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 like Walmart and Target are limiting the number of containers that can be purchased at one time.
While the situation has improved since mid-July, the out-of-stock figures for powder formula on store shelves in late August remained at 23 percent, still above the 10 percent it was before the recall and shutdown, according to the Chicago-based 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,” Mr. 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 manufacturing plant in Sturgis, Mich., 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 that 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 F.D.A. said it was now receiving weekly updates from domestic manufacturers and has 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 M. Califf, the commissioner of the F.D.A. “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 see 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 at their factories, the F.D.A. 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.
While the foreign formula is only supposed to be allowed into the United States on a temporary basis, ending around Nov. 14, the F.D.A. said it would release guidance this month on how the new companies can 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 who owns the British baby formula Kendamil. The company has spent the last three years working through the formal process, including clinical trials, necessary to get its organic infant formula approved by the F.D.A.
Kendamil was one of the earliest formulas to get its application approved by the F.D.A. in the wake of the Sturgis plant shutdown, and the company has begun sending two 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.
Ms. 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.
Ms. Robinson, who lives in Bucks County, Pa., said she would prefer that the F.D.A. streamline approvals for new American-made formula brands to diversify the market.
The F.D.A. has allowed more than a dozen non-U.S. companies to ship more than 18 million cans of formula into the United States, a mix of established manufacturers like Danone and Nestle in Europe but also smaller, lesser-known companies like Global Kosher, based in the United Kingdom, and Care A2+, an Australian company that started operations in October 2020.
But other larger global manufacturers that had formula available to ship were left on the sidelines. Some, like Organic-Family GmbH, a unit of the Swiss company Holle, said it had not gotten an update from the F.D.A. on its application. Thorben Nilewski, a managing director at GmbH, said in an email, “It feels like our offer or opinion isn’t really of interest at this point.” And the stock of the Australian formula manufacturer A2 Milk Company dropped in early August after it said the F.D.A. had notified it that it was “deferring further consideration” of its application to import formula into the United States.
In an emailed statement, the F.D.A. said the letters sent to firms did not mean that their formulas were unsafe, but rather that there were issues that would probably not be quickly resolved.
“There are a variety of reasons why certain infant formulas may not have been moved forward,” Dr. Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the F.D.A., said in an interview. “The key criteria for us was whether the manufacturer had formula available immediately as our goals were to get formula on the shelves as rapidly as possible.”
Priority was also given to applications from manufacturers that could provide medical and specialty formulas, she added. She said the agency was still reviewing applications.
In late August, Abbott said it was set to resume manufacturing of Similac formulas at its plant in Sturgis.
The company also said that it increased production at other U.S.-based manufacturing plants and one in Ireland, and that it would supply the United States with more than eight million pounds of formula in August, an increase from the year before. But it noted it would take six weeks for the Similac product from the Sturgis plant to start to hit store shelves.
But some industry experts say it will take time for Abbott to gain back the market share it once had. “To be frank, there is a lot of consumer mistrust around Similac right now,” said Mr. Dittmeier of the W.I.C. program.
That could be a boon for Reckitt Benckiser, which has been running its formula manufacturing plants at full tilt all summer, hoping to hold on to the market share it has gained at Abbott’s expense. Its market share has climbed to nearly 60 percent from 35 percent before the recall, said Robert Cleveland, who oversees the Mead Johnson nutrition business at Reckitt.
“We remain committed to making as much formula as we can,” Mr. Cleveland said. “We continue to maximize our domestic manufacturing, running overtime and going 24/7.” He added that the company had received approval to bring in formula from its plants in Singapore and specialty formula from its facilities in Mexico.
Still, in late August, when Lori Sharp, a first-time mother in Port Hueneme, Calif., realized she was down to one container of Reckitt’s Enfamil Sensitive infant formula for her 3-month-old daughter, the formula was out of stock on Walmart.com.
Panicking, she scoured more websites and widened her geographic search. She eventually discovered a container of formula at a Target 40 minutes away in Moorpark, Calif. “I went into the store and they actually had four more, but their shelves were so bare,” Ms. Sharp said. “I bought all of them.”
In Georgia, some of the most acute shortages are in rural areas. Jennifer Kelly, who is the family services manager at the early Head Start program in Swainsboro, which is between Macon and Savannah, said trying to find formula earlier this summer had become a “daily chore.”
The 14 babies she watches drink seven different kinds of formula. She and her staff were often driving to Walmart, Walgreens or a local grocery chain or scouring Amazon for some of the more obscure brands.
“It’s not like it was a few months ago when the shelves were bare,” Ms. Kelly said. “I am hoping we are on the other side of this dilemma.”
When the formula shortage was at a crisis point in May, Ms. Robinson of Bucks County, Pa., created a Facebook group that connected parents around the country. The group, called Formula Hunters, does not exchange money to keep out profiteers who have been hoarding formula and seeking to resell it at a markup.
The group operates on the notion that a parent who buys a hard-to-find formula brand and sends it to another parent in the group will eventually be repaid when others do the same for them.
Formula Hunters now has 1,500 members, who are still actively helping each other locate formula. “This has been going on for so many months,” Ms. Robinson said. “The frustration has been high.”