FDA Sends Letter Calling for Improved Baby Formula Practices

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In early March, the U.S. Food and Drug Administration (FDA) sent a letter to members of the infant formula supply chain. The FDA called on recipients—including manufacturers, distributors, and others, to notify the agency if bacterial pathogens have been detected in their baby formula product samples and to beef up safety practices to prevent and detect such harmful contaminants.

“The FDA is calling on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants,” the agency said in a prepared statement. “The FDA will continue conducting inspections and working with industry to advance research and regulatory activities included in the prevention strategy to ensure the safety of all infant formula in the U.S. market.”

The agency reports it has been conducting inspections of food safety operations in infant food manufacturing facilities and is making its findings known.

Last year’s contamination-based recall and temporary halting of infant formula production wreaked havoc on the industry’s supply chain, a disruption that the FDA has taken to steps to prevent from re-occurring in the future.

A Cronobacter Prevention Strategy

The FDA’s constituent update highlighted a Cronobacter prevention strategy aimed at ensuring that all infant formula in the U.S. market is safe for consumption.

In its letter, the agency called on all infant formula industry participants to evaluate their existing systems of production and in-process controls and ensure regulatory compliance. Specifically, industry members were asked to take the following steps to prevent contamination of infant formula products:

  • Control water in dry production areas.
  • Use environmental monitoring to verify the effectiveness of controls.
  • Establish procedures for when a pathogen is detected in a product sample or environmental sample.
  • Implement strong supply-chain controls for biological hazards.
  • Identify all relevant biological hazards.

Product Liability Litigation in Baby Formula Lawsuits

The agency’s actions come on the heels of several months’ worth of contaminated powdered baby formula lawsuits connected to the recall of certain Similac, Alimentum, and EleCare products. According to the lawsuits, infants became sick with Salmonella after consuming formula contaminated with Cronobacter sakazakii bacteria at the Abbott manufacturing facility in Sturgis, Michigan.

Plaintiffs in the lawsuits include individuals:

  • Who bought Similac, Alimentum, or Elecare or fed any of these products to a child between 2019 and 2022, after which the baby suffered gastrointestinal distress
  • Whose baby suffered severe gastrointestinal distress and was diagnosed with Cronobacter sakazakii or Salmonella
  • Purchased or used formula batches in the recall, including those with a code between 22-37 and containing K8, SH, or Z2, and for which the expiration date is 4/1/22 or later.

Criminal Penalties

Business Insider has reported that Abbott could face a $500,000 criminal penalty for each offense as the Department of Justice investigates the plant conditions that prompted last year’s nationwide baby food shortage.