200Module 3 of 8
US Cosmetics Labeling (21 CFR 701)
INCI ingredient declaration, warnings, cosmetic vs. drug claims, and why 'hypoallergenic' isn't defined.
7 minutes
UScosmeticsLesson Video
US Cosmetics Labeling (21 CFR 701)
Module Content
1) Executive Summary
Five–seven essential insights
- Ingredient list format is rigid. Declare in descending order of predominance; ingredients at ≤1% may be in any order after the >1% ingredients; color additives may be listed last in any order; “Fragrance”/“Flavor” may be listed by those collective terms. [1][2][3][17]
- Name choice = INCI in practice. Names are those established by the Commissioner or, lacking that, from referenced compendia; operationally, INCI is expected and standard. [1][3][4][5]
- Warnings are both general and product‑specific.If safety isn’t adequately substantiated pre‑market, the PDP must bear: “Warning—The safety of this product has not been determined.” Aerosols, feminine deodorant sprays, foaming bath products, certain coal‑tar hair dyes, and suntanning products have specific 21 CFR 740 warnings. [6][7][8][18]
- Claims drive classification. Structure/function or disease prevention/treatment claims make a product a drug (or drug/cosmetic combo); OTC Drug Facts then apply. No legal “cosmeceutical” category. [9][16]
- “Hypoallergenic” isn’t defined. FDA has no binding definition; a 1970s attempt was vacated in Almay v. Califano. Use is largely marketing and can mislead without strong substantiation. [10][11]
- Change on the horizon: fragrance allergen disclosure (MoCRA).Congress authorized labeling of specified fragrance allergens; as of this review, no FDA final rule—monitor and prepare EU‑style disclosure structures. [12]
Recommended actions
- Lock a label build: statement of identity (PDP), net quantity (PDP), name/place of business, ingredient list (information panel), and any required warnings. [1][2][6][7]
- Use INCI consistently; maintain a master INCI BOM with 1% rule flags and color additive handling. [1][3][4]
- Run claims through a Cosmetic vs Drug screen before artwork lock. [9][16]
- Apply 21 CFR 740 warnings where applicable; document safety substantiation to avoid the §740.10 PDP warning. [6][7][8]
- Track MoCRA fragrance‑allergen rulemaking; pre‑model EU/UK style disclosures. [12][13][14]
Key risks (12–24 months)
- Fragrance allergen labeling may require rapid relabeling—prepare data and artwork patterns now. [12]
- Claims enforcement if language drifts into drug territory. [9]
- Global discrepancies complicate harmonized packs. [13][14]
2) Definitions & Concepts
- INCI — International Nomenclature Cosmetic Ingredient used on labels across many markets; de facto U.S. naming practice. [1][3][4][5]
- PDP — Principal Display Panel; holds identity and net quantity. [2][15]
- Information panel — Panel other than PDP; houses ingredients and name/place of business. [1][2]
- Adequate safety substantiation — Evidence allowing qualified experts to conclude safe use; lacking this triggers the §740.10 PDP warning. [6][8]
- Cosmetic vs Drug — Intended use determines category; claims implying disease/structure effects trigger drug rules. [9]
Concept map (bullet diagram)
- Label architecture → PDP (identity, net qty) → Info panel (ingredients, address) → Conditional: 21 CFR 740 warnings → Claims review → If drug triggers → add Drug Facts (21 CFR 201.66). [1][2][7][9]
3) Standards, Regulations, and Governance (US focus; EU/UK contrast)
Core U.S. sources (titles & anchors)
- 21 CFR Part 701 (Cosmetic labeling): identity, name/place, ingredient declaration; compendial naming references. [1][2][3][4]
- 21 CFR Part 740 (Warning statements): general + product‑specific warnings. [7][8]
- FDA “Cosmetic or Drug?” interpretive guide; Drug Facts (21 CFR 201.66) for combos. [9][16]
- MoCRA (2022): authorizes fragrance allergen labeling; rulemaking pending. [12]
Per‑region contrast (high level)
| Topic | United States | European Union | United Kingdom |
|---|---|---|---|
| Ingredient list naming | Common/usual or compendial; INCI used | INCI per Art. 19; EU INCI glossary | INCI under retained 1223/2009 |
| Fragrance allergens | Pending MoCRA rule | Mandatory labeling of specified list | Mandatory; aligned with retained EU law |
| Warnings (examples) | §740.10 safety‑not‑substantiated; aerosols; feminine deodorant sprays; foaming bath; coal‑tar hair dyes; suntanning | Annex restrictions + SCCS opinions | Similar to EU (retained law + OPSS) |
4) Evidence Base & Benchmarks
Ingredient declaration rules
- Order: descending by predominance; ≤1% may be listed in any order after >1%; color additives last (any order); fragrance/flavor by collective term permitted. [1][2][17]
- Naming: names established by the Commissioner or from referenced compendia (CTFA/INCI); use INCI. [1][3][4][5]
Warnings (selected anchors)
- §740.10 PDP warning text (safety not substantiated). [6]
- §740.11 self‑pressurized containers (aerosols) warning specifics summarized by FDA guide. [8]
- §740.18 coal‑tar hair dye carcinogenicity warning. [18]
Cosmetic vs Drug
- Intended use; disease or structure/function claims → drug; no “cosmeceutical” status. [9]
