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Wednesday, May 25 2022

Full Issue

FDA OKs Import Of 2 Million UK Baby Formula Cans

Meanwhile U.S. manufacturer Abbott, at the center of the current formula controversy, said it would allow the release of about 300,000 specialty formula cans for children with medical needs. It will also restart production June 4 at its Michigan plant.

The U.S. Food and Drug Administration is easing regulations to allow infant formula imports from Britain, a move it said on Tuesday would bring around 2 million cans onto empty shelves by June to ease a nationwide shortage. The FDA said it was "exercising enforcement discretion" to allow Britain-based Kendal Nutricare to import certain infant formula products under the Kendamil brand that it has no safety or nutrition concerns over following an evaluation. (Aboulenein and Rajesh, 5/24)

Danone SA [of France] has been doubling shipments to the United States of Neocate formula for infants allergic to cow's milk while Enfamil maker Reckitt is also working to boost supplies amid a nationwide shortage, company executives said on Wednesday. ... Danone - the world's second-biggest baby formula maker after Nestle but a relatively small player in the United States with less than 5% of market share - is stepping up supply of Neocate. ... The French company declined to say how many cans or tonnes of product it is exporting. (Naidu, 5/25)

Abbott Laboratories will release about 300,000 cans of a specialty infant formula for children in urgent medical need, while U.S. health regulators cleared the import of about 2 million cans of formula from the U.K. to try to mitigate a shortage. Abbott, of Abbott Park, Ill., said Tuesday it is releasing limited quantities of EleCare, an amino acid-based powder for infants with severe food allergies or gastrointestinal disorders. (Loftus, 5/24)

Abbott Laboratories plans to restart production of infant formula at its Michigan facility June 4, and it will begin releasing specialty formula EleCare in the next several days, the company said Tuesday. The announcement comes amid a nationwide shortage of infant formula caused by supply chain issues and exacerbated by a recall of formulas made at Abbott鈥檚 Sturgis, Mich., facility. Abbott recalled a number of infant formulas produced at that facility in February as the U.S. Food and Drug Administration announced that it was investigating complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies鈥 deaths, according to the FDA. (Schencker, 5/24)

More response from the FTC and FDA 鈥

The Federal Trade Commission (FTC) announced an inquiry Tuesday into the infant formula shortage and said it will assess the impact of mergers and acquisitions in the market. The agency said it will investigate bots reselling formula at 鈥渆xorbitant prices鈥 and seek public comment on the factors that 鈥渃ontributed to the shortage or hampered our ability to respond to it.鈥 (Schonfeld, 5/24)

Federal plans to inspect a baby formula factory linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and other logistical problems, according to prepared testimony from the head of the Food and Drug Administration. FDA Commissioner Robert Califf is set to answer questions Wednesday from House lawmakers probing the events leading to the formula shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies. (Perrone, 5/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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