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                Infant Formula Guidance Documents & Regulatory Information

Infant Formula Guidance Documents & Regulatory Information

                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response Home
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          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Infant Formula Guidance Documents & Regulatory Information
          Status Update on FDA’s Infant Formula Response ActivitiesInfant Formula Guidance Documents & Regulatory Information Status Update on FDA’s Infant Formula Response Activities
  
  	
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What’s New

January 10, 2024

Products produced during the same finished product campaign as the U.S.-recalled product were distributed in at least the following countries: Argentina, Belgium, Belize, Canada, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Ireland, Israel, Jamaica, Mexico, Nicaragua, Peru, Poland, Spain, United Kingdom, and Venezuela. Reckitt/Mead Johnson Nutrition has indicated to FDA that the company has already contacted the regulatory authorities in each of the countries to determine the proper disposition of these products.

December 31, 2023

On December 28, 2023, the FDA received information concerning a confirmatory analysis for a *Cronobackter sakazakii*positive finding in Nutramigen, a hypoallergenic powdered infant formula product manufactured by Reckitt/Mead Johnson Nutrition. The Israeli Ministry of Health identified the positive finding during routine sampling during import operations. The FDA has initiated an inspection at the Reckitt/Mead Johnson Nutrition Zeeland, MI facility and Reckitt/Mead Johnson Nutrition is voluntarily recalling certain Nutramigen Hypoallergenic Infant Formula Powder products due to possible *Cronobacter sakazakii*contamination.

The voluntarily recalled Nutramigen product was manufactured between June 6, 2023, and June 29, 2023, and includes batch numbers: ZL3FHG (12.6 oz cans), ZL3FMH (12.6 oz cans), ZL3FPE (12.6 oz cans), ZL3FQD (12.6 oz cans), ZL3FRW (19.8 oz cans), and ZL3FXJ (12.6 oz cans). The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025. Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products. There are no known illnesses associated with this product to date, and likely most of the product that was distributed in the U.S. has already been consumed. Consumers who have Nutramigen Powdered Infant Formula with the above batch numbers should stop using it and throw it away.

Additional information on the recall is available:

Constituent Update: Reckitt/Mead Johnson Nutrition Voluntarily Recalls Certain Nutramigen Hypoallergenic Powdered Infant Formula Products
	Recall Announcement
	Government of Canada Recall Announcement


Since the Abbott infant formula recall in February 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agency’s infant formula response and the Reagan-Udall foundation’s evaluation of the FDA’s Human Foods Program (conducted at FDA’s request) to identify areas for improvement within the Agency. While work continues on all fronts, the FDA is committed to transparency. Below is an update on actions the FDA has taken, and those underway, to strengthen the safety and resiliency in the supply of nutritious infant formula. Additionally, the Agency has published a more specific progress update on the actions taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response.


December 2023 Status Update

Safety of Infant Formula

In FY23, FDA conducted 47 routine annual inspections of foreign and domestic facilities that produce infant formula (including some that also produce medical foods), meeting FDA’s assignment targets for FY23. Appropriate follow-up actions were taken as warranted. Importantly, FDA had set targets to inspect facilities that produce infant formula annually, even prior to a requirement to do so established in the Food and Drug Omnibus Reform Act of 2022.
	In September 2023, the FDA released an update on its strategy to prevent *Cronobacter sakazakii* illnesses associated with the consumption of powdered infant formula, originally released in November 2022. The update included notable actions to advance the goals of the strategy 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 and goes into effect in 2024. The FDA, along with CSTE and CDC, have been meeting regularly to discuss how best to support implementation of this new notification process.
		Released an update to chapter 29of the Bacteriological Analytical Manual (BAM) with an updated method for testing powered infant formula samples for *Cronobacter*. The improved method reduces background interference which greatly reduces the risk of false positive results and provides additional guidance to find *Cronobacter*colonies on recommended agar plates. The FDA is collaborating with the CSTE to share this method with state partners across the U.S. to help build capacity for testing for *Cronobacte*r in powdered infant formula.
		Updating and reorganizing infant formula related materials on FDA.gov to provide both consumers and industry with more accessible information, including:
		Infant Formula
			**Cronobacter* sakazakii*
			New resource on handling infant formula safely in both English and Spanish.
	In November 2022, the FDA advanced a charge through the National Advisory Committee on Microbiological Criteria in Foods (NACMCF) to gain scientific insight on possible industry and public health interventions to address *Cronobacter* infections associated with powdered infant formula. The 2021-23 NACMCF provided a draft interim report in response to question one of the charge (i.e., current prevalence and level of *Cronobacter* spp. contamination in powdered infant formula in the U.S. market, what is known about *Cronobacter* spp. in other foods and in the home environment, and the frequency with which these foods and environmental sources contribute to human infections). The 2023-25 NACMCF will be incorporating the interim report into their final report addressing all questions from FDA’s charge.
	FDA has expanded the availability of education materials to help consumers better understand *Cronobacter* risks associated with powdered infant formula and the steps they can take at home to help minimize any potential contamination.
	FDA continues to work with Abbott Nutrition under the consent decree entered by the U.S. District Court for the Western District of Michigan on May 16, 2022. This consent decree requires Abbott to take the steps necessary to safely produce infant formula in close coordination with FDA and under our oversight of its manufacturing and food safety processes.
	In August 2023, FDA issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.
	The FDA continues to engage with stakeholders from a wide variety of perspectives on infant formula safety, including but not limited to the Safe Food Coalition, Center for Science in the Public Interest, and the Infant Formula Nutrition Council of America.Resiliency in the Supply of Nutritious Infant Formula

