Food Labeling & Claims (FDA / USDA)

Overview

Draft and validate U.S. food product labels and labeling claims compliant with FDA 21 CFR 101, USDA FSIS, NLEA, FALCPA, and FASTER Act. Validates required label elements, allergen declarations, nutrient content claims against nutrition data, health claims, and organic/bioengineered disclosures.

The skill covers two major U.S. regulatory jurisdictions and all common claim types:

• FDA-regulated foods — Full label compliance per 21 CFR Part 101: statement of identity, ingredient list, Nutrition Facts panel (2020 format with Added Sugars, Vitamin D, Potassium), allergen declarations per FALCPA/FASTER Act (9 major allergens including sesame), and all categories of claims.
• USDA/FSIS-regulated products — Meat and poultry labeling per 9 CFR Parts 317/381, inspection legend, safe handling instructions, sketch approval requirements, and “Natural”/“Lean”/“Extra Lean” claims.
• Claims validation — Nutrient content claims (calorie, fat, sodium, sugar, “Good Source,” “High”), health-claim screening (including key claim-specific prerequisites), structure/function claims with disclaimer verification, organic labeling tiers, and special-claim screening (e.g., gluten-free). Bioengineered/COOL checks are workflow guidance items, not full automated validations.

Getting Started

Add your product information — formulation data, existing label drafts, nutrition analysis reports, or ingredient specifications — to the project workspace. Then activate the Food Labeling & Claims (FDA / USDA) skill. The agent will confirm your product’s regulatory jurisdiction, draft all required label elements using the built-in template, evaluate your claims against actual nutrition data, run allergen audits, and validate the result with both automated tools.

Example Conversation

Below is an example of how a typical food labeling session unfolds. The agent scopes the product, builds the label, evaluates claims, and validates everything.

You: We’re launching a new organic granola bar called “Nature’s Harvest Oat & Honey Bar.” It’s USDA Organic certified (96% organic ingredients). Composition includes: organic rolled oats, organic honey, organic peanut butter, organic coconut oil, organic flaxseed, whey protein concentrate, natural vanilla flavor, sea salt, and sesame seeds. We want to make “Good Source of Fiber” and “Low Sodium” claims on the front panel. We also want to include a heart health claim about fiber. Here’s our nutrition data per 40g bar: Calories 180, Total Fat 8g, Sat Fat 3g, Trans Fat 0g, Cholesterol 0mg, Sodium 95mg, Total Carb 24g, Dietary Fiber 4g, Total Sugars 8g, Added Sugars 5g, Protein 5g, Vitamin D 0mcg, Calcium 20mg, Iron 1.8mg, Potassium 120mg.

Agent: Great product! Let me scope this and work through the label systematically.

Jurisdiction: This is an FDA-regulated food (not meat/poultry), so we follow 21 CFR Part 101.

Organic status: At 96% organic ingredients, this qualifies for the “Organic” tier (>=95%) per 7 CFR 205.301. You may use the USDA Organic seal and state “Organic” on the PDP. I’ll need the name of your certifying agent for the label.

Allergen audit — this is critical: I’ve identified 4 major allergens in your ingredients:

1. Peanuts (peanut butter)
2. Milk (whey protein concentrate)
3. Tree nuts — coconut (coconut oil — FDA classifies coconut as a tree nut for FALCPA)
4. Sesame (sesame seeds — 9th major allergen per FASTER Act, effective Jan 1, 2023)

Your “Contains” statement must list all four: “Contains: peanuts, milk, tree nuts (coconut), sesame.”

Additionally, if your facility also processes wheat, other tree nuts, or soy, we should add an advisory statement.

Now let me evaluate your claims:

1. “Good Source of Fiber” — Dietary Fiber = 4g per 40g bar. The DV for fiber is 28g, so 4g = 14.3% DV. This falls within the 10–19% DV range required for “Good Source” per 21 CFR 101.54(c). PASSES.

2. “Low Sodium” — Sodium = 95mg per serving. “Low Sodium” requires <=140mg per RACC. The RACC for cereal bars/granola bars is 40g, which matches your serving size. 95mg <= 140mg. PASSES.

3. Fiber & Heart Disease health claim — To use this claim (21 CFR 101.77), the food must be “low saturated fat” (<=1g), “low cholesterol” (<=20mg), and “low fat” (<=3g), AND contain >=0.6g soluble fiber per RACC without fortification. Your bar has Sat Fat 3g and Total Fat 8g, which do NOT meet “low fat” (<=3g) or “low saturated fat” (<=1g). This health claim is NOT eligible. I recommend removing it or switching to a qualified health claim about whole grains, which has different criteria.

I’ve started the label from the template. Let me also check disqualifying levels for your nutrient content claims: Fat 8g (under 13g threshold), Sat Fat 3g (under 4g), Cholesterol 0mg, Sodium 95mg (under 480mg) — no disclosure statement needed.

You: Good catch on the health claim — let’s drop it. Our certifying agent is Oregon Tilth. The facility also processes wheat and other tree nuts (almonds). Please add the advisory statement and finalize the label.

Agent: I’ve completed the label with all elements. Let me run validation.

I ran food_label_compliance_checker — all 5 required elements present, all 15 mandatory nutrients in correct order, allergen declaration complete with all 4 allergens in the “Contains” statement. One INFO: the advisory “May contain wheat and tree nuts (almonds)” is present and appropriate.

I also ran nutrient_claim_validator — both “Good Source of Fiber” (14.3% DV) and “Low Sodium” (95mg) pass their thresholds. No health claims to check. Organic claim verified with certifying agent named.

The label is ready for print review. Shall I check anything else?

