Search results for: infant formula

  • On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which requires infant formula manufacturers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infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the U.S. The draft guidance is titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of Infant Formula.”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 The draft guidance discusses notification requirements for infant formula manufacturers, including: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.
  • On August 30, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to three infant formula manufacturers as part of the Agency’s recent push to enhance regulatory oversight in the infant formula industry.  The warning letters, which were issued to ByHeart Inc., Mead Johnson Nutrition, and Perrigo Wisconsin, LLC, allege violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations.
  • At the time of FDA inspections of the facilities, the Agency issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace. 
  • Importantly, FDA does not advise consumers to discard or avoid purchasing any particular infant formula at this time.  These warning letters are not associated with any current recalls and therefore, FDA does not anticipate any impact to the availability of infant formula on the market.  Consumers should know that the U.S. infant formula supply is healthy with in-stock rates at 85% or higher since the beginning of 2023.
  • FDA states that it is issuing these letters now “as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations.”  Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking.
  • On June 1, a group of bipartisan lawmakers led by Senator Mike Lee, R-UT, introduced the Formula 3.0 Act which would permanently remove tariffs and other trade restrictions on imported infant formula base powder. This bill follows the expiration of the Formula Act, an emergency measure signed into law by President Biden in July 2022 that temporarily removed tariffs on infant formula in response to the nationwide infant formula shortage. Proponents of the bill said the Formula 3.0 Act aims to address vulnerabilities in the domestic infant formula market highlighted by the shortage last year.
  • As our readers likely recall, FDA issued a recall of powdered infant formula originating from Abbott Nutrition’s facility in Sturgis, Michigan in February 2022. At the time, the Abbott facility supplied 40% of the nation’s infant formula. The recall and subsequent shutdown of the facility resulted in a monthslong infant formula supply shortage which drew attention to vulnerabilities in the domestic supply and to high tariffs and other obstacles imposed on imported infant formula.
  • According to a 2022 report from the Congressional Research Service, imports of infant formula have increased substantially over the last decade, accounting for approximately 4.3 million kilograms (valued at $28.8 million) of domestic consumption in 2021. The most-favored-nation (MFN) tariff rate for these products typically ranges from 14.9% to 17.5%. Though tariffs were temporarily waived by the emergency measures enacted in July 2022, these measures have since expired.
  • Keller and Heckman will continue to monitor developments on issues pertaining to infant formula.
  • On March 28, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by the temporary shutdown of Abbot’s facility in Sturgis, Michigan in February 2022 due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility. To view our past blog posts regarding FDA’s response to last year’s infant formula crisis, please follow this link.
  • As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, FDA devised a national strategy describing the immediate actions the Agency took to address the infant formula shortage and detailing the Agency’s plans for improving the resiliency of the infant formula supply. Among other things, FDA is working to conduct surveillance food safety inspections of all infant formula manufacturers at least annually, use remote regulatory assessments, expand and improve infant formula training for investigators, monitor the infant formula supply and supply chain, expedite review of premarket submissions for new infant formula products to mitigate or prevent shortages, and build a consumer education program.
  • This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.  The long-term strategy will also explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend other necessary authorities to gain insight into the supply chain and risks for shortages.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula, asking for them to share current safety information and to take action to improve processes for the protection of infants.
  • Last year, safety concerns at one of the largest infant formula manufacturing facilities in the U.S. prompted a nationwide recall and temporary pause in production, leading to a national infant formula shortage.  Since then, FDA has issued multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula through enforcement discretion.  The Agency has also developed a cronobacter prevention strategy, enhanced inspection activities, increased engagement with the industry, and has pursued regulatory action in some cases.
  • In the recent months, FDA food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent cronobacter illness.  The letter reflects the information gained during these meetings, as well as the latest available science.
  • In its update, FDA calls on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for infant protection.  FDA will continue to inspect and work with the industry to advance research and regulatory activities included in the prevention strategy.
  • Keller and Heckman will continue to monitor and report on any developments in this area.