The U.S. Food and Drug Administration is ringing alarm bells over a potent, opioid-like substance that’s being sold in plain sight—often next to energy drinks, supplements, or flavored vapes. It’s called 7-hydroxymitragynine, or 7-OH, and it’s a concentrated compound derived from the kratom plant.

You’ll find it in gummies, powdered drink mixes, flavored shots, and even ice cream cones. Sold mostly in gas stations, corner stores, and vape shops, these products look benign—but they’re not. According to the FDA, 7-OH has a high potential for abuse and no approved medical use. And now, after a sweeping scientific review, the agency is recommending that 7-OH products be added to the Controlled Substances Act (CSA)—in the same category as heroin and LSD.

Here’s what this means, why it’s happening now, and what consumers should understand before they reach for that "all-natural" stress-relief gummy at the checkout counter.

What Is 7-OH?

Kratom is a tropical tree that grows natively in Southeast Asia. Leaves of the tree were used for centuries as a traditional herbal medicine. In the United States, kratom has become popular as an unapproved pain, anxiety treatment, and even opioid withdrawal alternative therapy. Some 1.7 million Americans age 12 and up used kratom in 2021, federal data suggest.

Kratom has two major chemical constituents: mitragynine and 7-hydroxymitragynine (7-OH). The more prevalent and weakly active of these is mitragynine, whereas 7-OH is significantly stronger—directly affecting the brain's mu-opioid receptors, just like morphine or codeine.

Some manufacturers have started isolating and concentrating 7-OH into high doses and selling it separately, completely bypassing the “natural” kratom leaf. These concentrated forms are not regulated, not approved, and far more dangerous than the kratom plant itself.

Why Has FDA Issued A Warning?

Unlike prescription opioids, 7-OH products are sold without a prescription or medical oversight, often labeled as supplements or energy enhancers. The FDA has found them being sold in brightly packaged gummies, fruity drinks, tablets, and “wellness shots,” frequently marketed to young people. Many of these items aren’t clearly labeled and may not disclose the amount of 7-OH they contain—or even that it’s included.

In June, the agency sent warning letters to seven companies for illegally selling 7-OH products in violation of federal law. These companies were selling 7-OH in various forms and often making unverified health claims, such as pain relief, anxiety treatment, or arthritis relief—without any scientific evidence to back them up.

According to FDA Commissioner Dr. Marty Makary, “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.”

The FDA’s latest report includes a clear recommendation: Schedule 7-OH as a controlled substance under the CSA. If accepted, this would make it illegal to sell, distribute, or possess 7-OH without special DEA approval. It would also allow for criminal penalties for unauthorized use.

The Drug Enforcement Administration (DEA) is now reviewing the recommendation. Before any action is finalized, a public comment period will be held, as required by federal law.

The agency made it clear that this action targets only 7-OH, not natural kratom leaf products. However, the distinction is critical, as 7-OH is not lawful in any food or dietary supplement in the United States. It has no FDA-approved uses, and when concentrated, it poses a high risk of abuse, addiction, and overdose.

What Makes 7-OH So Risky?

7-OH mimics the action of opioids in the brain by binding to the same mu-opioid receptors. While users may experience temporary relief from pain or anxiety, the effects can quickly lead to physical dependence, tolerance, and withdrawal symptoms—all hallmarks of substance use disorder (SUD). Some individuals using 7-OH have reported:

• Cravings and compulsive use
• Needing higher doses over time to feel the same effects
• Withdrawal symptoms when trying to stop
• Continued use despite serious personal or physical consequences

In rare cases, deaths have been reported in connection with kratom and 7-OH use, though many involved polydrug interactions, making it hard to isolate the role of 7-OH alone. Still, the FDA is not waiting for a full-blown crisis before acting.

Why Kratom Isn’t Safe Either?

While the FDA’s current push is focused on 7-OH, kratom as a whole remains under scrutiny. The agency has not approved any kratom-based drug for treating any condition, and it cannot legally be sold as a dietary supplement or added to food. Products containing kratom are considered “adulterated” under the Food, Drug, and Cosmetic Act.

That’s because, according to FDA analysis, there is insufficient evidence to guarantee that kratom—or its active compounds—can be safely used by consumers. The agency has linked kratom use to liver toxicity, seizures, and interactions with other medications.

The U.S. is still recovering from a devastating opioid crisis, and regulators are keen to avoid repeating history with a new, under-the-radar substance. 7-OH’s legal gray zone, paired with its accessibility and potent opioid-like effects, makes it especially dangerous.

The rise of vape shops and convenience store supplements has allowed these products to proliferate with minimal oversight. In many cases, they’re marketed using the same language as CBD or herbal wellness products—confusing consumers and bypassing safety checks.

“This isn’t just about one compound,” said HHS Secretary Robert F. Kennedy, Jr. “It’s about building a framework that protects youth and families from unregulated, addictive substances dressed up as wellness solutions.”

What You Should Do as a Consumer?

