FDA Issues Warning About Un 1

FDA Issues Warning About Unproven Claims that Kratom can Cure Opioid Addiction

FDA Issues Warning About Unproven Claims that Kratom can Cure Opioid Addiction

The US Food and Drug Administration (FDA) has issued warnings to two companies that it says are illegally marketing products containing kratom as opioid withdrawal and addiction treatments. The Agency also says that the companies are making claims that their products can work as a cure.

What is Kratom?

Kratom is an herbal extract that grows naturally in Southeast Asia. The trees can grow as tall as 100 feet in height in the wild. When used in low doses, it can act as a stimulant. At higher doses, it can provide pain relief and may promote a sense of euphoria.

Its advocates state that kratom is an effective treatment for opioid withdrawal and that it is an effective alternative to opioids as a pain reliever. According to the FDA, the drug interacts with the same receptors as morphine (an opioid) and can leave users vulnerable to abuse and addiction.

FDA Issued Safety Warnings Previously

The FDA has already issued safety warnings about kratom products. These included ones related to a salmonella outbreak across several states. Concerning side effects of this drug include the following:

• Breathing suppression
• Dizziness
• Drowsiness

In high enough doses, kratom use can cause coma and even be fatal.

FDA Says Kratom Products May Cause Illness and Not Cure Opioid Addiction

The FDA has advised consumers[1] not to use products made by Kratom NC because microorganisms discovered in its products could cause illness. The Agency recommended to the company that it recalls its product line; the company had failed to do so.

The Agency contends that the two companies, Cali Botanicals and KratomNC, could stop people addicted to opioids from getting appropriate treatment. The FDA stated that the companies claimed their kratom products could also be used to treat conditions like anxiety, depression and cancer.

Kratom NC claims online that its product can be used for migraines, chronic pain, ADD/ADHD, arthritis, insomnia and other medical conditions. Cali Botanicals has said that kratom can be used as a treatment for chronic pain, anxiety and depression. The company has also stated that this product can “has essential uses in combating opiate addiction and the harrowing withdrawal that comes with trying to kick the habit.” The latter company has recently removed the reference to using kratom for treating opioid addiction from its website.

Each company was given up to 15 days after receipt of the FDA’s warning letters to respond to the Agency about the steps they are taking to correct their respective violations. Kratom NC was warned on May 16 and Cali Botanicals was warned on June 11, 2019.

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[1] https://www.cnbc.com/2019/06/25/fda-warns-companies-against-claiming-herbal-drug-cures-opioid-addiction.html