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US Food Labeling (21 CFR 101)

Required statements, Nutrition Facts formatting, allergens, ingredient lists, net quantity, and boundaries of allowable claims.

8 minutes
USfood
Next: EU Food Information to Consumers (Reg. 1169/2011)
Lesson Video
US Food Labeling (21 CFR 101)
Module Content

1) Executive Summary

Top 7 takeaways
  1. Five "musts" live on every FDA food label: (a) Statement of identity (PDP), (b) Net quantity (PDP), (c) Nutrition Facts (info panel unless exempt), (d) Ingredient list, (e) Name & place of business. [1–5]
  2. Nutrition Facts has hard graphic specs (type sizes, bold rules, bars, leading) and content order; "Calories" and its numeral have the largest required sizes. [6]
  3. Major allergens = 9 (sesame added 2023). Declare by food-source name via a Contains line or parenthetical in ingredients; fish/shellfish require species; tree nuts require the specific nut. [7–9]
  4. Ingredient mechanics: descending order, sub‑ingredients in parentheses; flavor/color/preservatives declarations per 21 CFR 101.22. [10–12]
  5. Net quantity on the PDP lower area in specified type sizes; federal allows separate metric; many labels use dual units due to state practice. [13–15]
  6. Claims live within tight fences: nutrient content (Subpart D), health (Subpart E/qualified), gluten‑free bright line (≤20 ppm), and "healthy" updated (effective Apr 28, 2025; 3‑year window). [16–21]
  7. EU/UK differ: 14 allergens with emphasis, QUID, metric‑only net quantity, different nutrition format. See §3 table. [22–24]
Priority actions for designers
  • Lock a label map (PDP vs info panel) for the five "musts". [1–5]
  • Build an NFt master that meets §101.9 graphic rules (sizes, bolding, rules, dual columns). [6]
  • Run an allergen audit; set species/nut specificity and Contains logic. [7–9]
  • Standardize ingredient list templates with sub‑ingredient parentheses and §101.22 phrasing. [10–12]
  • Decide on net quantity units (dual vs metric‑only) in light of state UPLR practice. [14–15]
  • Pre‑clear claims (Subpart D/E; Green Guides for environmental claims). [16–18, 25–27]
Key risks (12–24 months)
  • "Healthy" implementation: design/QA updates to meet criteria by compliance date. [21]
  • Allergen enforcement & sesame: ensure accurate Contains use. [7, 28]
  • Green Guides refresh: recyclability substantiation thresholds. [26]

2) Definitions & Concepts

  • PDP — Principal Display Panel (front panel most likely seen); identity + net quantity. [1, 13]
  • Information panel — panel immediately to the right of PDP; NFt, ingredients, address. [2, 4, 5]
  • RACC — Reference Amounts Customarily Consumed; serving size basis. [29]
  • Major food allergens — 9 (incl. sesame). [7]
  • Nutrient content claim — characterizes level of a nutrient (e.g., low, good source). [16]
  • Health claim — relationship to disease/condition; authorized or qualified. [17–18]
  • Green Guides — FTC environmental claims guidance (labels). [26–27]
Concept map (bullet diagram)
  • Label architecture → PDP (identity, net qty) → Info panel (NFt, ingredients, address) → Claims zones → US vs EU/UK deltas.

3) Standards, Regulations, and Governance (US; EU/UK deltas)

Core U.S. authorities (FDA, 21 CFR Part 101)
  • §101.3 Statement of identity. [1]
  • §101.7 Net quantity on PDP; placement/format. [13–14]
  • §101.5 Name/place of business. [5]
  • §101.4 Ingredient designation. [10]
  • §101.9 Nutrition labeling (content + formatting). [6]
  • §101.12 RACCs (serving size basis). [29]
  • §101.22 Flavors, colors, preservatives. [12]
  • Subpart D nutrient content claims. [16]
  • §101.14 & Subpart E health claims. [17]
  • §101.91 Gluten‑free (≤20 ppm; fermented/hydrolyzed). [19–20]
  • FD&C §403(w) Allergen labeling (FASTER; sesame). [7–8]
  • "Healthy" final rule (effective Apr 28, 2025; 3‑year window). [21]
What differs by region (high‑level)
TopicUS (FDA)EU (Reg 1169/2011)UK (retained)
Allergen list9 majors (incl. sesame)14 specified allergens14 specified allergens
Allergen emphasisContains or parentheticalEmphasis in ingredient list (typographic)Same as EU
QUIDNot general (limited contexts)Required for characterizing ingredientsSame as EU
Units (net qty)US customary; metric may also appearMetric onlyMetric (imperial only for some non‑foods)
Nutrition tableNutrition Facts (101.9)Nutrition Declaration (kJ/kcal… salt)As EU; UK nuances via guidance

4) Evidence Base & Benchmarks

Nutrition Facts formatting "musts" (selected)
  • Headings in bold/extra bold; Calories label ≥16 pt; Calories numeral ≥22 pt; most others ≥6 pt; required leading and rules; avoid reverse printing as highlighting. [6]
Allergen declaration benchmarks
  • Contains line immediately after/adjacent to ingredients, or parenthetical sources; species for fish/shellfish; specific tree‑nut names; sesame included since 2023. [7–9]
Net quantity presentation
  • PDP lower area, uninterrupted; type size scales tied to PDP area; metric may accompany US customary; dual units common due to state practice. [13–15]

Evidence nuance: FPLA excludes foods; state UPLR + FDA practice drive dual units—adopt dual unless counsel advises otherwise.

