FACT SHEET: The Biden-Harris Administration's Progress Addressing the Infant Formula Shortage

On Friday, June 17th, Vice President Harris will travel to Dulles International Airport to announce the arrival of over 14,000 pounds of Kendamil infant formula—the equivalent of more than 200,000 8-ounce bottles of formula—that will be used to add more supply to shelves. This shipment is the latest through the Biden-Harris Administration's Operation Fly Formula, a multi-agency partnership through which the U.S. Department of Agriculture (USDA), the Department of Health and Human Services (HHS), the General Services Administration (GSA), and the Department of Defense (DOD) ship infant formula so it can get to store shelves faster.

By this week's end, Operation Fly Formula will have delivered the equivalent of 13 million 8-oz bottles since its inception—4 million of which were delivered this week alone. The shipment that the Vice President announces on Friday was donated by United Airlines and constitutes just one of ten international shipments of baby formula facilitated through Operation Fly Formula for the week of June 13th, which also include:

• June 13: A United Airlines flight arrived at Dulles International Airport from London Heathrow carrying Kendamil infant formula.
• June 14: Two United Airlines flights arrived at Dulles International Airport from London Heathrow carrying Kendamil infant formula.
• June 15: A United Airlines flight arrived at Dulles International Airport from London Heathrow carrying Kendamil infant formula.
• June 16: A flight arrived in Columbus, OH, from Melbourne, Australia, carrying Bub's Australia infant formula. And, a flight arrived in Louisville, Kentucky from Switzerland carrying medical specialty infant formula from Nestlé.
• June 18: A United Airlines flight will arrive at Dulles International Airport from London Heathrow carrying Kendamil infant formula.
• June 19: Two United Airlines flights will arrive at Dulles International Airport from London Heathrow carrying Kendamil infant formula.

Operation Fly Formula represents just one component of the Biden-Harris Administration's multi-pronged approach to ensuring families are able to access safe baby formula. While there is more work to do, these successes have meant more product on shelves and fewer families in need.

Additional Actions Taken to Get Formula Back on Shelves and Increase the Supply of Infant Formula Quickly and Safely

The Administration is executing an all-of-government approach to produce more infant formula and get it on the shelf. The federal government—including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), Department of Agriculture (USDA), Department of Justice (DOJ), Department of Transportation (DOT), U.S. Trade Representative (USTR), Department of Homeland Security (DHS), Department of Commerce (DOC), Department of Defense (DoD), and the White House—has worked around the clock to address the shortfall in infant formula production while the Sturgis plant remains offline. The recent actions described below build upon the prior actions taken by FDA and USDA to address this shortage at its earliest stages.

• Invoking the Defense Production Act: To ensure that manufacturers have the necessary ingredients to make safe, healthy infant formula here at home, President Biden has invoked authorities under the Defense Production Act (DPA). The DPA empowers the government to require suppliers to direct needed resources to infant formula manufacturers before any other customer who may have ordered that good. The Administration has already invoked this authority to direct firms to prioritize and allocate the production of key infant formula inputs like raw materials, formula ingredients and bottling and packaging materials. This will continue to help manufacturers increase production and speed up supply chains. To date, the President's invocation of the DPA has resulted in three priority orders:
  • Abbott Nutrition receiving priority orders of raw materials like sugar and corn syrup for infant formula, enabling a planned 25% increase production so they can manufacture at 100% capacity.
  • Reckitt receiving priority orders for consumables like single-use products such as filters, which Reckitt expects will allow the company to expand production by 40%.
  • Cargill Inc. receiving priority on materials such as corn products, sweeteners, and oils to maximize production of formula.
• Cutting Red Tape to Increase Imports: The FDA is cutting red tape to increase the supply of safe, high-quality formula through increased imports. The FDA, with import inspection support from USDA and Customs and Border Protection (CBP), is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities, and will continue to actively work with USDA, the UK, Australia, New Zealand, Singapore, and European authorities to expedite entry for products made abroad, and FDA. The Administration has thus far approved nine applications, representing over 210 million 8-ounce equivalent bottles eligible and committed for import, including:
  • Bubs Australia will provide at least 1.25 million cans of several varieties of its infant formula from Melbourne, Australia, which will make at least 27.5 million 8-ounce bottles.
  • Kendal Nutricare will provide at least 58 million bottle-equivalents of its routine infant formula from the UK.
  • Nestle will provide approximately 33 million bottle-equivalents of Gerber Good Start Gentle formula from Mexico.
  • Nutricia (Danone) will provide 5 million bottle-equivalents of its Neocate Infant DHA/ARA specialty formula from the UK.
• Facilitating WIC Waivers for Families in Need: Earlier this month, the President called on WIC state agencies that were not yet taking full advantage of the of flexibilities available in WIC to act immediately to adopt any waivers that could help those they serve. Since then, all 50 states have acted, allowing greater flexibility for WIC families to get the formula they need. Additionally, thanks to Congress' quick action, USDA will also have added flexibility to waive rules and allow WIC participants to purchase multiple brands of formula during supply chain disruptions or other crises. This new legislation will also require formula companies to demonstrate they have a plan in place to respond to an infant formula recall, including how they would prevent shortages.
• Getting the Abbott Facility Reopened Safely: This past February, the largest infant formula manufacturer in the country—Abbott Nutrition—initiated a voluntary recall of several lines of powdered formula. This came after concerns about bacterial contamination at Abbott's Sturgis, Michigan, facility after four infants fell ill and two died. The Sturgis plant closed as a result of the contamination. Since then FDA has entered into a consent decree with Abbott to ensure its facility can reopen safely. FDA is working with Abbott to ensure that the product manufactured at the Sturgis plant is safe for families.
• Cracking Down on Price Gouging:The DOJ is engaging with state attorneys general to encourage them to use their powers to monitor and address price gouging in the infant formula market, and urging them to devote more resources to monitoring predatory behavior in the market for infant formula, which states like New Jersey have recently announced. In addition, following President Biden's call for the Federal Trade Commission (FTC) to use all its available tools to monitor and investigate reports of illegal and predatory conduct, the FTC launched an inquiry into the ongoing shortage for infant formula including examining deceptive, fraudulent, or otherwise unfair business practices that take advantage of families.