Food Labeling & Claims (FDA / USDA) Skill — Complete Guide

The Food Labeling & Claims (FDA / USDA) skill helps regulatory affairs, quality assurance, and product development professionals draft and validate U.S. food product labels in compliance with FDA 21 CFR Part 101, USDA FSIS 9 CFR Parts 317/381, NLEA, FD&C Act §403(w) (FALCPA/FASTER Act allergens), and related claim/disclosure rules. This guide explains the compliance problem the skill addresses, how the agent works through the labeling workflow, all regulatory checks it runs, the references it uses, and how to prompt it — both when drafting a label from scratch and when validating an existing one.

The problem it solves

U.S. food label compliance spans a web of interlocking regulations. A product going to retail must satisfy mandatory element requirements under 21 CFR 101.3–101.9 and 101.105 (or FSIS 9 CFR 317/381 for meat and poultry); allergen declaration rules under FD&C Act §403(w) (as amended by FALCPA (2004) and the FASTER Act (2021, adding sesame as the 9th major allergen)); nutrient content claim thresholds under 21 CFR 101.13 and 21 CFR 101.54–101.65 (many distinct claim types with precise numerical cutoffs); health claim prerequisites under 21 CFR 101.14 and the claim-specific requirements in 21 CFR 101.72–101.83; organic certification tiers under 7 CFR Part 205; bioengineered food disclosures under USDA AMS NBFDS (7 CFR Part 66); and the Nutrition Facts panel format updates (including Added Sugars, Vitamin D, Potassium, revised Daily Values).

Getting all of this right simultaneously — and keeping it consistent across reformulations, line extensions, and changing regulations — is time-consuming and error-prone. Common failure points include:

• Partial “Contains:” statements that miss one allergen (non-compliant under FD&C Act §403(w) even if the ingredient list is correct)
• Health claims applied to products that exceed disqualifying nutrient levels (e.g., a fiber-and-heart-health claim on a product with 5g saturated fat per RACC)
• Nutrition Facts panels missing the 2020 mandatory nutrients (Added Sugars, Vitamin D, Potassium) or showing them in the wrong order
• “Good Source” or “High” claims that don’t match the actual % DV in the panel
• Relative claims (“Reduced,” “Light”) without a named reference food and quantified comparison statement (e.g., % difference)
• USDA meat/poultry labels missing the inspection legend, establishment number, or safe handling statement
• Organic seal used on “Made with Organic” products (the USDA Organic seal is reserved for “100 percent organic” and “organic” (≥95%), not “made with organic…”)

The skill encodes a broad practical rule set — thresholds, prerequisites, declaration methods, and format requirements — so the agent can draft a compliant label from product data alone and run strong automated screening before final regulatory/legal review.

What the skill covers

The skill handles two regulatory jurisdictions and all mainstream claim categories:

FDA-regulated foods (21 CFR Part 101)

All packaged foods regulated by FDA: complete label structure, Nutrition Facts panel (current format per 21 CFR 101.9, including Added Sugars, Vitamin D, and Potassium), ingredient list requirements (21 CFR 101.4), allergen declarations (FD&C Act §403(w)), and the full range of nutrient content, health, structure/function, gluten-free, and “healthy” claims.

USDA/FSIS-regulated products (9 CFR 317, 381)

Meat and poultry products regulated by FSIS: core label elements plus the inspection legend/establishment number, safe handling instructions for raw or partially cooked products (when applicable), FSIS label-approval pathways (generic vs sketch approval) under 9 CFR Part 412, and FSIS-specific claim policies/definitions (e.g., “Natural” and meat/poultry “lean/extra lean” criteria).

Claims strategy

The skill evaluates and drafts all claim categories: nutrient content claims (calorie, fat, saturated fat, cholesterol, sodium, sugar, fiber, vitamins and minerals, “lean,” “healthy”); authorized SSA health-claim screening checks (21 CFR 101.72–101.83) together with general health-claim eligibility rules in 21 CFR 101.14; qualified health claims (guidance-oriented); structure/function claims (dietary supplement disclaimer requirements apply to supplements, not conventional foods); relative claims (“Reduced,” “Less,” “More,” “Light”) with reference food and quantitative comparison; organic labeling tiers (100% Organic, Organic, Made with Organic); and gluten-free screening. If you provide sourcing and ingredient-origin details, the agent can also help with checklist-style review and draft language for bioengineered food disclosures (USDA AMS NBFDS, 7 CFR Part 66) and commodity-specific country-of-origin statements — but these are not currently validated by the two automated tools described below.

