Infant Formula Safety and Compliance

Infant formula safety is governed in the United States by 21 CFR Part 106, FDA's rule setting current good manufacturing practice, quality control, quality factors, records, and notification requirements specifically for infant formula. Because formula is often the sole food for a vulnerable population, the rules are stricter than for ordinary food: mandatory pathogen testing, nutrient controls, stability testing, and advance notice to FDA.

The stakes are why the rulebook is its own thing. A newborn on formula has no other diet and little immune reserve, so a single unsafe or nutritionally deficient batch can do lasting harm. This post covers how infant formula is regulated under 21 CFR Part 106, why Cronobacter and Salmonella drive the microbiological program, what nutrient and stability testing require, the notification rules, and what recent recalls have taught the industry.

How is infant formula regulated in the United States?

Infant formula is regulated under the Federal Food, Drug, and Cosmetic Act as amended by the Infant Formula Act, with the detailed requirements in 21 CFR Part 106 and the nutrient specifications in 21 CFR Part 107. Part 106 is a dedicated GMP-plus rule: on top of ordinary good manufacturing practice it adds a required quality control system, defined quality factors, mandatory microbiological and nutrient testing, and notifications to FDA that no other food category carries.

The regulation covers the whole operation. It requires a production and in-process control system, environmental monitoring for specific pathogens, testing of each production aggregate, controls to ensure nutrients are present and stable, and detailed records. It sits on the same foundation as any food plant, solid GMP and a HACCP-based food-safety plan, but layers infant-specific controls on top. Manufacturers do not choose whether to follow Part 106; it is mandatory for anyone making formula for the U.S. market.

Why do Cronobacter and Salmonella drive the microbiology?

Cronobacter species (formerly Enterobacter sakazakii) and Salmonella species are the two pathogens FDA identified as the organisms of concern for powdered infant formula, and Part 106 builds the microbiological program around them. Powdered formula is not sterile, and both organisms can survive in the dry powder and cause severe, sometimes fatal, illness in infants, Cronobacter in particular is linked to meningitis and sepsis in newborns.

Because of that, Part 106 requires both environmental monitoring for these organisms in the plant and testing of the finished product before it is distributed. The sampling plans are deliberately stringent, reflecting how serious a positive would be:

Compliance is determined using the current edition of FDA's Bacteriological Analytical Manual. The environmental side matters as much as the product side: because the powder is not sterilized in the can, the whole strategy is to keep these organisms out of the processing environment in the first place. That makes the plant's environmental monitoring program and its hygienic zoning central, not supporting, controls.

What testing does infant formula require beyond pathogens?

Beyond microbiology, Part 106 requires that every batch actually delivers the nutrition an infant needs and holds that nutrition for its whole shelf life. Three testing obligations do that work:

• Nutrient testing. Each production aggregate is tested to confirm the required nutrients are present at the levels set in 21 CFR Part 107. Formula must contain every required nutrient within the minimum and, where set, maximum amounts, too little is as much a violation as contamination.
• Stability testing. The manufacturer must show nutrients remain at required levels through the end of the product's shelf life, not just on the day it is made. Some nutrients degrade over time, so stability data across the claimed shelf life is required to set and support the expiration date.
• Quality factors. Part 106 requires assurance of two quality factors: normal physical growth and sufficient biological quality of the protein. These are demonstrated before a new formula reaches the market, confirming the formula actually supports an infant, not just that it lists the right numbers.

The nutrient and stability requirements are why an infant formula recall can be triggered by a nutrient shortfall, not only a pathogen, a batch that loses a required nutrient before its expiration date is out of compliance and can harm an infant who depends on it.

What are the notification requirements?

Part 106 and the Act require manufacturers to notify FDA at specific points, which is unusual for a food and reflects how closely formula is overseen. There are two notifications new manufacturers must plan around, plus recall reporting.

