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FDA Opens, Expands Baby Formula Market to Foreign Suppliers

Dealing with a crippling shortage of infant formula that has many U.S. parents desperate, the Food and Drug Administration on Monday announced “increased flexibilities” in allowing foreign manufacturers to help boost American supply of the vital product.

Also on Monday, the FDA announced that an Abbott Nutrition baby formula manufacturing facility in Michigan that has been closed since February due to safety issues will likely resume operations in two weeks, helping to further boost supply.

Supply chain issues are a major cause of the current shortage, but the shortfall first began in February, when Abbott Nutrition’s Sturgis, Mich. plant issued a voluntary recall of some of its powdered infant formula products. Abbott on Monday entered a consent decree with the FDA, paving the way for the plant to reopen.

In a news conference late Monday, agency commissioner Dr. Robert Califf said “Abbott has agreed to take actions that would be expected to ultimately result in an increase of infant formula products and ensure a safe, powdered infant formula is produced at the facility.”

However, experts estimate that even if the Michigan plant opens in two weeks, it may still take six to eight weeks for new baby formula to reach store shelves.

“We know many parents and caregivers are feeling frustrated by their inability to access needed or desired infant formula and critical medical foods,” Califf said. “Please know that we at the FDA are doing everything in our power to address these challenges as quickly as possible.”

In the meantime, the FDA says it is changing policies to help boost the level of imported product.

According to an agency news release, the United States usually produces 98% of the infant formula its market requires, with only a small percentage coming from countries such as Mexico, Ireland and the Netherlands.

But faced with the current crisis, the FDA will loosen rules to help boost those imports and avoid another shortage.

“We’ve set up a mechanism that streamlines the ability for companies that do not normally sell infant formula in this country to do so, and it provides other flexibilities to domestic distributors who can help increase availability,” Califf said.

For example, the agency said it will “prioritize” new product submissions for approval from international companies.

“The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of products available and/or those who can get product onto U.S. shelves the quickest,” Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in the briefing. The FDA is already in discussions with some manufacturers and suppliers regarding additional supply.

Besides a fast-tracked approvals process, the the agency said it is also streamlining the offloading of imported product at American ports of entry, and speeding distribution throughout the country.

As for domestic manufacturers, the agency say they’ve ramped up production, too.

“We know that all important manufacturers who supply to the U.S. have already stepped up to the challenge, and already telling us they’re producing at expanded capacity,” Frank Yiannas, deputy commissioner for food policy and response at the FDA, said at the briefing. “For example, Gerber increased the amount of their infant formula available to consumers by approximately 50% in March and April.”

What does that mean for parents facing empty shelves at local stores? Real improvement, Yiannas said. He said the most recent data is showing an 80% in-stock rate of infant formula.

“Let’s say a local supermarket typically carries 50 different infant formula products,” Yiannas explained. “An 80% in-stock rate would mean that 40 of those 50 product types are still available. What these data combined are telling us is that while there is more product being sold, it may be of less variety compared prior to the recall.”

Panicked consumers may be part of the issue, he added, especially with it comes to “specialty and metabolic products” that some infants by necessity must consume.

“For those who fall into this category, we’ve already taken steps with Abbott Nutrition to make products available to those with life-threatening conditions on a case-by-case basis, and we will continue all efforts to make sure these products are even more readily available,” Yiannas said.

“If you’re in dire need of a specialty or metabolic product from Abbott Nutrition, please call their hotline, which is also listed on FDA’s website as well for assistance,” he added.

And in the meantime, the FDA strongly advises against attempting to mix up a batch of infant formula at home.

Dr. Richard So, a pediatrician at Cleveland Clinic Children’s, agreed.

“It’s not safe. Formulas are very, very physiologically balanced for a baby’s body composition,” he said. Babies can develop electrolyte imbalances, nutritional deficiencies and weight loss if your homebrew formula is off by even a little, the pediatricians said.

Panic-buying and hoarding will only also exacerbate a bad situation, said Dr. Joshua Wechsler.

“You’re really just harming someone else in the process when you hoard. I know that’s hard to tell someone because when you’re desperate to feed your kids and you have the resources, you’re going to go out and buy what you can,” said Wechsler. He’s an assistant professor of pediatrics at Northwestern University School of Medicine and medical director of the eosinophilic gastrointestinal diseases program at the Children’s Hospital of Chicago.

More information:

HealthDay has more tips for parents from So and Wechsler here.

SOURCES: U.S. Food and Drug Administration, news briefing, May 22, 2022; also FDA news release.

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