On April 3, 2018, FDA issued its first mandatory recall order for a food product. The order was issued to Triangle Pharmanaturals LLC for all its all food products containing powdered kratom. The order came after several products were found to contain Salmonella, and the company refused the agency’s request for a voluntary recall.
The Food Safety Modernization Act gave FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. These requests by FDA are titled, “Notification of Opportunity to Initiate a Voluntary Recall,” but are sometimes called the “last chance letter,” because the letter provides the company with a last opportunity to issue a recall before FDA enforcement action.
