Search results for: infant formula

  • On July 13, 2026, FDA issued a letter to infant formula manufacturers and their supply chain partners in response to several serious public health events, calling on the industry to increase vigilance to “ensure ingredient and infant formula safety.”
  • The letter details FDA’s investigation into two multistate outbreaks of infant botulism that led to voluntary recalls of powdered infant formula, as we previously reported. The investigation identified Clostridium botulinum contamination in a dairy-based ingredient, which FDA linked to both affected formulas. In addition, the letter discusses a global outbreak of cereulide intoxication, which resulted in an ingredient supplier being placed on an FDA Import Alert.
  • In the letter, FDA emphasizes that these incidents reflect a pattern of risks entering through the supply chain. The letter outlines FDA’s expectation for manufacturers to conduct supplier audits and verification activities, as well as monitor recalls, outbreak investigations, and FDA Import Alerts. The letter also reminds the industry of its obligations under 21 CFR Parts 106 and 117 and the Food and Drug Omnibus Reform Act of 2022.
  • The letter concludes by stating that FDA is continuing its investigations into the root causes of the 2025 and 2026 infant botulism outbreaks and provides industry with a list of resources, including Information for Infant Formula Manufacturers and Retailers and Guidance for Industry: Hazard Analysis and Risk-Based Preventative Controls for Human Food.
  • Keller and Heckman will continue to report on developments related to infant formula manufacturing.
  • On May 21, 2026, FDA issued a final guidance for Industry: “Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein” for manufacturers of infant formula and laboratories conducting testing on infant formula.
  • Under FDA’s Current Good Manufacturing Practices (CGMPs) for infant formulas, an infant formula must meet the quality factor of “sufficient biological quality of protein.” 21 CFR 106.96(e). This new final guidance seeks to help manufacturers design, conduct, and evaluate PER studies to meet this requirement. The guidance includes an overview of AOAC Official Method 960.48 and appropriate modifications thereto, as well as guidance on the development of protocols and reports and reference guidelines.
  • A PER study in an animal model permits the determination of a formula’s protein quality and ensures that infants will not be fed a formula with inadequate or biologically unavailable protein.
  • Keller and Heckman will continue to report on developments related to infant formula manufacturing.
  • On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in the United States. As part of Operation Stork Speed and the agency’s broader Closer to Zero initiative, FDA analyzed more than 300 retail products, generating over 120,000 data points across a wide range of potential chemical contaminants. The testing covered powdered, ready-to-feed, and concentrated liquid formulas and included analysis for heavy metals, pesticides, PFAS, phthalates, and other substances that may be present due to environmental or agricultural factors.
  • Overall, FDA’s findings reinforced that all infant formula products on the U.S. market meet a high safety standard, with most samples showing undetectable or very low levels of the contaminants tested. Agency leadership emphasized that these results are encouraging and affirm the general safety of the U.S. infant formula supply.
  • Specifically, all samples tested contained levels of lead, mercury, cadmium, and arsenic that were significantly below U.S. Environmental Protection Agency drinking water standards when prepared for feeding. Pesticides were not detected in 99 percent of samples tested, and none of the 25 out of 30 tested most commonly assessed PFAS compounds were detected in any sample. Among the remaining PFAS analytes, 95 percent of products had total PFAS levels at or below 28 parts per trillion, while 95 percent of samples showed phthalate concentrations at or below 116 parts per billion.
  • FDA plans to continue targeted and routine surveillance, expand testing to additional contaminants, and work with manufacturers to push contaminant levels as low as reasonably achievable. The agency also indicated it will continue developing formal action levels where appropriate.
  • Keller and Heckman will continue to monitor regulatory and policy developments affecting infant formula safety and supply.
  • Infant formula maker ByHeart has recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack sticks due to an outbreak of infantile botulism linked to the company’s products. ByHeart initiated the recall of two batches of formula on November 8, 2025, after it was notified of approximately 13 reported cases of botulism in infants that had consumed its products throughout the U.S. The company expanded the recall three days later after an additional 10 cases were reported.
