In early March, FDA sent a letter to members of the infant formula industry requesting that they better protect those using powdered formula. In the letter, which was sent to manufacturers, packers, distributors, exporters, importers, and retailers of formula, the agency requests that these companies be in full compliance with all relevant regulations.
FDA wants the infant formula industry to evaluate their systems of production and in-process controls at all stages of processing; be in full compliance with all relevant regulations, including infant formula requirements pertaining to current good manufacturing practices, quality control procedures, quality factors, records and reports, and notifications rule; implement a plan on when to take corrective actions; improve adherence to the notification requirement of an adulterated or misbranded infant formula any time this type of product has left a facility; and voluntarily notify FDA any time a product sample tests positive for Cronobacter or Salmonella.
This latest letter was sent in the wake of President Biden’s request for more than $7 billion for FDA as part of his latest budget proposal. The President requested the additional funding in part to boost food safety activities and invest more in infrastructure, with a renewed focus on farm-to-bottle assessment on infant formula.
While requesting that industry take a proactive approach to enforce safety standards, efficiently manage suppliers, and better prepare for recalls might seem like basic requests, critics argue that the regulatory apparatus moves too slowly.
Mitzi Baum, CEO of STOP Foodborne Illness, a nonprofit organization focused on the prevention of illness and death from foodborne pathogens, notes that five “areas of concern” identified in the letter are basic food safety concepts and are activities that all food manufacturing plants should be conducting daily to ensure that their systems are effective and their products are safe. “The request is to self-regulate when the FDA is not present,” she tells Food Quality & Safety. “This means the manufacturers must understand the regulations—which were cited in the letter along with hyperlinks—monitor to the regulatory standard, and document any findings and corrective actions.”
On March 21, the House Committee on Oversight and Accountability, called on FDA to provide documents and communications related to its response to the U.S. infant formula crisis, reiterating serious concerns over the Biden Administration’s failure to respond to the nationwide shortage. The committee has scheduled a hearing for March 27 and Frank Yiannas, former deputy commissioner for food policy and response at FDA, is expected to testify.
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