FDA issues final guidance on mandatory food recalls
The US Food and Drug Administration (FDA) yesterday announced that it has issued final guidance that outlines its mandatory recall authority, part of efforts to answer questions about new mandatory recall authority that the agency gained with the passage of the Food Safety Modernization Act (FSMA) of 2011.
According to a statement from FDA Commissioner Scott Gottlieb, MD, the guidance describes how the FDA will give the responsible party an opportunity to issue a voluntary recall before ordering a mandatory recall. He said the guidance offers more detail about evidence or circumstances the FDA may consider when deciding on a mandatory recall, such as clarifying situations for which FDA would deem the product a serious health risk.
Typically, the FDA relies on companies to voluntarily recall their products when a health risk arises, and, on average, a recall occurs within 4 days of a problem being discovered. Since the passage of FSMA, the FDA has had to issue only one mandatory recall to protect public health, which involved food products containing powered kratom, after Salmonella contamination was found in the company's products.
"Our goal is protecting consumers," Gottlieb said. "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."
Nov 5 FDA statement
Nov 5 FDA Q&A on the guidance
Multiple Duncan Hines cake mixes recalled after Salmonella cases noted
Conagra Brands, the company behind Duncan Hines, is recalling several baking mixes after Salmonella was found in a retail sample of Duncan Hines Classic White cake mix.
According to a news release from the FDA yesterday, Conagra is voluntarily recalling the Classic White cake mix and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same period.
Both the FDA and the Centers for Disease Control and Prevention (CDC) are investigating five Salmonella illnesses that may be linked to tainted cake mix.
"Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked," the FDA said. "Consumers are reminded not to consume any raw batter."
The recalled mixes carry "best by" dates ranging from Mar 7, 2019, to Mar 13, 2019.
Nov 5 FDA statement