21 CFR Part 101 – Food Labeling

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / FSMA • Human Food Labeling

21 CFR Part 101 sets the U.S. FDA’s core food labeling rules for human food. It prescribes what must appear on labels—statement of identity, net quantity, ingredient list, major allergens, manufacturer info—and how the Nutrition Facts panel must be formatted. It also governs nutrient content claims, health claims, and other voluntary statements. Part 101 works alongside 21 CFR Part 117 (FSMA Preventive Controls) and Part 11 for electronic records.

“Part 101 is the final-mile control: turning safe product into a label consumers and inspectors can trust—every time, on every unit.”

1) What It Is

Part 101 specifies what must be declared on consumer food labels and exactly how it must be presented—panel placement, type size, rounding rules, serving sizes, and the permitted/forbidden language for claims.

Scope & application. Applies to most packaged human foods distributed in the U.S. (with specific exemptions/variances). Dietary supplements use Supplement Facts under 21 CFR 101.36 and are manufactured under Part 111.

Frequently cited sections:

• 101.3 – Statement of identity (common/usual name) on the principal display panel (PDP).
• 101.5 – Name/place of business of manufacturer, packer, or distributor.
• 101.4 – Ingredient list in descending order by weight; sub-ingredient declaration.
• 101.9 – Nutrition Facts format, mandatory nutrients, RACC/serving size, rounding.
• 101.22 – Flavor/color declarations (e.g., “natural flavor”), added color specifics.
• 101.105 – Net quantity of contents declaration on PDP (U.S. customary + metric).
• 101.13/101.14/101.70+ – Nutrient content claims and health claims (criteria and authorization).
• 101.36 – Supplement Facts format for dietary supplements.
• FALCPA/403(w) – Major allergen declaration, including sesame as the ninth allergen.

2) Labeling Practice & Data Integrity

Inspectors expect a controlled labeling system that prevents mix-ups and enforces accuracy from formulation through print. Best practice is to link approved formulations (ingredients, allergens, nutrition) to label templates and print devices, so only the correct label can be printed for a given SKU/lot.

• Master data control. Manage formulas/allergens in a controlled system (see Recipe Management).
• Nutrition calculation. Use current database values and RACC rules; lock rounding to 101.9.
• Allergen change control. Any reformulation triggers label updates and QA re-approval.
• Print enforcement. Approved templates only; label↔SKU/lot binding and line-clearance via WMS and eBR.
• Electronic records. Store approvals, calculations, and print logs under Part 11.

3) FAQ

Q1. What must appear on a U.S. food label?
Statement of identity, net quantity, name/place of business, ingredient list with sub-ingredients, major allergens, and a compliant Nutrition Facts panel.

Q2. How are serving sizes set?
Using FDA RACCs; the declared serving drives Nutrition Facts values, rounding, and claim eligibility.

Q3. How are allergens declared?
Declare the nine major allergens using common names in the ingredient list and/or a “Contains:” statement consistent with 403(w) and Part 101.

Q4. What’s the difference between nutrient content and health claims?
Nutrient content claims describe nutrient levels (101.13) and must meet numeric criteria; health claims link a nutrient/food to disease risk reduction and require FDA authorization (101.14/101.70).

Q5. When is a “Supplement Facts” panel used?
For dietary supplements per 101.36; manufacturing follows Part 111 cGMP.

Q6. Where is the rule?
eCFR text: 21 CFR Part 101.

4) How It Relates to V5

V5 by SG Systems Global operationalizes Part 101 by tying formulation master data to label generation and printing with full auditability.

• Controlled masters. Ingredients, allergens, specs, and claims approval in Recipe Management.
• Label enforcement. Only approved templates can print for the selected SKU/lot; label-to-lot reconciliation in WMS.
• Nutrition & CoA linkage. Calculations and finished-product tests flow into CoA and label claims.
• Change control & e-signatures. All edits routed through QMS with Part 11 audit trails.
• Traceability. Labels bind SKU↔lot↔allergen state; mislabel risk is reduced at print time and at shipment release.

End-to-end example. A new granola SKU is formulated in V5. Ingredients and allergens populate the label template; Nutrition Facts are calculated to 101.9 rules; QA approves the label in QMS; during packaging, only the approved label can be printed for the SKU/lot; WMS reconciles label counts and blocks shipment if the wrong template is scanned.

Primary References:
• eCFR: 21 CFR Part 101
• Preventive Controls (FSMA): 21 CFR Part 117
• Electronic Records: 21 CFR Part 11
• CoA & Labeling Data: Certificate of Analysis | WMS