• New infant formula submission. At least 90 days before introducing a new formula into interstate commerce, the manufacturer submits notice to FDA under 21 CFR 106.120, including the formulation, an explanation of why it is new, and assurances it will meet nutrient and quality-factor requirements. The formula cannot be marketed before 90 days after the complete submission's filing date.
• Verification submission. After first processing but before marketing, the manufacturer submits written verification, including a summary of nutrient test results, demonstrating the formula as actually produced complies with the Act.
• Recall and adulteration reporting. If a batch is found adulterated or misbranded in a way that presents a risk, the manufacturer must act on it, and infant formula recalls carry their own FDA reporting and monitoring under the Act.

How do you build an infant formula compliance program?

For a manufacturer entering or running the category, the compliance work sequences like this:

1. Build the Part 106 quality system. Stand up the production and in-process control system, written procedures, and records that Part 106 requires on top of your base GMP program.
2. Design the environment against the two pathogens. Engineer hygienic zoning and an environmental monitoring program aimed at Cronobacter and Salmonella since keeping them out of the plant is the core strategy for a non-sterile powder.
3. Control incoming ingredients. Apply rigorous incoming material inspection and supplier controls, because a contaminated ingredient can carry a pathogen straight into a product that is not cooked again.
4. Confirm nutrients and quality factors. Establish nutrient testing to Part 107 levels and demonstrate the growth and protein-quality quality factors for each formula.
5. Run stability studies. Test nutrient retention across the shelf life to set and support the expiration date.
6. Test every aggregate and hold it. Run the finished-product pathogen and nutrient testing on each production aggregate and hold product until results confirm release.
7. File the notifications. Submit the new formula submission at least 90 days ahead and the verification submission before marketing.

Steps two, three, and six are where most of the real risk lives, keeping pathogens out of the environment and ingredients, and never releasing an aggregate before its results are in.

What have recent recalls taught the industry?

Two recent events reshaped how the industry and FDA think about formula safety. In February 2022, Abbott Nutrition recalled powdered formula made at its Sturgis, Michigan plant after FDA and CDC investigated infant illnesses, including reports of Cronobacter sakazakii and one Salmonella Newport infection; the recall and the plant's shutdown contributed to a national formula shortage. It put Cronobacter environmental control and the fragility of a concentrated supply chain at the center of the conversation.

Then, across 2025 into 2026, ByHeart recalled all of its infant formula in what CDC described as the first documented U.S. botulism outbreak attributed to infant formula, with dozens of infants hospitalized across many states. FDA testing identified Clostridium botulinum in an organic whole milk powder ingredient. The lesson pointed hard at ingredient safety and supplier verification, the contamination entered through a raw material, not the finished process, and reinforced why incoming material inspection and a real hold and release program are not optional in this category.

What are the key infant formula numbers?

The regulatory anchors and the facts from recent events:

• Infant formula GMP, quality control, quality factors, records, and notifications are set in 21 CFR Part 106 with nutrient specifications in 21 CFR Part 107.
• A new infant formula submission must be made to FDA at least 90 days before marketing under 21 CFR 106.120 followed by a verification submission before sale.
• The 2022 Cronobacter investigation involved reported Cronobacter and Salmonella infections tied to one plant and triggered a national shortage.
• The 2025–2026 infant botulism outbreak was the first documented U.S. botulism outbreak attributed to infant formula, with C. botulinum found in a powdered milk ingredient.

Read together, the rules and the recalls say the same thing: in this category, environment and ingredients are where safety is won or lost, and the paperwork proving control is not optional.

How do you keep an infant formula program provable?

An infant formula program generates an enormous, interlocking record set: environmental swabs, finished-aggregate pathogen and nutrient results, stability data, ingredient and supplier records, batch records, hold and release decisions, and FDA notifications. On scattered systems, proving that a specific can was made from verified ingredients, in a monitored environment, tested clean, and released on results becomes a manual archaeology project, exactly when, during a recall or an FDA inspection, you have no time for it.

Holding those records in one connected system is what makes the program provable on demand. When an aggregate's environmental history, test results, ingredient lots, and release decision live in one linked record, a trace runs in minutes and a slipping trend is visible before it becomes a positive. This category also leans on strong GFSI-aligned systems and a culture that treats every check as load-bearing. That connected, floor-level view is what Harmony is built to provide, see how the platform works.