5) Design & Production Implications

Rules of thumb (with regs)
  • Identity bold on PDP; size reasonably related; parallel to base; include form (e.g., "slices") unless visible. [1]
  • Net quantity in PDP lower 30% with clear area; follow type size scale in §101.7. [13]
  • NFt masters that scale (standard/tabular/linear) with correct abbreviations and dual‑column rules. [6]
  • Ingredients by predominance; parentheses for sub‑ingredients; flavor/color/preservative phrases per §101.22. [10, 12]
  • Allergens via a clean Contains line; species/nut specificity; keep cross‑contact warnings separate. [7–9]
  • Address block as one unit; street may be omitted if publicly listed; include city, state, ZIP. [5]
Manufacturability flags
  • Reserve space for 22‑pt Calories number; use tabular/linear NFt in small packages with reduced mins. [6]
  • Multi‑SKU ingredient swings: consider "and/or" constructs where allowed; maintain version control to avoid mislabeling. [10, 28]

6) Sustainability & Compliance Considerations (claims)

  • Gluten‑free regulated at §101.91 (≤20 ppm); special handling for fermented/hydrolyzed. [19–20]
  • "Healthy" final rule effective Apr 28, 2025; 3‑year window. Coordinate reformulation vs comms. [21]
  • "Natural" lacks binding FDA definition; policy‑based—use with caution/substantiation. Evidence gap: no CFR definition. [31]
  • Environmental claims: Green Guides—unqualified "recyclable" generally requires ≥60% access, else qualify conspicuously. [26–27]

7) Workflow & Tooling

Checklists
  • Print‑ready compliance: PDP identity (bold), PDP net quantity (lower 30%, units/type), info panel NFt (format & sizes), ingredients formatting, Contains, address block. [1, 13, 4, 6, 7, 10, 5]
  • Allergen controls: confirm 9 majors; species/nut specificity; supplier attestations on cross‑contact. [7–9]
  • Claims pre‑flight: nutrient claims vs Subpart D; health claims authorization/qualified language; gluten‑free eligibility; Green Guides substantiation. [16–20, 26]
Decision trees
  • NFt format: package area small? → tabular/linear (§101.9(j)(13)); else standard vertical; multi‑serving → dual column? [6]
  • Allergen declaration: any of 9 present? → parenthetical vs Contains; fish/shellfish/tree nuts → species/nut names. [7–9, 30]
  • Net quantity units: default to dual (US + metric) unless counsel approves metric‑only for markets. [14–15]
Calculator blueprints
  1. Yield math: pieces/roll or sheet = ⌊usable area ÷ (die + gaps)⌋.
  2. NFt space planner: min panel to fit 22‑pt Calories, 16‑pt label, 6‑pt body, leading & rules (constants from §101.9).
  3. Net quantity type: choose type‑size bin by PDP area per §101.7 to compute min character height.
Templates‑to‑be
  • RFQ: substrate, ink system, NFt variant, allergen/ingredient specs, legal status.
  • Artwork versioning: sku_brand_size_flavor_lang_rev_YYYYMMDD.ai with locked rev at regulatory sign‑off.

8) Category‑Specific Guidance

Beverages (juice): "% juice" declaration if represented as juice; align with §101.30 (add to label map for beverage lines).
Bakery/snacks: sesame risk (breads, toppings); ensure Contains: Sesame if present; beware "no added sugar" triggers under §101.60(c).
Dairy analogues/plant‑based: identity naming to avoid "imitation" issues if nutritionally inferior (§101.3(e)); prefer qualified claims. [1]

9) Case Studies (Problem → Approach → Result)

1) Small bottle, big constraints
Problem: 8‑oz beverage lacked room for standard NFt.
Approach: Use tabular/linear NFt under §101.9(j)(13); tighten ingredients to single column; no dual column.
Result: QA pass; improved readability. [6]
2) Sesame surprise in "everything" topping
Problem: Supplier added sesame post‑spec; label lacked Contains: Sesame.
Approach: Supplier attestation + Contains line; PLM trigger on allergen change.
Result: Corrected labels; audit trail supports compliance. [7–9]
3) "Recyclable" icon on flexible
Problem: Wanted unqualified "recyclable" badge; access limited.
Approach: Access study <60%; changed to qualified claim with how/where info per Green Guides §260.12.
Result: Reduced enforcement risk; clearer guidance. [26–27]

10) Common Pitfalls & Red Flags

  1. Tiny net quantity or wrong location (not PDP lower area). [13]
  2. NFt typography off (non‑bold headings, undersized Calories). [6]
  3. Allergen omissions or over‑declarations (e.g., stating sesame when absent). [7, 28]
  4. "No added sugar" misuse when sugars increase by processing or reference food doesn’t normally contain added sugars. [18]
  5. "Healthy" used under old criteria post‑final rule—calendar transition. [21]
  6. "Natural" without substantiation—policy‑based, litigable. [31]
Next: EU Food Information to Consumers (Reg. 1169/2011)