21 CFR Part 101: Food Labeling
Part 101 of title 21 runs to 50 sections across 7 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 50
- Subparts
- 7
- Words of regulation
- 104,379
- Current to
- 2026-09-10
What this clause controls in practice
A food safety plan controls one hazard under 21 CFR part 101, and FDA food recalls name an undeclared allergen in 7,778 enforcement records since 2012. That is where the clause belongs, not a finding against any firm named below: a recall record states a reason, and most FDA food recalls are initiated by the firm itself.
Recent records naming one of those hazards:
Subpart A: General Provisions
- 101.1 Principal display panel of package form food4
- 101.2 Information panel of package form food27
- 101.3 Identity labeling of food in packaged form19
- 101.4 Food; designation of ingredients37
- 101.5 Food; name and place of business of manufacturer, packer, or distributor5
- 101.7 Declaration of net quantity of contents46
- 101.8 Vending machines39
- 101.9 Nutrition labeling of food277
- 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims1
- 101.11 Nutrition labeling of standard menu items in covered establishments140
- 101.12 Reference amounts customarily consumed per eating occasion55
- 101.13 Nutrient content claims—general principles88
- 101.14 Health claims: general requirements38
- 101.15 Food; prominence of required statements14
- 101.17 Food labeling warning, notice, and safe handling statements92
- 101.18 Misbranding of food9
Subpart B: Specific Food Labeling Requirements
Subpart C: Specific Nutrition Labeling Requirements and Guidelines
- 101.36 Nutrition labeling of dietary supplements79
- 101.42 Nutrition labeling of raw fruit, vegetables, and fish8
- 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish7
- 101.44 What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?3
- 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish22
Subpart D: Specific Requirements for Nutrient Content Claims
- 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”35
- 101.56 Nutrient content claims for “light” or “lite.”36
- 101.60 Nutrient content claims for the calorie content of foods50
- 101.61 Nutrient content claims for the sodium content of foods41
- 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods132
- 101.65 Implied nutrient content claims and related label statements37
- 101.67 Use of nutrient content claims for butter8
- 101.69 Petitions for nutrient content claims70
Subpart E: Specific Requirements for Health Claims
- 101.70 Petitions for health claims48
- 101.71 Health claims: claims not authorized3
- 101.72 Health claims: calcium, vitamin D, and osteoporosis17
- 101.73 Health claims: dietary lipids and cancer22
- 101.74 Health claims: sodium and hypertension24
- 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease27
- 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer23
- 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease30
- 101.78 Health claims: fruits and vegetables and cancer27
- 101.79 Health claims: Folate and neural tube defects31
- 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries38
- 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD)42
- 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD)28
- 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD)39
Subpart F: Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
Subpart G: Exemptions From Food Labeling Requirements
Read 21 CFR part 101 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 101 cover?
- 21 CFR part 101 is Food Labeling. It runs to 50 sections across 7 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
- Which hazards does 21 CFR part 101 control?
- A food safety plan controls an undeclared allergen under part 101. Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
Every section of part 101 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.