Regulatory references encoded in the skill

The skill bundles four reference files that the agent reads when it needs authoritative guidance. Understanding what each file contains explains why the agent can resolve even nuanced labeling questions without the professional needing to cite the CFR themselves.

fda-label-requirements.md — Mandatory elements

Covers the five mandatory label elements for FDA-regulated foods per 21 CFR 101.3, 101.4, 101.5, 101.9, and 101.105:

• Statement of identity (21 CFR 101.3) — common or usual name on the Principal Display Panel (PDP), bold type, size proportional to the most prominent text; standardized food names per their standard of identity; form qualifiers (sliced, diced, whole).
• Net quantity of contents (21 CFR 101.105) — bottom 30% of PDP, both metric and U.S. customary units per the Fair Packaging and Labeling Act, minimum type sizes by PDP area (from 1/16 inch for ≤5 sq. in. to 1/2 inch for >400 sq. in.).
• Ingredient list (21 CFR 101.4) — descending order of predominance by weight, sub-ingredients in parentheses, chemical preservatives with stated function, FD&C-certified colors by name, flavors as natural/artificial.
• Nutrition Facts panel (21 CFR 101.9) — required nutrients/line items in prescribed order, serving size based on RACC (21 CFR 101.12), dual-column format for packages 200–300% of RACC, 2020 Daily Values, and format/typography requirements in 21 CFR 101.9(d) (type sizes vary by available label space and circumstances).
• Manufacturer/distributor (21 CFR 101.5) — name and full address; qualifying phrase if not the manufacturer.

The reference also encodes USDA/FSIS mandatory elements (9 CFR 317, 381) — inspection legend, establishment number, safe handling instructions — and the complete rounding rules per 21 CFR 101.9(c) for each nutrient (e.g., calories <5 → declare as 0; 5–50 → nearest 5; >50 → nearest 10; Total Fat <0.5g → 0g; Sodium 5–140mg → nearest 5mg).

nutrient-claims-thresholds.md — Claim thresholds and Daily Values

Contains the full threshold tables for nutrient content claims codified across 21 CFR 101.13 and 21 CFR 101.54–101.65, with CFR citations:

It also encodes the disclosure and disqualifying levels (21 CFR 101.13(h) and 21 CFR 101.14). As a common baseline for many foods, when a food bearing a nutrient content claim exceeds Total Fat >13g, Saturated Fat >4g, Cholesterol >60mg, or Sodium >480mg per RACC, a disclosure statement is typically required; and disqualifying nutrient rules can make a food ineligible for a health claim. (Note: the CFR contains important category-specific details, including different criteria for meals/main dishes and special calculation bases for foods with small RACCs.)

The 2020 Daily Values are encoded for the required Nutrition Facts nutrients/line items (including Added Sugars DV = 50g; Sodium DV = 2,300mg; Vitamin D = 20 mcg; Potassium = 4,700mg).

health-claims-guide.md — Health claims and prerequisites

Covers all three categories of health-related claims and their specific requirements:

Authorized health claims (SSA standard): All 12 claims codified in 21 CFR 101.72–101.83, each with its substance–disease relationship and food-level prerequisites:

General health claim requirements (practical summary): in addition to the claim-specific rules in 21 CFR 101.72–101.83, 21 CFR 101.14 contains general eligibility requirements (including disqualifying nutrient levels and a minimum “beneficial nutrient” content requirement, subject to limited exceptions). Authorized health claim model language uses risk-reduction phrasing (e.g., “may reduce the risk of…”) and should avoid absolute prevention/cure language.

Qualified health claims: emerging evidence not meeting SSA standard; require qualifying/disclaimer language reflecting evidence rank (A–D); based on FDA enforcement discretion letters, not codified in CFR.

