The US FDA has issued a major update to its Compliance Program 7321.005, now titled: “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import.”
It replaces the previous 2010 version of the program and reflects the latest in labeling regulations, enforcement priorities, and inspection procedures—both in the U.S. and abroad.
The Compliance Program (CP) is a guide book playbook for FDA inspectors that outlines how they evaluate food facilities (domestic and foreign), how they collect labeling-related samples, and how they decide what’s compliant or not. Its goal is to ensure food products are truthfully labeled, meet safety standards, and don’t mislead US consumers.
FDA’s updates bring the CP in line with more recent regulatory changes and public health priorities. Major updates include:
1. Sesame Now a Major Allergen
Sesame is officially the 9th major food allergen and must be clearly declared on labels. If your products contain sesame (or are processed in facilities that handle it), your labeling must reflect this.
2. Stricter Gluten-Free Labeling Guidelines
The program includes clearer direction on gluten-free labeling requirements. If you’re importing specialty or health food products, you must ensure your gluten-free claims meet FDA definitions and are substantiated.
3. Nutrition Facts Label Modernization
The update reflects the 2016 Nutrition Facts label changes, including:
- Bolder calorie counts
- Updated serving sizes
- Mandatory declaration of added sugars
- Revised daily values for nutrients
All imported foods must comply with these updated formatting and nutrient declaration rules.
The FDA is sharpening its focus on label accuracy, with increased scrutiny at ports of entry. Mislabeling – whether it’s undeclared allergens, outdated formats, or unsubstantiated claims – could lead to detentions, refusals, and additional costs.
This new guidance gives FDA field investigators more consistent tools to identify noncompliant labels, so proactive compliance is key.
For additional guidance, please review the FDA’s Food Labeling and Nutrition page here.
