Last week’s urgent food safety warnings demonstrate the importance of the speed at which the industry responds to concerns. The mandatory recall authority FDA was given under the Food Safety Modernization Act (FSMA) is nudging retailers to move quickly on their own when a food recall takes place.
“FSMA overhauled the nation’s food safety systems for the first time in over a generation. Among other changes, the food safety law gave the FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded, and that the food could cause serious illnesses or death,” says Michael Droke, partner at the international law firm Dorsey & Whitney.
Before the FSMA, the FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.
An Increased Focus on Transparency
FSMA enhances the FDA’s ability to oversee the millions of food products coming into the United States from other countries each year.
The Final Mandatory Recall Guidance issued earlier this month is part of FDA’s efforts to be as robust and transparent as possible and provide answers to questions that many have asked about the FDA’s mandatory recall processes, says FDA Commissioner Scott Gottlieb.
“Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products,” Gottlieb says.
A Look at the Recall Process
The FDA’s mandatory recall authority now applies to all foods (other than infant formula) that are manufactured, processed, packed or held at a food facility subject to the Food, Drug and Cosmetics Act. It applies to all food for people and animals and the ingredients that go into that food.
Once the FDA has determined that the criteria for a mandatory recall have been met, the FDA must provide the responsible party with an opportunity to voluntarily cease distribution and issue a voluntary recall. The FDA will notify the responsible party of this opportunity in writing, Droke says.
However, if the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, the FDA may order the recall. Droke says they must also allow the responsible party to request an informal hearing to be held within two days after the order is issued.
“The FSMA mandatory recall authority gives teeth to the FDA’s enforcement right,” Droke says. “This agency’s guidance helps employers understand when that authority will be used and will encourage companies to voluntarily recall products to avoid a mandatory sanction. Food and ingredient companies should prepare in advance for the need to recall their products to minimize the risk of a mandatory order.”
FSMA Strengthens Collaborations
FSMA calls for the strengthening of existing collaboration among all food safety agencies. More actions to improve recall policies will be forthcoming, Gottlieb says.
“We are committed to ensuring that recalls by companies – voluntary or involuntary – are initiated, overseen, and completed promptly and effectively,” Gottlieb says. “Our goal is protecting consumers. Most of our regulated industry partners share our commitment. But when they don’t, Americans should know that the FDA won’t hesitate to take steps to protect their health.”