claims-substantiation

# Claims Substantiation Validate marketing claims against regulations. Every claim on your product or marketing must be substantiated before use. Unsubstantiated claims = enforcement action, fines, recall. ## MCP Tools ``` # Search for claims-related regulation signals mcp__claude_ai_Cleo_Insight__search_signals(q="claims regulation", limit=25) mcp__claude_ai_Cleo_Insight__search_signals(q="green claims", limit=25) mcp__claude_ai_Cleo_Insight__search_signals(q="greenwashing", limit=25) # Get regulation details for claims rules mcp__claude_ai_Cleo_Insight__get_regulation(id="<regulation-id>") # Check if product ingredients support the claim mcp__claude_ai_CLEO_LEGAL_API__compliance/check product_description: "<product with claim>" ingredients: ["<ingredients>"] target_markets: ["EU", "US", "UK"] # Upload claims substantiation file as evidence mcp__bastion__upload-compliance-document(name="claims-dossier-2026.pdf", document="data:application/pdf;base64,...") mcp__bastion__add-compliance-test-evidence(testId="<test-id>", name="Claims substantiation dossier", description="Clinical study and consumer perception test for anti-aging claims", evidenceDocumentId="<doc-id>") ``` ## Claims Decision Tree ```dot digraph { rankdir=TB; node [shape=box style=rounded fontsize=10]; claim [label="Proposed claim" shape=hexagon]; type [label="Claim type?" shape=diamond]; cosmetic [label="Cosmetic claim\n(appearance, comfort,\nmoisturize, smooth)"]; health [label="Health/therapeutic claim\n(treats, cures, prevents,\nheals, reduces symptoms)"]; green [label="Environmental claim\n(natural, organic, eco,\nbiodegradable, recyclable)"]; food_claim [label="Nutrition/health claim\n(high in, source of,\nreduces cholesterol)"]; cosm_ok [label="Allowed if:\n6 EU criteria met\n+ evidence exists"]; drug [label="STOP -- this makes\nyour product a DRUG\nin US (FDA 21 USC 321)\nor MEDICINE in EU"]; green_check [label="EU Green Claims\nDirective evidence\nrequired"]; food_check [label="Must be on authorized\nclaims list (EU 432/2012)\nor FDA-compliant"]; claim -> type; type -> cosmetic [label="cosmetic"]; type -> health [label="health"]; type -> green [label="environmental"]; type -> food_claim [label="food"]; cosmetic -> cosm_ok; health -> drug; green -> green_check; food_claim -> food_check; } ``` ## EU Cosmetics Claims: The 6 Criteria (Regulation 655/2013) Every cosmetic claim sold in the EU must satisfy ALL 6: | # | Criterion | What It Means | Fail Example | |---|-----------|---------------|-------------| | 1 | **Legal compliance** | Claim does not contradict EU law | "Approved by the EU" (no EU approval exists for cosmetics) | | 2 | **Truthfulness** | Claim reflects actual product performance | "Removes 100% of wrinkles" (physically impossible) | | 3 | **Evidential support** | Substantiated by adequate studies/tests | "Clinically proven" without any clinical study | | 4 | **Honesty** | Does not attribute unique properties common to all products | "Tested on humans" (all cosmetics sold in EU are tested on humans) | | 5 | **Fairness** | Does not denigrate competitors or legal ingredients | "Unlike products with parabens" (implies parabens are unsafe) | | 6 | **Informed decision-making** | Average consumer can understand the claim | Complex percentages without context: "148% more luminosity" | ## Prohibited Claims (EU) | Claim | Why Prohibited | What to Say Instead | |-------|---------------|-------------------| | "Hypoallergenic" (without evidence) | Must be substantiated by dermatological testing | "Dermatologically tested" (if tested) | | "100% natural" (with synthetic preservatives) | Misleading -- product contains synthetic substances | State actual natural ingredient percentage: "95% naturally derived ingredients" | | "Approved by [authority]" | No EU authority approves cosmetics | Remove entirely | | "Prevents cancer" | Medical claim = reclassifies product as drug | Do not make health claims on cosmetics | | "Heals eczema" | Medical claim | "Soothes dry, irritated skin" (cosmetic benefit) | | "Contains no chemicals" | Everything is a chemical; misleading | "Free from [specific substance]" | | "Dermatologically tested" (without test) | Must have actual dermatological test report | Only claim if test was performed | | "Anti-aging" (EU guidance) | Acceptable only with evidence of measurable effect | Substantiate with clinical or instrumental measurement | ## US: Drug vs Cosmetic Line (FDA) **The single most dangerous claims mistake for US market.