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It was on January 31st, 2023, Food and Drug Administration (FDA) made a groundbreaking announcement proposing the redesign of the Human Foods Program ,, a decision that came in the wake of crucial insights from an external evaluation conducted by an expert panel from the Reagan-Udall Foundation, as well as an internal review of the FDA’s 2022 infant formula incident.
On 27th June 2023, the FDA unveiled some developments with regard to the Human Foods Program, bringing more clarity to its structure. Dr. Robert M. Califf, Commissioner of Food and Drugs, emphasized that the proposed changes would lead to a revamped framework that is more agile and capable of effectively preventing and responding to emergencies such as recalls.
The program will now integrate elements from the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response, and select components of the Office of Regulatory Affairs (ORA). The envisioned improvements are based on feedback from employees and stakeholders and aim to enhance the FDA’s ability to unify fieldwork and align inspection resources with the priorities of their centers and programs, all while providing support to both employees and the public they serve.
Unraveling FDA’s Motive for Evolving Human Foods Program
The FDA holds the distinction of being the oldest comprehensive consumer protection agency in the U.S. federal government. Over the years, Congress has granted the FDA legislative powers to oversee the food supply more comprehensively, particularly through notable laws, including the 1958 Food Additives Amendment, 1980 Infant Formula Act, 1990 Nutrition Labeling and Education Act, 1994 Dietary Supplement Health and Education Act, and the 2004 Food Allergen Labeling and Consumer Protection Act. The FDA Food Safety Modernization Act, enacted later, focused on preventive measures and the importance of robust foodborne illness and outbreak surveillance systems.
What began as a focused mission to ensure truth in labeling and product purity grew incrementally through legislation and led to the establishment of the FDA’s Human Foods Program, which now carries greater responsibilities concerning public health, food safety, and nutrition. Presently, the Human Foods Program encompasses nine primary functions, as outlined by the Office of the Commissioner:
- Standards setting and policy development
- Education, outreach, and training
- Premarket notification and petition review
- Surveillance activities
- Response actions
- Enforcement of standards
- Inter- and intra-governmental relations
- Information management
- Cross-cutting support activities
FDA has thoroughly examined the results and suggestions derived from the two evaluations of the Reagan-Udall Foundation and an internal review of the agency’s response to the infant formula supply chain. This led to highlighting concerns related to culture, structure, resources, and authorities within the agency. Following are some key findings that ushered in the overhaul of the Human Foods Program:
“FDA has dedicated staff who are committed to protecting public health, but the current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal”.
“While the Human Foods Program has specified functions, a clear unifying vision and mission for the entire program is not apparent”.
“The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil”.
“The Human Foods Program approach of relying on consensus has significant drawbacks for making decisions about taking regulatory action”.
“A culture of cooperation and accountability in the Human Foods Program’s field operations needs to be re-established to fulfill the potential of program alignment and to optimize the performance of the Human Foods Program”.
“The Human Foods Program culture appears to foster an aversion to risk that undercuts its ability to meet its public health mandate”.
On behalf of the FDA, Dr. Robert M. Califf pointed out the need to build a stronger Human Foods Program and Office of Regulatory Affairs due to the rapidly evolving human food landscape so that as consumer preferences, products, and manufacturing processes become more complex and public health needs increase, FDA would be able to adapt accordingly.
Understanding FDA’s Latest Update on FDA’s Unified Human Foods Program
Over the past few months, a cross-cutting working group of agency officials with expertise in various functional and operational areas has been collaborating to identify opportunities to strengthen operations within the new HFP and ORA. Following this, an update was released, introducing modifications, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These changes are designed to improve coordination, prevention, and response activities across the FDA, ultimately supporting its public health mission more effectively. Given below are the proposed improvements:
- ORA’s core mission will be focused on conducting investigations, inspections, and imports for all FDA-regulated products. Assignments will be made in collaboration with the HFP and other product programs or centers. The new Deputy Commissioner for Human Foods will oversee all budget and resource allocations for the entire HFP, including ORA resources.
- Compliance functions currently managed within ORA will be merged into the HFP and the compliance functions of other product centers. This streamlining of operations aims to expedite decision-making.
- The eight Human and Animal Food laboratories currently managed by ORA will be realigned into the HFP. These labs will join forces with the four labs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and Center for Veterinary Medicine (CVM) director to coordinate research priorities. These labs will continue to operate in their current geographic locations.
- Certain functions from the Office of Security and Emergency Management, which are currently in the Office of Operations, will be transitioned to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant Centers and Offices to coordinate responses to emergency situations involving regulated products, such as recalls, hurricanes, fires, floods, etc.
