August 18, 2019

August 16, 2019

Subscribe to Latest Legal News and Analysis

August 15, 2019

Subscribe to Latest Legal News and Analysis

FDA Finds High Levels of Heavy Metals in Kratom Products

  • In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal.

  • Over the past year, FDA has issued numerous warnings about the serious risks associated with the use of kratom. The agency has also issued an import alert, seized product containing kratom, and issued warning letters to kratom marketers. Most notably, earlier this year, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.

  • Continuing its actions to address the regulation and enforcement of kratom, the Commissioner’s November 27th statement notes that FDA scientists tested 26 separate kratom products obtained by field investigators. Lead and nickel were found at levels not considered safe for human consumption. In addition to those 26 products, the Commissioner noted FDA’s concern that there may be other kratom products on the market that also contain heavy metals. In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider.

© 2019 Keller and Heckman LLP

TRENDING LEGAL ANALYSIS


About this Author

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...

202-434-4100