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Foodborne illnesses impact millions of Americans every year—ranging from mild cases to hospitalizations to death. Reducing foodborne illness is a focus for the U.S. Food and Drug Administration (FDA), as reflected in several recent actions, including the proposed Food Traceability Rule (published on September 23, 2020) and the 2021 Foodborne Outbreak Response Improvement Plan (FORIP).
FDA recently took another step toward reducing the public’s exposure to the risks of foodborne illness on March 3, 2022, issuing its final guidance for voluntary recalls: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.
About Voluntary Recalls
A voluntary recall involves actions taken by a company to correct or remove a violative product from the market, either on its own initiative or in response to a recommendation from the FDA. FDA Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D., emphasizes that “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.”
FDA’s new guidance outlines the steps companies should take before a recall is mandated, including developing policies and procedures, establishing training, maintaining records, and initiating communications.
BEFORE: Preparation Guidance
FDA’s guidance applies to any products that fall under the agency’s jurisdiction, including any food, drug, or device intended for human or animal use. The guidance breaks down the agency’s recommendations for activities companies (including manufacturers and distributors) should take in advance of a potential recall to be “recall ready.” These include the following:
- Establish a recall communications plan to address communications with employees, FDA, supply chain, direct accounts, and the public, as necessary. Identify key contacts and develop draft templates that can be easily customized and distributed when needed.
- Identify and train appropriate personnel (and alternates) on recall-related responsibilities. The recall team should have a thorough understanding of recall procedures and their respective roles in carrying out a recall plan. Regular training, including mock recalls, help ensure competency.
- Identify any reporting requirements for distributed products, if required by FDA. This might include a report to the Reportable Food Registry, an adverse event report for a dietary supplement, or a report to FDA upon product correction or removal.
- Establish and implement product coding to ensure traceability throughout production and distribution. This will enable more effective lot identification to accurately define and limit the recall scope.
- Maintain distribution records to allow for easier and faster identification of products to be recalled. Distribution records should include contact information for all direct accounts that received the product.
- Establish recall initiation procedures. Prepare, maintain, and document written procedures for initiating a recall to minimize delays and uncertainty when/if a voluntary recall becomes necessary. Procedures should be covered in training and should describe actions to carry out the following:
- Stop distribution, shipment, and/or sales of affected products.
- Outline a recall strategy that considers the scope/depth of the recall and associated risks.
- Notify direct accounts throughout the distribution chain and communicate instructions for appropriate disposition of product.
- Notify the public, when appropriate, if a product presents a health hazard.
DURING: Identifying and Initiating a Potential Recall
Identifying a potential problem is the first step in initiating a potential recall. It is vital that companies ensure timely identification and response to product problems that might lead to a recall. FDA suggests that the following indicators may suggest a potential concern:
- Internal reports of product specification deviation
- Out-of-specification testing results
- Consumer complaints
- Inspectional observations or laboratory results
- Reports of adverse events (e.g., illness, injury, death)
It is then the company’s responsibility to investigate the potential problem to determine 1.) whether a deviation has occurred, and 2.) whether the safety, effectiveness, purity, or potency of distributed products has been affected. A voluntary recall should not be delayed pending results of this investigation. Rather, companies should follow established procedures (see above) to decide whether to initiate a recall, determine the appropriate scope/depth of the recall, and resolve whether to discontinue production or distribution of impacted product(s).
To initiate a voluntary recall, companies should:
- Notify the FDA immediately if the company believes the product to be violative.
- Promptly issue recall communications to affected direct accounts and to the general public, if appropriate.
- Follow the procedures established in the company’s recall plan to implement the recall in accordance with 21 CFR 7.46.
- Provide instructions to the distribution chain regarding disposition of the product.
AFTER: Working with FDA
The FDA is committed to working with companies to help facilitate prompt response (i.e., removal or correction) to violative product that enters the marketplace. The agency has designated recall coordinators organized by product type located throughout the country who can work with company recall teams to develop strategies, review communications, monitor disposition of the product, coordinate with other regulatory bodies, etc.
The FDA may request a company initiate a recall under 21 CFR 7.45 after conducting discussions with the firm if the product presents a risk of illness, injury, or gross consumer deception; the firm has not initiated a voluntary recall; or agency action is required to protect public health.
The food industry and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges, including foodborne illness outbreaks. FDA’s most recent guidance is intended to help companies proactively address these risks—reducing response time in a foodborne illness outbreak and, subsequently, the number of people impacted.