Structure/function claims (21 CFR 101.93): for dietary supplements, requires the exact FDA disclaimer (“This statement has not been evaluated by the Food and Drug Administration…”) in boldface ≥1/16 inch, immediately adjacent to the claim; FDA notification required within 30 days of first marketing. For conventional foods, no disclaimer or notification required, but claim must not be a disease claim.

allergen-labeling.md — FALCPA and FASTER Act requirements

Contains the full allergen framework:

Nine major allergens per FD&C Act §403(w): Milk, Eggs, Fish (species required), Crustacean shellfish (species required), Tree nuts (species required), Peanuts, Wheat, Soybeans, and Sesame (added by FASTER Act, effective January 1, 2023).

Two declaration methods (you may use one or both; if “Contains:” is used, it must be complete):

• Method A — Parenthetical: allergen source in parentheses after the ingredient name in the ingredient list (e.g., “casein (milk), flour (wheat)”).
• Method B — “Contains:” statement: separate line after the ingredient list listing ALL major allergens present. A partial “Contains:” statement is non-compliant under FALCPA — if you use this method, every allergen in the product must be listed.

Species identification requirements: for tree nuts (21 species listed), fish (must name species — salmon, tuna, cod, etc.), and crustacean shellfish (shrimp, crab, lobster, crawfish, prawns). Generic “tree nuts” or “fish” alone is not FALCPA-compliant in the “Contains:” statement.

Common hidden allergens: the reference includes a lookup table for hard-to-spot allergen sources — casein/whey/lactalbumin (milk), lecithin (may be soy-derived), natural flavors (may contain any allergen), modified food starch (may be wheat-derived), surimi (fish + egg), tahini/halvah (sesame), marzipan/nougat (tree nuts), Worcestershire sauce (fish/anchovy), pesto (pine nuts).

Advisory statements: “May contain” / “Produced in a facility that also processes” — voluntary, not required by FALCPA; must be based on actual cross-contact risk and not used as a substitute for allergen controls.

How to use the skill: drafting a food label from scratch

When you have product formulation data (ingredient list, nutrition analysis) but no label yet, activate the Food Labeling & Claims (FDA / USDA) skill and describe your product. The agent follows a structured workflow:

Step 1 — Scope and jurisdiction: The agent asks you to confirm the product type (FDA vs. USDA/FSIS) and your intended claims strategy (nutrient content claims, health claims, organic, gluten-free, etc.). For USDA products, it flags that labels with special statements/claims may require FSIS sketch approval (vs generic approval) under 9 CFR Part 412.

Step 2 — Mandatory element drafting: Using the assets/food-label-template.md, the agent drafts all required sections: statement of identity, net quantity with both metric and U.S. customary units, ingredient list in descending order of predominance with sub-ingredients, Nutrition Facts panel with required nutrients/line items in required order and current Daily Values, and manufacturer/distributor block.

Step 3 — Allergen audit: The agent cross-references every ingredient and sub-ingredient — including multi-component ingredients, flavors, processing aids, and hidden sources — against all 9 major allergens. It proposes either parenthetical declarations or a complete “Contains:” statement. For tree nuts, fish, and shellfish, it verifies that species are named. If facility cross-contact is a factor, it drafts an appropriate advisory statement.

Step 4 — Claims evaluation: For each claim you want to make, the agent checks the applicable threshold against your nutrition data:

• For “Good Source of Fiber,” it calculates the % DV of dietary fiber (DV = 28g) and confirms it falls in the 10–19% range per 21 CFR 101.54(c).
• For “Low Sodium,” it checks that sodium ≤140mg per RACC per 21 CFR 101.61(b)(3).
• For a health claim (e.g., soy protein and coronary heart disease per 21 CFR 101.82), it checks claim-specific prerequisites (e.g., minimum grams of soy protein per RACC) and the general eligibility requirements in 21 CFR 101.14 (including disqualifying nutrient levels).
• If the product exceeds a disqualifying nutrient level, the agent flags the claim as ineligible and suggests alternatives.

