\n<\/aside>\nInfant formula provides the sole source of nutrition for infants who are not being breast fed and often supplements breast milk for those who are. Only 47% of infants are exclusively breast fed in the first three months of life, a figure that declines to 26% by six months. Specialty formulas are the only nutrition option for infants who, because of medical problems, cannot utilize standard formulas or breast milk.<\/p>\n
It’s also one of the most regulated foods in our country. The Food and Drug Administration’s strict nutritional and labeling requirements make it difficult for foreign producers to export formula to the US, despite evidence that their products are safe and nutritionally adequate. Tariffs – as high as 17.5% – further discourage importation. Consequently, nearly all the formula consumed in the US is produced domestically by four companies. This makes the supply vulnerable to closures of large domestic plants.<\/p>\nThe FDA’s requirements make it difficult for foreign producers to export baby formula to the US.<\/figcaption>Getty Images \/ Sarah Silbiger<\/span><\/figcaption><\/figure>\nThe FDA had “concerns about infant formula and special medical food shortages given their production at a small number of facilities controlled by a handful of firms” over two years ago, internal reports show. Yet the agency did little to address formula shortages that began last summer and rapidly increased over the late fall and winter. <\/p>\n\n\t<\/aside>\nThe shortages were exacerbated by the FDA-encouraged February 2022 closure of Abbott’s Sturgis, Mich., Plant – one of the largest formula facilities in the country and one of the only producers of specialty preparations – in response to possible bacterial contamination. <\/p>\n
The FDA conducted a routine inspection of the Sturgis plant on Sept. 20-24, 2021. It reported five observations – including standing water and inadequate hand washing – but nothing about bacteria. At the same time (Sept. 20), the FDA received a report of Cronobacter sakazakii illness in an infant who had consumed formula produced at the plant. Two additional complaints of Cronobacter illness possibly associated with the Sturgis plant arrived Dec. 1 and Jan. 11. <\/p>\n
In late October, multiple FDA officials received a whistleblower report electronically and via FedEx alleging safety issues and record falsifications at the Sturgis plant. The informant was interviewed two months later. The FDA claims its leadership did \u201cnot receive direct copies of the complaint due to an isolated failure in FDA’s mailroom\u201d and that leadership was only notified, four months later in mid-February, via email.<\/p>\n
It wasn’t until Jan. 31 that the agency began a new inspection, lasting until March 18, of the Sturgis plant. When early samples from plant surfaces were positive for Cronobacter, the agency advised Abbott to recall products on Feb. 15. The company voluntarily closed the plant and recalled product. Days later, a fourth sick infant possibly connected to the plant’s formula was reported. <\/p>\n