Q.01

What does the FDA require on a Nutrition Facts label?

Under 21 CFR 101.9, nutrition labeling is required for all food intended for human consumption and offered for sale unless an exemption in paragraph (j) applies [1]. The label must be a "Nutrition Facts" panel in a set format. It lists a fixed set of mandatory nutrients per serving, each with a % Daily Value where one is set.

Approach: I read the current eCFR text of 21 CFR 101.9 (Title 21, Part 101). Related sections it refers to, such as the reference amounts in § 101.12 and the graphic specifications in Appendix B to Part 101, were not reviewed in detail here.

Mandatory nutrients, in the required order

Nutrients must use the names given in the regulation and appear in this order. Nothing outside the mandatory and voluntary lists may appear in the panel [2].

NutrientUnit and roundingConditional relief
CaloriesNearest 5 up to 50; nearest 10 above 50; under 5 may be shown as 0 [3]None
Total fatg; 0.5 g steps below 5 g, 1 g steps above [4]None
Saturated fat (indented)gCan be left off if total fat is under 0.5 g, no fat claims are made and calories from saturated fat are not declared; the label must then say "Not a significant source of saturated fat" [5]
Trans fat (indented)gSame total-fat condition [6]
Cholesterolmg, nearest 5Not required below 2 mg if no fat or cholesterol claim; the label must then say "Not a significant source of cholesterol" [7]
Sodiummg; 0 below 5 mg, 5 mg steps up to 140 mg, 10 mg steps above [8]None
Total carbohydrateg, calculated by difference [9]None
Dietary fiber (indented)gNot required below 1 g. Isolated or synthetic fibers count only if FDA has determined they have a beneficial physiological effect [10]
Total Sugars (indented)gNot required below 1 g if no sugar claims are made [11]
Added SugarsShown as "Includes X g Added Sugars" under Total SugarsNot required below 1 g if no claims are made. Records are required where added and naturally occurring sugars are mixed [12]
Proteing%DV is required, or a "not a significant source" statement, when PDCAAS is below 20% (below 40% for foods for ages 1-3) [13]
Vitamin D, calcium, iron, potassiumAmount by weight plus %DV, in that orderOther vitamins and minerals become mandatory when added as a nutrient supplement or when a claim is made about them. Folic acid must be declared by weight when added or claimed [14]

Voluntary nutrients:

  • Polyunsaturated and monounsaturated fat: each becomes mandatory when the other is declared or when a fatty acid or cholesterol claim is made [15][16]
  • Sugar alcohol: mandatory with certain sugar claims [17]
  • Fluoride: mandatory if a claim is made [18]

Daily Values:

  • The reference values (RDIs and DRVs) are set for four groups: adults and children 4 and over, infants, children 1-3, and pregnant and lactating women. Examples for adults: sodium 2,300 mg, added sugars 50 g, dietary fiber 28 g, vitamin D 20 mcg, potassium 4,700 mg [19][20]
  • Foods for a specific group must use that group's values; all other foods use the adult values [21]

Format and type size

  • Box: hairline box, all black or one colour, on a white or neutral contrasting background where practical [22]. FDA strongly recommends the Appendix B graphics [23].
  • Heading: "Nutrition Facts", in type no smaller than anything else in the panel except the calorie number [24].
  • Servings: "servings per container" comes next, at least 10 pt. Then "Serving size", bold, at least 10 pt [25][26].
  • Amount per serving: the subheading "Amount per serving" goes below a bar [27].
  • Calories: in bold, with the word "Calories" at least 16 pt and the number at least 22 pt (smaller sizes are allowed in tabular and small-package formats) [28].
  • % Daily Value column: headed "% Daily Value*", with percentages rounded to the nearest whole percent [29][30].
  • Vitamins and minerals: separated from the other nutrients by a bar [31].
  • Footnote: "*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice." Foods for children 1-3 use 1,000 calories instead [32].

Serving size and when dual columns are needed

  • Serving size: the amount customarily consumed per eating occasion, in a household measure, based on the reference amounts in § 101.12(b) [33][34].
  • Under 200% of the reference amount: a package sold individually counts as a single serving [35].
  • 200% to 300%: the label needs an extra column for the whole package [36]. These columns must be separated by vertical lines [37].

