The FDA will allow manufacturers’ discretion in enforcing its standards to increase the variety and supply of infant formula in the U.S.
The U.S. Food and Drug Administration (FDA) announced it would allow manufacturers of infant formula products to use enforcement discretion to increase the diversity and supply of infant formula in the United States.
Recent industry guidelines from May 16, 2022, and later in September 2022, have given the FDA a pathway for infant formula manufacturers to continue marketing their products while following FDA rules.
The FDA uses the term "enforcement discretion" for lower-risk products that meet the definition of a medical device but don't need to be submitted, reviewed, and approved by the government before they can go on the market.
A voluntary recall by Abbott Nutrition in February 2022 and later voluntary cease of production at their Sturgis facility, combined with pressures on supply networks during the COVID-19 pandemic, raised worries about the availability of some infant formulas within the FDA.
In March, the FDA announced that it would temporarily exercise enforcement discretion for specific infant formula regulations to encourage increasing infant formula supply.
According to the FDA announcement, the goal of this measure was to improve newborn formula supplies in the U.S. while protecting infants' health, as formula is typically their only source of nourishment during this vital growing stage. However, the guidance expired on November 14, 2022.
The new regulations released in September 2022 make it possible for companies that make baby formula and received a letter of enforcement discretion based on the May 2022 guidance to keep selling their products while they work to meet all FDA rules.
The FDA shared a chart showing which companies want to stay on the U.S. market and what formulas they plan to change to make them legal to sell. The formulas they list meet U.S. nutritional needs with a few restrictions. Premature or low-birth-weight newborns, infants with low iron levels at birth, or infants at risk for iron deficiency owing to sickness should not have infant formula.
The FDA also notes the following:
“Parents and caregivers of infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness should check with their child’s health care provider to determine if this formula is appropriate for their child. Additional iron may be needed in these instances.”
The FDA found information about each formula's nutrients and ingredients, a copy of the product label and description of packaging, current or anticipated inventory of the formula, microbiological testing results, and facility inspection history. This was done to help the agency consider enforcement discretion on a case-by-case basis.
“For an infant formula with a label that did not list the nutrients in the order required, but that otherwise meets applicable requirements, the FDA indicated it would likely determine that enforcement discretion is appropriate. In contrast, an infant formula with meaningful differences in required nutrients might not be an appropriate candidate for enforcement discretion,” said the report.
The enforcement discretion period for these products was extended until January 6, 2023. Firms interested in staying in the U.S. market and take steps to do so can be eligible for more extensions.
Companies without a Letter of Intent by December 5, 2022, lost enforcement discretion on January 6, 2023. On Nov. 14, 2022, the FDA stopped accepting enforcement discretion requests.