Step 5 — Special disclosures: The agent checks whether the product triggers any additional disclosures: gluten-free criteria (<20 ppm); organic tier (100% Organic, Organic ≥95%, Made with Organic ≥70%) and certifying agent; and (when you provide the necessary sourcing details) checklist-style review/draft language for bioengineered food disclosures (USDA AMS NBFDS, 7 CFR Part 66) and commodity-specific country-of-origin statements. (At present, NBFDS/COOL items are not automatically validated by the two tools below.)

Step 6 — Validation: The agent runs both automated tools (described below) and iterates until no errors remain.

What you can prompt

How to use the skill: validating an existing label

Add your current label document (draft or final) to the project workspace and ask the agent to validate it. The agent reads the label, runs both automated tools, and surfaces all errors and warnings with specific CFR citations.

What you can prompt for validation

The two automated validation tools

The skill ships with two extension tools that run automatically during and after drafting. Both operate on your label document in the project workspace and return structured reports.

food_label_compliance_checker

Validates structural completeness and regulatory compliance. Runs six categories of checks:

1. Required label elements — Verifies all five mandatory elements are present in the document: statement of identity (21 CFR 101.3), net quantity of contents (21 CFR 101.105), ingredient list (21 CFR 101.4), Nutrition Facts panel (21 CFR 101.9), and manufacturer/distributor information (21 CFR 101.5). Missing elements are reported as ERRORs.

2. Allergen declaration completeness — Detects all 9 major allergens in the ingredient list using an exhaustive pattern library that covers direct names and common hidden sources (e.g., casein → Milk; lecithin → possible Soy; tahini → Sesame; surimi → Fish). If a “Contains:” statement is present, it cross-checks that every allergen found in the ingredient list is also listed in “Contains:”. A partial “Contains:” statement that omits any allergen is flagged as an ERROR. If allergens are present but no declaration method is found, a WARNING is issued.

3. Species identification — For tree nuts, fish, and crustacean shellfish, checks whether the specific species is named. If only the generic term is used (e.g., “fish” without naming the species), a WARNING is issued under FD&C Act §403(w) requirements.

4. Nutrition panel validation — Verifies required nutrients/line items are present in the correct order per 21 CFR 101.9(c), checks for the “Serving size” declaration (ERROR if missing), and checks for the required footnote text as applicable under 21 CFR 101.9(d) (WARNING if missing unless an alternative format/exemption clearly applies).

5. USDA/FSIS checks — When jurisdiction is set to “usda” or “both,” checks for the inspection legend/establishment number and screens for safe-handling language in likely raw/partially cooked contexts.

6. Placeholder detection — Scans for unfilled template markers ([TODO:…], [TBD], [INSERT…], [VALUE…], [PRODUCT…], [COMPANY…], [ADDRESS…]) and reports them as INFO items.

The tool accepts an optional jurisdiction parameter: “fda” (default), “usda”, or “both”.

Result levels: PASS (no errors, no warnings) → REVIEW NEEDED (warnings only) → NON-COMPLIANT (errors present) → INCOMPLETE (fewer than three required elements found).

Example output:

======================================================================
FOOD LABEL COMPLIANCE REPORT
FDA 21 CFR 101 / USDA FSIS / FALCPA / FASTER Act
======================================================================
Document: output/granola-bar-label.md
Jurisdiction: FDA

--- REQUIRED LABEL ELEMENTS ---
  FOUND Statement of identity (21 CFR 101.3)
  FOUND Net quantity of contents (21 CFR 101.105)
  FOUND Ingredient list (21 CFR 101.4)
  FOUND Nutrition Facts panel (21 CFR 101.9)
  FOUND Manufacturer/distributor info (21 CFR 101.5)

--- ALLERGEN DECLARATION ---
  Allergens detected in ingredients: Peanuts, Milk, Tree nuts, Sesame
  "Contains" statement present: YES

--- NUTRITION FACTS PANEL ---
  Mandatory nutrients detected: 15 / 15

--- SUMMARY ---
  Required elements: 5 / 5
  Nutrients detected: 15 / 15
  Allergens in ingredients: 4
  Errors:   0   Warnings: 0   Info: 2

