By Ernie Mundell HealthDay Reporter
THURSDAY, May 19, 2022 (HealthDay News)
Faced with mounting pressure to help desperate parents, President Joe Biden on Wednesday invoked the power of the wartime Defense Production Act to get more of the precious product into American homes.
Under the new powers, the federal government can use commercial aircraft or air cargo planes owned by the Defense Department to transport infant formula from countries abroad and fly it into the United States, getting it more rapidly onto store shelves.
The move comes two days after the U.S. Food and Drug Administration announced that it was also expediting the approvals process, so that foreign suppliers of baby formula could quickly get their products into the United States.
“I know parents all across the country are worried about finding enough infant formula to feed their babies — as a parent and as a grandparent, I know just how stressful that is,” Biden said in a video posted on Twitter. He said he was ordering his administration “to do everything possible to ensure there’s enough safe baby formula and that it’s quickly reaching families that need it the most.”
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.
As the crisis around baby formula has steadily worsened, Biden has faced increasing political pressure from within his own party to fix the problem, according to The New York Times. Many Democrats have pressed Biden to invoke the Defense Production Act as one lever he could use to quickly boost supply.
In another move underway Wednesday evening, the House was expected to approve bipartisan legislation that would grant the federal government emergency authority to broaden the types of formula that can be purchased using benefits from the Special Supplemental Nutrition Program for Women, Infants and Children, known as WIC, the Times said.
About half the formula purchased in the nation is paid for through WIC. Allowing parents to use the benefits to purchase all types of formula is a move that’s expected to gain bipartisan support.
“I know what it means to not be able to stretch out milk for the entire month,” Representative Jahana Hayes, Democrat of Connecticut and a sponsor of the bill, said this week, the Times reported. Hayes said she had used WIC benefits herself to purchase formula in the past.
“With everything going on right now, the last thing a family should have to worry about is feeding their children,” she said.
Even with the new powers triggered by the president, fully stocked shelves could still be weeks away. Speaking confidentially to the Times, one White House official said it will still take time for companies to take advantage of the Defense Department’s offer to ship product.
In the meantime, the FDA says it will change 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 on Monday said it 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 at an FDA briefing on Monday.
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 Monday briefing. The FDA is already in discussions with some manufacturers and suppliers regarding additional supply.
Besides a fast-tracked approvals process, 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 FDA says 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.
SOURCES: President Joe Biden, twitter; The New York Times; U.S. Food and Drug Administration, news briefing, May 16, 2022
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