<< Status Update on FDA’s Infant Formula Response Activities

FDA Evaluation of the Infant Formula Response

December 2023 

Recommendation 1: The FDA should review its systems and processes for receiving information from external parties, including but not limited to industry, consumers, other federal agencies, and international regulators regarding product safety and quality, adverse events, and manufacturing. The FDA should consider the feasibility, resource requirements, and potential benefits of connecting existing systems or developing a single system to receive, track, and process such information and ensure timely notification of appropriate personnel of potential signals of significant public health threat.

Update:

• The FDA created a Consumer Complaints and Inquiries (CC/I) Working Group in February 2023 and three associated workstreams to analyze the business processes and systems associated with the receipt of CC/I.
• The FDA also explored opportunities to improve interoperability between technological systems or develop a single system that can receive, track and process CC/I. While there is significant support for this kind of endeavor, additional funding would be necessary to implement such an effort.

Recommendation 2: The FDA should identify clear definitions for the terms “whistleblower,”

“confidential informant,” and “informant,” and develop policies and provide training to staff regarding how to identify, escalate, and appropriately manage confidentiality of such complaints. The agency should also consider connecting complaints from such individuals to information received from product safety complaints, and product manufacturing concerns systems to support more complete access to all safety information. The FDA is evaluating how best to integrate this data to gain a holistic view of all FDA-regulated products and/or manufacturing facilities. The FDA should also review and update its mail and package delivery procedures to ensure that all mail and packages are delivered and received by addressees in a timely manner.

Update:

• The FDA has made the following Agency-wide improvements to its handling of complaints from whistleblowers and confidential sources, as defined below: 
  • Whistleblower: An individual who discloses information regarding an FDA-regulated entity/product that the individual acquired during their current or former employment, alleging potential violation(s) of federal law or an illicit or unsafe product or activity.
  • Confidential Source:[1]  An individual who provides non-public information about an FDA-regulated entity/product, alleging potential violation(s) of federal law, or an illicit or unsafe product or activity, and who requests anonymity.
• The FDA created a new policy across the agency that generally requires triage and expedited initial action on complaints from whistleblowers and confidential sources. Under the new policy, Centers/Offices are required to gather available information pertaining to such complaints within 21 business days of FDA’s initial receipt, and then management will have 3 business days to review and determine next steps. Centers/Offices are working to establish written implementation procedures and are generally able to adhere to the above-described policy in the interim. An agency-wide Staff Manual Guide (SMG) is also in development; the SMG will be public once finalized.
• In addition, earlier this year, FDA’s Office of Operations (OO) initiated procedures to improve the tracking of accountable mail, which may include complaints, through the point of delivery.  This action will help to ensure that accountable mail is received and acted upon by the appropriate staff, within a reasonable timeframe.

Recommendation 3: The FDA should evaluate procedures for shipping and testing samples sent to regulatory laboratories and consider whether changes should be made to analytical capability and capacity, and ways to enable immediate notification and escalation of analytical results for significant public health threats. Data integration of laboratory findings with complaints and other reports has the potential to improve timely awareness of emerging public health threats.

Update:

• In April of 2023, the FDA expanded our capacity to ship samples by awarding a government-wide Next Generation Delivery Service (NGDS) to allow for the use of additional shipping contractors.
• As of September 2023, FDA’s laboratory capacity to test for Cronobacter has been expanded to all 7 ORA laboratories.
• All FDA laboratories have received new procedures for escalating significant testing results to senior leaders.

Recommendation 4: The FDA should thoroughly evaluate its policies and procedures related to the formation, staffing, and operation of Incident Management Groups, Incident Management Teams, and Agency Executive Groups during complex food safety-related emergencies. This evaluation should include criteria for forming and demobilizing such entities, quickly identifying the leadership and expertise needed for the specific incident, and establishing appropriate roles, responsibilities, and decision-making processes. The FDA should also consider ways to rapidly increase the availability of trained staff to boost capacity and capabilities for incident response, especially during multiple simultaneous public health emergencies.

Update:

• FDA leadership has reviewed and updated emergency procedures, including forming Incident Management Groups. Discussions continue around establishment and demobilizing criteria and as part of the reorganization package, it has been proposed to consolidate Agency emergency response into ORA via the Office of Emergency Operations. Once the re-organization is fully implemented you can expect to see changes in FDA’s emergency response and emergency management efforts under their new organization structure within the new ORA.

Recommendation 5: The FDA lacks authority for remote access to records or other information for many food related products. The agency should continue its evaluation of the additional authorities, tools and resources needed to remotely gather information from firms during public health emergencies when in-person inspections may not be feasible.

