June 28, 2019 -- The FDA this week again cracked down on marketers and sellers of products containing kratom, an herbal plant used recreationally and as medicine but is not legally marketed in the U.S. as a drug or dietary supplement.

The FDA issued warning letters to Cali Botanicals of Rancho Cordova, CA, and Kratom NC of Wilmington, NC , ''for illegally selling unapproved, misbranded kratom-containing products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms."

The latest warnings are two of several the FDA has issued to alert consumers about what it says are the serious risks associated with the use of the products.

The herb is legal on the federal level, although the Drug Enforcement Administration (DEA) is considering labeling it a Schedule I drug -- a category that includes heroin, marijuana, LSD, and ecstasy. Kratom is illegal in six states, Washington, D.C., and several cities, according to the American Kratom Association. It has been on the DEA’s list of drugs and chemicals of concern.

The FDA has approved no uses for kratom, and the agency says it has received concerning reports about its safety, including claims of deaths. The two companies use websites and social media to make unproven claims, such as saying the plant acts like morphine, that it can be used to overcome opiate addiction and can manage chronic pain, help depression, anxiety, diabetes, and fatigue and protect against cancer, the FDA says.

Only companies with FDA-approved drugs may make those types of claims.

Eric Webb, spokesperson for Cali Botanicals, says his company has changed the language on its product as the FDA requested. "We were not attempting to deceive anybody," he says. He points out that ''All over [the site] it says this hasn't been evaluated by the FDA. It's more of a holistic treatment."

Kratom NC has not replied to a request for comment.

More About Kratom

Kratom is technically known as Mitragyna speciosa. The herb grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. It affects the same opioid brain receptors as morphine, the FDA says, and brings risks of abuse, addiction, and dependence.

The FDA has also said it found dangerous levels of heavy metals in some kratom products.

"I'm concerned [about kratom] because it has not been researched, and there have been some deaths," says Michael E. Schatman, PhD, assistant professor of public health and community medicine at Tufts University School of Medicine.

A CDC analysis found kratom as a cause of death in 91 of more than 27,000 overdose deaths in 27 states from July 2016 to December 2017. The National Institute on Drug Abuse (NIDA) says most deaths from kratom have involved other substances including opioids. That agency is funding two studies totaling nearly $7 million to better understand how it works. One goal of the research is to understand why it’s been used without harm for hundreds of years in Southeast Asia while being linked to harm in Western countries.

The herb is often used to treat pain and withdrawal from opioids. Kratom “has been shown numerous times in reports from users to help recovering Opiate addicts, treat pain, combat depression and anxiety, and much more,” says a petition from the American Kratom Association against making the herb a Schedule I drug.  “There are many people who will suffer from this.”

A recent study said that the herb “may have useful activity in alleviating pain and managing symptoms of opioid withdrawal, even though well-controlled clinical trials have yet to be done.” Still, the study went on to say, “There are legitimate concerns about the safety and lack of quality control of purported 'kratom' products that are being sold in the U.S.”

Robert Glatter, MD, an emergency medicine doctor at Lenox Hill Hospital in New York, applauds the FDA for continuing to pressure manufacturers who market and distribute kratom in a misleading, harmful, or fraudulent manner.

Glatter says side effects of kratom include seizures, dangerously high blood pressure, damage to liver and kidneys, swelling of the brain, breathing problems, and cardiac arrest. The chances of these problems are even higher when people use kratom with alcohol or with other drugs, he says.

"Sadly, I think that the bulk of people who chronically use kratom to treat anxiety, opiate withdrawal, or elevate their mood will continue to do so, regardless of announcements from the FDA regarding illegal marketing or even safety concerns,” Glatter says.

"It's also important to realize that kratom can be addictive, leading to acute withdrawal symptoms when users discontinue the substance."

Schatman is a consultant for Kaleo and Quest Diagnostics.

Show Sources

National Institute on Drug Abuse: "What is Kratom?"

News release, FDA.

Michael E. Schatman, PhD, director of research and network development, Boston Pain Care; assistant professor of public health and community medicine, Tufts University School of Medicine.

Robert Glatter, MD, emergency medicine doctor, Lenox Hill Hospital, New York.

Eric Webb, spokesperson, Cali Botanicals, Rancho Cordova, CA.

Morbidity and Mortality Weekly Report, April 12, 2019.

National Institute on Drug Abuse.

Drug Enforcement Administration.

News release, University of Florida.

International Journal of Drug Policy: “Kratom policy: The challenge of balancing therapeutic potential with public safety.”

Speciosa.org: “Petition Please do not make Kratom a Schedule I Substance,” “Kratom Legality Map.”

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