On the heels of last week’s recall of romaine lettuce due to a multi-state outbreak of E. coli O157:H7, the CDC has traced a multi-state outbreak of listeria to a Houston manufacturer’s Vietnamese ready-to-eat pork products.
Long Phung Food Products has issued a recall of its ready-to-eat pork products, which were shipped nationwide.
“It’s unprecedented to have a second urgent food warning in such a short period of time,” says Michael Droke, a partner at the international law firm Dorsey & Whitney, which is devoted to the areas of agriculture and cooperative law. “This one involves listeria which causes significant fear among consumers. Large retailers and restaurants will be pulling the product immediately. The timing and type of warning in both of these incidents demonstrates the importance of food safety and the speed at which the industry responds.”
A substantial part of Droke’s practice has been representing agriculture and food-based companies. He acts as outside general counsel in the industry, handles corporate governance, and manages domestic and international transactions.
Of these most recent recalls and what they mean for retailers, Droke says the mandatory recall authority given to the FDA this month under the Food Safety Modernization Act (FSMA) is an additional nudge for retailers to move swiftly on their own.
Read Droke’s full comments on the effects of FSMA below.
“The Food Safety Modernization Act overhauled the nation’s food safety systems for the first time in over a generation. Among other changes, the food safety law gave the Federal Food and Drug Administration (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. Put another way, the FDA was given authority to force a recall even if the retailer, supplier or producer wanted to avoid it. The FDA must allow the responsible party to conduct a voluntary recall before ordering a mandatory recall. Prior to the FSMA, the FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.
“The FDA’s mandatory recall authority 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 humans, animals and the ingredients that go into that food. Infant formula has its own recall requirements under a different law.
“Before the FDA can use its mandatory recall authority, the FDA must make a determination that there is a reasonable probability that the food is adulterated or misbranded. The FDA must also make a determination that there is a reasonable probability that using or exposure to such food will cause serious adverse health consequences or death to humans or animals (in a tongue twister, referred to as “SAHCODHA” hazard).
“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. 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. The FDA must also allow the responsible party to request an informal hearing to be held within two (2) days after the order is issued.
“The FSMA mandatory recall authority gives teeth to the FDA’s enforcement right. This agency’s guidance helps employers understand when that authority will be used, and will encourage companies to voluntary 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.”