US FDA Food Labeling Regulations (21 CFR Part 101)
The FDA's food labeling regulations: identity and net quantity on the principal display panel, ingredient declaration, the Nutrition Facts and Supplement Facts panels with serving sizes and accuracy tolerances, menu labeling for chains, defined nutrient content and health claims including 'healthy', warning statements, gluten-free, structure and function disclaimers and juice percentage declarations.
US FDA Food Labeling Regulations (21 CFR Part 101) is a compliance framework from United States (federal; USDA-regulated meat, poultry and egg products follow 9 CFR instead) with 4 domains and 25 controls. The largest domains are Subpart A: General provisions (principal display panel, information panel, identity, ingredients, name and place of business, nutrition labeling, warnings, misbranding) – US FDA Food Labeling Regulations (21 CFR Part 101) (14 controls), Subparts D and E: Nutrient content claims and health claims – US FDA Food Labeling Regulations (21 CFR Part 101) (5 controls), Subpart B: Specific food labeling requirements (flavors, colors, juice, dietary supplements) – US FDA Food Labeling Regulations (21 CFR Part 101) (3 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (4)
Subpart A: General provisions (principal display panel, information panel, identity, ingredients, name and place of business, nutrition labeling, warnings, misbranding) – US FDA Food Labeling Regulations (21 CFR Part 101)
| Code | Title |
|---|---|
| us-fda-food-labeling-regulations-21-cfr-part-101::101.105 | Net quantity of contents: on the PDP in the lower 30 percent, in weight, measure or count with metric and US customary units, in the minimum type sizes by PDP area, free from packaging material and with the reasonable variation and 'jumbo' prohibitions (101.105) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.11 | Menu labeling in covered restaurants and similar retail food establishments with 20 or more locations: calories on menus and menu boards, the succinct statement, additional written nutrition information on request, and the reasonable basis requirement (101.11) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.15 | Prominence of required statements: conspicuousness, type size and contrast, English language with foreign-language duplication rules, and no obscuring design (101.15) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.17 | Food labeling warning, notice and safe handling statements: self-pressurized containers, protein products, dietary supplements with iron, shell eggs safe handling, juices not processed to reduce pathogens, and the related statements (101.17) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.18 | Misbranding of food: false or misleading labeling, misleading statements of identity, undue prominence of an ingredient (for example 'butter' in a shortening blend), and misleading pictorial representations (101.18) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.2 | Information panel: placement of ingredients, name and place of business and nutrition labeling immediately to the right of the PDP, together without intervening material, in type at least one-sixteenth inch, with the small-package and intervening-material rules (101.2) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.3 | Statement of identity on the PDP: the common or usual name, standardized name or descriptive name, in bold type parallel to the base, with form of the food and the 'imitation' rule (101.3) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.4 | Ingredient designation: common or usual names in descending order of predominance by weight, sub-ingredient declaration, the 2 percent rule, collective names, and the specific rules for spices, flavors, colors, fats, sweeteners and water (101.4) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.5 | Name and place of business of the manufacturer, packer or distributor, with 'manufactured for' or 'distributed by' where not the manufacturer, and the street address rule (101.5) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.9-ACC | Compliance and accuracy: Class I and Class II nutrient tolerances (at least 100 percent for added vitamins, at least 80 percent for naturally occurring beneficial nutrients, no more than 120 percent for calories, fats, sugars and sodium), composite sampling and record keeping for added sugars and fiber determinations (101.9(g)) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.9-CONTENT | Nutrition labeling: the mandatory Nutrition Facts declaration (calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, potassium) with Daily Values, rounding and the voluntary nutrients (101.9(a) to (d)) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.9-EXEMPT | Nutrition labeling exemptions: small business (fewer than 100 full-time equivalent employees and fewer than 100,000 units) with annual notice, low-volume, foods of no nutritional significance, restaurant and ready-to-eat foods, bulk foods, infant and young children foods, and the loss of exemption when claims are made (101.9(j)) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.9-FORMAT | Nutrition Facts format: the standard, tabular, linear, dual-column and aggregate formats, type sizes, the calories prominence, footnote, and the single-serving and multi-serving container rules (101.9(d) to (f)) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.9-SERV | Serving size based on the Reference Amounts Customarily Consumed (101.12) expressed in common household measures with the metric equivalent, servings per container and the discrete unit rules (101.9(b), 101.12) |
Subpart B: Specific food labeling requirements (flavors, colors, juice, dietary supplements) – US FDA Food Labeling Regulations (21 CFR Part 101)
| Code | Title |
|---|---|
