Have you ever asked yourself: What does FDA or FSIS say I should be doing to ensure I am prepared for a recall? Or … What does FDA or FSIS expect me to do if I suspect a problem with a distributed product? Or even …How do I initiate a voluntary recall and work with FDA or FSIS? From our perspective, we work with many different food companies, both FDA and FSIS regulated, to provide assistance during a recall or a crisis. Sadly, many are not as prepared as they could be, and as such don’t always optimize their response to a crisis or recall situation. TAG is a huge proponent of being crisis ready and practicing crisis management or a recall on a regular basis. FDA sees recall preparedness in the same way and makes the comment that it is “critical for food companies to be recall ready.” Anticipating that there are many in the food industry with the questions above, FDA recently put out a draft guidance specifically addressing those. In fact, the main Discussion section of The Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Draft Guidance (written for both Industry and FDA Staff) is set up as a Q&A with responses to those very questions as we cite below. 1. How should a firm in a product distribution chain prepare to facilitate timely initiation of a voluntary recall? Noting that it is critical for food chain companies to be “recall ready” to help minimize public exposure to harmful products, FDA sees six key preparation steps as essential: identify appropriate personnel; train personnel on their responsibilities; establish a recall communications plan; identify any reporting requirements associated with your products; use adequate product coding; maintain distribution records. In addition to these, FDA recommends that firms consider preparing and maintaining written recall initiation procedures to help reduce the amount of time a violative product is on the market and extend the recall quickly throughout the distribution chain. The written document should: assign responsibility and describe the steps to perform all actions related to initiating a recall, including, as appropriate: ceasing distribution, shipment, and/or sales, developing a recall strategy, and notifying direct accounts with instructions for response, disposition, public notification when appropriate. 2. What should a firm do if there is an indication of a problem with a distributed product? Certain products have specific regulatory requirements related to identifying, investigating and reporting product problems. In addition to those, FDA recommends that all firms: implement procedures to identify indicators that there may be a problem with a distributed product; assign responsibility and describe the steps to investigate a potential problem and ensure timely decisions for control; and consult with FDA. 3. How should a firm initiate a voluntary recall? A firm should initiate a voluntary recall by promptly sending recall communications to each affected direct account, and issuing a press release or other public notice, if appropriate. The date of the first communication about a recall constitutes the date of initiation, at which time the firm should follow the initiation procedures in its recall plan. FDA will generally request copies of the firm’s issued or proposed recall communications which it will review and recommend changes as appropriate, however, the recall should not be held to await this review. Recall communication recipients should then implement their own recall initiation procedures, with the recalling firm following up if a recipient does not take action. 4. How does FDA work with a recalling firm to initiate a voluntary recall in a timely manner? FDA recall coordinators, who are organized by product type (e.g., food, drug, or medical device), and located throughout the country, act as agency points of contact for recalling firms. Recall coordinators provide the recalling firm with information about the process and are available to work closely with the firm throughout the recall. FDA also may take the first step, informing a firm that it has determined that a distributed product violates the law and recommending or requesting that it cease distribution and recall the product. If the firm recalls the product, the action is still considered a voluntary recall. In addition to the guidance, FDA published a statement on the new steps to strengthen the process of initiating voluntary recalls noting the three key areas of the guidance as being: Training. Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. Recordkeeping. Thorough and organized recordkeeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology to further advance our mission of protecting public health. Procedures. Written recall initiation procedures help minimize delays created by uncertainty. For companies that initiate a recall, using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market and that in turn reduces the potential exposure to consumers. For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain. The draft guidance provides a good overview of steps needed for the preparation and initiation of a recall. However, it is just that – an overview, or outline, of the steps. With this as a basis, each firm must then work through and write out the details of the specific procedures applicable to its business, processes, and supply chain. While this, like all guidance, contains “nonbinding recommendations,” I would see it as a very strong “recommendation” that you have your recall initiation plan in writing, practice using it, and be prepared to provide it to FDA upon request. It’s not a simple task, but it is essential. And it is an area in which TAG can provide the critical expertise to assist you with preparation, practice and execution of a recall. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
