FDA Initiates Independent Study of U.S. Baby Formula Industry in Response to Safety Concerns and Regulation Issues
The U.S. Food and Drug Administration (FDA) has authorized an independent study to investigate the baby formula industry in response to growing concerns about safety and regulation of U.S. manufacturers.
The study will be carried out by the National Academies of Sciences, Engineering, and Medicine, with sponsorship from the FDA. Upon completion, a report will be submitted to Congress and the FDA.
The committee’s evaluation will cover the following aspects:
- Supply challenges and market competition.
- Characteristics of the U.S. infant formula market.
- Disparities in the marketing of baby formula between the U.S. and the European Union, including differences in nutritional content, labeling, and regulatory requirements.
- Diversity among manufacturers.
- Manufacturing processes.
This study is part of the Food and Drug Omnibus Reform Act of 2022, which expanded the FDA’s authority for inspections both domestically and internationally. Congress has also instructed the FDA to develop the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, a guidance document released in March. The findings from the NASEM study will contribute to the formulation of a long-term national strategy, as stated by the FDA.
The FDA’s strategy report acknowledges that the infant formula supply is highly concentrated among a few manufacturers, which means that a production issue in one company can have a significant impact on the overall supply. In 2022, four companies controlled 99% of the infant formula market.
The decision to conduct this study follows a challenging year for the industry, marked by recalls, contamination incidents, and a prolonged shortage of baby formula.
According to the FDA’s National Strategy report, the shortage in 2022 was a result of multiple factors, including supply chain disruptions caused by the COVID-19 pandemic. The report specifically mentions the unsanitary conditions at the Abbott Nutrition facility in Sturgis, Michigan, which heavily relied on that facility for routine and critical specialty formulas. Insufficient backup production capacity and redundancy plans for powdered formula exacerbated the supply chain disruption that affected the entire U.S. market.
If your premature baby was diagnosed with NEC (necrotizing enterocolitis) after consuming Similac or Enfamil baby formula, you can request a free case review to explore your options for legal recourse.
Recalls were prompted by the detection of harmful bacteria in baby formula products. Abbott Nutrition, a leading manufacturer of Similac, EleCare, and Alimentum formulas, recalled seven million pounds of products in February 2022 due to Cronobacter sakazakii and Salmonella Newport contamination after receiving consumer complaints. Both bacteria can be harmful, and even fatal, to infants. As a result, parents have initiated lawsuits against the manufacturers.
In February, Reckitt, another major American baby formula manufacturer, recalled its Enfamil ProSobee Simply Plant-Based Infant Formula due to concerns about Cronobacter contamination. Politico reported that the FDA had knowledge of positive Cronobacter test results at Reckitt since November, months before the recall.
The FDA’s new guidance for baby formula manufacturers requires them to report contamination issues to the agency, even if the affected products are destroyed and do not reach the market.
The FDA has expressed its commitment to collaborating with government partners to enhance the resiliency of the infant formula supply and ensure that consumers have full confidence in the safety and nutritional quality of infant formula available in the U.S.
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