FDA Investigation into Formula Shortage Finds Critical Gaps in Understanding of Infant Feeding

October 10, 2022

Have You Seen the FDA’s Report Its Response to the Formula Shortage?

In September, the U.S. Food and Drug Administration (FDA) published a report reviewing its own response to the infant formula recall and shortage from earlier this year.

In a statement announcing the results of the internal review, the initiative’s leader reported “there is no single action to explain the events that occurred; rather the report identifies a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.”

The findings that are most interesting to our work, however, focus on how infant formula as a medical food has been viewed by the government and consumers, as well as the perceived carelessness of its production by manufacturers

It’s disappointing to see how infants and families have been let down at each turn throughout this national crisis. For example:

  • The critical nature of infant formula products as a sole source of nutrition posed unique challenges to public health, complicating compliance actions compared to typical food compliance actions … Typically, product safety is the primary driver during food safety incidents and product availability does not impact compliance actions. (Finding 9)
  • The infant formula industry employs dated technology and record keeping practices that can cause delays in collecting critical information needed to perform and define the scope of recalls. (Finding 10)
  • Conditions observed at the Abbott Nutrition facility were not consistent with a strong food safety culture. (Finding 11)
  • The FDA’s infant formula compliance program lacks specificity regarding Cronobacter and is limited by scientific gaps related to this pathogen. (Finding 14)
  • Consumer education regarding the safe handling and preparation of infant formula is limited. (Finding 15)

The report highlights a lack of prior understanding by the FDA of what it means for an infant or child’s sole source of nutrition to come from a breastmilk substitute — including the extreme care and caution required in overseeing the safe production, storage and distribution of infant formula. The fact that the FDA’s formula compliance program didn’t have specifics regarding Cronobacter is further evidence of how little the agency understands of the risks associated with artificial breastmilk substitutes.

Additionally, we see that though the infant formula industry spends millions of dollars in marketing its products, Abbott Nutrition was not investing in a culture of food safety expected in the production of medical foods.

The consumer education finding can’t be overlooked. Too often, education implies that safe preparation of powdered infant formula is dependent on the quality of the water used when the safety of the powder used should also be considered questionable. We must do a better job of encouraging families who use powdered formula to follow the CDC’s recommended preparation methods. You can download a step-by-step guide here.

We fully support the U.S. Breastfeeding Committee’s (USBC) vision for infant nutrition security.

The formula recall and resulting shortage brought a glaring spotlight on a national problem every lactation advocate already knows: There is no substitute for a mother’s own milk when it comes to optimal infant nutrition and yet, we lack the systemic structure required to support lactation and human milk feeding in the U.S. We need:

  • federal regulation of the formula industry’s marketing practices in alignment with the WHO’s International Code of Marketing of Breast-Milk Substitutes;
  • paid family leave at the federal level, ideally up to 12 months;
  • all perinatal hospitals to adopt either Baby-Friendly USA’s Ten Steps to Successful Breastfeeding or an alternate process that includes evidenced-based policies and practices and targeted outcomes;
  • robust donor milk programs in every NICU, and expansion of nonprofit human milk banks throughout the nation; 
  • adequate health insurance coverage to provide lactation education, clinical care and supplies and equipment; and
  • a formal plan for feeding infants and young children in emergencies that is protective of lactation and chest/breastfeeding.