15/16 November 2023
The US Food and Drug Administration (FDA) finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of food, drugs, and devices (for human or animal use), cosmetics, biological products (for human use), and tobacco products.
According to the FDA, a voluntary recall is an action taken by a company to correct a violative product or to remove it from the market. The company may act on its own initiative or the agency may inform the company that a distributed product violates the law. It is critical for companies in a product distribution chain to be “recall ready”, the FDA says. Therefore it is recommended that companies make adequate preparations to their operations in advance of when a recall may be needed (e.g., prepare and execute a recall communications plan). In addition to these preparations, the FDA recommends that companies consider preparing, maintaining, and documenting written procedures (in paper or electronic format) for initiating a recall and performing actions related to initiating a recall. Moreover, the document addresses how companies should develop a recall strategy and train personnel on executing a recall, as well as how companies should use adequate product coding.
The agency made only minor changes compared to the draft version issued in April 2019 (e.g., addition of the terms correction and market withdrawal to the terminology section, addition of language encouraging the use of electronic communications for conveying voluntary recall communications). The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the root cause. 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. In the event that the recalling actions do not adequately protect the public from a violative product, i.e., the company fails to initiate a recall effectively, FDA may consider taking other appropriate actions.
The guidance complements FDA's efforts in recent years to improve the recall process, including issuing guidance on public availability of lists of retail consignees to effectuate certain human and animal food recalls, mandatory recalls for human and animal foods, and public warnings and notifications for FDA-regulated products, which makes reference to FDA's weekly Enforcement Reports listing all product recalls.
More information is available in FDA´s final guidance document Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.