FDA Launches New Human Foods Program

A Restructured Approach to Food Safety and Regulation

On October 1, 2024, the FDA's new Human Foods Program (HFP) officially launched, marking a significant shift in the agency's approach to food safety and regulation. This new program aims to streamline operations, improve coordination, and enhance consumer protection by centralizing and strengthening various aspects of food oversight.

Key Changes and Implications

The HFP introduces several key changes, including the creation of the Office of Inspections and Investigations and a new online consumer complaint form. These changes are designed to improve surveillance, response times to outbreaks, and communication with stakeholders.

This reorganization also signifies a renewed focus on several core areas:

• Preventive Controls and Food Safety Programs: The HFP emphasizes the preventive vision of the Food Safety Modernization Act (FSMA), placing greater importance on proactive measures to prevent foodborne illnesses. This means food businesses need to be even more diligent in implementing and maintaining robust food safety plans that comply with FSMA requirements, such as Hazard Analysis and Risk-Based Preventive Controls (HARPC).
• Nutrition and Chronic Disease Prevention: The HFP elevates the role of nutrition in public health, aiming to reduce diet-related chronic diseases. This could lead to increased scrutiny of food labeling and the nutritional content of food products, with potential implications for product formulation and marketing. Food companies should be prepared for potential updates to labeling regulations, such as those related to added sugars and serving sizes, and consider proactively reformulating products to align with public health goals.
• State Partnerships and Agricultural Technologies: Recognizing the importance of collaboration, the HFP seeks to strengthen partnerships with state agencies and leverage advancements in agricultural technology to enhance food safety across the supply chain. This highlights the need for food businesses to stay informed about both federal and state regulations and consider adopting new technologies to improve traceability and safety.
• Risk Management and Prevention: The HFP establishes new "risk management super offices" to improve resource allocation, strategic planning, and communication with stakeholders. This centralized approach to risk management could lead to more efficient identification and mitigation of potential hazards, but it also underscores the importance of proactive engagement with the FDA for food businesses.

What This Means for Your Business

These changes have significant implications for food businesses of all sizes.

"The HFP's focus on prevention and proactive risk management means that companies can no longer afford to take a reactive approach to food safety," says David Graham, a litigator at Gardner Law specializing in FDA law and food. "Staying ahead of the curve requires a deep understanding of evolving regulations, robust food safety plans, and a commitment to continuous improvement."

Gardner Law is closely monitoring the HFP and its impact on food regulations. We can help you navigate these changes by:

• Analyzing and evaluating your existing food safety and labeling programs
• Ensuring compliance with current and future FDA regulations
• Developing and implementing robust preventive controls
• Staying informed about emerging trends and best practices

Contact Gardner Law today to discuss how we can help you protect your business and ensure the safety and compliance of your food products.