Why “hypoallergenic” has no binding meaning
- FDA: no Federal definition. [10]
- Almay v. Califano vacated FDA’s 1975 rule. [11]
5) Design & Production Implications
Rules of thumb (artwork & hierarchy)
- Front (PDP): Identity + net quantity sized per §701.13; place net quantity in PDP lower area. [3][15]
- Back/side: Ingredient list + name/place of business on information panel (§§701.3, 701.12). [1][2]
- Use INCI spellings uniformly; avoid mixing marketing synonyms with INCI in the declaration. [1][3][4]
- Fragrance/Flavor: declare as “Fragrance/Flavor” unless listing components; prepare for future allergen disclosures. [1][12]
- Combo products: If claims/actives trigger drug status, present Drug Facts; list actives first, then cosmetic ingredients. [2][16]
Designer tip
Build a two‑tier ingredient layout: (1) >1% in descending order; (2) a divider; (3) ≤1% in any order; then (4) color additives last. Mirrors §701.3(f)(2)–(3) and reduces reflow. [1][2]
Manufacturability flags
- Small panels/mini formats: use §701.9 placement flexibilities where applicable; maintain warning conspicuousness (21 CFR 740.2 suggests ≥1/16‑inch letters). [7][8]
6) Sustainability & Compliance Considerations
- Claims risk: Avoid drug‑leaning sustainability/efficacy claims (“detoxifies,” “heals,” “rebuilds collagen”) unless compliant with drug rules. [9]
- Fragrance allergens transparency: U.S. is behind EU/UK; consider voluntary EU‑style disclosures to reduce future relabeling. [12][13][14]
- Trade secrets: If FDA‑granted confidentiality, may appear as “and other ingredients” at end; retain documentation. [2]
Compliance watch
“Hypoallergenic” remains unregulated; if used, hold robust substantiation (e.g., HRIPT/patch‑test data, composition rationale). [10][11]
7) Workflow & Tooling (PDA‑ready)
Checklists (US cosmetic pre‑flight)
- PDP: identity (§701.11); net quantity sized correctly (§701.13). [2][3][15]
- Info panel: name/place (§701.12); ingredient list per §701.3 (order, ≤1%, colors, fragrance/flavor). [1][2]
- Warnings: scan Part 740 triggers (aerosols, feminine sprays, foaming bath, coal‑tar dyes, suntanning; plus §740.10 PDP warning). [6][7][8]
- Claims: Cosmetic vs Drug screen (if drug → 21 CFR 201.66 Drug Facts). [9][16]
Decision tree: Cosmetic vs Drug
- Any claim implies treat/cure/prevent disease or affects structure/function? → Drug (or combo).
- Covered by an OTC monograph/NDA? If yes, add Drug Facts; if no, revise claims to cosmetic language. [9][16]
Calculator blueprint (to‑be)
- Net quantity type size calculator keyed to PDP area (§701.13 and cross‑references). Inputs: PDP area (in²), container class. Output: minimum type height. [3][15]
Template specs (RFQ/Artwork)
- Ingredient master: INCI, function (fragrance/flavor), color additive status, typical wt.%, regulatory notes (trade secret, allergen potential). [1][3][12]
8) Category‑Specific Guidance
Hair color: Follow coal‑tar dye constraints and warnings; never for brows/lashes. [18]
Aerosol styling & dry shampoos: ensure §740.11 warnings and conspicuousness. [8]
Suntan oils (no SPF): §740.19 warnings (no sunburn protection). [7]
9) Case Studies (outline)
1) Aerosol hairspray
Approach: Applied §740.11 warning; ingredient list split per §701.3(f) with color additives last; removed “repairs hair” phrasing.
Result: Clean cosmetic classification. [1][8][9]
2) Moisturizer w/ SPF
Approach: Classified as drug/cosmetic combo; added Drug Facts; listed actives first; cosmetic list after. [2][16]
Result: Meets OTC format; reduced enforcement risk.
3) “Hypoallergenic” eye pencil
Approach: Removed the claim; replaced with “tested with ophthalmologists” + sensorial cosmetic claims supported by HRIPT.
Result: Lower risk given lack of FDA definition. [10][11]
10) Common Pitfalls & Red Flags
- Listing ≤1% ingredients before higher‑level ingredients (order violation). [1]
- Using “cosmeceutical” or therapeutic language. [9]
- Omitting §740.10 PDP warning when safety isn’t substantiated. [6]
- Using “hypoallergenic” without strong internal substantiation. [10][11]
Key References
- 21 CFR §701.3 — Designation of ingredients. [1]
- FDA Cosmetics Labeling Guide (overview; warnings). [2][8][17]
- 21 CFR §701.13 — Net quantity of contents. [3]
- 21 CFR §701.30 — Ingredient names; compendia references. [4]
- Cosmetic Ingredient Names (FDA). [5]
- 21 CFR §740.10 — Safety not adequately substantiated. [6]
- 21 CFR Part 740 Subpart B — Warning statements. [7]
- Is It a Cosmetic, a Drug, or Both? (FDA). [9][16]
- “Hypoallergenic” Cosmetics (FDA); Almay v. Califano. [10][11]
- FDA Unified Agenda — Fragrance allergens (RIN 0910‑AI90). [12]
- EU/UK sources on allergen disclosure and labelling. [13][14][17]
- 21 CFR §701.10 — PDP; cross‑refs for type size under FPLA. [15]
- 21 CFR §740.18 — Coal‑tar hair dyes (cancer risk). [18]
Note. Citations mirror the module’s bracket numbering; consult eCFR/ FDA links in course materials for current texts.
Evidence gaps & monitoring
- U.S. fragrance‑allergen list & thresholds: not final; monitor FDA RIN 0910‑AI90. [12]
- UK timetable for future EU allergen changes: track OPSS. [17]