RESULT: PASS — label contains all required elements with proper declarations.
======================================================================

nutrient_claim_validator

Cross-checks all claims against the nutrition data in the document. Detects over 40 claim types using pattern matching across the full document and then applies the relevant threshold rule. Runs six categories of checks:

1. Nutrient content claim thresholds — For each detected claim, looks up the exact regulatory threshold and compares it against the extracted nutrition value. Examples: “Fat Free” requires Total Fat <0.5g per RACC per 21 CFR 101.62(b)(1) — if Total Fat = 2g, the tool reports an ERROR. “Good Source” (10–19% DV) requires determining which nutrient the claim applies to and checking its % DV from the Nutrition Facts panel.

2. Disqualifying nutrient levels — If the food bears a nutrient content claim and disqualifying nutrient criteria are exceeded, the tool checks for a disclosure statement per 21 CFR 101.13(h). (Note: thresholds and calculation bases vary by category, including different criteria for meals/main dishes and foods with small RACCs.)

3. Health claim prerequisites — For each detected health claim (calcium/osteoporosis, sodium/hypertension, fiber/CHD, soy protein/CHD, etc.), the tool checks disqualifying nutrient levels (an ERROR if any is exceeded), 10% DV beneficial nutrient screening (21 CFR 101.14(e)(6)), “may/might” risk-reduction language (21 CFR 101.14(d)(2)(iv)), and key claim-specific prerequisites where parsable from the label text. Complex claim conditions still require manual/legal review.

4. Structure/function claim disclaimer — If a structure/function claim is detected (e.g., “supports bone health,” “maintains immune function”) in a dietary supplement context, the tool checks for the exact FDA-required disclaimer text. A missing disclaimer is an ERROR per 21 CFR 101.93.

5. Relative claims — For “Reduced,” “Less,” “More,” “Light,” and similar comparative claims, checks that (a) a reference food is named and (b) a quantitative comparison statement (e.g., % difference) is present. Missing reference food is an ERROR; missing quantitative comparison is a WARNING, per 21 CFR 101.13(j).

6. Organic claim tiers — Checks that an organic claim is associated with a certifying agent (WARNING if absent per 7 CFR 205.303) and that “Made with Organic” products do not display the USDA Organic seal (ERROR per 7 CFR 205.310).

Result levels: COMPLIANT (all claims pass) → REVIEW NEEDED (warnings) → NON-COMPLIANT (one or more claims fail) → NO CLAIMS (no claims detected to validate).

Example conversation: full labeling session

The following example illustrates a complete session — from product brief to validated label — for a Regulatory Affairs Manager launching a new product.

You: We’re launching a new high-protein Greek yogurt called “ProBalance Plain.” It’s FDA-regulated. Ingredients: pasteurized skim milk, live active cultures (S. thermophilus, L. bulgaricus, Bifidobacterium lactis). No other ingredients. Nutrition per 5.3oz (150g) container: Calories 100, Total Fat 0g, Sat Fat 0g, Trans Fat 0g, Cholesterol 5mg, Sodium 55mg, Total Carb 7g, Dietary Fiber 0g, Total Sugars 5g, Added Sugars 0g, Protein 17g, Vitamin D 0mcg, Calcium 200mg, Iron 0mg, Potassium 240mg. We want to claim “Fat Free,” “Good Source of Calcium,” and explore a calcium-osteoporosis health claim.

Agent: Great — let me work through this systematically.

Jurisdiction: FDA-regulated food, 21 CFR Part 101.

RACC: The RACC for yogurt is 225g (21 CFR 101.12). Your package is 150g — under 200% of RACC — so single-serving format applies and your serving size should be declared as “1 container (150g).”

Allergen audit: I see only milk in the ingredients. Milk is a major allergen under FD&C Act §403(w). I’ll declare this in the “Contains:” statement: “Contains: Milk.”

Claims evaluation:

1. “Fat Free” — Total Fat = 0g per serving. Threshold: <0.5g fat per RACC (and per labeled serving) (21 CFR 101.62(b)(1)). Your product has 0g. PASSES.

