Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration. They are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.

But our work doesn’t stop there. When it comes to recalls and how quickly they are executed, consumers depend on the FDA to protect their health and we work quickly because it could minimize consumer exposure to a health risk and prevent consumers from being injured. We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a recall is initiated. That’s why the FDA’s work is also keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations. As part of these efforts, today we’re issuing a new draft guidancethat, when finalized, will provide industry with clear information on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and promptly.

The draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” includes recommendations in three key areas:

  • Training: Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations. Specifically, this new draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
  • Record Keeping: Thorough and organized record-keeping 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. The draft guidance also advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall possible
  • Procedures: Written recall initiation procedures help to 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 guidance recommends that firms consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from the market. These procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall. They should also help ensure that necessary actions are not overlooked and may minimize the disruptive effect a recall can have on a company’s operations.

Today’s guidance reflects the latest step in the agency’s ongoing commitment to working with companies to quickly act to protect consumers from potentially dangerous products. It builds upon 18 months of proactive and systematic improvements to the FDA’s recall processes, during which the agency alerted companies of the situations where the FDA would disclose certain supply chain and retail distribution information during certain human and animal food recalls; provided mandatory recall guidance for human and animal foods, which answered common questions about the mandatory food recall provisions; and issued final guidance on public warnings and notifications of recalls for all FDA-regulated products outlining specific circumstances in which the agency would expect a company to issue a public warning about a voluntary recall. The agency has also adopted new policies for moving forward with rapidly posting new recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA.

Together, these actions have resulted in more timely information being available to consumers, allowing them to protect themselves and their families. There are many examples of this over the last 12 months across the FDA-regulatory portfolio. This includes alerts, advisories, or consumer warnings related to many products like Kellogg’s Honey Smacksrecalled vegetablesromaine lettuceangiotensin II receptor blocker (ARB) drugs like Valsartan, Losartan and IrbesartanKing Bio homeopathic productstest strips for home-use monitoring of Warfarin, and contaminated pet food. The agency also issued the first mandatory recall order for Kratom products, and released detailed retail distribution information during a recall of pre-cut melon associated with an outbreak of Salmonella infections, so consumers could better identify where the recalled food may have been purchased or distributed.

These efforts have made important improvements toward our goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products. But we know there is more that needs to be done. Moving forward, the agency will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts. The FDA will also continue to refine and improve our ability to quickly communicate information to the public on recall situations. We remain committed to learning from every recall and seeking out opportunities for improved processes, education and awareness in order to ensure that American consumers are kept safe from potentially dangerous products. These collective efforts will help the agency to prevent future recalls and work quickly with companies to remove products from the market when an issue does arise.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.