ConsumerLab.com uses JavaScript to provide the best possible experience for our content, but your browser has it disabled. Learn how to enable it here.

About ConsumerLab.com

Posted September 12, 2018

FDA Urges Consumers to Avoid Kratom

On September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., urged consumers not to use products containing the kratom, an herb that is often promoted for pain relief and for relieving symptoms of opioid withdrawal.

"While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse." Commissioner Gottlieb stated. "And its use has been on the rise and is of concern to the FDA." He noted that kratom is banned in a number of states and municipalities in the U.S., and is illegal or controlled in countries such as Australia, Denmark, Germany, Malaysia and Thailand. 

The active compounds in kratom are opioids which can have effects similar to morphine and heroin. Consumption of kratom has been associated with agitation, irritability, tachycardia, nausea, drowsiness, and hypertension. Risks of using kratom include hepatotoxicity, psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor concentration and hallucinations, and there are at least 44 deaths associated with its use.

Gottlieb also raised concerns about the claims used to promote kratom products, stating that "...there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans." He also noted that the FDA recently issued warning letters to "two more unscrupulous vendors" of kratom products because statements used to promote the products were found to be drug claims: 
  • The owner of www.chillinmixkratom.com, which sells Maeng Da Powder, White Vein Powder, Red Vein Powder, Green Malaysian Powder and other kratom products was warned for making claims such as "It has been long reported that kratom has been used to treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal."

  • Mitra Distributing, Inc. which sells products such as Bali Green Kratom Powder, Bali Red Kratom Powder and Borneo Green Kratom Powder, was warned for making claims such as "Kratom has been used for hundreds of years to help eliminate withdrawal symptoms from opiates of all kinds. Kratom has been used to treat everything from mild pain pill addiction to heroin addiction."
In August 2016, the U.S. Drug Enforcement Agency (DEA) announced its intent to classify the active compounds (mitragynine and 7-hydroxymitragynine) in kratom as Schedule I controlled substances. However, the agency withdrew its proposal several months later after receiving "numerous comments from members of the public challenging the scheduling action." The agency has taken the public comments into consideration, and will now receive a scientific and medical evaluation and scheduling recommendation from the FDA before making a final decision on classification of the herb. However, several states have now classified kratom as a Schedule I substance.

Kratom products have also been the subject of numerous recalls over the last year due to an outbreak of illness associated with Salmonella contamination in kratom products.

See these related warnings:

Kratom Recalled Due to Salmonella Risk

Salmonella Outbreak Linked to Kratom Powders, Pills and Teas

FDA Links 44 Deaths to Kratom

Police Officer Dies From Kratom Overdose, Herb Currently Legal in Most States

Kratom To Be Classified a Schedule I Controlled Substance

U.S. Marshals Seize $150,00 Worth of Kratom

Over $400,000 Worth of Kratom Supplements Seized by U.S. Marshals

U.S. Marshals Seize $5 Million Worth of Kratom

Products Containing Kratom Recalled Following FDA Import Alert

To read FDA's full statement, use the link below.