The U.S. Food and Drug Administration (FDA) announced on Tuesday it will allow about 2 million cans of baby formula from the United Kingdom into the country, and allow Abbott Laboratories to release about 300,000 cans of specialty formula, to help ease the ongoing nationwide shortage.
“We continue to do everything in our power as part of the all-of-government efforts to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” FDA Commissioner Robert Califf said in a statement. “Our recent steps will help further bolster supply of infant formula, including through the import of safe and nutritious products from overseas based on our increased flexibilities announced last week.
“Importantly, we anticipate additional infant formula products may be safely and quickly imported into the U.S. in the near-term based on ongoing discussions with manufacturers and suppliers worldwide.”
The FDA announced it is “exercising enforcement discretion” to allow the importation of the 2 million cans from UK-based company Kendal Nutricare. The cans, which are under the company’s Kendamil brand, have no safety or nutrition concerns after an evaluation, and are expected to land on U.S. store shelves starting in June, the FDA said.
Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch, the agency said, adding that the U.S. Department of Health and Human Services is discussing options to get those cans into the country as soon as possible.
The FDA also announced it is letting Abbott release some 300,000 cans of its EleCare amino acid-based formula for babies and infants who urgently need it to survive, on a case-by-case basis.
The cans of specialty formula were previously produced at Abbott’s facility in Sturgis, Michigan, where other baby formula products that were recalled by Abbott on Feb. 17 were produced.
“These products will undergo enhanced microbiological testing before release. Although some EleCare product was included in Abbott Nutrition’s infant formula recall, these EleCare products that will be released were in different lots, have never been released and have been maintained in storage under control by Abbott Nutrition,” the FDA noted.
“Given the critical need of this product for some individuals, the FDA encourages parents and caregivers to consult with their health care providers to weigh the potential risk of bacterial infection with this product,” it added. “Parents and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.”
The ongoing baby formula shortage in the United States was recently exacerbated after Abbott Laboratories, the biggest U.S. supplier of powder baby formula, in February recalled some products, including those under the brand Similac, and temporarily shuttered its manufacturing facility in Sturgis, Michigan, which was producing up to one-quarter of the country’s baby formula.
The recall came after reports of bacterial infections among four infants, two of whom died. The FDA, which launched an investigation into the matter following consumer complaints, cannot conclude whether the cases of infants that fell sick were directly related to the Abbott facility until its investigation is concluded, Califf previously said.
Production at the Sturgis facility is set to restart on June 4, Abbott said in a statement. The company said it would prioritize making EleCare and supplying it on or about June 20. It also the formula would be provided to children in need for free.
Prior to the Abbott recall, the baby formula shortage among multiple manufacturers was brought on by supply chain pressures linked to COVID-19 pandemic lockdowns.
Also on Tuesday, the Federal Trade Commission launched an inquiry into the ongoing shortage of baby formula in the country, calling for public input on the matter.
The Biden administration has sought to relieve the shortage by importing emergency supplies from Europe via Defense Department-contracted commercial aircraft under “Operation Fly Formula.” The first lots of formula arrived in Indianapolis, Indiana, from Germany on Sunday.
President Joe Biden has also invoked the Cold War-era Defense Production Act to help manufacturers obtain ingredients to produce more formula.