FDA Launches New Study Focusing on Infant Formula Industry Following Recalls, Shortages

The infant formula study was sparked by last year's Similac recall, which led to a nationwide infant formula shortage and safety concerns.

Federal food safety officials have announced they are launching an in-depth investigation into the infant formula industry, amid recent problems with recalls and supply chain issues, which have left parents scrambling to find food for their babies and questioning the safety of formula still on store shelves.

The U.S. Food and Drug Administration (FDA) issued a press release on May 19, indicating that it has charged the National Academies of Science, Engineering, and Medicine (NASEM) to conduct the independent study.

Similac Recall Sparked National Infant Formula Shortage

The study comes in response to the fallout from a massive Abbott Laboratories recall of Similac, Alimentum and Elecare formula products in February 2022, which was issued after it was discovered that powdered formula manufactured at a Michigan facility was contaminated with Salmonella Newport and Cronobacter sakazakii bacteria.

Widespread distribution of the contaminated formula has been blamed for causing hundreds of infant illnesses nationwide, and subsequent investigations have revealed Abbott ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits.

Shortly after the Similac recall, individual and class action lawsuits started to be brought, and it is ultimately expected that several thousands Similac, Alimentum and EleCare Recall lawsuits may be included in the litigation. However, over the past year, little has been done to reassure parents about the safety of formula products they find on store shelves.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


“The study will explore the current state of the U.S. infant formula market, including the diversity of manufacturers; the types of formulas they produce (e.g., non-specialty or specialty, powdered or liquid); manufacturing facilities, production, and production capacity; the amounts of infant formula produced domestically and the amounts imported; and other characteristics,” the FDA indicates. “The study will also examine how these characteristics compare to those of the market prior to the COVID-19 pandemic, and just prior to the Abbott recall in February 2022.”

According to the agency, the study will look at a range of conditions that could affect competition in the infant formula market. It will also look at differences in nutritional content, labeling and other infant formula requirements as well as differences in regulations here in the U.S. and in Europe.

The FDA did not give a projected timeline for the study’s completion, which is required by the Food and Drug Omnibus Reform Act of 2022. The law called for the FDA to release an immediate national strategy to prevent future infant formula shortages, which was announced by the agency in March. The results of the NASEM study is expected to help the agency develop a more long-term strategy to the problem.

June 2023 Similac Recall Lawsuit Update

Problems with 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 for all Similac lawsuits and Enfamil lawsuits brought over the risk of necrotizing entercolotis (NEC) caused by cow’s milk formula products, which are centralized before U.S. District Judge Rebecca R. Pallmeyer.

While early pretrial proceedings before Judge Kennelly are still being established in the litigation over contaminated baby formula, several Similac NEC lawsuits before Judge Pallmeyer have been selected for bellwether trials, which will be held to help the parties evaluate how juries will respond to certain evidence and testimony about the risks associated with use of cow’s milk formula among premature infants, which has been linked to NEC.

Although the outcome of these bellwether trials will not be binding on other plaintiffs pursuing lawsuits against Abbott, they may have a large impact on the amount of Similac settlements the manufacturer may pay to avoid the need for each individual lawsuit to go before a separate jury.


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