Simplified format and exemptions

  • Simplified format: allowed when the food has insignificant amounts of 8 or more of the core nutrients (6 or more for foods for infants and young children) [38].
  • Exemptions under (j): most of these are lost if the food makes any nutrition claim or carries other nutrition information.
    • Small retailers selling direct to consumers: annual sales of $500,000 or less, or $50,000 or less in food sales [39]
    • Restaurant and food-service foods [40]
    • Foods with insignificant nutrient amounts, such as coffee, tea and flavour extracts [41]
    • Bulk shipments for further manufacture [42]
    • Raw fruits, vegetables and fish, which follow the voluntary guidelines in § 101.45 [43]
    • Packages with less than 12 sq in of labelling surface; these must give an address or phone number for nutrition information [44][45]
    • Low-volume products for which a claim for exemption has been filed [46]
  • Labelled under separate rules:
    • Dietary supplements, under § 101.36 [47]
    • Infant formula, under Part 107 [48]
    • Medical foods, if they meet the conditions in (j)(8) [49]
  • Unpackaged food: the information goes at the point of purchase, for example on a sign, counter card or booklet [50].

Compliance testing

  • Sampling: FDA tests a composite of 12 consumer units, each from a different randomly chosen shipping case, analysed by AOAC methods [51].
  • Upper limit: calories, total and added sugars, total, saturated and trans fat, cholesterol and sodium are misbranded if the composite is more than 20% above the declared value [52].
  • Lower limit: vitamins, minerals, protein, carbohydrate, fiber and unsaturated fats have separate minimum-content requirements [53].

I can go further into the reference amounts in § 101.12, the small-package tabular and linear formats, or the dual-column "as prepared" rules if useful.

Q.02

What font sizes does it need?

Under 21 CFR 101.9(d)(1)(iii), the Nutrition Facts panel has three main minimums: 8 point for the nutrient lines, 16 point bold for the word "Calories", and 22 point bold for the calorie number. The other items have their own minimums of 6, 9 or 10 point, and smaller sizes are allowed in tabular and small-package formats [28].

Approach: I read the current eCFR text of 21 CFR 101.9 (Title 21, Part 101), mainly paragraphs (d)(1) to (d)(10) and the small-package rules in (j)(13). I did not read the sample label graphics in (d)(12) or Appendix B.

Minimum type sizes, standard vertical format

Label elementMinimum sizeSmaller size allowed
"Nutrition Facts" headingNo smaller than any other text on the label, except the calorie number. Set across the full width of the nutrient information unless impractical [24]The size rule does not apply to the tabular, aggregate-display, dual-column tabular, small-package tabular and linear formats
"__ servings per container"10 pt [25]9 pt in the small-package tabular and linear displays
"Serving size"10 pt, bold or extra bold [26]9 pt in the (d)(11) and (e)(6)(ii) tabular displays and the small-package tabular and linear displays. 8 pt on any package if the declaration does not fit the space
"Amount per serving" subheading ((d)(4)) [27]6 pt
The word "Calories"16 pt, bold or extra bold10 pt in the (d)(11), (e)(6)(ii) and small-package tabular displays and the small-package linear display
Calorie number22 pt, bold or extra bold14 pt in the small-package tabular and linear displays
"Calories from saturated fat" (if declared, indented)8 pt [54]
"% Daily Value*" column heading ((d)(6)) [29]6 pt
Nutrient lines ((d)(7)) and vitamin/mineral lines ((d)(8)) [55][31]8 pt
% DV footnote ((d)(9)) [32]6 pt
Calories-per-gram conversion line, if used ((d)(10)) [56]6 pt

All sizes in the table come from § 101.9(d)(1)(iii) [28], except where a row cites another paragraph.

"Not a significant source" statements

  • When cholesterol, dietary fiber, total sugars or added sugars is not declared, the "Not a significant source of …" statement goes at the bottom of the nutrient table in the same type size [7][10][11][12].
  • For vitamins and minerals under 2% of the RDI, the "Contains less than 2 percent…" or "Not a significant source of…" statement must be in the same type size as the indented nutrients [57].

General typography rules for the whole panel

  • Type style: one easy-to-read type style [58].
  • Case: upper and lower case letters [59].
  • Leading (space between lines): at least 1 point, and at least 4 points for the nutrient lines and vitamin/mineral lines [60].
  • Spacing: letters should never touch [61].

