In Wake of Similac Recall, FDA Announces Strategy to Keep Cronobacter Out of Infant Formula Products

The FDA is considering updating regulations and creating a team of specialized inspectors whose job will be keeping cronobacter out of infant formula products

Federal regulators have outlined a new strategy intended to prevent infant formula cronobacter infections, following a massive recall impacting Similac, Alimentum and EleCare formula earlier this year, which were all manufactured by Abbott Laboratories at the same Michigan plant that has been plagued by problems.

On November 15, the U.S. Food and Drug Administration (FDA) announced a cronobacter prevention strategy outline, which the agency hopes will broaden its scientific understanding of Cronobacter sakazakii, which sickened infants nationwide and has been linked to reported deaths.

The agency also hopes the strategy will help improve oversight of powdered infant formula production, and increase communications and engagement with stakeholders, such as industry, the public, government and other public health organizations.

Abbott Laboratories issued a Similac formula recall in February 2022, after disclosing the powdered infant formula manufactured at a Michigan facility was contaminated with Cronobacter sakazakii and Salmonella Newport bacteria.

Subsequent investigations have revealed that Abbott ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits, leading to individual and class action lawsuits filed throughout the federal court system.

Abbott now faces dozens of Similac recall lawsuits brought by families of infants nationwide who were diagnosed with Salmonella, Cronobacter or other infections linked to bacteria at the manufacturing facility, and serious questions are being raised about why the problems were not addressed much earlier.

Most of the illnesses linked to the recall appear to have been salmonella-related. Cronobacter illnesses, especially among infants, are much rarer.

Cronobacter Sakazakii Risks in Infant Formula

Cronobacter sakazakii is a rare type of bacteria, often found in dry foods, such as infant formula, skimmed milk powder, tea and starches. The bacteria exists in the environment and can survive in very dry conditions, making transmission of the infection possible by touching contaminated surfaces.

The infections can be particularly deadly for infants and the elderly, or those with weakened immune systems. In fact, the U.S. Centers for Disease Control and Prevention (CDC) warn the bacteria may cause serious infections or urinary tract infections and poses a heightened mortality risk to those with conditions, such as HIV, organ transplants, or cancer.

“Typically, the…CDC receives 2-4 reports of severe Cronobacter infections in infants annually from health departments across the country,” the FDA indicates in the strategy outline. “Public health investigations primarily link these infections to formula contamination during preparation.”

FDA Infant Formula Cronobacter Prevention Strategy

The strategy calls for the FDA to increase collaborations with stakeholders to help the agency better understand the infant formula manufacturing process and how to make it safe. The agency also hopes to strengthen regulatory activities and improve oversight.

Some ways the FDA is considering improving oversight and enforcement include the possibility of establishing a team of investigators who specialize in infant formula production after putting them through additional training on how to inspect and investigate the manufacturing facilities, and review and update the Infant Formula Compliance Program to factor in the current state of science on cronobacter.

The FDA strategy also calls for a review and update on current guidance on manufacturing powdered infant formula products, determining what improvements could be made for testing requirements, improving communication with consumers, give federal, state and local partners more ability to identify and investigate cronobacter illnesses, and continuing to research cronobacter to better understand it in order to better protect public health.

The strategy was released on the same day the FDA held a virtual public meeting for its National Advisory Committee on Microbiological Criteria for Foods, which focused on potential new safety regulations for powdered infant formula products.

The FDA indicates it will keep the public notified of the development of the strategy as those changes are decided.

Necrotizing Enterocolitis (NEC) Lawsuits Over Similac and Enfamil

Concerns about Abbott’s handling of contaminated baby formula came as the company was already facing hundreds of necrotizing enterocolitis (NEC) lawsuits filed by parents of premature infants who developed a devastating gastrointestinal condition after they were fed the cow’s milk formula in the hospital or NICU, emerging that the company has placed its desire for profits before the safety of infants for decades.

That litigation emerged following studies that found premature infants face a substantially greater risk of developing NEC after they are fed Similac, Enfamil or other cow’s milk-based formula products, as opposed to a mother’s breast milk, donor milk or human milk formula products.

Although there is evidence that Abbott Laboratories has known about the NEC risks for premature infants for years, the company has engaged in aggressive marketing to hospitals and parents of new borns, including versions of their product specifically intended for premature infants. As more information has come out about the risk, the company has also engaged in abusive and aggressive legal tactics in response to early NEC lawsuits, including threats to lawyers advertising to raise awareness among families about the potential for a settlement.

November 2022 Similac Lawsuit Update

The problems over Similac formula have resulted in two separate coordinated proceedings in the federal court system, including one multidistrict litigation (MDL) established before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois for all Similac, Alimentum and EleCare recall lawsuits. A separate MDL proceeding has been established before U.S. District Judge Rebecca R. Pallmeyer for the Similac NEC lawsuits, as well as Enfamil NEC lawsuits brought over problems linked to the competing cow’s milk formula.

While early pretrial proceedings before Judge Kennelly are still being established in the litigation over contaminated baby formula in November 2022, Similac NEC lawsuits before Judge Pallmeyer are proceeding through a “bellwether” selection process, where the parties are selecting a small group of representative claims to prepare for early trial dates.

Although the outcome of these bellwether trials will not be binding on other plaintiffs pursuing lawsuits against Abbott, they will be used to gauge how juries are likely to respond to certain evidence and testimony about the aggressive strategies employed by the company to withhold information about the risks associated with their products, and may have a large impact on the amount of Similac settlements Abbott may pay to avoid the need for each individual lawsuit to go before a separate jury.