Recalls and Warnings
(Date Posted: 6/25/2019)
|Kratom Is Dangerous and Not Proven to Treat Addiction, FDA Warns Marketers
On June 25, 2019, the FDA issued warning letter to two marketers and distributors of kratom products, listed below, for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.
"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," Acting FDA Commissioner Ned Sharpless, M.D. stated in a news release about the warnings. "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."
- Cali Botanicals, LLC -- Sold products such as 12 Gram Kratom Powder Samples and Borneo Yellow Vein Kratom and promoted them with statements such as "Kratom has essential uses in combating opiate addiction and the harrowing withdrawal that comes with trying to kick the habit" and " ... used in higher doses, an individual will experience an analgesic effect along with euphoria, a lower sensitivity to pain both physically and emotionally, relaxation, anti-depression, and anti-anxiety."
- KratomNC -- Sold products such as Green Bali Powder and Red Indo Powder and promoted them with claims such as "Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction."
The active compounds in kratom can have opioid-like 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. According to a report by the CDC, kratom was determined to be a cause of death in 91 cases of unintentional drug overdoses between July 2016 and December 2017.
In addition, the FDA has reported finding dangerous levels of toxic metals in kratom products on the market and has urged consumers not to use kratom.
Kratom products have also been the subject of numerous recalls over the past year due to an outbreak of illness associated with Salmonella contamination in kratom products.
For more information about kratom, see ConsumerLab.com's answer to the question: Is kratom too dangerous to use?
See related warnings and recalls:
CDC: Kratom Linked to 91 Deaths
Dangerous Levels of Lead and Nickel Found in Kratom Products
FDA Urges Consumers to Avoid Kratom
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
To see the FDA's news release, use the link below.
For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.