (Drug Enforcement Administration): U.S. federal agency responsible for combating trafficking and abuse of controlled substances. It is tasked with evaluating and approving the classification of new substances according to the CSA, after public consultation.
- Opioid addiction: Chronic condition characterized by compulsive use of substances acting on opioid receptors in the brain. Effects can include tolerance, withdrawal, physical and psychological damage. 7-OH is among the substances at risk due to its binding with these receptors.
- 7-OH energy shot: Concentrated drinks in small formats (such as vials) containing 7-OH, often sold as stimulants or supplements. Some are distributed illegally or without clear indications.
- FDA (Food and Drug Administration): U.S. federal agency that regulates drugs, foods, supplements and medical devices. Responsible for public health protection. In this case it requested the scheduling of 7-OH as a controlled substance.
- Kratom: Plant native to Southeast Asia. The leaves are traditionally used as a stimulant at low doses or sedative at higher doses. Despite its historic use, in the U.S. it is debated: some isolated components, like 7-OH, may have opioid-like effects.
- Mitragynine: Main alkaloid contained in kratom. Responsible for most of the plant’s effects. During metabolism it can transform into 7-OH. However, in industrial products 7-OH is extracted and concentrated in much higher amounts.
- Opioids: Class of chemical substances, natural or synthetic, that bind to pain receptors in the nervous system. They include drugs like morphine and oxycodone, but also heroin and fentanyl. 7-OH acts on the same receptors and is considered dangerous.
- Vape shop: Stores specialized in selling electronic cigarettes, liquids and related accessories. In the U.S., some of these also offer products containing substances like 7-OH, sold as supplements or snacks.