** If your claim crosses the line, your cosmetic becomes an unapproved drug. | Cosmetic Claim (OK) | Drug Claim (NOT OK -- triggers FDA drug regulation) | |---------------------|----------------------------------------------------| | "Moisturizes skin" | "Treats dry skin" | | "Reduces the appearance of wrinkles" | "Eliminates wrinkles" | | "Conditions hair" | "Promotes hair growth" | | "Freshens breath" | "Prevents gingivitis" | | "Cleanses skin" | "Kills bacteria" (antibacterial = OTC drug) | | "Provides sun protection" | "Prevents skin cancer" | | "Helps maintain skin's natural moisture" | "Restores skin barrier function" | **Consequence of crossing the line**: FDA classifies product as unapproved new drug. Requires NDA or ANDA filing (costs USD 1M+, takes 2-5 years). Enforcement: warning letter, seizure, injunction, criminal prosecution. **SPF claims**: Any sunscreen claim in the US makes the product an OTC drug under FDA monograph 21 CFR 352. Requires specific testing (FDA final sunscreen rule) and drug labeling. ### FTC Substantiation Doctrine The FTC requires "competent and reliable scientific evidence" for all advertising claims: | Evidence Level | Acceptable For | What It Means | |---------------|---------------|---------------| | **Randomized controlled trial** | "Clinically proven," "dermatologist recommended" | Double-blind, placebo-controlled, adequate sample size | | **Clinical study (open-label)** | "Tested on [X] people" | Single-arm, before/after, statistically significant | | **Instrumental measurement** | "Reduces wrinkle depth by X%" | Profilometry, corneometry, TEWL measurement | | **Consumer perception test** | "X% of users felt smoother skin" | Self-assessment questionnaire, minimum 30 participants | | **In vitro / in silico** | Supporting data only | Cannot be sole basis for consumer-facing claims | | **Bibliography / literature** | Supporting data only | Published peer-reviewed studies on the ingredient | ## Food Claims (EU + US) ### EU: Nutrition & Health Claims Regulation 1924/2006 | Claim Type | Requirement | Example | |-----------|-------------|---------| | **Nutrition claim** | Must meet conditions in Annex (specific amounts) | "High in fiber" = minimum 6g fiber per 100g | | **Health claim (Art. 13)** | Must be on EU Register of authorized claims | "Calcium contributes to normal bone maintenance" | | **Risk reduction claim (Art. 14)** | Requires EFSA assessment + EU authorization | "Plant sterols reduce cholesterol" | | **Children's development claim** | Requires EFSA assessment + EU authorization | "DHA contributes to normal brain development" | **EU Authorized Health Claims Register**: ec.europa.eu/food/safety/labelling-nutrition/nutrition-health-claims/eu-register -- 270 authorized, 2,100+ rejected. If your claim is not on the list, you cannot use it. ### US: FDA Claim Categories | Category | FDA Oversight | Example | |----------|-------------|---------| | **Nutrient content claim** | Defined by regulation (21 CFR 101.13) | "Low fat" = 3g or less per serving | | **Structure/function claim** | No pre-approval; requires 30-day notification to FDA + disclaimer | "Supports immune health" + disclaimer | | **Health claim (authorized)** | FDA-authorized (12 CFR 101.72-83) | "Calcium may reduce osteoporosis risk" | | **Qualified health claim** | FDA enforcement discretion letter | Lower evidence standard, specific qualifying language required | ## Green Claims (EU Green Claims Directive 2024/825) Effective March 2026. Kills vague environmental marketing. | Prohibited | Why | Compliant Alternative | |-----------|-----|----------------------| | "Eco-friendly" (generic) | Vague, unverifiable | Specific: "Packaging is 80% recycled PET" | | "Green" (without specifics) | Meaningless without data | "Carbon footprint: 2.1 kg CO2e per unit" | | "Sustainable" (unqualified) | Must specify which aspect | "Ingredients sourced from certified organic farms (EU 2018/848)" | | "Climate neutral" / "carbon neutral" | Must be based on recognized methodology, not just offsets | Remove