- State and local food safety partnership functions and certain aspects of international food safety partnerships will be unified into an Office of Integrated Food Safety System Partnerships in the HFP. This office will again report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will closely collaborate with the CVM director to advance a truly integrated food safety system.
- Support functions across ORA will be reviewed, and certain resources and personnel will be realigned to support the proposed changes. This includes staff and resources in ORA’s Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management.
- There will be a focus on recruiting, retaining, and training field-based employees to support the agency’s ongoing efforts to increase inspectional activities domestically and internationally.
As part of the unified HFP and new ORA model, the agency presented high-level organization charts to illustrate the proposed changes.
Reference: Proposed Human Foods Program Organization Chart (FDA) – https://www.fda.gov/media/169814/download?attachment
By bringing the right organizational configuration through these changes, FDA will attain the following benefits in achieving its mission:
- Setting the strategic direction and successful operations of the Human Foods Program
- Communicating to internal and external stakeholders about who oversees the various facets of the Program
- Facilitating timely and predictable decision-making, with a preference for action
- Recruiting qualified internal and external candidates into senior management positions
Finally, the Deputy Commissioner for Human Foods will be empowered to have full authority over all foods-related resources and set the strategic direction for them. The FDA is also currently considering a renaming effort for ORA to better align its title to the structure and functional duties of the agency’s field operations.
Potential Impact of Proposed Changes on Food Manufacturers and Suppliers
As the regulatory landscape for the U.S. food industry evolves with FDA’s restructuring, it becomes crucial to consider the potential effects of the proposed changes on food manufacturers and suppliers. It is important to note that the specific impacts on these entities may vary depending on the nature of their products, the size of their operations, and their current compliance practices. Embracing the proposed changes and ensuring smooth transitions would demand meticulous assessment, proactive measures, and continuous collaboration with regulatory authorities. Let’s look at the anticipated implications and shed light on the necessary steps that food manufacturers and suppliers may need to undertake to thrive in this evolving regulatory environment.
Streamlined Regulations
The consolidation of departments and offices under the Unified Human Foods Program would lead to streamlined regulations for food manufacturers and suppliers. This could result in clearer guidelines and quicker responses to issues related to FDA-regulated products, making it easier for them to understand and comply with the regulations. They may also experience changes in how emergency situations are managed, permitting faster resolution of compliance-related matters, recalls, or emergency situations aided by efficient communication channels and response timelines.
Centralized Regulatory Supervision
With the merger of compliance functions from various centers into the HFP, food manufacturers and suppliers will face a more centralized regulatory oversight structure. This means that the regulatory requirements, inspections, and enforcement actions will be coordinated under a unified program, potentially leading to more standardized processes and consistent application of regulations. This could drive more rigorous inspections, augmented monitoring, and stricter enforcement of regulations. Food manufacturers and suppliers would need to ensure that their operations and products meet the required standards to avoid penalties or recall.
Collaboration & Coordination
The Unified Human Foods Program emphasizes coordination and collaboration among different agencies, organizations, and stakeholders involved in food safety, paving the way to closer partnerships between the FDA and stakeholders. Food manufacturers and suppliers may see a greater emphasis on science-based regulations and standards through collaborative efforts such as sharing information, best practices, and resources to ensure the safety and quality of food products, which could influence their product development and manufacturing processes.
Reorganized Compliance Activities
The concentration on field-based employees to optimize overall inspectional activities signifies a heightened focus on surveillance and monitoring of food manufacturing and supply chain processes. Consequently, food industries will be subjected to frequent inspections, which could impact their operations and require them to maintain higher levels of compliance readiness. Food manufacturers and suppliers need to adapt to the new regulatory structure and ensure that their operations align with the updated requirements. This may involve additional training, adjustments to processes, and potential changes in reporting or documentation, along with alterations in how they interact with various regulatory offices and their audit management strategies.
Enhanced Food Safety Assessment
The proposed changes aim to enhance food safety and promote nutrition, hugely affecting consumer perceptions. As a result, consumers may have higher expectations for the safety and quality of food products. Food manufacturers and suppliers would need to prioritize food safety measures, maintain transparency, and communicate effectively with consumers to build trust and meet their expectations. The establishment of a unified food laboratory enterprise under the HFP could lead to more comprehensive testing and analysis of their products, which may help in faster product approvals or prompt resolution of complaints, product holds, and deviations.
Food Safety System Partnerships
The unification of state and local food safety partnership functions and aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP may affect how food manufacturers and suppliers interact with regulatory agencies at different levels. They can play a pivotal role in advancing a cohesive food safety system by fostering relations with authoritative bodies to accomplish the goal of ensuring the safety of FDA-regulated food products throughout the supply chain, eventually influencing how products are regulated across different regions and countries.
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