  • California officials reported that a sample taken from an open can of ByHeart formula contained Clostridium botulinum, which leads to botulism infection. According to ByHeart, no previously unopened product has tested positive for the bacteria. In addition to recalling product, the company is conducting testing of every batch of formula through a third-party laboratory and providing FDA and the California Department of Public Health access to its facilities and unopened product for testing.  
  • The families of at least two babies who were treated for botulism have sued ByHeart, alleging the company negligently sold defective formula that they purchased because they viewed it “as a natural, healthier alternative to traditional baby formulas.” The families are seeking payment for medical bills, emotional distress, and other harm.  
  • Illnesses linked to ByHeart formula began between August 9 and November 11 and were reported in 13 states. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak.
  • Keller and Heckman will continue to monitor and report on this and other foodborne illness outbreaks.
  • On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which requires infant formula manufacturers to notify FDA of a permanent discontinuance or interruption in the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the U.S. The draft guidance is titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of Infant Formula.”
  • Section 424 of the FD&C Act requires manufacturers to notify the FDA “as soon as practicable, but not later than 5 business days” after a permanent discontinuance or interruption of infant formula manufacture that is likely to cause a significant supply disruption. The draft guidance discusses notification requirements for infant formula manufacturers, including:
    • What constitutes a permanent discontinuance or interruption;
    • The definition of a “meaningful disruption;”
    • What information should be included in a notification;
    • How to notify FDA; and
    • Consequences of a failure to notify FDA.
  • The guidance is intended as one step to “improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious.”
  • FDA is accepting comments on the guidance and will consider any comments submitted before February 3, 2025, in its development of a final guidance document. Comments can be submitted through regulations.gov to docket number FDA-2024-D-1334.
  • Last month, the National Academies of Science, Engineering, and Medicine (NASEM) released a 401-page report which analyzed the 2022 infant formula shortage, highlighted the vulnerabilities in the infant formula market, and made recommendations to improve the market’s resilience and mitigate the impact of future crises.
  • The vulnerabilities in the infant formula market identified by the report can be broken down into 5 broad categories:
    • Risk management planning. The report discusses failures in the market to implement effective risk management plans at both the facility level and at a sector-wide level.
    • Market concentration. Although the report recognized problems of sales concentration at the state and national levels, it identified production line concentration as the most significant vulnerability to supply disruptions.
    • Ability to support a speedy recovery. The report found that certain aspects of FDA’s lack of authority as well as regulatory requirements inhibiting the import of infant formula slowed restoration of production in times of crisis.
    • Government management of adverse effects on consumers. Inadequate communication with the public, lack of coordination between government and industry, and challenges related to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) heightened adverse impacts.
    • Protection, promotion, and support of breastfeeding. The report concluded that continued breastfeeding reduced the proportion of families severely affected by the shortage of infant formula.
  • The report offers 14 detailed recommendations to address these challenges. The report follows a Federal Trade Commission (FTC) report released earlier this year which addressed market factors contributing to the infant formula crisis.
  • We will continue to report on infant formula issues, including any government responses to the recommendations made in the report.
  • Earlier this month, the Federal Trade Commission (FTC) released a report which analyzes market factors contributing to the infant formula market disruptions that occurred in 2022 following the recall of infant formula manufactured at Abbot’s Sturgis, Michigan manufacturing facility due to potential bacterial contamination.
  • The report describes how the U.S. infant formula market has been highly concentrated among only a few manufactures for decades; primarily Abbot, Mead Johnson (owned by Reckitt Benckiser), Perrigo (owns PBM Holdings), and Nestle (which sold the U.S. and Canadian rights to Gerber Good Start brand to Perrigo along with its Wisconsin manufacturing facility). The report also discusses two principal factors which have contributed to market concentration.
