# Label Content Worksheet

This is where you build the copy for one product's label before it goes to a designer
or a printer — every regulated element assembled from your own recipe and records, in
one place, so nothing required is missing and nothing on it is a guess. Fill one out
per product and per package size, and reach for it whenever you formulate a new
product, reformulate an old one, or change a package.

A food label is a legal document. FDA regulates the required elements in 21 CFR Part
101, and this worksheet walks the six that carry the most risk: the statement of
identity, the net quantity of contents, the ingredient list, the allergen declaration,
the Nutrition Facts source data, and any claims you print. Fill each section from the
source that owns it — your formulation for the ingredient statement and allergens, your
lab or nutrition database for the Nutrition Facts, and your substantiation file for
every claim. The front of the pack (principal display panel) carries the statement of
identity and the net quantity; the information panel carries the ingredient list, the
allergen "Contains" statement, the Nutrition Facts, and your name and address.

This worksheet helps you assemble complete, accurate copy; it does not replace a review
against the current regulation or FDA's Food Labeling Guide, and a mislabeled product is
misbranded even when the mistake was honest. Every example value below is an
illustration — your entries come from your own recipe, lab or nutrition analysis, and
substantiation, never from the samples here.

Primary sources (verified July 2026):

- Food labeling, 21 CFR Part 101: https://www.law.cornell.edu/cfr/text/21/part-101
- Statement of identity, 21 CFR 101.3: https://www.law.cornell.edu/cfr/text/21/101.3
- Net quantity of contents, 21 CFR 101.7: https://www.law.cornell.edu/cfr/text/21/101.7
- Ingredient list, 21 CFR 101.4: https://www.law.cornell.edu/cfr/text/21/101.4
- Major food allergens defined (Big 9, incl. sesame), 21 U.S.C. 321(qq): https://www.law.cornell.edu/uscode/text/21/321
- Allergen "Contains" statement (FALCPA), 21 U.S.C. 343(w): https://www.law.cornell.edu/uscode/text/21/343
- FASTER Act — sesame the ninth allergen, effective January 1, 2023: https://www.fda.gov/food/food-allergies/faster-act-sesame-ninth-major-food-allergen
- Nutrition labeling and rounding, 21 CFR 101.9: https://www.law.cornell.edu/cfr/text/21/101.9
- Nutrient content claims, 21 CFR 101.13: https://www.law.cornell.edu/cfr/text/21/101.13
- Gluten-free claim (< 20 ppm), 21 CFR 101.91: https://www.law.cornell.edu/cfr/text/21/101.91

---

## Statement of identity

The statement of identity is the legal or common name of the food — what the product
actually is — as distinct from your brand name. Under 21 CFR 101.3 it goes on the
principal display panel as one of its principal features, in bold type, in a size that
relates to the most prominent print on the panel. Use the name a federal standard
requires if one exists; otherwise the common or usual name; otherwise an appropriately
descriptive term. Your brand name is separate and does not satisfy this.

| Field | Example | Your entry |
| --- | --- | --- |
| Brand name | Casa Verde | |
| Statement of identity (regulated / common name) | Roasted tomato salsa | |
| Form or style, if part of the name | Medium | |
| Basis for the name (federal standard / common name / descriptive) | Common or usual name | |
| On the principal display panel, bold, prominent? (Y / N) | Y | |

## Net quantity of contents

The net quantity is how much food is in the package, not counting the container. Under
21 CFR 101.7 it sits in the bottom 30% of the principal display panel, as a distinct
line. Declare it in U.S. customary units — weight (avoirdupois pound and ounce) for
solid, semisolid, or viscous foods, and fluid measure for liquids. Federal law permits
a metric equivalent; most states require both under the Uniform Packaging and Labeling
Regulation, so declare both.