2. “Good Source of Calcium” — Calcium = 200mg per serving. DV for calcium = 1,300mg. 200 ÷ 1,300 = 15.4% DV. This falls within the 10–19% DV range for “Good Source” per 21 CFR 101.54(c). PASSES.

3. Calcium and osteoporosis health claim (21 CFR 101.72): One key prerequisite is ≥20% DV calcium per RACC. Your panel shows 200mg calcium per 150g serving; the yogurt RACC is 225g, so per RACC that’s (200/150 \times 225 = 300mg), or 23.1% DV. On calcium content alone, the product can be eligible, provided the general health-claim rules in 21 CFR 101.14 and the rest of 21 CFR 101.72’s conditions are also met and you use appropriate authorized/model claim language.

Disqualifying nutrient check for “Fat Free” and “Good Source” claims: Total Fat = 0g (under 13g), Sat Fat = 0g (under 4g), Cholesterol = 5mg (under 60mg), Sodium = 55mg (under 480mg) — no disclosure statement required.

I’ll now draft the full label. Would you like to include the authorized health claim language, or keep the label to nutrient content claims only (“Fat Free” and “Good Source of Calcium”)?

You: Yes — drop the health claim. Finalize the label and run the validators.

Agent: Label drafted. Running validation now.

food_label_compliance_checker — PASS: all 5 required elements present, required nutrients/line items in correct order, allergen declaration complete (“Contains: Milk”), no placeholders.

nutrient_claim_validator — COMPLIANT: “Fat Free” passes (0g fat < 0.5g threshold, 21 CFR 101.62(b)(1)); “Good Source of Calcium” passes (15.4% DV in 10–19% range, 21 CFR 101.54(c)). No disqualifying nutrient levels exceeded. No errors, no warnings.

The label is ready for print review. Would you like me to add date marking language or a bioengineered food disclosure review?

Worked examples: common scenarios

Scenario 1 — Hidden allergen caught at draft time

You provide an ingredient list that includes “hydrolyzed vegetable protein” without specifying the source. The skill’s allergen audit flags this as a possible hidden allergen (soy and/or wheat are common HVP sources) and asks you to confirm the source. If it is soy-derived, the agent adds Soybeans to the “Contains:” statement. If the spec is ambiguous, it recommends you obtain confirmation from your ingredient supplier before finalizing the label.

Scenario 2 — Relative claim missing a required element

A label draft includes “Reduced Sodium” but no reference food is named and no % reduction is stated. The nutrient_claim_validator reports two findings: an ERROR for the missing reference food identification and a WARNING for the missing quantitative comparison statement, both citing 21 CFR 101.13(j). The agent then asks you to confirm the reference food name and the actual percentage reduction, inserts the required language, and re-runs validation.

Scenario 3 — Organic seal used incorrectly

A product with 73% organic ingredients has “Made with Organic Ingredients” on the label. The skill confirms the correct tier (70–95% = “Made with Organic”). The nutrient_claim_validator then detects the USDA Organic seal in the document and reports an ERROR: the USDA Organic seal is not permitted for “Made with Organic” — it is reserved for “100 percent organic” and “organic” (≥95%) products per 7 CFR 205.310. The agent removes the seal from the draft.

Scenario 4 — Health claim disqualified by saturated fat

A protein bar claims “soluble fiber may reduce the risk of heart disease” (21 CFR 101.77). The nutrition data shows Saturated Fat = 5g per RACC, which exceeds the 4g disqualifying level. The nutrient_claim_validator reports the claim as DISQUALIFIED per 21 CFR 101.14(a)(5) and suggests the options: reformulate to bring Saturated Fat below 4g, drop the health claim, or explore a qualified health claim for fiber and heart disease (which has a lower evidence standard and carries required qualifying language).

Summary

Use the Food Labeling & Claims (FDA / USDA) skill when you need to draft or validate a U.S. food label and want the agent to apply strong FDA/USDA regulatory screening — with claim thresholds, allergen audit, health-claim prerequisite checks, and automated validation — without manually cross-referencing multiple CFR parts.