July 21, 2019

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FDA Releases Heavy Metal Test Results in Kratom

In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  Find further info on the topic here.

Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its only mandatory recall order due to Salmonella contamination.

On April 3, FDA released a summary of the heavy metal testing – now on 30 products.  In his comment accompanying the data release, Dr. Scott Gottlieb, the outgoing Commissioner of FDA, noted that FDA has “been attempting to work with the companies whose products were found to contain high levels of heavy metals”

FDA’s attention on kratom brings to the fore important reminders for all food and dietary supplement producers regarding raw materials testing, supplier verification and validation, and FDA recall authority.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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