Update:

• As part of the FY 2024 President’s Budget request, the agency included a number of legislative proposals, including one that would expand FDA’s authority to require records or other information in advance of or in lieu of inspections to include all FDA-regulated products by revising section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to explicitly include food, tobacco product, and cosmetic establishments. Additionally, this proposal would add explicit authority to conduct remote regulatory assessments with establishments, which may include remote interactive evaluations such as livestreaming video of operations, teleconferences, and screen sharing, so FDA may interact virtually with an establishment and assess its compliance with applicable laws and regulations. This proposal will promote regulatory compliance and help to protect the public health, particularly during a public health emergency like the COVID-19 pandemic where in-person inspections and investigations were limited, by allowing FDA to conduct certain oversight activities prior to arriving for, or instead of, an inspection, thus improving the efficiency of FDA resources and reducing FDA’s on-site inspectional time, and by allowing the FDA to assess conditions at a facility without going onsite when an in-person visit is not feasible or deemed necessary by FDA.
• FDA also established a Work Group that examined current authorities, tools and resources to conduct remote oversight, and options for strengthening these capabilities going forward.  Expanding the scope of section 704(a)(4) noted above remains on the list of options; preliminary recommendations from that group are currently under review.

Recommendation 6: The FDA should consider holding after action meetings with appropriate regulatory and public health partners, including but not limited to the Department of Justice, the Department of Agriculture, the Department of Health and Human Services, and the Centers for Disease Control and Prevention, to identify challenges encountered during this incident, including different agency interests related to public health and legal investigations, and develop solutions to improve future collaboration.

Update:

• Since the recall in Feb. 2022, FDA has remained in close contact with multiple regulatory agencies and public health partners on all aspects related to infant formula.  During these conversations, which included, but were not limited to, participants from DOJ, USDA, HHS, and CDC, FDA has collected information both formally and informally about the challenges and potential solutions to timely communication during any potential future public health emergencies.
• The FDA built on these discussions by developing an immediate national strategy, in consultation with other federal partners, to increase the resiliency of the U.S. infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to infant formula and the information they need.

Recommendation 7: The FDA should determine the resources needed to develop a specialized training program for investigators and other personnel charged with inspection and oversight of infant formula and other medical foods manufacturing facilities, request those resources from Congress, and develop and implement a specialized training program.

Update:

• 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 utilizing existing resources, and specialized training programs are continuously being developed, piloted, and deployed as a part of that effort.
• In addition, over the last year, 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 also 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.
•  In October 2023, FDA hosted a webinar for investigators, compliance officers, and managers involved in infant formula inspections.  The webinar highlighted recent updates to the infant formula compliance program and provided an overview on new statutory requirements in this area. 

Recommendation 8: The FDA should evaluate its workforce needs related to infant formula regulation and oversight and utilize the appropriations process to help secure the resources needed.

Update:

• The FDA has evaluated the staffing needs for appropriate infant formula oversight and identified multiple areas where hiring is needed. In addition, with substantive input from FDA, the Food and Drug Omnibus Reform Act of 2022 authorized the creation of an Office of Critical Foods (OCF) (including infant formula products). Utilizing 21 Century Cures hiring authorities, FDA has begun to announce, interview, and staff 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, and a Senior Regulatory Counsel for Critical Foods.

Recommendation 9: The FDA should review its compliance procedures for critical food products and determine whether there is a need to clarify roles and responsibilities, consider the need for a decision matrix, and consider alternative activities to minimize product availability concerns when the product is a sole source of nutrition.

Update:

• FDA fully reviewed its compliance procedures for infant formula and other critical foods and has made significant updates to its infant formula compliance program, which was made available in October 2023.

Recommendation 10: The FDA should articulate to the infant formula industry what the agency has determined are best practices for product sampling, hygienic design of facilities, environmental monitoring, traceability information, and recordkeeping based on current science and technology. The FDA should consider all options for how best to clearly communicate such practices to industry.

Update:

• On March 8, 2023, FDA sent a letter to industry that discussed, among other things, properly evaluating process controls, ensuring compliance with current regulations, and implementing best practices for remediating contamination.
• The FDA has committed to issuing the following guidance for industry: “Evaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event.”
• The Agency is in discussions and providing technical assistance to a group led by the Infant Nutrition Council of America (INCA) to develop a best practice guide to improve manufacturing safety across the powdered infant formula industry.
• The FDA issued warning letters to three infant formula firms for inspection findings related to, among other things, failing to establish a system of process controls designed to ensure that infant formula does not become adulterated due to the presence of microorganisms;

Recommendation 11: A strong food safety culture is a prerequisite to effective food safety management. The FDA has initiated action with the New Era of Smarter Food Safety to foster, support, and strengthen food safety cultures in food facilities, and in homes. The FDA should evaluate this initiative for specific actions to target the infant formula industry.

