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Checklist

Master FDA Food Label Compliance: Your Essential Checklist

Navigating FDA food labeling rules can be complex. This checklist simplifies the process, helping CPG brands ensure full compliance. Avoid costly errors and protect your brand's integrity.

Key Takeaways
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General Labeling Essentials
Product name is clearly visible on the principal display panel (PDP)
Net quantity of contents is declared in both US and metric units
Manufacturer, packer, or distributor name and address is present
Font size meets FDA minimum requirements for all required elements
PDP size meets regulatory requirements based on package surface area
Nutrition Facts Panel
Nutrition Facts label uses the updated FDA format (post-2020)
Serving size reflects the amount typically consumed (RACC-based)
Servings per container is accurate
Calories per serving is prominently displayed in bold
All required nutrients are declared (total fat, saturated fat, trans fat, cholesterol, sodium, total carbs, dietary fiber, total sugars, added sugars, protein, Vitamin D, calcium, iron, potassium)
Daily Value percentages are correct based on 2,000 calorie reference
Added sugars are declared separately under Total Sugars
Ingredients and Allergens
All ingredients are listed in descending order of predominance by weight
All 9 major allergens are identified: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame
A "Contains" statement is present immediately after or adjacent to the ingredient list
Sub-ingredients of compound ingredients are declared in parentheses
Incidental additives that serve no function in the finished product are omitted
Claims and Special Labeling
All marketing claims (natural, organic, gluten-free, non-GMO) are substantiated
Any health claims are FDA-approved and meet specific criteria
For organic products: USDA Organic seal usage complies with NOP regulations
For organic products: organic percentage is correctly calculated and displayed
Gluten-free claims comply with FDA definition (less than 20 ppm gluten)
Country of origin labeling (COOL) is present if required
Barcodes and Traceability
UPC/EAN barcode is present and scannable
Lot number or production code is present for traceability
Best by / use by / sell by date format is clear and unambiguous
For FSMA 204 compliance: Key Data Elements (KDEs) are traceable to this label
✓
Label review complete.

Ready to submit for compliance review or retailer approval.

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This checklist reflects workflows Guidance is being designed to connect. The commercial rebuild is being validated with CPG design partners.

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Frequently Asked Questions

Why is FDA food label compliance important?

It ensures consumer safety, builds trust, and helps avoid costly recalls, fines, and legal issues. Proper labeling is fundamental to market access.

How often should I review my food labels?

Labels should be reviewed annually or whenever there are changes to ingredients, formulations, or FDA regulations. Regular audits prevent non-compliance.

Can Guidance help with label compliance beyond this checklist?

Yes, Guidance provides tools for real-time COGS, organic mass balance, and lot traceability, all of which support robust label claim substantiation and compliance management. Our platform streamlines operational data for accuracy.

Built for CPG Operators

Help shape the commercial release.

A working prototype validated Guidance's core operating model. The commercial rebuild is translating that proof into production-ready workflows with CPG design partners.

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Working prototype validated. Help shape the commercial release.

Guidance is rebuilding the platform for commercial release with CPG design partners.

Apply as Design Partner