Abbott To Release Similac, Other Infant Formula Products on Case-by-Case Basis, as FDA Investigation of Contamination Problems Continues

The FDA is allowing Abbott to release Similac infant formula and similar products if they are specialty and metabolic formulations which may help infants with life-threatening conditions.

Following a recent Similac formula recall issued due to bacterial contamination problems that sickened infants nationwide, federal regulators are allowing Abbott Laboratories to begin releasing specialty and metabolic products on a case-by-case basis, if they could help treat or prevent life-threatening conditions for newborns and infants.

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

Within days of the recall, reports began to surface that suggested the company knew about the Similac contamination problems at its facility since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infant infected with Cronobacter.

The U.S. Food and Drug Administration (FDA) is still investigating how the formula products were manufactured, and reported in an update on April 29 that Abbott has agreed to do “enhanced testing” on future products, which will slow production.

“In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below on a case-by-case basis,” the agency’s update states. “The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products.”

Infant formula products which fall under this category include:

• Glutarex-1
• Glutarex-2
• Cyclinex-1
• Cyclinex-2
• Hominex-1
• Hominex-2
• I-Valex-1
• I-Valex-2
• Ketonex-1
• Ketonex-2
• Phenex-1
• Phenex-2
• Phenex-2 Vanilla
• Pro-Phree
• Propimex-1
• Propimex-2
• ProViMin
• Calcilo XD
• Tyrex-1
• Tyrex-2
• Similac PM 60/40

The permission comes at a time of a nationwide infant formula shortage caused by supply chain problems linked to the pandemic, and exacerbated by the Similac recall.

Nationwide supplies of baby formula have become extremely strained following the recalls, with 11,000 stores reportedly indicating 30% of the most popular brands are sold out, and some large cities have seen more than half of their baby formula supply depleted. That number is up from 11% in November, according to an analysis by Datasembly.

The Infant Nutrition Council of America is advising parents on what to do if they cannot find baby formula. The group advises parents check other stores, such as baby supply stores and drug stores if their regular local store is sold out. It also reminds them they can order baby formula online and advises them to buy the largest size possible, but to not horde supplies by buying more containers than they need.

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.