Small packages

  • Which packages can use the tabular or linear formats: packages with less than 12 sq in of labelling surface. Packages of up to 40 sq in qualify too, if the shape or size cannot fit a standard vertical or tabular display. The linear format is allowed only if a tabular display will not fit [62].
  • Footnote: in these formats the full footnote is not required, and "% DV = % Daily Value" may be used instead [44].
  • Under 12 sq in, labelled anyway: this applies when the package carries nutrition labelling voluntarily or because it makes a claim. All required information must then be at least 6 point, or all capitals at least 1/16 inch high. Individual serving packets served with meals and not sold at retail may follow § 101.2(c)(2) instead [63].
  • Multiunit packs: inner units must carry "This Unit Not Labeled For Retail Sale" in type at least 1/16 inch high [64].

I can also map out the leading and bar-weight details shown in the § 101.9(d)(12) sample labels.

Q.03

Can small businesses skip it?

Yes, with conditions. 21 CFR 101.9(j) has two separate small-business exemptions: one for small retailers selling direct to consumers, and one for low-volume products made by companies with few employees. Both are lost if the label, labeling or advertising carries any nutrient content claim, health claim or other nutrition information.

Approach: I read the current eCFR text of 21 CFR 101.9(j)(1) and (j)(18). I did not read paragraph (j)(18)(v) or the definitions in (j)(18)(vi)(A) to (C), apart from the full-time equivalent definition in (vi)(D).

1. Small retailers selling direct to consumers, § 101.9(j)(1)(i)

  • Who qualifies: a person who sells directly to consumers, such as a retailer. Annual gross sales to consumers must be no more than $500,000, or annual food sales to consumers no more than $50,000 [39].
  • No notice is needed under this paragraph.
  • Condition: the food must carry no nutrition claims or other nutrition information anywhere: on the label, in labeling or in advertising. Any such claim or information brings the food back under § 101.9, § 101.10 or § 101.11, whichever applies [39].

2. Low-volume products of small businesses, § 101.9(j)(18)

This one is for manufacturers, packers and distributors, and it applies product by product.

Thresholds (j)(18)(ii):

  • The exemption covers any 12-month period if, over the previous 12 months, the person claiming it had fewer than an average of 100 full-time equivalent employees.
  • In the same 12 months, fewer than 100,000 units of that product must have been sold in the US.
  • For a product not sold in the previous 12 months, the test is whether fewer than 100,000 units are reasonably expected to be sold during the exemption period [65].
  • Paragraph (j)(18)(i) also sets higher thresholds (300 and 200 employees). These only covered the 1995-1997 transition periods [66][67].

Counting employees:

  • Employees include all staff of the person and all of its affiliates.
  • The count is total paid hours divided by 2,080 [68].

Conditions:

  • A claim for exemption must be filed before the period it covers begins.
  • The labels, labeling and advertising must give no nutrition information and make no nutrient content or health claim [46].

The notice to FDA (j)(18)(iv):

  • It is filed with FDA's Office of Nutrition and Food Labeling [69]. It must give:
    • the claimant's name, address and a named contact [70]
    • the product names, including all brand names [71]
    • the manufacturer, distributor or importer, if different from the claimant [72]
    • the average number of full-time equivalent employees [73]
    • the approximate US unit sales of each product [74]
  • A responsible individual must sign it, certify that it is accurate, and promise to tell FDA if either threshold is exceeded [75].
  • When no notice is needed: for a person that is not an importer and has fewer than 10 full-time equivalent employees, for any product with annual sales under 10,000 total units [69]. Importers must always file.

Losing the exemption (j)(18)(iii):

  • This happens if employees or unit sales go over the limits during the exemption period, or if the product no longer qualifies when the period ends.
  • The business then has 18 months from the date it stopped qualifying to bring the label into line with § 101.9 [76].

Practical points

  • Neither exemption is a general size-based waiver. The retailer exemption depends on selling direct to consumers. The low-volume exemption is per product and, in most cases, needs a notice filed in advance.
  • Marketing language such as "low fat", "high in fiber" or a health claim cancels either exemption.
  • Other exemptions in (j) may still apply whatever the company's size, such as those for very small packages or foods with insignificant nutrient amounts, which I covered earlier.

I can check whether FDA has issued guidance on the low-volume notice process, or look at how these exemptions apply to restaurant and vending menu labeling under § 101.11, if useful.

Q.04