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Wednesday, Sep 21 2022

Full Issue

FDA Made Many Missteps During Infant Formula Crisis, Internal Review Finds

Problems included outdated technology at the FDA, limited training on formula among FDA investigators, funding limitations, and gaps in the understanding of cronobacter, the type of bacteria that prompted Abbott鈥檚 recall, The Wall Street Journal reported.

An internal review of the Food and Drug Administration's actions leading up to the infant formula crisis finds a combination of human error, antiquated technology, and poor communication and accountability amongst an already threadbare food workforce all contributed to a perfect storm of problems which exacerbated the supply shortage. The issue was only worsened by the FDA's lack of a robust mandate to strong-arm industry players' compliance, the review found. (Pezenik, 9/21)

Problems ranged from outdated technology at the FDA to limited training on formula among FDA investigators, the report said. It said funding limitations and gaps in the understanding of cronobacter, the type of bacteria that prompted Abbott鈥檚 recall, impeded the FDA鈥檚 response to this year鈥檚 incidents and the agency鈥檚 ability to regulate and oversee formula. (Newman, 9/20)

Some parents and advocates had been looking forward to the review shedding specific light on FDA failures in order to provide accountability, but Califf said in an interview shortly after the report was released that the review was meant to 鈥渋dentify themes of issues鈥 FDA needs to improve going forward. FDA Chief Robert Califf noted that the agency had provided a detailed timeline of its response and that an independent review of the larger FDA foods division is ongoing. 鈥淲e鈥檙e not going to spend a lot of time going back,鈥 Califf said. 鈥淲e鈥檙e going to spend our time taking into account what happened then and moving forward.鈥 (Lee, 9/20)

Also 鈥

KHN: Formula May Be Right For Infants, But Experts Warn That Toddlers Don鈥檛 Need It聽

Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1 to 3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive. In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth. (Szalinski, 9/21)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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