In early March 2022, the United States Food and Drug Administration (FDA) finalized guidance to help regulated industries (i.e., drugs, devices, biological products, food, cosmetics, and tobacco) start prompt voluntary recalls of their products. This guidance finalizes draft guidance from April 24, 2019, of the same title. Under the guidance, a company may act on its own accord, or the FDA may inform the company of its distribution of a violative product and recommend its removal.
The guidance starts out by providing guidance on how a firm in a product distribution chain should prepare to facilitate a timely initiation of a voluntary recall, placing importance on firms to be “recall ready.” The guidance then outlines several recommendations for firms to become recall ready, such as assigning certain personnel recall-related responsibilities/authority to take certain steps; training those personnel on how to perform those activities; establishing a recall communications plan, including instructions on internal communications, communications with the FDA, and communications to direct accounts or the public; and identify reporting requirements for distributed products.
The guidance urges companies to act quickly to initiate a recall when public health is at risk and to do so before an investigation into the cause of the problem is completed. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers or vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary.
The final guidance also explains how companies should have adequate product coding and maintain distribution records to facilitate faster and more accurate recall actions. It also encourages companies that are subject to a recall to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about voluntary recalls.
The also notes that if there is an indication of a problem with a distributed product, the firm should identify the problem, investigate the problem (but not hesitate to issue a voluntary recall pending the completion of the investigation), make decisions, and take action. Further, firms can consult with the FDA about the problem, especially if there are concerns or questions about its own examination of a product problem.
“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”
As is typical, FDA guidance documents do not establish legally enforceable responsibilities but instead describe the Agency’s current thinking on a topic and should be viewed as recommendations unless certain statutory or regulatory requirements are cited.