House Democrats to hold hearing and introduce bill

House Democrats will hold hearings on US infant formula shortages and move to pass legislation to increase the staff of Food and Drug Administration inspectors to ensure imported foods are safe for infants to consume.

Rep. Rosa DeLauro, chair of the House Appropriations Committee, on Tuesday introduced legislation that would provide the FDA with $28 million in emergency funding to step up inspections at infant formula factories around the world.

The FDA is increasing imports of infant formula from other countries to reduce shortages. This is partly due to the closure of the Abbott Nutrition plant in Sturgis, Michigan due to a bacterial contamination at the facility. The US typically produces 98% of the infant formula Americans buy, and four manufacturers—Abbott, Mead Johnson Nutrition, Nestle USA, and Perrigo—control 90% of the domestic market.

Rep. Rosa DeLauro, CT (left), chair of the House Appropriations Committee, and Speaker of the House Nancy Pelosi, CA, huddle during a press conference on Democratic House’s $28 million emergency spending bill to resolve US infant formula shortages at the Capitol in Washington, Tuesday, May 17, 2022.

J. Scott Applewhite | AP

To sell formula in the US, foreign companies must submit applications to the FDA, who then review whether their products are safe and nutritious for babies.

However, DeLauro said she was told by the FDA that it only had nine people to review domestic formula plants, as well as seven facilities in Europe and two in Mexico. The FDA may end up having to inspect more plants if it approves additional applications for the mix.

“These facilities should be inspected. The FDA does not have adequate inspection forces to be able to do this and do it in a timely manner,” DeLauro, Conn., told reporters during a news conference on Tuesday. The law also includes funding for supply chain monitoring and money to eradicate fraud, she said.

DeLauro said House Democrats are also considering a bill that would strengthen the FDA’s authority to hold companies accountable. The regulatory body does not have the power to order manufacturers to recall unsafe products. It can only recommend a revocation when it finds security issues.

“The FDA has no authority to recall. We’re talking about a recall, but it’s really a matter of moral persuasion,” House Speaker Nancy Pelosi of California said at a press conference.

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The House Appropriations Subcommittee on Agriculture will hold a hearing Thursday with FDA Commissioner Robert Kaliff about the shortage of baby food, DeLauro said. The House Energy and Commerce Committee has scheduled another hearing with Kaliff and FDA food policy chief Frank Yannas for May 25, according to Representative Frank Pallone, committee chairman.

Representatives from infant formula manufacturers Abbott, Gerber and Reckitt will also attend the hearing next week, Pallone said.

The Justice Department, in a complaint filed in federal court on Monday, alleged that Abbott introduced falsified infant formula to the consumer market. Four babies who were fed formula produced at the Sturgis plant were hospitalized with bacterial infections, two of whom died.

Abbott said in a statement on Monday that there is “no conclusive evidence” linking childhood illnesses to the company’s products.

As Democrats step up their efforts to deal with the crisis, they are also stepping up their calls for accountability.

“I think there may be a need for an indictment,” Pelosi said, without specifying who should be indicted. The speaker’s office did not respond to requests for clarification.

Abbott and the FDA have reached an agreement, subject to federal court compliance, to reopen the plant after the company brings in outside experts to fix unsanitary conditions at the plant. However, Abbott said it would take about two weeks for operations to resume, subject to FDA approval. Shipping to stores can take up to eight weeks.

Abbott is subject to an agreement called a consent decree for at least five years. In case of non-compliance with the order, the company is subject to damages in the amount of $30,000 for each day of violation.

Abbott is required to close the Sturgis plant again if any product tests positive for Cronobacter sakazakii or Salmonella. Then he must dispose of the product, find the source of contamination and fix the problem.

Abbott will only be able to restart the plant after receiving approval from the FDA.

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