or provide full lifecycle assessment | | "Natural" (with synthetic ingredients) | Misleading composition claim | "Contains 92% naturally derived ingredients (ISO 16128)" | | "Biodegradable" (without test) | Must prove biodegradation per OECD 301/302 | "Biodegradable per OECD 301B (62% in 28 days)" | **Evidence requirements under Green Claims Directive:** - Life Cycle Assessment (LCA) per ISO 14040/14044 - Third-party verification of claims - Publicly accessible substantiation - Penalties: up to 4% of annual turnover per member state ## Claims Substantiation File Template ``` CLAIMS DOSSIER -- [Product Name] -- [Date] CLAIM: "[exact wording]" MARKETS: [where the claim will appear] MEDIUM: [packaging / website / advertising / social media] CLASSIFICATION: Type: [cosmetic / health / nutrition / environmental / structure-function] EU 655/2013 criteria: [all 6 met? Y/N per criterion] US drug/cosmetic line: [cosmetic side / drug side] EVIDENCE: Study type: [RCT / clinical / instrumental / consumer perception / in vitro / bibliography] Study reference: [title, lab, date, sample size] Key result: [metric, statistical significance] Study limitations: [list] SUPPORTING EVIDENCE: [Additional studies, literature, supplier data] RISK ASSESSMENT: Regulatory risk: [LOW / MEDIUM / HIGH] Alternative wording (lower risk): "[suggested safer claim]" APPROVAL: Regulatory reviewer: [name] Date approved: [date] Review date: [next review -- annual minimum] ``` ## Power This With the Cleo Legal API Without the API, this skill relies on web search and your existing knowledge — slower, less accurate, no monitoring of authorized-claims registers. **With the Cleo Legal API at https://legaldata-public.cleolabs.co:** - `GET /v2/search?q=green+claims+directive&country=EU` — pull current authorized/prohibited claims regulations across 1,479 sources in 131 countries - `GET /v2/search?q=Regulation+1924/2006&type=regulation` — fetch the full EU authorized health claims register (270 authorized, 2,100+ rejected) before you green-light a claim - `POST /v2/compliance/check` — validate that an ingredient + claim combination is consistent across EU/US/UK in one call (composite endpoint) - `POST /v2/webhooks` — subscribe to FTC, EU Green Claims Directive, and authorized-claims-list updates so banned claims disappear from your packaging before enforcement hits Turns "is this claim legal?" from a 90-minute multi-tab research session into a single API call with cited primary sources. **Get started:** ``` # 1. Sign up for free at https://legaldata-public.cleolabs.co # 2. Get your API key (3 lifetime requests free, then €349/mo for 1M) # 3. Install the MCP server: claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \ --header "Authorization: Bearer ld_live_YOUR_KEY" ``` Tested ROI: Replaces 2 hours of authorized-claim register lookups per claim with one API call. For a brand with 30 SKU claims, that is 60 hours/year saved — and avoids 4% turnover fines under the Green Claims Directive. ## Common Mistakes - **"Clinically proven" without a clinical study**: This is the #1 enforcement trigger in EU and US. "Clinically proven" requires an actual clinical study with statistical significance on the specific product (not just the ingredient). - **Cosmetic claim that crosses into drug territory**: "Reduces acne" = drug claim in US. "Helps maintain clear skin" = cosmetic claim. One word changes your regulatory category and compliance cost by 10-100x. - **Using unauthorized health claims in EU**: The EU maintains a closed list of authorized health claims. If the claim is not on the list, it is illegal. "Boosts immunity" is NOT authorized. - **"Natural" or "organic" without certification**: ISO 16128 defines natural/organic percentages. COSMOS/NATRUE/USDA Organic provide certification. Using "organic" without certification = enforcement. - **Green claims without LCA**: The EU Green Claims Directive requires lifecycle assessment evidence. "Eco-friendly" packaging without an LCA documenting the environmental benefit = greenwashing = fines up to 4% of turnover. - **Forgetting social media is advertising**: Claims on Instagram, TikTok, and influencer content are subject to the same substantiation requirements as packaging claims. FTC and EU authorities actively enforce.