4 Kratom Companies Sent FDA Warning Letters

Social media was also flagged by FDA/FTC in the letters, including a retweet that contained claims.

hand holding craft envelope with text WARNING on blue background, concept

Silver Spring, MD—On June 30, 2022, the Food and Drug Administration (FDA) issued warning letters, jointly with the Federal Trade Commission (FTC), to four companies selling kratom products. FDA stated that it has not approved kratom for the treatment or cure of opioid use disorder and withdrawal symptoms.

FDA also noted that it has received “concerning reports about the safety of kratom.” The agency is “actively evaluating all available scientific information on this issue and advises consumers not to use kratom or essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms.”

The 4 kratom companies receiving letters:

The warning letters included specific examples or problematic claims.

FDA pointed to a blog post titled, “Kratom and Low Blood Pressure” on https://herbsenskratom.com/blog/kratom-and-low-blood-pressure/ that said:

    • “Kratom has been used to manage numerous conditions, including opioids withdrawal symptoms.”
    • “[M]any Reddit users attest to Kratom’s ability to improve blood pressure.”

On https://klaritykratom.com/2018/09/20/kratom-an-introduction/, FDA flagged:

    • “[O]ver ninety percent of patients suffering from rheumatoid arthritis . . . have reported partial or total improvement in their symptoms after using Kratom.”
    • “Kratom may aid in lessening the symptoms of opioid withdrawal.”

In addition, FDA/FTC flagged social media, including a retweet from the Twitter social medial account https://twitter.com/Kratom_Exchange:

    • April 18, 2019 Retweet – “#Kratom users claim it helps them manage the symptoms of . . . #depression.”

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FDA/FTC Also Warned An Essential Oil Company

FDA and FTC noted that the essential oils were positioned for the treatment or cure of opioid use disorder and withdrawal symptoms. FDA extended its caution to consumers not to use essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. MONQ, LLC received the letter.

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