Food Safety Magazine

News | April 4, 2018

FDA Issues First Mandatory Recall for Food Product

By Staff

FDA Issues First Mandatory Recall for Food Product

Yesterday, the U.S. Food and Drug Administration (FDA) issued a mandatory product recall for any and all food products that contain powdered kratom--a naturally-derived supplement often used for pain relief. This is a first for FDA when it comes to issuing a mandatory recall order to protect Americans from contaminated food products.

The company on the receiving end of the order is Triangle Pharmanaturals LLC. Sample testing detected traces of Salmonella in the company’s kratom products.

FDA forced the recall after Triangle Pharmanaturals did not respond to FDA’s initial request to issue a voluntary product recall.

Under the FDA’s Food Safety Modernization Act, the agency does have the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.

“This action is based on the imminent health risk posed by the contamination of this product with Salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” says FDA commissioner Scott Gottlieb, M.D. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”

FDA has advised consumers to discard all kratom products they may have in their possession. Brands and varieties that have been recalled include Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The recalled products are not limited to just these brands, though.

Kratom is naturally derived from a plant that’s mostly found in parts of Asia. It is not approved for use in all 50 states.

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