US infant-formula manufacturer Abbott Laboratories is facing investigations by the Securities and Exchange Commission (SEC) and the Federal Trade Commission (FTC), documents show.
The company, at the heart of last year’s infant-formula crisis, faces “various claims, legal proceedings, and investigations”, with 399 pending lawsuits in federal and state courts involving the manufacturer, it said in an SEC filing.
In November the Department of Justice launched a criminal investigation into Abbott and in December it received a subpoena requesting further information on its business.
The probes follow a US-wide infant formula shortage last year after a reported salmonella outbreak at an Abbott factory in Michigan prompted its closure and a mass product recall.
Abbott said it does not expect the legal proceedings to impact the company financially. It said: “Abbott is involved in various claims, legal proceedings, and investigations… While it is not feasible to predict the outcome of such pending claims, proceedings, and investigations with certainty, management is of the opinion that their ultimate resolution should not have a material adverse effect on Abbott’s financial position, cash flows, or results of operations.”
In January the company received a civil investigative demand from the United States Federal Trade Commission, which was investigating the bidding process for infant formula contracts.
The SEC filing adds: “In addition, multiple civil lawsuits have been filed against Abbott regarding Abbott’s manufacturing of certain powder infant formula products.”
Meanwhile, The Food and Drug Administration (FDA) began an overhaul earlier this month into its structure and food-safety procedures following criticism over its handling of the infant-nutrition crisis.
In September, an internal review concluded that the FDA made mistakes in the way it responded to the infant-formula crisis and pointed to “systemic vulnerabilities”.
“Clear priorities that are focused on protecting and promoting a safe, nutritious US food supply that more quickly adapts to an ever-changing and evolving environment” will be visited, the FDA said. Amongst other changes, the agency will appoint a deputy commissioner with responsibility for human foods.
