Information for Infant Formula Manufacturers and Retailers

Information for Infant Formula Manufacturers Main Image

Manufacturers of infant formula must comply with applicable Federal Food, Drug, and Cosmetic Act requirements and those contained in FDA’s implementing regulations. Detailed information on these requirements can be found on FDA’s Infant Formula Guidance Documents & Regulatory Information webpage. Manufacturers can also learn more about infant formula requirements by watching a series of FDA-held webinars:

A manufacturer who intends to market a new infant formula in the U.S. must register with, notify, and submit a written verification of regulatory compliance to FDA. The FDA encourages infant formula manufacturers to contact IF_manufacturer_questions@fda.hhs.gov with questions about infant formula. New infant formula submissions must generally be sent to FDA at least 90 days before the introduction or delivery for introduction into interstate commerce of a new infant formula.

Strengthening the Resiliency of the Infant Formula Supply

In response to the infant formula supply disruption that followed the 2022 Abbott voluntary recall, FDA has taken multiple steps to improve the resiliency of the infant formula supply.

Operation Stork Speed: In March 2025, Operation Stork Speed launched with FDA announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for certain contaminants. Increasing testing of infant formula and its ingredients for spore-forming microbiological contaminants, such as Clostridium botulinum and Bacillus cereus, to further inform risk reduction strategies. The agency is also encouraging new entrants into the market as well as encouraging companies to develop new infant formulas and clarifying opportunities to help inform consumers about formula ingredients.
Long-term National Strategy: In January 2025, FDA issued the Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which outlines long-term actions to improve information-sharing across all stakeholder groups and addresses implementing measures for preventing contamination, incentivizing new infant formula manufacturers to enter the U.S. market, as well as authorities needed to gain better insight into the supply chain and risk for shortages.
Enhanced Safety: The agency has taken steps to enhance the safety of powdered infant formula through the development of a prevention strategy, enhanced inspection activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.
- In December 2025, to improve recall effectiveness and enhance safety, FDA issued a letter reminding industry, in particular retailers, of their responsibilities to efficiently and effectively conduct recalls. This letter noted the particular importance of these responsibilities when recalling foods like infant formula or other products for infants and children. Additionally, the letter reaffirmed FDA’s call to action to the industry to strengthen all aspects of the recall process, which require both clear communication and prompt, thorough action by all supply chain participants.
- In March 2023, FDA issued a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of infants.
  - In the letter, FDA asked that firms voluntarily notify FDA any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed. For these notifications of product positives, FDA recommends that firms report this information through the Office of Inspections and Investigations (OII) Division representative in which the manufacturing facility is located (see this OII Field Leadership Contacts for further information). Continued communication through this established channel will help ensure that the information is received, acted on, and routed most appropriately in an efficient and timely manner.
Warning Letters: Additionally, FDA also issued three warning letters to infant formula manufacturers to reinforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected and to comply with FDA’s laws and regulations. In September 2023 FDA updated its infant formula compliance program to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities related to the oversight of infant formula.
Low Moisture Ready-to-Eat Guidance: In January 2025, FDA issued draft guidance intended to help manufacturers and processors of Low Moisture Ready-to-Eat (LMRTE) human foods, including powdered infant formula, comply with requirements for current good manufacturing practices, hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply.
Enforcement Discretion: In Fall 2022, FDA provided a pathway for domestic and foreign infant formula manufacturers to add new infant formulas to the market through an initial exercise of enforcement discretion. This led to a total of 12 new infant formula products added to the U.S. market. You can learn more about this work through the Agency’s Infant Formula Transition Plan for Exercise of Enforcement Discretion.

Spotlight

The Food and Drug Omnibus Reform Act of 2022 amended the Federal Food, Drug, and Cosmetic Act to add new requirements for manufacturers of critical foods, such as infant formula.