Update:

• As a Core Element of the New Era of Food Safety, FDA is committed to fostering, supporting, and strengthening food safety culture on farms, in food facilities, and in homes. While the New Era portfolio is broader than the infant formula industry, we have taken lessons learned from the work on improving food safety culture and tailored it to the specifics of this industry.  
• In continued conversations with the infant formula industry, FDA has stressed the importance of a healthy food safety culture from the production line employee level all the way to the executive leadership. Ongoing conversations with all levels of the organization have stressed the importance of proper product sampling, hygienic design of facilities, environmental monitoring, traceability information, and recordkeeping to protect public health.

Recommendation 12: The FDA should conduct an analysis of its capabilities related to supply chain management for critical food products. The agency should work with the administration, Congress, and other federal agencies to establish industry and government roles and responsibilities for managing the supply chain of critical food products and identifying and securing authorities and resources to carry out those responsibilities where appropriate.

Update:

• As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, the FDA developed an Immediate National Strategy, which evaluated the events that led up to the voluntary recall of infant formula by Abbott Nutrition in February 2022 and the subsequent infant formula shortage; described immediate actions the FDA took to address the infant formula shortage; and detailed the agency’s plans for improving the resiliency of the infant formula supply, while noting multiple issues beyond the purview of the FDA.
• The FDA has also initiated work with National Academies of Sciences, Engineering, and Medicine (NASEM), which will conduct an independent study on challenges in supply, market competition, and regulation of infant formula in the United States.
• The FDA has also transitioned functionality of the 21 Forward tool to the FDA’s Office of Digital Transformation. The tool, which was developed via contract, helped to inform work to track and anticipate supply chain disruptions first during COVID-19 and later through the infant formula shortages.

Recommendation 13: The FDA should work with researchers in federal and state government, academia and industry to address gaps in scientific knowledge of Cronobacter. Based on an expanded scientific understanding, the FDA should update its policies, processes, and procedures to ensure the agency provides infant formula manufacturers appropriate preventive control measures for Cronobacter.

In addition, the FDA should consider resuming, as well as reordering, unannounced surveillance inspections at domestic infant formula facilities each year and should evaluate factors such as including inspectional history, consumer complaints, and supply chain impacts.

Update:

• The FDA supported 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 charged the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) with addressing some of the most pressing knowledge gaps surrounding Cronobacter, including current prevalence, risk factors, effective management practices, and opportunities for improved messaging. NACMCF has formed its committee and meetings are underway on the topic. FDA remains committed to updating their regulations and guidance for the infant formula industry based on best scientific evidence available.
• The FDA continues to pursue these and other research efforts as part of our Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula.
• The FDA has resumed unannounced surveillance inspections at all domestic infant formula facilities. As with other commodities, the timing of these inspections changes year after year based on multiple pieces of information, including inspectional history and consumer complaints. 

Recommendation 14: The FDA should review and update its compliance program and associated Compliance Policy Guide for infant formula manufacturers to ensure it reflects current science on Cronobacter, provides consistent industry oversight, and provides better tools for investigators and compliance officers, enabling the agency to take a comprehensive approach to inspections of infant formula manufacturing facilities and compliance activities.

Update:

• In October 2023 the FDA updated  its compliance program for infant formula, which is available online
• The FDA hosted a webinar in October 2023 to brief field investigators, compliance officers, and managers on significant updates to the compliance program.  

Recommendation 15: The FDA should work with the CDC, USDA, and other stakeholders, especially including those in the pediatric field and other health care providers, to identify and develop additional tools and resources to educate parents and caretakers, so they understand the potential risks associated with powdered infant formula and how to reduce those risks through proper handling and preparation.

Update:

• Based on our improving understanding of Cronobacter and its associated risk factors, the FDA, in close collaboration with CDC, USDA, HHS, and other stakeholders, has created new web pages, fact sheets, and other content to highlight the importance of safe handling practices and the mechanisms for reducing the risk of Cronobacter infection during infant formula preparation. Additionally, we have worked with stakeholders in the pediatric and other health care fields to ensure that these materials are accessible to those populations most directly affected.
• The FDA has developed a new resource on handling infant formula safely, which is available in both English and Spanish.

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[1] FDA’s use of the term “confidential informant,” the term used in recommendation 2, is limited to criminal investigations, in line with the Department of Justice’s definition of the term.  For purposes of regulatory activities, the term “confidential source” is used.