Two companies have been issued warning letters by the Food and Drug Administration (FDA) for illegally selling unapproved, misbranded kratom-containing drug products. 

Kratom, a plant indigenous to Southeast Asia, has been growing in popularity in the US, with circulating claims of it being a safe treatment with a range of healing properties. However, the herbal product, which has been shown to exert similar effects as opioids, is currently not approved by the FDA for any medical use. 

In the warning letters, the Agency noted that the companies are in violation of sections 505(a) and 301(d) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for selling unapproved new drugs with unproven health claims. Some of the intended uses observed on the company websites included treatment of opioid addiction, chronic pain, anxiety, depression, arthritis, and insomnia.

Acting FDA Commissioner Ned Sharples, MD, said, “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.” 

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A scientific analysis conducted by the FDA on kratom further supports the Agency’s concerns about its potential for abuse, addiction, and serious health consequences. The investigation revealed that the botanical substance shares structural similarities with controlled opioid analgesics. In addition, an analysis conducted earlier this year found dangerously high levels of heavy metals in kratom products. 

In 2017, there were 682 kratom-related calls to the National Poison Data System, with 51.9% of these linked to serious medical outcomes. 

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