The FDA is urging consumers to read labels carefully, avoid products that claim to contain kratom or 7-OH, and report adverse events. The agency is also encouraging healthcare professionals to speak openly with patients about supplement use—especially those purchased outside of pharmacies.

Until thorough research proves safety and effectiveness, the risks of 7-OH far outweigh any perceived benefits. Consumers looking for help with pain, anxiety, or substance use disorders should consult licensed medical professionals—not convenience store counters.

The push to regulate 7-OH underscores a growing challenge in public health: the intersection of wellness marketing, legal loopholes, and addictive substances. As agencies like the FDA and DEA step in, the public’s awareness and skepticism of “natural” supplements needs to catch up. Just because something is sold on a shelf doesn’t mean it’s safe.

Health officials in the US have issued a risk of leptospirosis — a bacterial illness — in Hawaii, after the “Kona low” storm floods.

The Hawaii Department of Health (DOH) and the Hawaiian Humane Society (HHS) have urged residents and recovery workers to monitor for signs of leptospirosis that can affect both people and pets.

Leptospirosis is caused by bacteria Leptospira, which are carried in the urine of infected animals, including rats, mice, mongoose, livestock, and dogs.

The disease can spread via the urine of infected animals and can enter the human body through broken skin or through the mouth, nose, or eyes.

“Hawaii already has among the highest rates of leptospirosis in the country due to its warm, wet climate,” said HHS and DOH in a joint statement.

“Flooding events like the recent Kona low storm can dramatically increase exposure risk by spreading contaminated soil and water across a broad area,” it added.

The agency urged people to check out symptoms in pets, such as fever, decreased appetite, vomiting, diarrhea, and muscle soreness, and get medical help.

The risk of Leptospirosis outbreak is common after a storm, because the dead animals are likely to spread the bacteria. Further, flooding also forces rodents out of their burrows, leading them into homes, shelters, and debris piles where they shed bacteria more easily.

What Is Leptospirosis?

Leptospirosis is one of the most prevalent zoonotic diseases worldwide, often linked to poor sanitation and agricultural practices that involve contact with animals or contaminated water.

The bacteria can survive in contaminated water or soil for weeks to months, primarily spreading through the urine of infected animals.

Also read: With Rising Temperatures A Major Rat Infestation Is Taking Over The World- Why Is This A Health Hazard?

Humans can contract the disease through direct contact with infected urine or through contaminated food, water, or soil.

There are two main forms of leptospirosis: icteric leptospira, which presents with jaundice, and anicteric leptospira, a milder variant without jaundice. Leptospirosis can also manifest as Weil's disease, a severe complication.

What Are Symptoms Of Leptospirosis in humans?

Symptoms typically develop 2 to 30 days after exposure and can range from mild to severe. Initial signs often include

• high-grade fever,
• red eyes (conjunctival suffusion),
• calf tenderness,
• headache,
• dry cough,
• nausea,
• diarrhea.

In more serious cases, the infection can lead to complications such as

• jaundice,
• kidney damage
• liver damage,
• meningitis,
• respiratory issues,
• hemorrhages.

Pulmonary hemorrhage — acute bleeding from the lungs — can also occur, posing life-threatening risks such as respiratory and renal failure. The illness may last from a few days to several weeks, and without treatment, recovery can take months, according to the US Centers for Disease Control and Prevention (CDC).

What Precautions Should Be Taken?

To reduce the risk of leptospirosis infection, individuals are advised to take several important precautions. According to the CDC, it is essential to avoid wading through dirty rainwater, especially during the rainy season, and to wear gumboots in such conditions.

Proper care of any injuries or cuts is crucial, and frequent handwashing, particularly after handling food or working in potentially contaminated environments, is highly recommended. Additionally, individuals should avoid contact with animals that appear sick or are known carriers of the bacteria.

Vaccination is also vital—pet owners should ensure their pets are vaccinated against leptospirosis, especially if they are frequently exposed to water or wildlife. Staying hydrated by drinking plenty of clean water and preventing water stagnation around the home can further minimize the risk of infection.

The emerging COVID variant, BA 3.2, nicknamed “Cicada,” has revived memories of the COVID-19 pandemic that disrupted the world and raised fresh concerns about the possibility of severe illness.

The variant has been given the nickname “Cicada” due to its reappearance after remaining dormant or undetected for a long period, much like cicadas that emerge after years underground.

With the variant already spread to 23 nations, as of February, experts are urging people to use masks to avoid transmission.

What Is The Cicada COVID Variant?

Cicada was first identified in a respiratory sample in South Africa in November 2024.

It is a descendant of the Omicron BA.3 lineage, and is genetically distinct from the previously circulating JN.1 lineages (including LP.8.1 and XFG).

BA.3.2 comprises two major branches, BA.3.2.1 and BA.3.2.2. BA.3.2.2 also has substitutions like: K356T, A575S, R681H, and R1162P.

The World Health Organization (WHO) has designated BA.3.2 as a Variant Under Monitoring (VUM). It means the variant may not be that dangerous yet, but it may have concerning mutations.

