Products containing concentrated 7-hydroxymitragynine, commonly called 7-OH, are being sold online and at some gas stations, convenience stores and smoke or vape shops. Although they may be packaged as gummies, tablets, drink mixes or liquid shots, federal health officials warn that concentrated 7-OH acts as a potent opioid and may cause addiction, withdrawal, respiratory depression and overdose.

What is 7-OH?

7-OH is a chemical that occurs naturally in trace amounts in the kratom plant, which is native to Southeast Asia. The products drawing concern from federal regulators are not traditional kratom leaves. They contain added, enhanced or manufactured concentrations of 7-OH that can be significantly stronger than the amounts occurring naturally in the plant.

The U.S. Food and Drug Administration reports that 7-OH activates the same mu-opioid receptors affected by drugs such as morphine and fentanyl. One study cited by the FDA found that 7-OH was 13 times more potent than morphine at activating those receptors.

The FDA has not approved any 7-OH product for medical use. Concentrated 7-OH also is not considered a lawful dietary supplement ingredient and cannot lawfully be added to conventional foods.

Why do people use it?

People may purchase 7-OH products for their opioid-like effects. Products have been marketed for pain relief, relaxation, improved mood, increased energy, anxiety and relief from opioid withdrawal symptoms.

Some people may also use the products recreationally because concentrated 7-OH can produce euphoria or a “high.” Regular use can lead to tolerance, meaning a person may need increasingly larger amounts to produce the same effect. Users may also develop physical dependence and experience withdrawal symptoms when they stop.

The FDA has not found 7-OH products to be safe or effective for treating pain, anxiety, mood disorders, opioid withdrawal or any other medical condition. 

Why are the products still on store shelves?

The presence of a product in a retail store does not mean it has been reviewed or approved by the FDA.

Unlike prescription drugs, dietary supplements generally do not undergo FDA approval before being placed on the market. Some companies have marketed concentrated 7-OH products as dietary supplements, botanical products, wellness products or ordinary foods even though the FDA states that 7-OH cannot lawfully be used in those ways.

The products also entered the market faster than federal agencies could investigate manufacturers, identify distributors and establish specific controlled-substance regulations. Enforcement actions may require investigations, warning letters, product seizures or court proceedings. Products can therefore remain in stores or online while those actions are underway.

Packaging and labeling may create additional confusion. Some products are marketed as kratom even though their 7-OH concentrations are substantially higher than the trace amounts found in natural kratom leaves. Others resemble energy shots, candy or ordinary dietary supplements.

Retailers may obtain these products through wholesalers and distributors without fully understanding their contents or regulatory status. However, retailers and distributors remain responsible for ensuring that the products they sell comply with federal and state laws.

Who is selling the products?

Concentrated 7-OH products are distributed under numerous brand names through websites, wholesalers, smoke and vape shops, gas stations and convenience stores.

In July 2025, the FDA announced that it had issued warning letters to seven companies for allegedly illegally marketing products containing added or enhanced levels of 7-OH:

  • Shaman Botanicals LLC
  • My Smoke Wholesale
  • Relax Relief Rejuvenate Trading LLC, doing business as RRR Trading or EDP Kratom
  • Thang Botanicals Inc., doing business as 7-OHMZ
  • Royal Diamond Imports Inc., doing business as Roxytabs.com
  • Hydroxie LLC
  • 7Tabz Retail LLC

FDA warning letters identify alleged violations and request corrective action. They do not necessarily establish that each company physically manufactured every product it marketed or distributed.

In December 2025, the FDA and the U.S. Department of Justice announced the seizure of approximately 73,000 units of concentrated 7-OH products from three firms in Missouri. The seized tablets and liquid shots were valued at approximately $1 million.

What is the current federal status?

The FDA has stated that concentrated 7-OH cannot lawfully be added to food, marketed as a dietary supplement or sold as a drug intended to treat a medical condition. However, it has not historically been controlled under federal drug-scheduling laws in the same manner as heroin, fentanyl and other controlled opioids.

In July 2026, the Drug Enforcement Administration announced its intent to temporarily place concentrated 7-OH and three related synthetic substances into Schedule I of the federal Controlled Substances Act.

The proposed action targets synthetic 7-OH and products containing concentrations above a specified threshold. It is not intended to apply to botanical kratom containing only naturally occurring trace amounts of 7-OH.

Once a temporary scheduling order takes effect, the manufacture, distribution, sale and possession of the covered substances become subject to the criminal, civil and administrative provisions of the Controlled Substances Act. State laws may impose additional restrictions. 

Reported exposures are increasing

America’s Poison Centers received 3,803 reports involving exposure to kratom or kratom-derived products in 2025. By June 30, 2026, poison centers had received 3,190 reports, placing the country on pace for a 67.8% increase over 2025.

Among cases involving 7-OH alone, 38.8% resulted in serious health problems, 63.8% were treated at healthcare facilities and 20.5% required hospitalization. Adults ages 20 to 39 accounted for 48.4% of reported kratom and kratom-derivative exposures.

Poison-center figures include cases reported to the centers and may not represent every exposure that occurred. 

Possible health effects

Reported or potential effects associated with concentrated 7-OH include:

  • Addiction and physical dependence
  • Anxiety and depression
  • Nausea and other gastrointestinal problems
  • Difficulty sleeping
  • Seizures
  • Slowed or stopped breathing
  • Loss of consciousness
  • Withdrawal symptoms, including restlessness, body aches, fatigue, irritability and cold sweats

Combining 7-OH with alcohol, prescription opioids, sedatives or other substances that slow the central nervous system may increase the risk of a medical emergency.

Recognizing a possible overdose

Signs of a possible opioid overdose include:

  • Inability to wake the person
  • Slow, shallow or stopped breathing
  • Gurgling, choking or unusual snoring sounds
  • Blue, gray or pale lips, skin or fingernails
  • Very small, pinpoint pupils

Anyone who suspects an overdose should call 911 immediately and administer naloxone, commonly sold under the brand name Narcan, if it is available. The person should be kept breathing, placed on their side to reduce the risk of choking and monitored until emergency responders arrive.

Naloxone can restore normal breathing within two to three minutes, although more than one dose may be required. A person who regains consciousness after receiving naloxone still needs emergency medical care because the effects of naloxone can wear off while the opioid remains in the body. 

For assistance with a suspected poisoning or exposure, contact the Texas Poison Center Network at 1-800-222-1222. The service is available 24 hours a day.

 

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