Following Baby Formula Contamination that Resulted in Similac Recall, Operations Resume at Abott’s Michigan Facility

Abbott Laboratories was allowed to restart production at its Sturgis, Michigan baby formula facility late last week, after meeting conditions of a consent decree with the federal government that required the manufacturer to address widespread problems that led to the distribution of contaminated Similac, Alimentum and EleCare formula, which caused severe illnesses and deaths among infants nationwide.

Production at the plant recommenced on June 4, in what some hope is the beginning of the end of an infant formula shortage which has sent parents, stores and the U.S. government scrambling to meet the nutritional needs of its most vulnerable citizens.

Abbott Laboratories first announced a Similac, Alimentum and EleCare recall on February 17, following nationwide reports of illnesses and at least two deaths among infants fed versions of powdered formula manufactured at the same plant in Michigan, which were contaminated with Cronobacter sakazakiiis or Salmonella Newport bacteria.

As a result of the recall, as well as supply chain issues caused by the ongoing COVID-19 pandemic, a serious baby formula shortage has hit the United States this year.

Early last month, it was estimated that about 40% of formula products were out of stock nationwide. Some states have been hit worse than others, with more than 50% of infant formula products absent from shelves in Missouri, Texas and Tennessee. The FDA had resorted to importing large quantities of formula from European nations to battle the shortage.

Health experts and parents are now breathing some relief with the plant’s reactivation, but there are still many concerns over why it was shut down in the first place, and the vulnerabilities it revealed about the infant formula supply chain.

Similac Manufacturing Problems Raise Safety Concerns

At a Congressional hearing in late May, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf detailed for lawmakers the egregious conditions which led to the facility’s temporary shuttering.

During the hearing, FDA Commissioner Califf told the House about multiple deficiencies found at Abbott Nutrition’s plant, which included leaks in the roof that allowed water to enter and sit stagnant on the floor and on production equipment. This is suspected to have contributed to the outbreak of pathogens that caused infant illnesses and deaths after being fed Similac, Alimentum and EleCare formula products.

Califf further stated multiple quality control problems were identified, such as Abbott not following up on complaints of illnesses and other concerns, even knowing they proposed a potential health risk to infants.

The plant is reopening under the conditions of a consent decree agreed to by Abbott and the U.S. Department of Justice last month. It detailed what Abbott was required to do to restart production, such as cleaning and sanitizing the facility and all of its equipment; adding environmental monitoring, additional product testing and employee training; and required Abbott to hire an independent third party to review the company’s improved sanitizing and manufacturing processes.

The FDA was required by the agreement to sign off on the improvements before allowing the plant to restart production.

Similac & Enfamil Baby Formula Health Risks

In addition to concerns about the shortages and recent problems with contamination, Abbott is also facing a growing number of Similac lawsuits that are now being pursued by families of premature babies who developed necrotizing enterocolitis (NEC) after being fed the cow’s milk products while still in the NICU.

NEC is a serious health condition that primarily impacts preterm infants, causing intestinal tissues to become inflamed and die. If left untreated, it can cause dangerous perforations in the intestines, which allow bacteria to leak into the abdomen or infiltrate the bloodstream. This can lead to life-threatening infections, narrowing of the intestines, short bowel syndrome, developmental delays and a failure to thrive.

A number of studies published over the past three decades have highlighted the link between NEC and cow’s milk formula like Similac and Enfamil, yet manufacturers have continued to market and promote versions of their products specifically for use by premature infants.

According to allegations raised in the baby formula NEC lawsuits, many of those infants may have avoided the condition if the manufacturers hadn’t provided false and misleading information to parents and the medical community, which diminished the importance of breast feeding or using human donor milk.