| us-fda-food-labeling-regulations-21-cfr-part-101::101.22 | Spices, flavorings, colorings and chemical preservatives: 'artificially flavored' and 'with other natural flavor' labeling, the natural and artificial flavor definitions, colors declared by name (certified colors such as FD&C Yellow No. 5) and the 'color added' designation, preservative function statements, and the flavor supplier certification (101.22) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.30 | Percentage juice declaration for beverages that contain fruit or vegetable juice, 'contains X% juice', the 'flavored' naming for beverages with less than 100 percent juice, and reconstituted and concentrated juice rules (101.30) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.36 | Dietary supplements: the 'Supplement Facts' panel with serving size, dietary ingredients with RDIs or DRVs and percent Daily Value, other dietary ingredients and proprietary blends, the format rules, and the plant part and source designation (101.36) |
Subparts D and E: Nutrient content claims and health claims – US FDA Food Labeling Regulations (21 CFR Part 101)
| Code | Title |
|---|---|
| us-fda-food-labeling-regulations-21-cfr-part-101::101.13 | Nutrient content claims: only claims defined by regulation, the general requirements for relative claims (reference food, percentage difference, quantitative comparison), the disclosure statement for foods exceeding fat, saturated fat, cholesterol or sodium thresholds, the 'free' and 'low' terms and implied claims (101.13) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.14 | Health claims: only authorised claims, the general requirements (disqualifying nutrient levels, the 10 percent minimum nutrient contribution, complete and truthful wording, no claim on infant foods), and qualified health claims under enforcement discretion (101.14) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.54-62 | Defined nutrient content claims: 'good source', 'high', 'more' (101.54); 'light' (101.56); calories ('calorie free', 'low calorie', 'reduced calorie', 'sugar free', 'no added sugars') (101.60); sodium ('sodium free', 'very low sodium', 'low sodium', 'reduced sodium') (101.61); fat, fatty acid and cholesterol ('fat free', 'low fat', 'reduced fat', 'saturated fat free', 'cholesterol free', 'lean', 'extra lean') (101.62) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.65-69 | Implied nutrient content claims, the 'healthy' criteria (food group content and limits on saturated fat, sodium and added sugars under the 2024 rule), 'fresh' and 'freshly' (101.95), and the petition procedure for new claims (101.65, 101.67, 101.69, 101.95) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.70-83 | Authorised health claims and their conditions: calcium and vitamin D and osteoporosis (101.72), dietary lipids and cancer (101.73), sodium and hypertension (101.74), saturated fat and cholesterol and coronary heart disease (101.75), fiber-containing grains, fruits and vegetables and cancer (101.76), fruits, vegetables and grains with fiber and coronary heart disease (101.77), fruits and vegetables and cancer (101.78), folate and neural tube defects (101.79), sugar alcohols and dental caries (101.80), soluble fiber from certain foods and coronary heart disease (101.81), soy protein and coronary heart disease (101.82), plant sterol and stanol esters and coronary heart disease (101.83), and the petition procedure (101.70) |
Subparts F and G: Exemptions and specific labeling provisions (gluten-free, supplement statements, fresh) – US FDA Food Labeling Regulations (21 CFR Part 101)
| Code | Title |
|---|---|
| us-fda-food-labeling-regulations-21-cfr-part-101::101.100 | Exemptions from labeling requirements: foods in bulk for processing or repacking, foods for institutional use, open containers in retail, incidental additives and processing aids, sulfites at 10 ppm, and the conditions on shipment and ingredient declaration (101.100) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.91 | Gluten-free labeling: 'gluten-free', 'no gluten', 'free of gluten' and 'without gluten' only on foods containing less than 20 ppm gluten with no gluten-containing grain or derived ingredient from which gluten was not stripped out, including fermented and hydrolyzed foods and the records they require (101.91) |
| us-fda-food-labeling-regulations-21-cfr-part-101::101.93 | Dietary supplement structure and function statements: the 30-day FDA notification, the disclaimer 'This statement has not been evaluated by the Food and Drug Administration...' in boldface with the required placement, and the distinction from disease claims (101.93) |
What is US FDA Food Labeling Regulations (21 CFR Part 101) and who does it apply to?
US FDA Food Labeling Regulations (21 CFR Part 101) is a compliance framework from United States (federal; USDA-regulated meat, poultry and egg products follow 9 CFR instead) with 4 domains and 25 controls. The FDA's food labeling regulations: identity and net quantity on the principal display panel, ingredient declaration, the Nutrition Facts and Supplement Facts panels with serving sizes and accuracy tolerances, menu labeling for chains, defined nutrient content and health claims including 'healthy', warning statements, gluten-free, structure and function disclaimers and juice percentage declarations. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does US FDA Food Labeling Regulations (21 CFR Part 101) actually require?
US FDA Food Labeling Regulations (21 CFR Part 101) has 25 controls organised across 4 domains. The largest domains are Subpart A: General provisions (principal display panel, information panel, identity, ingredients, name and place of business, nutrition labeling, warnings, misbranding) – US FDA Food Labeling Regulations (21 CFR Part 101) (14 controls), Subparts D and E: Nutrient content claims and health claims – US FDA Food Labeling Regulations (21 CFR Part 101) (5 controls), Subpart B: Specific food labeling requirements (flavors, colors, juice, dietary supplements) – US FDA Food Labeling Regulations (21 CFR Part 101) (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of US FDA Food Labeling Regulations (21 CFR Part 101) do I already cover?
US FDA Food Labeling Regulations (21 CFR Part 101) does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
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