| Field | Example (solid) | Example (liquid) | Your entry |
| --- | --- | --- | --- |
| Net quantity, U.S. customary | Net wt 16 oz (1 lb) | Net 12 fl oz | |
| Metric equivalent | 454 g | 355 mL | |
| Measure basis (weight / fluid measure) | Weight | Fluid measure | |
| In the bottom 30% of the front panel? (Y / N) | Y | Y | |

## Ingredient list

The ingredient list runs on the information panel. Under 21 CFR 101.4, every ingredient
appears by its common or usual name in descending order of predominance by weight, and
a compound ingredient — one made of more than one thing — has its own components shown
in parentheses. Build the order from the recipe: weigh each ingredient as it goes into
the batch, then sort high to low. The finished statement must read letter-for-letter the
same as the line you copy onto the product's spec sheet.

| Ingredient (common or usual name) | Amount in batch | % by weight | Rank | Compound? sub-ingredients in ( ) |
| --- | --- | --- | --- | --- |
| (example) Tomatoes | 40 lb | 50% | 1 | |
| (example) Onions | 16 lb | 20% | 2 | |
| (example) Jalapeño peppers | 8 lb | 10% | 3 | |
| (example) Tomato paste | 6 lb | 7.5% | 4 | (tomatoes, citric acid) |
| (example) Distilled vinegar | 4 lb | 5% | 5 | |
| | | | | |
| | | | | |

| Field | Example | Your entry |
| --- | --- | --- |
| Final ingredient statement (descending by weight, as printed) | Tomatoes, onions, jalapeño peppers, tomato paste (tomatoes, citric acid), distilled vinegar, salt, garlic, cilantro, spices | |

## Allergen declaration and the "Contains" statement

U.S. law recognizes nine major food allergens (the Big 9): milk, egg, fish, Crustacean
shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. Sesame is the ninth, added
by the FASTER Act and required on labels since January 1, 2023 (21 U.S.C. 321(qq)). For
each allergen present as an ingredient, you declare the food source name — the specific
tree nut (almond, walnut), the specific fish (cod, salmon), the specific Crustacean
shellfish (shrimp, crab), or the plain source (milk, egg, wheat, peanut, soybean,
sesame). Fill one row per allergen, working from the recipe.

| Major allergen | Present as an ingredient? (Y / N) | Food source name to declare | Ingredient(s) it comes from |
| --- | --- | --- | --- |
| Milk | N | | |
| Egg | N | | |
| Fish | N | | |
| Crustacean shellfish | N | | |
| Tree nuts | N | | |
| Wheat | N | | |
| Peanuts | N | | |
| Soybeans | N | | |
| Sesame | N | | |

Under FALCPA (21 U.S.C. 343(w)) you declare every allergen present one of two ways: a
"Contains" statement immediately after or adjacent to the ingredient list, or the food
source name in parentheses inside the ingredient list itself. If you print a "Contains"
statement, it must name every major allergen in the product, in type no smaller than the
ingredient list. Pick one method and build it here. Note: only Crustacean shellfish
(crab, lobster, shrimp) is a major allergen; molluscan shellfish such as clams, mussels,
oysters, and scallops is not one of the nine.

| Field | Example | Your entry |
| --- | --- | --- |
| "Contains" statement (names every allergen source) | (example) none — no major allergen is an ingredient | |
| Or: parenthetical sources shown in the ingredient list? (Y / N) | N | |
| Advisory ("may contain" / "made on shared equipment") | (example) only if your cleaning validation does not support absence | |

## Nutrition source data

The Nutrition Facts panel is a graphic your designer builds, but the numbers behind it
are yours to source and round. This section captures the source data — the analytical
value for each nutrient — and the label value after you apply the nutrient-specific
rounding. Get the source values from a lab analysis or a nutrition-database calculation
on your finished recipe, and set the serving size from the FDA Reference Amount
Customarily Consumed (RACC) for your product category, not by choosing a round number.

