In a strategic move to align with current food labelling regulations and reinforce public health protection, the U.S. Food and Drug Administration ( US FDA) has revised its Compliance Program 7321.005, now renamed “General Food Labelling Requirements and Labelling-Related Sample Analysis – Domestic and Import.” This update replaces the 2010 version and underscores the FDA’s continued commitment to ensuring food labels are truthful, not misleading, and fully compliant with federal law.
What Is US FDA Compliance Program 7321.005?
Compliance Programs (CPs) are internal US FDA documents that outline inspectional strategies, priorities, and procedures for FDA investigators. CP 7321.005 specifically addresses general food labelling, guiding inspectors in evaluating compliance of both domestic and imported food products with U.S. food labelling laws.
The program is a cornerstone of the FDA’s regulatory framework, enabling uniformity and consistency across inspections while reinforcing the agency’s public health mission.
Key Highlights of the Update
The latest revision to the US FDA Compliance program brings significant enhancements, including:
- Recognition of Sesame as a Major Allergen
Following the FASTER Act of 2021, sesame is now officially listed as the ninth major food allergen in the U.S. Food manufacturers must now declare sesame on food labels, similar to peanuts, milk, and soy. - Updated Guidance on Gluten-Free Labelling
The revised program includes detailed inspection protocols to verify the proper use of “gluten-free” claims, ensuring that only compliant products carry the designation. - Alignment with 2016 Nutrition Facts Label Changes
The FDA program reflects the updated requirements related to the Nutrition Facts label, including new formatting, changes in required nutrients (like added sugars), and revised Daily Values (DVs). These updates are designed to help consumers make more informed dietary choices. - Enhanced Oversight of Imported Foods
The program provides a more robust framework for assessing imported food products, aiming to ensure the same compliance standards are maintained as those for domestic foods. - Strengthened Data Consistency Across FDA Operations
With standardized protocols, the updated CP enhances the reliability of data collected during inspections and sample analyses, allowing the FDA to better monitor compliance trends and target enforcement.
Implications for Food Manufacturers and Importers
This update signals a proactive shift in US FDA enforcement strategy. Food business operators—whether manufacturing in the U.S. or exporting to the U.S. market—must now be even more vigilant about their labels. Failure to comply with the revised standards could result in warning letters, product recalls, or import refusals.
For companies exporting to the U.S., this is a critical time to revisit their labelling protocols, allergen declarations, and use of nutrient content claims. Third-party audits and internal label reviews may be prudent to avoid regulatory pitfalls.
Staying Compliant: Next Steps
To ensure compliance:
- Reassess current product labels for sesame and other allergen disclosures.
- Review and update any “gluten-free” claims as per FDA definitions.
- Align your Nutrition Facts panels with the 2016 formatting requirements.
- Train quality assurance teams on the revised CP guidelines.
- Consider regulatory consultancy or label review services to proactively mitigate risks.
For full details and guidance documents, visit the official US FDA page: FDA Food Labelling & Nutrition
Conclusion
The US FDA had announced Uniform Compliance Date for Food Labeling Regulations on the 30th of December 2024. The update to US FDA Compliance Program 7321.005 marks a pivotal step in strengthening food labelling enforcement and harmonising domestic and international compliance efforts. For the food industry, this is not just a regulatory update—it’s a call to action to ensure labels are scientifically accurate, legally sound, and consumer-trustworthy. To read more about this, click here.