Store shelves are no longer bare, but baby formula remains in short supply
More than six months after one of the largest infant formula manufacturing plants in the United States issued a recall and was then shut down because of contamination concerns, a newborn staple remains in short supply.
In parts of the country, parents and their families are scrambling to locate precious containers of formula for their babies and many large retailers remain out of stock of popular brands. Some companies such as Walmart and Target are limiting the number of containers that can be purchased at one time.
Although the situation has improved since mid-July, the out-of-stock figure for powdered formula on store shelves in late August remained at 23%, still above the 10% it was before the recall and shutdown, according to the market research firm IRI.
“It all depends on geography and the retailer,” said Brian Dittmeier, the senior director of public policy at the National WIC Association, a nonprofit organization. The WIC program provides nutritional assistance for women, infants and children and accounts for about half the formula use in the country. “There are some locations,” Dittmeier said, “where the supply of infant formula is healthy and others where it is not.”
But even as the scarcity subsides, parents and caregivers say that the federal Food and Drug Administration, which regulates the formula industry, is not doing enough to address systemic problems exposed by the February shutdown of the Abbott Nutrition factory in Sturgis, Michigan, that set off the nationwide shortages.
The shutdown occurred after reports of infections in four babies — two of them fatal — who had consumed formula manufactured at the plant. On Feb. 17, two days after the shutdown, Abbott recalled batches of three powdered formulas over complaints of serious bacterial contamination. (Abbott has said there is no “conclusive evidence” to link the company’s formulas to the illnesses.) That disruption made it clear just how dependent Americans were on a few formula manufacturers, and the Biden administration found itself scrambling to figure out how to make more product available.
The FDA said it was now receiving weekly updates from domestic manufacturers and had arranged for nearly 18.9 million cans of formula to be brought in from abroad. “Is there enough formula to go around? The answer is yes, there already is enough formula here,” said Dr. Robert Califf, the commissioner of the FDA. “We just have to continue to work to get the distribution improved.” He noted, however, that it would take another couple of months before consumers saw the broad array of formulas on store shelves that were available at the beginning of the year.
While the two other domestic manufacturers, Reckitt Benckiser, which makes the popular Enfamil brand of formula, and Perrigo, which manufactures generic formula for retailers, ramped up production, the FDA also relaxed some of the restrictions on imports. The result was an avalanche of applications from manufacturers all over the world.
The U.S. market, estimated at $2 billion to $4 billion annually, has been notoriously tough for foreign formula companies to crack, owing to regulatory hurdles and tariffs.
Although the foreign formula is supposed to be allowed into the United States on a temporary basis, ending about Nov. 14, the FDA said it would release guidance this month on how the new companies could continue to sell in the United States past this fall.
“Parents in the U.S. have been looking for a better product than what they were being offered,” said Will McMahon, one of the members of the family that owns British baby formula Kendamil. The company has spent the past three years working through the formal process, including clinical trials, necessary to get its organic infant formula approved by the FDA.
Kendamil was one of the earliest formulas to have its application approved by the FDA in the wake of the Sturgis plant shutdown, and the company has begun sending 2 million cans of formula to the United States.
But some parents say relying on foreign manufacturers is not a long-term solution. “It boggles my mind that the supply chain was so fragile and could be broken in such a major way,” said Christine Robinson, whose 8-month-old son is fed with formula.
Robinson said she worried that relying on non-U.S. brands could lead to issues for babies whose sensitive digestive systems do not adapt easily to change once the U.S. suppliers are able to ramp up production and the foreign formulas are phased out.
Robinson, who lives in Bucks County, Pennsylvania, said she would prefer that the FDA streamline approvals for new American-made formula brands to diversify the market.