Infant 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.
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.
The 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.
The 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.
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.
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 “not receive direct copies of the complaint due to an isolated failure in FDA’s mailroom” and that leadership was only notified, four months later in mid-February, via email.
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.
The FDA must answer:
- How could a plant with few problems on a September 2021 inspection have — according to FDA head Robert Califf — “egregiously unsanitary” conditions, including cracks in equipment, a leaking roof and bacterial contamination on an inspection four months later? It doesn’t inspire confidence in the agency’s routine inspections.
- Why did the FDA essentially ignore a whistleblower complaint for four months? Blaming the mailroom is like claiming the dog ate my homework. Multiple FDA officials initially received the complaint, interviewed the whistleblower, and emailed the higher-ups.
- How could the FDA allow three months to elapse between closure of the critical Sturgis plant and the agency’s May 16 announcement that it would make case-by-case, enforcement discretion determinations to allow importation of safe foreign formula? Formula from Australia and the UK will be imported but could take weeks to reach store shelves. The agency will finally allow release of 300,000 cans of a specialty formula that it instructed Abbott to hold back in February — it has repeatedly tested negative for contamination.
- Finally, why did it take three months to conclude an agreement to reopen the Abbott plant? The FDA was aware of the formula shortage and the critical role the plant plays in the nation’s supply. And it remains unclear whether the Abbott plant infected anyone: None of the product samples in the four cases tested positive for Cronobacter and genomic sequencing of the two available patient samples found no close genetic relation to the Cronobacter strains found at the factory.
The FDA had to move more rapidly. Even now, more than two weeks after the May 16 consent decree, the plant is not up and running.
Commissioner Califf claims the FDA is understaffed, with only nine employees to inspect formula plants domestically and abroad. A $6 billion agency could have hired additional inspectors to address a formula shortage, ongoing for 10 months.
The FDA budget will increase by a third in FY 2023. In addition, the House of Representatives emergently appropriated $28 million for the FDA to address the shortage.
Simply spending more, though, is not the answer. The FDA must make its newfound discretionary flexibility for importing foreign formulas permanent — it would increase supply, lower prices and provide redundancy. It must increase the number of inspectors so that complaints can be addressed in a timely and competent manner. And it must speed up its investigation and remedial processes so that alleged problems at key plants can be rapidly assessed and corrected.
Commissioner Califf has acknowledged that the FDA’s response was “too slow” and its decisions “were suboptimal.” The agency must do better.
Read the full article at the New York Post.