| Field | Example | Your entry |
| --- | --- | --- |
| Serving size (household measure + metric) | 2 tbsp (30 g) | |
| Servings per container | About 15 | |
| Basis for serving size (RACC for the category) | RACC for salsas | |
| Source of nutrient values (lab / database + reference) | Lab report NF-2026-02 | |

The rounding is nutrient-specific: each nutrient has its own increment, and using the
wrong one misbrands the product even when the source data is perfect. Round each value
per 21 CFR 101.9(c).

| Nutrient | Source (analytical) value | Rounding rule per 21 CFR 101.9(c) | Declared value |
| --- | --- | --- | --- |
| Calories | | Nearest 5 up to and including 50; nearest 10 above 50; under 5 may be 0 | |
| Total fat | | Nearest 0.5 g below 5 g; nearest 1 g above 5 g; under 0.5 g is 0 | |
| Saturated fat | | Same as total fat | |
| Trans fat | | Same as total fat | |
| Cholesterol | | Nearest 5 mg; under 2 mg may be 0 | |
| Sodium | | Under 5 mg is 0; 5–140 mg to nearest 5 mg; above 140 mg to nearest 10 mg | |
| Total carbohydrate | | Nearest 1 g; under 1 g may state "less than 1 gram" | |
| Dietary fiber | | Nearest 1 g; under 1 g may state "less than 1 gram" | |
| Total sugars | | Nearest 1 g; under 1 g may state "less than 1 gram" | |
| Added sugars | | Nearest 1 g; under 1 g may state "less than 1 gram" | |
| Protein | | Nearest 1 g; under 1 g may state "less than 1 gram" | |
| Vitamin D, calcium, iron, potassium | | Declared as the absolute amount plus %DV; the %DV rounds to nearest 2% up to 10%, nearest 5% from 10–50%, nearest 10% above 50% | |

## Claims checklist

Anything on the label that characterizes a nutrient, a health benefit, or a quality is a
claim, and every claim has a rule. Under 21 CFR 101.13, a nutrient content claim —
express or implied, like "low sodium" or "good source of fiber" — may only appear if the
regulation defines it and your product meets that definition. A "gluten-free" claim
requires less than 20 ppm gluten under 21 CFR 101.91. List every claim you intend to
print and clear each one before it goes on the label.

| Claim as printed | Claim type (nutrient content / health / gluten-free / structure-function / other) | Defined by | Product meets the definition? (Y / N) | Substantiation on file (ref) | Required disclosure present? (Y / N / n/a) |
| --- | --- | --- | --- | --- | --- |
| (example) Low sodium | Nutrient content | 21 CFR 101.61 | | | n/a |
| (example) Good source of fiber | Nutrient content | 21 CFR 101.54 | | | |
| (example) Gluten-free | Gluten-free | 21 CFR 101.91 (< 20 ppm) | | Test report | n/a |
| | | | | | |
| | | | | | |

Making any nutrient content or health claim also pulls in two rules. Full Nutrition
Facts labeling becomes required, and a disclosure statement — "See nutrition information
for ___ content" — must sit next to the claim when, per the reference serving, the
product has more than 13 g total fat, 4 g saturated fat, 60 mg cholesterol, or 480 mg
sodium (21 CFR 101.13). Terms like "natural," "healthy," and "no preservatives" carry
their own conditions — treat each as a claim to substantiate, and confirm the current
rule before you print it.

## Sign-off

Number and date every version of a product's label copy so the floor, the designer, and
the printer all work from the same one. Re-issue the worksheet whenever a fact on it
changes — a reformulation, a new supplier that shifts an allergen, a package size, or a
new claim.

| Field | Example | Your entry |
| --- | --- | --- |
| Product and package size | Roasted tomato salsa, 16 oz jar | |
| Worksheet version | Rev. 2 | |
| Prepared by (name, role) | Sam Ortiz, QA Lead | |
| Date prepared | 07/15/2026 | |
| Reviewed against current 21 CFR Part 101 by | | |