FDA Announces Mandatory Kratom Recall Due to Salmonella Contamination

Scott Gottlieb, MD

In a first-time issuance under the Food Safety Modernization Act, the US Food and Drug Administration (FDA) has announced a mandatory recall order for all food products containing powdered kratom that were manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, due to several containing salmonella.

This is not the first time kratom has been linked to the bacteria. Last month, the FDA and Centers for Disease Control and Prevention (CDC) investigated a multistate outbreak linked to the plant product.

Triangle has reportedly failed to cooperate with the administration’s request for a voluntary recall. FDA Commissioner Scott Gottlieb said that the action taken today is solely based on the risks of contamination being posed by the products.

The FDA is working with the CDC to investigate the salmonella outbreak. It has advised that customers who have obtained the following products to discard them immediately:

• Raw Form Organics Maeng Da Kratom Emerald Green
• Raw Form Organics Maeng Da Kratom Ivory White
• Raw Form Organics Maeng Da Kratom Ruby Red

A duo of samples from the Triangle products sold in the retail locations of Torched Illusions in Tigard, Oregon, tested positive for the bacteria, as well as 4 additional samples collected by the FDA of “various types of kratom product associated with the firm,” according to the administration.

FDA investigators and local officials were “denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” per the FDA.

“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,” Gottlieb, MD, said in a statement. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately...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.”

Triangle was issued a Notification of Opportunity to Initiate a Voluntary Recall on March 30, 2018, however, the request was ignored, and followed with a notice to cease distribution of the products and notify applicable parties, as well as the opportunity to request a hearing, on March 31, which was Triangle did not respond to outside the allotted timeframe.

“If consumers have one or more of these products in their homes, they should discard them immediately,” the FDA wrote in its statement. “As a precaution, kratom no longer stored in its original packaging should be discarded and the containers used to store it should be thoroughly washed and sanitized. In order to prevent cross-contamination, consumers should wash their hands, work surfaces and utensils thoroughly after contact with these products, and not prepare any food in the area at the same time.”

Last month, the FDA announced the voluntary destruction and recall of kratom-containing dietary supplements Botany Bay, Enhance Your Life, and Divinity from another company, Divinity Products Distribution of Grain Valley, Missouri. In that announcement, the administration also reiterated its concerns regarding the plant-based product, which it officially classified as an opioid on February 6, 2018.