More baby formula is being airlifted to the United States to help address a severe shortage. And this time, enough formula to fill millions of baby bottles is heading to store shelves.
Wednesday, President Joe Biden announced two more airlifts — the third and fourth in Operation Fly Formula — from overseas. The two earlier flights contained tons of hypoallergenic baby formula that hospitals and health care providers were tasked with getting to children who cannot have regular baby formula because of allergies to cow milk protein.
The new imports are different.
Kendal Nutricare formula is being imported from the United Kingdom for sale at Target stores. United Airlines has agreed to fly enough formula to fill 3.7 million 8-ounce baby bottles, with the first shipment arriving next week.
Subsequent flights of Kendal’s formula will follow over the next couple of weeks, Biden said. Those later flights will contain about 3.2 million 8-ounce bottle equivalents of Kendamil Classic Stage 1 and 540,000 bottle equivalents of Kendamil Organic. United Airlines is donating its service and cargo space for the flights.
The fourth airlift will bring in enough Bubs Australia formula — 380 tons — to make 4.6 million 8-ounce bottles. One Bubs Australia flight will arrive in Pennsylvania on June 9 and another in California on June 11. Then, over the coming weeks, Bubs is expected to provide enough formula for 27.5 million total bottles of several of its formula varieties.
The flights to bring in Food and Drug Administration-approved formulas are just part of the national strategy to combat a shortage Biden said he really only become aware of in April. It has been widely reported that manufacturers saw the risks and alerted retailers in February.
That’s around the time that the largest U.S. infant formula manufacturer, Abbott Nutrition, issued a voluntary product recall and its Sturgis, Michigan, plant was temporarily closed over concerns raised by inspectors.
“We knew from the very beginning this would be a very serious event,” said Robert Cleveland, senior vice president at Reckitt, another manufacturer, during the president’s briefing with five formula manufacturers. Abbott was not among them, though its absence was not addressed.
“From the moment that that recall was announced, we reached out immediately to retail partners like Target, Walmart to tell them this is what we think will happen,” Cleveland said.
Feds address shortage
Among other actions, Biden said he’s signed legislation to help make it easier for families to get the formula they need through the Women Infants and Children nutrition program, which helps low-income families with young children get basic important nutrition items, including formula.
During the same White House briefing, Health and Human Services secretary Xavier Becerra said the FDA is working with Abbott to reopen its facility safely. Under a consent decree, as soon as corrective steps are taken to address safety and sanitation issues, the plant can reopen. Abbott has said it expects to do so very soon.
Becerra also noted that he had invoked the Defense Production Act three times to accelerate the delivery of raw materials required to make baby formula and get it to production lines. Families looking for guidance to navigate the shortage should visit hhs.gov/formula, he said.
Boosting production
Cleveland said that Reckitt, the second-largest U.S. baby formula producer behind Abbott, has its plants running around the clock with unlimited overtime. They’ve also worked with retail partners like Walmart, Target and Kroger to make sure their trucks are unloaded first so that baby formula gets back on the shelf faster.
Cleveland added that Reckitt has increased its production by more than 30% and its delivery speed to stores by 40%. In total, he said, Reckitt is feeding about 311,000 more infants since the Abbott recall than it was before the recall.
In June, the company expects to produce 50 million feedings a week. It also has applications pending to bring in formula from its plants in Singapore and Mexico.
Infant formula manufacturer Gerber said it received 60 tons of hypoallergenic formula on one of the airlifts from a plant outside the U.S. and that half of those cans have already reached families that need the formula. Gerber also has an FDA application pending to bring in more formula.
Murray Kessler of Perrigo, which does a lot of manufacturing for 18 private labels sold by retailers like Walmart and Target, said its facilities are also running around the clock. The company ran a year’s worth of hypoallergenic formula first, he said, and has since focused on the highest volume formulas to feed as many babies as possible. They are running at 115% of what was deemed maximum capacity, he said, their output increased 32%.
And a new company, ByHeart — the first new U.S. baby formula maker in years — is gearing up to begin producing, too.
Advice for parents
During Wednesday’s briefing, U.S. Surgeon General Vivek Murthy made three points he hopes parents will heed as they deal with the infant formula shortage:
- The administration is pulling out the stops, but safety remains the priority. So they’re only bringing in high-quality formulas that meet the FDA’s “gold standards for safety.”
- Parents should not water down formulas or make formulas at home themselves or try to feed infants formulas designed for toddlers. Use the formulas as directed, he said, to avoid harm.
- Feel free to change brands if you need to, he said. Formulas approved to be on the store shelves are deemed safe and finding formula is more important than brand loyalty.
Timeline and inspection
In related news, how the FDA has handled events leading up to the formula crisis and the shortage itself is the subject of a probe.
“The Health and Human Services’ Office of Inspector General is launching an audit into how the Food and Drug Administration responded leading up to the massive February recall of baby formula and closure of Abbott Nutrition’s Sturgis plant,” ABC News reported.
The results are expected sometime in the fiscal year 2024.
ABC said the review will look at whether the FDA “upheld its duty to safeguard the nation’s food supply, including infant formula and ensure that all ingredients are safe,“ as well as whether regulators took proper action when cronobacter sakazakii bacteria was found in Abbott’s Sturgis plant.
Critics have slammed the agency over the timeline of events:
- Supply chain issues were already impacting formula production nationwide before an inspection in September 2021 criticized Abbott’s building maintenance and sanitation at the Sturgis plant.
- In October, an unidentified whistleblower from Abbott sent the FDA a complaint alleging violations of health and safety standards at the Sturgis facility. The FDA commissioner recently told a Congressional subcommittee it was lost in the mailroom.
- In early February, inspectors found the cronobacter sakazakii bacteria in the plant, though not in the formula being manufactured.
- A couple of weeks later, Abbott issued its voluntary recall.