Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls

FDA Commissioner Scott Gottlieb, M.D. marks improvements in the recall process and discusses new policies being considered to support more efficient and effective food recalls.

One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me. While the FDA has addressed many of the findings after the draft version was first released in 2016, we still have more work to do. I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission.

The FDA has authority to act in a variety of ways when it is made aware of an unsafe food product. But often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on. Among other steps, I want to do even more to make sure that consumers have the information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have been exposed to a recalled food product. The FDA is exploring various ways to better accomplish this goal. Among other steps, the agency will issue guidance on recall communications in the first half of 2018. As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.

Fortunately, most companies are cooperative and rapidly initiate a voluntary recall of a hazardous food product. On average, the recall occurs within four calendar days of the problem being discovered. These recalls are typically done in close coordination with FDA’s food program staff. Sometimes a company discovers the problem and initiates the recall, while other times a company acts after the FDA brings a concern to their attention. When the company does not cooperate, we have the authority to mandate certain product recalls thanks to the 2011 Food Safety Modernization Act. Regardless of how the recall occurs, the FDA oversees the company's recall strategy and assesses the adequacy of the recall.

Sometimes the recall process does not work as well as we’d like. As part of the OIG report, last year, the OIG reviewed a selective sample of 30 food recalls initiated from 2012 to 2015, including some very challenging ones, which occurred over this 3-year period. The OIG made a series of recommendations on how the agency might improve its management of recalls. A lot has changed since that timeframe when it comes to our food safety practices. But I know that much work remains to be done if we’re going to provide the highest assurance of safety. We’ve taken the OIG recommendations to heart, and worked quickly to put in place measures to address the proposals that the OIG outlined. One of the most significant steps we took in April of last year was to establish a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem if it isn’t clear. The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur.

Over the past year, this team of senior leaders, called the SCORE team (which stands for “Strategic Coordinated Oversight of Recall Execution”) has made a big difference in these situations. They’ve been involved in cases that range from lead contamination of a dietary supplement, Salmonella contamination of powdered milk, E. coli O157:H7 in soy nut butter and Listeria in hummus, soft cheese and smoked fish. In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or helped to expedite the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food to the marketplace. In addition to the establishment of SCORE, we’ve put in place several additional procedural and policy changes. Last year, after a comprehensive review of our recall process, we developed a new strategic plan that outlines actions to improve FDA’s recall management. The plan helps to standardize how the FDA assesses a company’s recall efforts, and provides additional training to our staff involved in recall efforts so they can properly monitor and assess the effectiveness of a recall.

Building on these early efforts, we intend to say more in early 2018 on additional policy steps we’ll take as part of a broader action plan to improve our oversight of food safety and how we implement the recall process. We’re looking at ways to improve the timeliness and scope of information we provide to the public about recalls of FDA regulated foods. I believe that consumers should have the actionable information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have already been exposed to a recalled food product. We’re committed to continuously improving our policies and practices to ensure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers. Let me assure you that we will use all the tools at our disposal to make sure that we carry through on this commitment.

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.