At the height of the supply challenges, FDA staff worked daily with clinicians and hospitals to address crucial issues of specialty and medically necessary formula supply for infants with serious metabolic diseases who were dependent on highly specialized formulas.
	The FDA supported our colleagues at HHS to mobilize Operation Fly Formula to arrange for emergency air transport of large volumes of formula at the peak of the crisis.
	The FDA worked with Customs and Border Protection (CBP) to implement legislation that provided temporary relief for infant formula importers from tariffs during the latter half of 2022.
	The FDA helped to expand access to infant formula by temporarily exercising enforcement discretion, on a case-by-case basis, for certain infant formula requirements. Twelve firms that manufacture infant formula have brought various infant formula products into the U.S. market under FDA’s exercise of enforcement discretion; this increased the number of firms supplying product to the U.S. market from 2021 to 2022.
	The FDA conducted an expedited review of certain food safety and nutrition records associated with the firms and products prior to issuing letters of enforcement discretion.
		The FDA also adjusted import screening criteria to help facilitate the immediate importation of millions of pounds of infant formula and infant formula base powder (an ingredient used in producing infant formula products).
	FDA also issued the Infant Formula Transition Plan for Exercise of Enforcement Discretion guidance that outlines a path for interested firms marketing products in the U.S. under the exercise of enforcement discretion to bring those products into compliance with U.S. requirements to facilitate longer-term supply resiliency in the U.S. market.
	During October and November 2022, FDA hosted a four-part webinar series to provide detailed information about the transition plan for infant formulas marketed under the exercise of enforcement discretion and to address questions.
		Eight firms that manufacture infant formula are currently participating in the transition plan to bring their formula products into compliance with all U.S. requirements for infant formula after having previously received a letter of enforcement discretion from FDA.
		The FDA continues working to review and provide feedback to infant formula manufacturers on their deliverables under the transition plan guidance (e.g., protein efficiency ratio rat bioassay, growth monitoring study, requests for exemptions) and to answer questions received from firms about requirements for new infant formula submissions.
		To date, FDA has received several new infant formula submissions well ahead of the timeframe outlined in the transition plan guidance and is diligently working to review.
	FDA has leveraged 21 Forward, a tool that was built to help track supply chain shortages during the COVID-19 pandemic, to now inform ongoing work to track and anticipate supply disruptions across the infant formula supply chain. The platform uses data provided to the agency voluntarily by infant formula manufacturers.
	FDA staff continue to meet regularly with infant formula manufacturers to discuss current and forecasted production and to identify potential distribution issues.
		As of September 2023, functionality of 21 Forward, which was built and maintained via contract, has moved in-house to FDA’s Office of Digital Transformation.
	The Agency coordinated with colleagues in the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) Defense Production Act (DPA) Office to leverage their capabilities and authority to identify and provide appropriate support to resolve raw material constraints on ingredients needed to manufacture formula – including through technical assistance and DPA authorities when needed.
	The FDA has remained in close contact with multiple regulatory and public health partners on all aspects of the infant formula market and FDA’s actions, including the U.S. Department of Justice, USDA, HHS, and CDC, and has collected feedback on the challenges and potential solutions to timely communication during any potential future public health emergencies.
	The FDA contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct an independent study on challenges in supply, market competition, and regulation of infant formula in the United States. The results of this study will help to inform FDA’s long-term strategy and shed light on where additional resources may be required.
	The committee’s work is underway and its progress can be followed on NASEM’s website.The FDA also contracted with NASEM to conduct anotherindependent study, this one focused on the state of the science pertaining to possible alternatives to the protein efficiency ratio and growth monitoring studies that are prescribed in FDA’s current regulations to satisfy quality factor requirements. The results of this study will help FDA assess where the science is sufficiently robust to support changes to our regulations and/or guidance documents to provide for additional flexibility regarding these important requirementsOperational Improvements

