The Food and Drug Administration (FDA) has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals.
Several of the products were found to contain Salmonella.
The action, which marks the first time the FDA has issued a mandatory recall order to protect consumers from contaminated food products, comes after the company failed to cooperate with the agency's request for a voluntary recall.
“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,” said 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.”
Failure to act
The FDA advised Triangle Pharmanaturals on March 30 that the agency could order the firm to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall.
Triangle did not comply with the request and, on March 31, the FDA ordered the firm to cease distribution of the products and the provided it with an opportunity to request an informal hearing.
Again, the company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety.
This marks the third time the FDA has invoked its mandatory recall authority, but the first time the agency ordered a mandatory recall because a company has opted not to act.
What to do
The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to:
- 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.
Consumers who have one or more of these products in their homes, should discard them immediately. 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.