FDA admits delays in response to baby food shortage

FDA admits delays in response to baby food shortage

WASHINGTON (AP) — The Food and Drug Administration on Tuesday acknowledged that its response to the infant formula shortage in the U.S. was slowed by delays in processing a whistleblower complaint and test samples from the country’s largest formula plant.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the US to ship millions of pounds of powdered formula from abroad.

The review focused on several key issues at the agency, including outdated data-sharing systems, insufficient staffing and training of food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to public health, if you have no idea how all the pieces fit together, then you have a real problem if you get into a crisis or a shortage,” FDA Commissioner Robert Califf told The Associated Press in an interview. “A lot of that happened here.”

Califf said the FDA will seek new authority to force companies to hand over important information.

A consumer lawyer said the evaluation does not go far enough to resolve the issues.

“This internal evaluation is addressing the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this review addresses the fragmented leadership structure that led to critical communications failures.”

The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shut down Abbott’s Michigan plant over safety concerns, rapidly scaling back domestic production within the highly concentrated formula industry.

A whistleblower from the company had attempted to alert the FDA of problems at the plant in September 2021, but government inspectors only investigated complaints in February after four babies became ill, resulting in two deaths. The FDA is still investigating links between those diseases and the formula.

The FDA previously told Congress that top agency officials were not aware of the complaint until February due to postal delays and failure to escalate the Abbott employee’s allegations. The new report stated that the FDA’s “inadequate processes and lack of clarity regarding whistleblower complaints” may have delayed inspectors to the factory.

“Whistleblower complaints come in in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary officer who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come in at the agency, they are triggered and escalated to the appropriate leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues from “third-party delivery companies” delayed results, the report said. The FDA also faced challenges in ramping up its testing capacity for cronobacter, a rare but potentially deadly bacterium that has been repeatedly linked to outbreaks in baby food.

The FDA also noted that it had to reschedule its first inspection of the Abbott plant due to cases of COVID-19 among company personnel. That delay came on top of previous missed inspections as the agency pulled its inspectors from the field during the pandemic.

The report concluded with a list of new resources Congress should approve to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts for the food division of the FDA;

— Improved information technology to share data on FDA inspections, consumer complaints and test results;

— New authority to force manufacturers to submit samples and data on production supply chains, production quality and safety.

According to IRI, a market research firm, US baby food inventories have improved, reaching over 80% stock levels last week. That’s up from the low of 69% in mid-July. The US has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay in the market long-term to diversify supply.

Califf has commissioned a separate external review of the FDA’s food division, citing “fundamental questions about the structure, function, funding and leadership” of the program. That review is led by former FDA Commissioner Dr. Jane Henney, who headed the agency during the final years of the Clinton administration.


Follow Matthew Perrone on Twitter: @AP_FDAwriter.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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