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Frank Yiannas, a senior official at US regulator the Food and Drug Administration (FDA), has resigned his post in a move linked in media reports to news of a criminal investigation into last year’s infant-formula crisis.

His decision, revealed in a Twitter post, comes just days after reports suggested that US baby-formula heavyweight Abbott Laboratories is to face a criminal investigation by the Department of Justice (DOJ) over an outbreak of salmonella at its Michigan plant last year that led to the facility’s temporary closure and nationwide product shortages.

In December, a wide-ranging report into the practices, culture and structure of the FDA in the wake of the infant-formula crisis called for change at the organisation.

In a tweet published yesterday (25 January), Yiannas said: “Today, I informed commissioner [Robert] Califf that I will be resigning my position as deputy commissioner for the Office of Food Policy and Response effective February 24. I am honoured to have served the American public, alongside each and every one of you, over these past four years.”

Accepting the resignation, the FDA tweeted: “The FDA can confirm Frank Yiannas has resigned from his position as deputy commissioner for Food Policy and Response effective February 24. The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission.”

The Washington Post newspaper said it had obtained a copy of Yiannis’s resignation letter which referred to having inherited a “decentralised structure” at the food programme he operated, which he said “significantly impaired the FDA’s ability to operate as an integrated food team and protect the public”.

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By GlobalData

On Tuesday (24 January), media reports revealed Abbott Laboratories is facing a DOJ criminal investigation into last year’s infant-formula crisis.

One year on

It was nearly a year ago when Abbott shut down its infant-formula manufacturing plant in Sturgis, Michigan, following consumer complaints related to cronobacter sakazakii or salmonella illness in children from the consumption of formula made at the plant.

The closure led to a large-scale product recall, which in turn led to severe shortages on supermarket shelves.

The issue became so serious that US President Joe Biden took executive action to try to help alleviate the country’s infant-formula shortage.

According to The Wall Street Journal (WSJ) newspaper, quoting people familiar with the matter, the DOJ’s consumer-protection branch is heading the probe into Abbott.

The WSJ said Abbott confirmed it had been told by the DOJ that the investigation is taking place and quoted the company as saying “we’re cooperating fully”.

Yiannas, who has been in post since December 2018, was among the officials leading the FDA during the infant-formula crisis.

According to the FDA website, he was the principal advisor to the FDA commissioner in the development and execution of policies related to food safety.

It said: “His leadership role within the agency covers a broad spectrum of food safety priorities, such as outbreak response, traceback investigations, product recall activities, and supply chain innovation across the full spectrum of FDA-regulated products.

“Mr. Yiannas is, in effect, the agency’s chief ambassador to reduce food-safety risks and achieve high rates of compliance with FDA food-safety standards, working to develop innovative collaborations with external partners and stakeholders and effective relationships with government and industry leaders, as well as consumer groups.”

Before joining the FDA, Yiannas had leadership roles at grocery giant Walmart and entertainment industry major the Walt Disney Company.

The scathing report published in December into the FDA’s role in the infant-formula crisis said it had a “culture, structure, and governance model” that detracts from its [food] programme’s effectiveness.

That report followed an internal review in September which concluded that the FDA made mistakes in the way it responded to the infant-formula crisis.

The scope of the DOJ’s probe into Abbott is unknown but US media outlets point out it has been alleged by company whistleblowers the company had covered up food-safety violations from the FDA prior to the plant’s closure.