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Bubs baby formula from Australia gets FDA import approval

HHS applies Defense Production Act to Cargill formula ingredients

The Biden administration on Friday took two more actions aimed at alleviating a critical domestic shortage of baby formula.

The Food and Drug Administration gave the green light to an Australian company to import its baby formula after relaxing strict regulatory requirements aimed at alleviating a critical domestic shortage. Also, Xavier Becerra, the Health and Human Services secretary, invoked the Defense Production Act for the third time in less than a week to help Cargill deliver raw materials used for infant formula production. 

Minneapolis-based Cargill supplies dozens of different products such as corn byproducts, sweeteners and oils to a wide range of infant formula manufacturers. The HHS order allows the company to place orders for infant formula manufacturers ahead of orders from other customers that use similar ingredients so they can produce formula at maximum capacity. 

Bubs Australia plans to provide at least 1.25 million cans of several varieties of its infant formula such as stage 1 and 2 cans of Bubs Organic Grass Fed, Bubs Supreme A2 Beta-Casein Protein and Bubs Easy-digest Goat Milk, that will make at least 27.5 million 8-ounce bottles. Some of the product is currently in stock for transport and more will be produced in the coming weeks and months, the FDA said.

The Department of Health and Human Services is evaluating the best option for transporting the formula to the U.S., which is expected to involve the use of commercial air freighters arranged and paid for by the U.S. Department of Defense.

This week Nestle formula from Switzerland was delivered by a U.S. Air Force cargo jet and a FedEx Express flight as part of the fledgling program known as Operation Fly Formula.

The FDA is exercising enforcement discretion for certain infant formula products after determining that microbiological testing, labeling and inspection information meets nutritional adequacy and safety standards. The same regulatory flexibility was also applied this week to Danone Nutricia formula from the U.K. and Germany and Kendal Nutricare products made in the U.K. The Danone batch is enough for 5 million 8-ounce bottles.

“We continue to work around the clock with our government partners and industry to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert Califf. “Steps like the one the agency is taking today means more infant formula will be available to parents and caregivers in the weeks and months ahead. We will not rest until our shelves are replete with safe and nutritious infant formula.”

The Biden administration’s primary focus is on specialty formulas that are in short supply for infants with allergies or critical health needs. The White House has engaged multiple agencies to help restore domestic stockpiles by urging extra domestic production, coordinating transportation and clearing away regulatory barriers.

President Biden delegated Defense Production Act authorization decisions to the HHS secretary. On Sunday, Becerra invoked the DPA to authorize manufacturers Abbott Nutrition (NYSE: ABT) and Mead Johnson/Reckitt to obtain raw materials and consumables needed to accelerate production of infant formula.

On Tuesday, the FDA issued guidance outlining how the agency is loosening rules for the importation of infant formula products intended for foreign markets or distribution in the U.S. of products manufactured domestically for export to foreign countries.

More FreightWaves/American Shipper stories by Eric Kulisch.

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Eric Kulisch

Eric is the Supply Chain and Air Cargo Editor at FreightWaves. An award-winning business journalist with extensive experience covering the logistics sector, Eric spent nearly two years as the Washington, D.C., correspondent for Automotive News, where he focused on regulatory and policy issues surrounding autonomous vehicles, mobility, fuel economy and safety. He has won two regional Gold Medals from the American Society of Business Publication Editors for government coverage and news analysis, and was voted best for feature writing and commentary in the Trade/Newsletter category by the D.C. Chapter of the Society of Professional Journalists. As associate editor at American Shipper Magazine for more than a decade, he wrote about trade, freight transportation and supply chains. Eric is based in Portland, Oregon. He can be reached for comments and tips at ekulisch@freightwaves.com