Another Evaluation of Infant Formula Crisis Concludes FDA Needs More Authorities to Prevent Shortages
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Following the U.S. infant formula crisis of 2022, the National Academies of Sciences, Engineering, and Medicine (NASEM) conducted an evaluation of the infant formula market before and during the shortage, and considered the U.S. Food and Drug Administration’s (FDA’s) response to the events. Summarized in a new report, titled, Challenges in Supply, Market Competition, and Regulation of Infant Formula in the U.S., NSAEM makes recommendations to FDA, the U.S. Department of Agriculture (USDA), and Congress about the vulnerabilities in the infant formula supply that need to be addressed to prevent future shortages.
Among other recommendations, the NSAEM report reiterates other sentiments expressed by FDA and the Reagan-Udall Foundation, as well as consumer advocacy groups; specifically, that FDA’s authority to oversee manufacturing significantly hindered the agency’s ability to facilitate an effective response or to prevent the shortage that occurred. NSAEM calls for Congress to grant FDA certain expanded authorities, for which the agency and stakeholders alike have been advocating.
NSAEM is a coalition of private, nonprofit institutions that provide independent, objective analysis and advice to the U.S. to solve complex problems and inform public policy decisions related to science, engineering, and medicine. The present report was sponsored by the U.S. Department of Health and Human Services (HHS).
Background
In 2021–2022, FDA was alerted about four cases of foodborne illness in infants—some of which were fatal—after consuming powdered infant formula that produced by Abbott Nutrition in its Sturgis, Michigan facility. FDA initiated an investigation at the facility and warned consumers not to use certain products manufactured there after detecting Cronobacter sakazakii, and Abbott implemented a voluntary recall and paused production. The pause in production, which was prolonged by flooding in the area, led to a widespread shortage of infant formula, unprecedented in its scope and duration, affecting families across the U.S. at all income levels. The report notes the shortage was particularly harmful to low-income households.
Infant formula produced or sold in the U.S. is subject to a complex regulatory environment that involves multiple federal agencies, including FDA, USDA, the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Centers for Medicare and Medicaid Services (CMMS). All FDA-registered manufacturing facilities, whether domestic or foreign, are subject to FDA inspection. About half of the infant formula purchased each year in the U.S. is provided to participants of USDA’s Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Recommendations to FDA, USDA, and Congress
To prevent future shortages of powdered infant formula in the U.S., NSAEM recommends FDA, USDA, HHS, and Congress take actions in several areas.
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Risk Management Planning
The report suggests HHS and FDA create a risk management plan for the entire sector, and that FDA should develop standards for risk management planning among infant formula manufacturers. Understanding and managing risks, and implementing a risk management plan in the case of a shortage, are key elements of a preparedness strategy for government and infant formula companies.
Concentrated Production
The report raises a red flag over the fact that infant formula production in the U.S. is concentrated to a select few facilities. Disruptions at any one facility—which is likely, and already happened in the case of Abbott Nutrition’s Sturgis, Michigan facility—can create nationwide shortages.
Congress should provide incentives to encourage infant formula manufacturers to modernize their plants and equipment, including implementing measures that would prevent the spread of contaminants from one part of the facility to another. These incentives should be contingent on having met FDA’s expectations for risk management planning.
Additionally, the report concluded that WIC’s competitive bidding process—which awards the supply of all infant formula to WIC vendors in a state to a single formula brand—is not the driver of industry concentration. Ending the competitive bidding process could drive up the cost of infant formula for WIC and impact wholesale and retail prices. The report recommends that USDA help protect consumers from the effects of a supply disruption by facilitating formula distribution to WIC vendors during a disruption, and require manufacturers with WIC contracts to plan for and take specific actions during a disruption.
Managing Public Impact
The report found that a lack of clear coordination between government and industry, inadequate government communication with the public, and the unique constraints faced by families who rely on WIC to obtain formula all adversely affected consumers during the 2022 shortage. In particular, many families struggled to identify an appropriate substitute for a formula they were already using when their supply ran low.
Therefore, FDA and CDC should work with infant nutrition experts and formula manufacturers to develop consistent guidance on how caregivers should substitute infant formula, based on ingredients, as well as guidance for caregivers on how to feed infants when no breast milk or formula is available.
At present, FDA is required to maintain a list of appropriate substitutes for specialized kinds of infant formula used to feed infants with metabolic issues or other health conditions, but not for standard infant formula or hypoallergenic formulas. The report recommends that FDA create and maintain a public list of all infant formulas currently marketed in the U.S. and their ingredients.
The report also recommends that USDA develop a dashboard to track critical data on the infant formula supply and possible shortages, and to update its requirements and expectations for crisis response.
Moreover, CMS, the largest provider of health insurance for children, should issue a rule requiring hospitals that accept Medicaid to have a plan in place in case of a disruption in nutrition support for hospitalized infants.
Facilitating Rapid Supply Recovery
Restoring infant formula production was slowed in 2022 by certain aspects of FDA’s authority to oversee manufacturing, as well as regulatory requirements that inhibited importing infant formula from outside the U.S.
The report recommends that Congress grant FDA the authority to remotely access records for critical foods to strengthen its oversight during a crisis. Congress should also require infant formula manufacturers to give sufficient advance notice to FDA when they decide to discontinue a formula that is likely to lead to a disruption prior to removing the product from the market, and establish a “trigger rule” to automatically suspend tariffs and quotas for imported infant formula and materials used in domestic formula production in the event of a meaningful market disruption.
The report says that forming a better understanding of potential barriers to importing infant formula produced outside the U.S. prior to a disruption would speed up needed action during a shortage. FDA should collect information on nutrient and labeling requirements used by other countries and create a database to be updated every four years, facilitating its ability to use enforcement discretion in the case of a shortage.
Finally, the report notes that families that were able to and chose breastfeeding were not as affected by the shortage, and that support for breastfeeding remains essential for infant health.
