Abbott agrees with the FDA to reopen an infant formula factory

A woman shops for baby formula at Target in Annapolis, Maryland, May 16, 2022, as a nationwide shortage of baby formula continues due to supply chain shortages related to the coronavirus pandemic that have already strained the country’s formula inventory, an issue , which was exacerbated by a major product recall in February.

Jim Watson | AFP | Getty Images

Abbott on Monday reached an agreement with the Food and Drug Administration to reopen the company’s Michigan manufacturing facility to alleviate a statewide shortage of baby formula after the facility closed due to bacterial contamination.

FDA Commissioner Robert Califf said Abbott, under the terms of the agreement, will correct the unsanitary conditions that led to the contamination and closure of the facility.

“The public should be assured that the agency will do everything in its power to continue to ensure that infant formula and other specialty foods manufactured by the company meet FDA safety and quality standards,” Califf said in a statement.

The agreement between Abbott and the FDA, known as the Consent Decree, was approved by the US District Court for the Western District of Michigan on Monday. Abbott can get the Sturgis, Michigan plant back online within two weeks, the company said. However, it said it would take six to eight weeks from the start of production for the formula to hit store shelves.

Mothers are struggling to find formula for their infants as shelves in many US stores are empty. According to Datasembly, a retail data tracker, more than 40% of baby formula sold out nationwide in the week ended May 8th. However, the FDA said Monday that nearly 80% of baby formula is in stock, citing data from Information Resources, another retail data company.

The supply shortage was triggered in part by the closure of Abbott Nutrition’s Michigan manufacturing facility after four infants consuming formula from the facility contracted bacterial infections, two of whom later died. Abbott is the largest manufacturer of infant formula in the United States

The Justice Department, in a complaint on behalf of the FDA, alleged that products made at Abbott’s Sturgis facility were adulterated because they were manufactured in unsanitary conditions.

FDA inspections found the factory to have Cronobacter sakazakii, a bacterium that can cause blood infections. According to the FDA, Abbott’s internal records also showed that the company destroyed some of its products due to the presence of the bacteria at the facility.

Under the consent decree to reopen the facility, Abbott has agreed to bring in outside experts to help the facility comply with food safety regulations, according to the Justice Department. The outside experts will design a plan for Abbott to reduce the risk of bacterial contamination at the facility and conduct regular assessments to ensure the company is compliant. According to the Justice Department, the trial will be under FDA oversight.

Abbott must shut down production if a product tests positive for Cronobacter or Salmonella, discard the product, find the source of the contamination, and correct the problem. The company cannot resume production until it receives FDA approval. If Abbott fails to comply, it faces $30,000 in damages for each day it violates annual penalties, which do not exceed $5 million. The Company is subject to the terms of the consent decree for a minimum of five years.

Attorney General Merrick Garland said in a statement Monday the Justice Department will vigorously enforce US food safety laws.

In February, Abbott issued a voluntary recall of its Similac PM 60/40, Similac, Alimentum and EleCare products manufactured at its Michigan facility. Abbott said last week that no formula distributed by the plant to consumers has tested positive for the bacteria, and genetic sequencing of two samples from the sick infants did not match the Cronobacter strains found in the plant.

The FDA completed its inspection in March. The Centers for Disease Control and Prevention has found no additional cases of infants infected with Cronobacter after consuming products from the Michigan facility.

The FDA said in a statement Monday it is working with other baby formula manufacturers to increase domestic production. Gerber increased the amount of formula available to consumers by 50% in March and April, and Reckitt has increased formula offerings by more than 30% so far this year, according to the drug regulator.

The FDA said it will also increase imports of baby formula into the US, which typically produces 98% of the formulas consumers buy. The FDA allows formulas originally made for foreign markets to be imported, but manufacturers must submit applications to the FDA, which will verify that the product is safe and provides adequate nutrients.

The FDA added that it will prioritize applications from companies that can demonstrate safety and nutritional standards and get large volumes of their products onto US shelves. Speaking to reporters, senior Biden administration officials said the imported formula will come from countries with similar regulatory standards, such as Ireland, Britain, Australia and New Zealand.

The drug regulator said it has also increased the supply of baby formula arriving at ports in the country since February, with imports up more than 300% year-on-year. The FDA has worked with the US Department of Agriculture and agencies in the UK and Europe on these imports.

CNBC Health & Science

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Gary B. Graves

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