Addressing the Infant Formula Shortage

The infant formula shortage exists because Abbott closed a facility in Sturgis, Michigan due to safety concerns from the FDA.

Progress so far:

• FDA and Abbott agreed on next steps to reopen the Sturgis plant, which is a critical step in resolving the shortages that are impacting families. FDA has outlined safety procedures to ensure that the product manufactured at the Sturgis plant is safe for families. 

To ensure that manufacturers have the necessary ingredients to make safe, healthy infant formula here at home, President Biden has invoked the Defense Production Act (DPA). HHS being authorized to use the DPA means infant formula manufacturers can go to the front of the line and get raw materials from their suppliers—like labels or oils—that will allow manufactures to speed up production of formula.

Progress so far:

• Abbott Nutrition is 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 is 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. is receiving priority on materials such as corn products, sweeteners, and oils to maximize production of formula.  

To speed up the import of infant formula and get more formula to stores as soon as possible, President Biden directed the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), the General Services Administration (GSA), and the  Department of Defense (DOD) to partner to pick up safe overseas infant formula so it can get to store shelves faster.

The agencies will work together to transport products from manufacturing facilities abroad. Bypassing regular air freighting routes has cut a transportation process that typically takes 3-4 week down to approximately 3 days, speeding up the importation and distribution of formula and supporting families in the near-term as manufacturers continue to ramp up production.

Progress so far:

• Ten Operation Fly Formula missions announced or completed – totaling 32 flights and carrying the equivalent of 19 million 8-ounce bottles of formula.
• Additional flights are regularly being announced bringing more bottles of safe infant formula into the United States.

Since February, the FDA and USDA have been working closely with other infant formula manufacturers to increase production domestically and abroad, and prioritize product lines that are of greatest need, particularly specialty formulas. To ensure companies continue to bolster production and fill in gaps while the Sturgis plant remains offline, President Biden spoke with retailers and manufacturers, including Wal-Mart, Target, Reckitt, and Gerber, to identify transportation and logistical needs.

Progress so far:

• Reckitt is supplying more than 30% more product year to date.
• Gerber has reported that it increased the amount of their infant formula available to consumers by approximately 50% in March and April 

The Food and Drug Administration (FDA) is cutting red tape to increase the supply of safe, high-quality formula through increased imports.

Progress so far:

• Bubs Australia will provide at least 1.25 million cans of several varieties of its infant formula, which will make at least 27.5 million 8-ounce bottles.
• Danone’s Nutricia business will be sending 500,000 additional cans of specialized medical formula to the U.S – amounting to more than 5 million full-size, 8-ounce bottles. 
• Kendal Nutricare estimates that about 2 million cans of infant formula—over 580 million full-size, 8-ounce bottles—are expected to land on U.S. store shelves beginning in June.
• Mead Johnson Reckitt will send 4.5 million pounds of base powder that will be used to produce about 66 million 8-ounce bottles of formula in the coming weeks. 
• Nestle’s Mexico facility will send 1.3 million cans of routine formula, equal to 33 million 8-ounce bottles, while its Germany facility will send over at least 7 million 8-ounce bottles of routine formula product.
• Abbott will ship in at least 16.5 million 8-ounce bottles of infant formula, including specialty medical formula.

USDA has been working with states to make it easier for families to purchase the formula they need with their WIC benefits.

Progress so Far:

• The President called on WIC state agencies that were not yet taking full advantage of the 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. 
• Thanks to Congress’ quick action, USDA will have added flexibility to waive rules and allow WIC participants to purchase multiple brands of formula during supply chain disruptions or other crises.
• States have issued more than 200 waivers across every state.

FDA is taking actions to make product available to those in need.

Progress So Far:

• The FDA is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Michigan, facility to individuals needing urgent, life-sustaining supplies of this specialty formula on a case-by-case basis. These products will undergo enhanced microbiological testing before release.

Parents looking to feed their child should not be taken advantage of by unscrupulous retailers unfairly jacking up prices. The President called on the Federal Trade Commission (FTC) and state attorneys general to crack down on price gouging or unfair market practices related to sales of infant formula.

Progress So Far:

• The FTC has launched an investigation into any deceptive, fraudulent, or otherwise unfair business practices taking advantage of families during the formula shortage.
• The Department of Justice 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.