Note: The Town of Trumbull will post any additional information about the infant formula shortage as we receive it.
05/16/22: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.
“The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D. “Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely. We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”
The U.S. normally produces 98% of the infant formula it consumes, with the primary source of imports coming from trading partners in Mexico, Ireland and the Netherlands. However, given the production and distribution issues that have led to reduced supplies of infant formula in some parts of the country, the FDA has outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. It also may provide flexibilities to those who manufacturer infant formula products domestically for export and may be able to increase further domestically produced product for the U.S. market.
Companies seeking to take advantage of these flexibilities should submit information for the FDA to quickly evaluate whether the product can be used safely and whether it provides adequate nutrition. For example, labeling, information on nutritional adequacy and safety testing, and information about facility inspection history. The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest. The FDA is already in discussions with some manufacturers and suppliers regarding additional supply.
As part of a number of significant actions the FDA has undertaken since February to increase supply, the agency had already implemented a streamlined process to facilitate the importation of infant formula at U.S. ports of entry so that formula coming from abroad can be dispersed quickly throughout the country. This work has already resulted in more infant formula coming into the U.S. Imports of infant formula year-to-date are up more than 300% from last year. The FDA has and will continue to actively work with the U.S. Department of Agriculture, U.K., and European authorities to expedite entry for products made abroad.
All of this around-the-clock work has already begun to improve supply and availability with most manufacturers, now producing at normal or expanded capacity. The FDA expects that the measures and steps it is taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward.
Data from Information Resources Inc. (IRI) indicate that in-stock rates in retail stores are improving and the FDA’s actions are expected to continue to increase product availability. While some data suppliers have reported lower in-stock rates, the most complete data sets available from IRI are showing nearly 80% in-stock rates at the week ending May 8. The agency’s best current assessment is that with all of the current actions, including today’s announcement, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, the supply of infant formula will continue to improve over the next couple of months. In the meantime, the agency is encouraged to see that as of early May the amount of infant formula sold in the U.S. continues to rise.
It is important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula products that would not pose significant health risks to consumers. The agency continues to advise against making infant formulas at home. Caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services has also released a fact sheet with information to help families find infant formula.
The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.
Related Information
05/16/22: Connecticut Department Of Public Health's WIC Program Continuing To Support Families Through Nationwide Formula Shortage
Officials from the Connecticut Department of Public Health have been utilizing numerous options to assist families of its Special Supplemental Nutrition Program for Woman, Infants and Children Program during the nationwide infant formula shortage. The formula shortage has made it difficult for WIC families to find formula, despite the additional products available to them. There is limited stock in stores due to decreased supply across the country, including in Connecticut. WIC has been feeling the impact of the formula shortage, which has become more significant since the recall in February.
"Families have to go to multiple stores to find enough formula or switch to another type of formula," said DPH Commissioner Manisha Juthani, MD. "Some of the specialty formulas for medical conditions are scarce as well, and formula redemptions in Connecticut are down because the supply is very limited."
Commissioner Juthani added that Connecticut is currently part of a multi-state contract with Abbott. However, because of the recall and through a waiver process with the United States Department of Agriculture, Abbott has been allowing the Connecticut WIC program to offer 80 comparable formulas when the company's products are not available without being in breach of contract. Additionally, DPH is not enforcing minimum stocking requirements for authorized retailers at this time as usually is suggested by USDA.
"Our team has been working closely with local agency staff to help families find retailers that have in stock products in their area, or even switch the participant's benefits package when needed," Commissioner Juthani said. "The staff also have been working directly with manufacturers to order emergency formula."
DPH WIC Program promotes breastfeeding as the normal and optimal method to feed infants for at least the first year of life with a special emphasis on the health benefits derived from exclusive breastfeeding for the first six months. For pregnant persons who were not considering breastfeeding, DPH strongly encourages expectant families to think about breastfeeding due to the unprecedented nationwide formula shortage. Exclusive breastfeeding, notwithstanding a formula shortage, is recommended by the American Academy of Pediatrics as the normal and optimal feeding method for infants through the first six months of life.
For individuals currently combining breastfeeding and infant formula feeding, DPH recommends breastfeeding more often to increase milk supply and reduce the need for infant formula. Additional information to families has been communicated through the local WIG agency staff, the WIG One Call text system, through DPH's social media channels and on the Connecticut WIG website: https://portal.ct.gov/dphM/ICM/lC .
The USDA and the Food and Drug Administration are taking measures to address the formula supply shortages, including working with major manufacturers to increase supply and helping to ensure that Abbott's Sturgis facility can safely resume production soon.