As per the US CDC’s latest Morbidity and Mortality Weekly Report, Cicada has “70 to 75 substitutions and deletions in the gene sequence of its spike protein”.

Time To Mask Up

Dr. Sai Balasubramanian, a doctor and healthcare strategy executive, writing in Forbes, stressed the need to follow COVID practices such as masks and hand hygiene.

"Healthcare professionals recommend taking general precautions, similar to those used to prevent most viral transmission: get vaccinations when appropriate, wear masks in crowded areas or indoors where there is a high risk of transmission," he said.

He also urged “avoid individuals who have known illness or infections, wash hands frequently, and continue to stay apprised of local community guidelines and the infection spread”.

Cicada variant “is different from the (Covid-19) viruses we have been dealing with for the last two years," Prof Ravi Gupta, of Cambridge University, who advised the UK government during the pandemic, was quoted as saying by The Mirror.

Will The Cicada Variant Cause Severe Illness?

The SARS-CoV-2 virus has the potential to turn deadly in people, especially among vulnerable populations such as those with a weak immune system.

The Cicada variant is particularly concerning as it provides no immune protection to people with previous infection or even vaccination.

Yet, the World Health Organization and health experts advise that existing COVID vaccinations can help prevent severe illness and hospitalization.

"It would appear that all the protections we have from our experience with the virus and with vaccines probably offer more limited—not zero—but more limited protection against this strain," Dr. William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center, was quoted as saying by Time.

Cicada Variant: Any New Symptoms?

The symptoms of Cicada aren't different from those of previous COVID variants. These include:

• sore throat,
• fever or chills,
• headache,
• cough,
• body aches,
• runny nose
• nausea
• diarrhea.

The European Medicines Agency (EMA) has advised patients and physicians not to use the antiviral drug Tecovirimat SIGA (marketed as Tpoxx) to treat mpox disease.

The advisory from the EMA’s Committee for Human Medicines (CHMP) is based on data from four studies carried out in different regions, which showed that compared with placebo treatment with Tpoxx did not

• heal lesions faster
• relieve pain
• help clear the virus from the body faster.

“The animal data demonstrated antiviral activity and a survival benefit when treatment was started early and a reduced efficacy if treatment was initiated later after exposure to the virus,” the EMA said in an official statement.

However, the clade 2 mpox outbreaks, which began in 2022, led the World Health Organization (WHO) to declare mpox a Public Health Emergency of International Concern (PHEIC), giving the drugmaker SIGA Technologies an opportunity to conduct efficacy studies in people.

A second PHEIC was declared in 2024 over clade 1 outbreaks.

Key recommendations by the EMA include:

• Restricting the use of Tpoxx over no benefit.
• Due to lack of safety concerns, patients who initiated treatment with Tpoxx can continue till course ends.
• Tpoxx can still be used as an antiviral to treat other orthopoxvirus infections, including smallpox and cowpox
• There is currently no other drug authorized in the EU for treating mpox infections.

Tpoxx For Mpox: What Does The US CDC Say

The Centers for Disease Control and Prevention also noted that the role of Tpoxx in treating mpox "is investigational".

The federal agency called for "additional clinical trials" to explore the role of Tpoxx in treating mpox infections in patients with severe immunocompromise, including advanced HIV.

"The findings from the clinical trials suggest that most patients with monkeypox who do not have severe disease or risk factors for severe disease (e.g., severe immunocompromise) will recover with supportive care and pain management," the CDC said.

Also read: Missouri Reports 2 Cases Of Deadly Clade I Mpox, US Tally Rises To 3 In 2026

What Is Mpox?

Mpox, earlier known as monkeypox, is a rare viral disease that belongs to the orthopoxvirus genus, the same family as the more well-known smallpox virus.

Though generally less severe, mpox can still lead to serious health complications, especially in immunocompromised individuals, children, and pregnant women.

The virus is transmitted from animals to humans and can spread from person to person through direct contact with infectious sores, scabs, body fluids, respiratory droplets, or contaminated materials.

Also read: Mpox Outbreak: First Case of Severe Strain Reported in New York City

The earliest signs of mpox start within 14 days of being infected. A person may not know they have mpox and can spread the disease.

The common symptoms include:

• fever,
• sweating,
• chills through the body.
• rashes, which start as a distant rash on the face and can continue throughout the body,
• swollen lymph nodes, migraine,
• muscle aches,
• fatigue,
• weakness
• back pain.

Mpox: Current Cases

In February, a total of 1,184 confirmed mpox cases and four deaths were reported from 46 countries, as per the WHO's latest outbreak update.

Of these cases, 58.6 percent were reported in Africa — mainly from Madagascar, the Democratic Republic of the Congo, Kenya, Burundi, and Liberia.

The WHO said all clades continue to circulate, and transmission of the virus continues mostly within sexual networks, followed by household transmission. All age-groups in some historically endemic areas are being affected.

“Unless mpox outbreaks are rapidly contained and human-to-human transmission is interrupted, there is a risk of sustained community transmission in all settings,” the WHO said.