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FDA Moves to Ease Nationwide Shortage of Baby Formula

The agency’s latest moves should help ease the dire situation many mothers face

WEDNESDAY, May 11, 2022 (HealthDay News) – The U.S. Food & Drug Administration announced Tuesday that it is continuing its efforts to boost the country’s supply of infant formula.

Amid shortages due to high demand and recall and supply issues, stores have limited the number of products consumers can purchase. Mothers across the United States have been desperately searching for more formula: Some are driving several hours, only to find more empty shelves, while others have looked up homemade infant formula recipes online. But the FDA has advised parents not to try to make formula at home.

“Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA,” FDA Commissioner Robert Califf, M.D., said Tuesday in an agency news release. “Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”

The latest FDA moves might help ease the dire situation many mothers face. Among the steps the agency has taken includes using a food supply chain continuity system, developed during the pandemic, to monitor the status of infant formula supply. Agency officials are also meeting regularly with major infant formula manufacturers to understand their production capacity, including their ability to ramp up production. Some manufacturers are meeting or exceeding capacity levels, the FDA said.

Several infant formula manufacturers are working to increase output by prioritizing the products that are most needed, as well as optimizing production schedules, the agency added. The FDA is also helping manufacturers bring safe products to the market by quickly reviewing manufacturing changes that will help speed production, especially for specialized formulas for medical needs. Another FDA effort is watching trends for in-stock rates regionally and nationally to know where formula is most needed and working with retailers to ask their members to place purchase limits on some products.

The FDA said it is helping ease foreign shipments by employing more flexibility for allowing products from abroad that are already permitted into the United States, including a streamlined import entry review for certain products from foreign facilities that have good inspection records.

The shortage first began in February, when the Abbott Nutrition Sturgis, Michigan, plant issued a voluntary recall of some of its powdered infant formula products. On a case-by-case basis, the FDA is allowing formula from that facility to be released to people who need urgent, life-sustaining supplies of certain specialty and metabolic formulas. The benefits of allowing caregivers in consultation with their medical providers to access these products may outweigh the potential risk for bacterial infection, the FDA said. The agency said it is also working with other major infant formula manufacturers to increase supply and help ensure that production of infant formula products can safely resume at the Abbott Michigan plant.

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