IMPORTANT FDA INFORMATION: Kratom Mandatory Recall – Additional Information for State Regulatory Partners

On April 2, 2018, the U.S. Food and Drug Administration (FDA) issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, (Triangle) after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products. The following is additional information the agency is providing to our state partners regarding Triangle’s mandatory recall order, as well as actions you can consider taking to help encourage the successful removal of this product from the marketplace.

Although Triangle has subsequently agreed to comply with the recall order, it have thus far failed to initiate the recall, and they have not provided FDA with required information such as a full list of products and distribution records. FDA is committed to providing our state partners with updated information once the firm shares their recall strategy and distribution records.

In the meantime, we anticipate that states may be contacted by the firm’s consignees, and/or concerned consumers of the products. Many state agencies may also be aware of or are currently identifying retailers or distributors selling the affected products. FDA is requesting that our state partners keep their local FDA District/Division counterparts aware of contacts made with the firm’s consignees, and any actions taken to prevent use or distribution of the affected products.

Consumers

Advise consumers to follow instructions in FDA’s Press Release, including discarding the products and sanitizing containers, surfaces, etc. that the product contacted. Collect consumers’ contact information, try to determine when and where the consumer purchased the product, and follow up with the retailer if warranted (or refer to your local FDA office for follow up).

Retailer/Internet Retailer

Advise retailers to discontinue selling and to quarantine products pending formal recall instructions from Triangle or an intermediate distributor. If a retailer refuses to remove products from sale, FDA advises state agencies to use their authority to effect removal. Should a retailer inform you that they are opting to destroy product rather than wait for a formal recall notice, attempt to witness the destruction and, if possible, document the method of destruction as well as the quantity and type of products destroyed. Also, please attempt to identify the supplier of the product and report that information to your local FDA office.

Distributors

Advise distributors to discontinue selling affected products and to quarantine stock pending receipt of a formal recall notice from Triangle or another intermediate distributor. While FDA expects that Triangle’s recall strategy to extend to the retail level (including asking intermediate distributors to subrecall), please encourage distributors to initiate their own subrecalls to prevent further illness from occurring while they await formal recall instructions from Triangle. Distributors who wish to do so should contact their local FDA recall coordinator for advice. Please attempt to determine whether that distributor received product directly from Triangle or from another intermediate distributor, and attempt to collect a consignee list from that distributor.

In closing, we thank you for your cooperation in this very important matter of public health.

This message is being broadcast by the Division of Communications in FDA’s Office of Regulatory Affairs (ORA).

Thank you,

FDA/ORA

Office of Communications and Project Management

Division of Communications

Mailbox: DivComm-ORA@fda.hhs.gov

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