FDA Issues Warning Letters to Companies Selling Kratom Products

June 28, 2019

Unsupported claims of safety and effectiveness have concnerned the FDA. 

Two distributors of kratom products have been issued warning letters by the FDA. 

Cali Botanicals of Folsom, California, and Kratom NC of North Carolina have been illegally selling unapproved, misbranded, kratom-containing drug products with unproven claims that the drugs treat or cure addition and withdrawal symptoms, according to an FDA release. The companies have also made unsupported claims that the products treat pain and other conditions like depression, anxiety, and cancer. 

Kratom is common term for the product made from Mitragyna speciosa, which is still not legally marketed in the United States as a drug or dietary supplement. According to the FDA, data is still being collected on the product, and further studies are encouraged to determine the products’ safety and effectiveness.

The FDA says that current data on Mitragyna speciosa suggests that aspects of the products made from the plant contain opioid properties that expose users to addiction, abuse, and dependence. 

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"We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls. As part of our efforts to assess kratom for contamination in the products tested, we also found high levels of heavy metals in kratom products. Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said Acting FDA Commissioner Ned Sharpless, MD. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”

Specific claims made by the companies and cited by the FDA include: 

  • “In fact many people use kratom to overcome opiate addiction.”

  • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”

  • “Usage: It is for the management of chronic pain, as well as recreationally.”

  • “Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue…Kratom has been reported to have taken the place of brand name drugs like Hydrocodone or Oxycodone for individuals, all the way to weaning people off of Heroin.”

  • “Some researchers have even claimed that kratom can protect you against cancer!”

  • “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat . . . Chronic Pain, Migraines, Opiate Addiction, ADHD/ADD, Anxiety, Depression, Arthritis, Insomnia and much more!”