FDA has revised its internal consumer complaint procedure to strengthen the escalation process to better define when certain consumer complaints need to be escalated to senior officials. This change involves rapid escalation of reports of serious illness or death to the highest levels of the agency and specifically addresses triggers for escalation of reports of any hospitalization or death involving an infant.
	The FDA has also established new procedures for managing complaints from whistleblowers and confidential sources.
	The FDA’s Office of Operations (OO) initiated procedures to improve the tracking of accountable mail, which may include complaints, through the point of delivery to ensure that such mail is received and acted upon in a timely manner.
	The FDA has completed the resource needs assessment to establish a critical foods cadre, whose purpose will be to focus solely on the inspection and oversight of critical foods, including infant formula. Hiring for the cadre is currently underway, and specialized training programs are continuously being developed, piloted, and deployed as a part of that effort.
	The Office of Regulatory Affairs (ORA) has expanded the agency’s capacity to test for *Cronobacter* to all seven ORA laboratories.
	All FDA laboratories have received new procedures for escalating significant testing results to senior leaders.
	The FDA has significantly expanded and improved a required infant formula online training course for investigators and other appropriate staff to ensure every infant formula inspection is robust, thorough, and focused on the most critical aspects of the infant formula manufacturing process.
	The FDA staff who conduct or support inspections of powdered infant formula manufacturers attended an interactive in-person powdered infant formula inspection workshop with specific training on conducting infant formula inspections in January 2023. The workshop provided critically relevant and timely inspectional information for investigators and other appropriate staff, including updates from lessons learned during previous inspections.
	The FDA updated its compliance program for infant formula.
	The FDA hosted a webinar in October 2023 to brief field investigators, compliance officers, and managers on significant updates to the compliance program.
	In February 2023, CFSAN issued a schedule with instructions for improved routine surveillance inspections and sampling to be conducted at domestic and foreign infant formula and medical food facilities in fiscal year (FY) 2023. These instructions, issued to FDA investigators, included numerous modifications that incorporate lessons learned during inspections conducted in FY22 and address feedback from internal and external stakeholders.
	In 2022, prior to FDA’s evaluation of the infant formula response, CFSAN began amending its instructions to ORA related to inspections of infant formula and medical food facilities. The changes provided additional considerations for environmental sampling, a renewed focus on the supply chain requirements under the Preventive Controls for Human Food Rule, and scheduling adjustments to minimize potential supply chain disruptions.
	CFSAN’s Office of Nutrition and Food Labeling has increased its staff by 66 percent to better facilitate infant formula reviews.
	The FDA is working to establish a new Office of Critical Foods (OCF) utilizing new authorities provided by Congress through the Food and Drug Omnibus Reform Act (FDORA) of 2022. The new office will be responsible for oversight, coordination, and activities related to critical foods, which is defined as infant formula and medical foods.
	In addition, the agency is using expanded 21st Century Cures hiring authorities to hire many positions related to the OCF as well as other positions, which will help to support infant formula oversight and regulation. This has included the hiring of a Chief Critical Foods Officer, a Senior Advisor for Critical Foods Enforcement and Compliance,] a Senior Regulatory Counsel for Critical Foods, and a Medical Officer for Critical Foods.
	The FDA has developed and distributed a fact sheet for critical foods manufacturers to help raise awareness and understanding of the new FDORA requirement for critical food manufacturers to develop, maintain and implement, as appropriate, redundancy risk management plans.
	The FDA is currently in the process of drafting guidance to support new requirements, established through FDORA, for critical foods manufacturers to notify FDA of a permanent discontinuance or interruption that is likely to lead to a meaningful disruption in infant formula supply.
	The FDA has successfully implemented new procedures for notifying Congress of infant formula recalls per new requirement under FDORA.The FDA continues to seek additional authority through the FY24 budget request to require that, among other things, manufacturers report to FDA final product positive test results for relevant pathogens, including those that have not left the manufacturer’s control; conduct more frequent environmental monitoring in their facilities to identify relevant pathogens; and maintain the results of such testing for FDA inspection, either in person or remotely. The combination of these new authorities would empower the FDA to work with firms in real time to resolve issues around product positive findings and better assure the safety of product entering the market.

*The FDA appreciates the continued collaboration with the infant formula industry, retailers, educators, and federal partners to strengthen the resiliency and safety of infant formula in the United States.*


**For more information**

Status Update on FDA’s Infant Formula Response Activities - March 2023
	Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula
	Strategy to Help Prevent *Cronobacter sakazakii* Illnesses Associated with Consumption of Powdered Infant Formula
	Letter to the Infant Formula Industry
	Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
	Infant Formula
	*Cronobacter sakazakii*

                                                                                  Content current as of:
      01/10/2024
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Infant Formula & FoodsInfant Formula Guidance Documents & Regulatory Information

          
                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response
 
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