  • One factor is the single-rebate system used in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. The WIC program, which is administered by USDA through state agencies, offers assistance, including nutritional assistance, to certain at-risk individuals. In 2018 56% of the infant formula sold in the U.S. was purchased by WIC participants. Infant formula purchased through WIC is heavily discounted because individual states negotiate significant rebates (averaging 92% of the wholesale price of infant formula in 2013) in exchange for market exclusivity within the state’s WIC program. These WIC-exclusivity agreements have spill-over effects in the broader infant formula market and dramatic (≈ 90%) increases or decreases in market share have been seen following the gain or loss of a WIC contract.
  • The report also discusses FDA’s extensive regulation of infant formula as a second factor contributing to market consolidation by acting as a barrier to entry. Infant formula must be of “sufficient biological quality” and must support growth, demonstration of which typically requires a specific 15-week preclinical study. Among the other requirements, new infant formula submissions are also required at least 90 days before marketing the formula.
  • The report is written in a neutral manner which details the primary factors contributing to the consolidation of the infant formula market, but acknowledges that these factors also have positive impacts (e.g., lower infant formula prices for WIC participants), and does not offer any recommendations.
  • On November 22, 2023, FDA released a one-page fact sheet answering questions regarding the redundancy risk management plan requirement in the Food and Drug Omnibus Reform Act of 2022. The fact sheet is intended to provide information to manufacturers of critical foods, which FDA defines as any infant formula or medical food. The redundancy risk management plan requirement was established in response to the 2022 infant formula shortage caused by insanitary conditions at a formula plant that led to a voluntary recall and temporary production stoppage.
  • The fact sheet describes the requirements for a redundancy risk management plan, which every critical food manufacturer is required to develop, maintain, and implement. According to FDA, a risk management plan may identify and evaluate risks to critical foods, as well as mechanisms to mitigate supply chain disruptions. A separate plan is needed for each manufacturing facility, but not for each product that is manufactured within the same facility.
  • Additional safety information for consumers and manufacturers is available on FDA’s infant formula landing page. Keller and Heckman will continue to monitor and report on issues relating to infant formula.
  • FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program comprehensively outlines the agency’s approach towards inspections, sample collection, sample analysis, and compliance activities to help ensure infant formula products in the US are safe and nutritious.
  • As our readers know, in September 2022, FDA published its internal evaluation of the infant formula response which identified five major areas of need to ensure the safety of the food supply. Specifically, the evaluation found that FDA’s infant formula compliance program lacked specificity regarding Cranobacter and is limited by scientific gaps related to this pathogen. The evaluation recommended that FDA review and update its compliance program and associated Compliance Policy Guide for infant formula manufacturers to ensure it reflects current science, provides consistent industry oversight, and provides better tools for investigators and compliance officers.
  • In line with these recommendations, the updated compliance program includes instructions for annual environmental sampling of Cranobacter and Salmonella at powdered infant formula facilities. It also provides instruction for FDA notification if a sample tests positive for Cranobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation. The program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated, and also provides additional background information on the risks associated with Cranobacter and Salmonella in infant formula products.
  • Today, FDA announced an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula, including:
    • Continuous collaboration with industry, coalitions, academia, and consumer groups to better understand and explore ways to enhance the safety of powdered infant formula.
    • Issuance of a letter to the powdered infant formula industry to share current safety information and a call to industry to take prompt action to improve processes related to the safe production of powdered infant formula.
    • Initiation of hiring to establish a dedicated cadre of investigators to conduct infant formula inspections. 
    • Initiation of hiring of staff to support the new Office of Critical Foods. 
    • Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was successfully adopted by the CSTE on June 29, 2023.
    • Updating and reorganizing infant formula related materials on FDA.gov to provide both consumers and industry with more accessible information, including:
    • Initiating work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to address knowledge gaps regarding Cronobacter. 
  • The updated prevention strategy webpage includes a full list of actions that have been taken to date. In addition, FDA has continued to undertake additional steps to enhance its regulatory oversight of the infant formula industry, including the recent issuance of three warning letters to infant formula firms in August 2023 and requirement that manufacturers to develop, maintain and implement risk management plans to identify and evaluate risks to the supply of the critical food, such as infant formula, and ways to mitigate such risks, as mandated by Congress.
  • Keller and Heckman will continue to monitor and report on issues relating to infant formula.