Sample Output Excerpt

Below is a representative excerpt from a validated food label document, showing the Nutrition Facts panel, ingredient list, and allergen declaration — the sections most scrutinized by FDA inspectors and retail buyers.

Food Product Label — Nature’s Harvest Oat & Honey Bar

Statement of Identity: Organic Granola Bar

Net Wt 1.4 oz (40g)

Nutrition Facts

% Daily Value (DV) 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.

Ingredient List

Ingredients: Organic rolled oats, organic honey, organic peanut butter (organic peanuts, salt), organic coconut oil, organic flaxseed, whey protein concentrate (milk), natural vanilla flavor, sea salt, sesame seeds.

Allergen Declaration

Contains: peanuts, milk, tree nuts (coconut), sesame.

May contain wheat and tree nuts (almonds) due to shared equipment.

Manufacturer

Distributed by Nature’s Harvest Foods, LLC 1234 Harvest Lane, Portland, OR 97201

Claims

Good Source of Fiber | Low Sodium

USDA Organic — Certified organic by Oregon Tilth

Best If Used By: See package for date

Built-in Validation Tools

The skill includes two automated validation tools that run against the food label document during and after drafting:

food_label_compliance_checker

Validates label structural completeness and regulatory compliance across FDA and USDA jurisdictions. Checks performed:

• Required label elements — Verifies presence of all 5 mandatory elements: statement of identity, net quantity of contents, ingredient list, Nutrition Facts panel, and manufacturer/distributor information
• Allergen declaration completeness — Detects all 9 major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame) in the ingredient list and verifies declarations are present via parenthetical and/or “Contains” methods. Flags partial “Contains” statements as non-compliant per FALCPA
• Species identification — Checks that tree nuts, fish, and crustacean shellfish identify the specific species (e.g., “almonds” not just “tree nuts”)
• Nutrition panel validation — Verifies all 15 mandatory nutrients are present and in the correct order for Nutrition Facts panels per 21 CFR 101.9(c), checks for serving size declaration, and screens footnote expectations
• USDA/FSIS compliance — When jurisdiction is set to “usda” or “both,” checks for inspection legend and establishment number, and screens safe-handling language for likely raw/partially cooked products
• Placeholder detection — Finds unfilled markers ([INSERT], [TODO], [TBD], etc.)

Accepts an optional jurisdiction parameter (“fda”, “usda”, or “both”) to tailor checks.

Example output (compliance checker)

======================================================================
FOOD LABEL COMPLIANCE REPORT
FDA 21 CFR 101 / USDA FSIS / FALCPA / FASTER Act
======================================================================
Document: output/food-label.md
Jurisdiction: FDA
Content size: 2,847 chars

--- 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 in the document against nutrition data to verify regulatory compliance. Checks performed:

• Nutrient content claim thresholds — Verifies each claim against its specific FDA threshold: “Fat Free” (<0.5g), “Low Fat” (<=3g), “Sodium Free” (<5mg), “Low Sodium” (<=140mg), “Sugar Free” (<0.5g), “Good Source” (10-19% DV), “High/Excellent Source” (>=20% DV), “Lean” (<10g fat), and 20+ other claim types with their exact CFR citations
• Disqualifying nutrient levels — Checks if any food bearing a claim exceeds fat >13g, saturated fat >4g, cholesterol >60mg, or sodium >480mg per RACC, and flags missing disclosure statements
• Health claim prerequisites — Validates disqualifying nutrient levels and key parsable prerequisites for major SSA health claims (calcium/osteoporosis, sodium/hypertension, fiber/CHD, soy protein/CHD, etc.)
• Structure/function claim disclaimer — For dietary supplements, verifies the exact FDA-prescribed disclaimer text is present
• Relative claims — Checks that “Reduced,” “Less,” “More,” and “Light” claims identify the reference food and state the percentage difference
• Organic claim tiers — Validates that “100% Organic,” “Organic,” and “Made with Organic” products don’t misuse the USDA seal
• Health claim language — Verifies “may” or “might” hedging language is used (absolute claims prohibited)

Example output

======================================================================
NUTRIENT & HEALTH CLAIM VALIDATION REPORT
FDA 21 CFR 101 / NLEA / FALCPA / NOP
======================================================================
Document: output/food-label.md
Claims detected: 3
Nutrition data points: 15

--- CLAIMS DETECTED ---
  Line 42: "Good Source" (dv-range)
  Line 42: "Low Sodium" (nutrient)
  Line 48: "Organic (USDA)" (organic)

--- NUTRITION DATA EXTRACTED ---
  calories: 180cal (line 15)
  total fat: 8g, 10% DV (line 18)
  saturated fat: 3g, 15% DV (line 19)
  sodium: 95mg, 4% DV (line 22)
  dietary fiber: 4g, 14% DV (line 25)
  ...

--- CLAIM VALIDATION ---
  [INFO] "Good Source" of dietary fiber (line 42): PASSES — 14% DV meets
         threshold (21 CFR 101.54(c)).
  [INFO] "Low Sodium" (line 42): PASSES — sodium = 95mg, within 140mg
         (21 CFR 101.61(b)(3)).
  [INFO] Organic claim "Organic (USDA)" (line 48): certifying agent present.

--- SUMMARY ---
  Claims analysed: 3
  Nutrition data points: 15
  Errors:   0
  Warnings: 0
  Info:     5

RESULT: COMPLIANT — all detected claims pass threshold and prerequisite checks.
======================================================================

The agent runs both tools iteratively — first the food_label_compliance_checker for structural completeness and allergen declarations, then the nutrient_claim_validator for claim verification — and surfaces findings inline so issues are resolved before printing or regulatory submission.