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FDA Orders First Ever Mandatory Recall Under FSMA

On April 3rd, 2018, the U.S. Food and Drug Administration (FDA) ordered a mandatory recall of all food products that contain powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. The Agency issued the order after several samples of kratom products manufactured by the Las Vegas based company tested positive for salmonella, a potentially dangerous pathogen known to cause diarrhea, fever, and abdominal cramps. This is the first time FDA has ever issued a mandatory recall order. FDA Commissioner Scott Gottlieb, M.D. stated that the action was “based on the imminent health risk posed by the contamination of this product… and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions (FDA.gov).”

Section 206 of the Food Safety Modernization Act of 2011 (FSMA) grants FDA the authority to order responsible parties to recall certain food articles if the Agency determines that there is a reasonable probability that a particular food product is adulterated or misbranded and that the use of or exposure to that food product will cause serious adverse health consequences or death to humans or animals. Despite this authority, FDA still relies on responsible parties to voluntarily recall products that are in violation of regulations. The Agency issued this mandatory order only after Triangle Pharmanaturals LLC failed to comply with earlier requests that the firm cease distribution and recall the product voluntarily.

Both voluntary and mandatory recalls can permanently damage a brand’s reputation. Companies that wish to reduce the risk of facing a recall may take various measures to help ensure that their products meet required regulatory standards and do not pose a threat to human or animal health. Registrar Corp offers a number of services specifically designed to make complying with FDA regulations easier for businesses. For example, Registrar Corp can dispatch a Food Safety Specialist to your facility to help you prepare for an FDA inspection by identifying potential food safety problems in the structure, processes, procedures and documentation used in your daily production. Furthermore, Registrar Corp can develop new food safety plans and programs for your facility or review your current systems and documentation. Businesses may also use Registrar Corp’s FDA Compliance Monitor to track suppliers, importers, and distributors for FDA warning letters, import alerts, and more so that they may become aware of and react to any FDA regulatory difficulties faced by current or potential commercial partners in their supply chain. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours-a-day at www.registrarcorp.com/livehelp.