Amanda Scott
Associate Editor
Loyola University Chicago School of Law, JD 2024
Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.
Background
The shortage concern was triggered in February 2022 when Abbott Nutrition issued a voluntary recall and subsequent voluntary cease in production at their Sturgis facility. The problem was further enhanced by the strains placed on supply chains throughout the COVID-19 pandemic. The shortage is still ongoing today, a full year after the initial recall by Abbott.
What enforcement discretion entails
The guidance offered by the FDA allowed for the distribution of formulas that did not comply with all FDA requirements. The FDA made these decisions by collecting information such as a list of and amount of all nutrients and ingredients, the product label and packaging description, current or anticipated inventory of the formula, microbiological test results, and facility inspection history. Through analysis of this information, the FDA considered on a case-by-case basis whether to exercise enforcement discretion. This analysis applies to infant formulas produced both abroad and domestically.
An instance in which the FDA may allow the formula to be distributed when it does not meet the requirement is when it does not list the nutrients in the required order on the label. If this formula otherwise meets the applicable FDA requirements, the FDA has indicated they would apply enforcement discretion. On the other hand, if requirements like clear identification of any allergens present in the product are not met or if there are not adequate instructions for safe product production and use, enforcement discretion may not be appropriate. Such cases are more carefully considered.
The FDA continues to act
In September 2022, the FDA issued a new guidance that created a pathway for those manufacturers who had received a letter of enforcement discretion to continue marketing their products while they showed they were working towards meeting all of the FDA requirements. Part of this showing included lawful marketing. This new guidance extended the period of enforcement discretion until January 6, 2023. However, on November 14, 2022, the FDA stopped accepting new requests for enforcement discretion. It has since been announced that companies that provided a Letter of Intent to the FDA by December 5, 2022, will continue to be considered for enforcement discretion. This letter was to demonstrate that the company wished to remain in the U.S. market and that they were working to meet all of the U.S. requirements, including those they had not previously met. This further action taken by the FDA will allow them to continue to triage the formula shortage crisis in cooperation with companies that have indicated they will work towards satisfying all of the FDA regulations.
Companies involved
The companies that have expressed intent to transition to lawful marketing and compliance with all U.S. regulations to stay on the U.S. market for regular infant formula are Australia (Bellamy’s Organic, Care A2+, Bubs Australia Ltd), Ireland (Danone), New Zealand (The a2 Milk Company), Singapore (Reckitt/ Mead Johnson), and the United Kingdom (Kendal Nutricare Ltd.).
Notably, Abbott (Spain) and Danone (Ireland, New Zealand) did not send letters of intent.
For specialty formulas for infants with special medical needs, those who signed letters of intent are Mexico (Reckitt/ Mead Johnson) and The Netherlands (Danone, Nutricia, and Vitaflo USA LLC).
Abbott (Spain) was among those that did not sign letters of intent for this category. This is noteworthy because they were the initial company to recall their formula and cease production, which in part triggered the shortage.
Importance of the FDA’s actions
The steps taken by the FDA in exercising enforcement discretion are critical for an end to the infant formula shortage. To emphasize the severity, in May 2022, forty-three percent of formula products were out of stock nationwide. This intense shortage is having the heaviest impact on the most vulnerable populations including low-income and working mothers, disabled populations, and parents. Low-income and working mothers have had to rely more on formula than breastfeeding oftentimes because they don’t have the time and support to sustain breastfeeding. By the FDA taking the steps they have in the use of enforcement discretion, they have made progress in getting more formulas back on the shelf to help these populations. Hopefully, they can continue to make strides toward getting formula back on the shelves where it belongs.