Experimentation & Claims Risk

1. Executive Summary

The 7 most important insights

“Intended use” is king (US). Any claim you make anywhere (pack, site, ad, sales deck) can define the product’s intended use and trigger drug/device or pesticide/biocide rules. Disclaimers (“for research only”, “pilot”) don’t save you if the overall impression is a regulated claim. [1, 2]
UK/EU: substantiation must exist before you publish. CAP Code 3.7 (UK) and UCPD/Directive (EU) require evidence in hand before dissemination, even for “small test” ads. [3, 4, 5]
Cosmetics boundary is strict. Words implying treat, heal, cure, SPF, antiperspirant, anti-acne can reclassify a cosmetic as a drug (US) or medicinal product/OTC. EU cosmetics claims must meet Reg. (EU) 655/2013 criteria and Article 20 of 1223/2009. [6, 7, 8]
Antimicrobial/antibacterial claims = pesticide/biocide territory. US EPA’s Treated Articles Exemption only permits claims about protecting the article itself (no public-health claims). EU BPR Article 58 governs treated articles and allowable statements. [4, 8]
Environmental claims are tightening fast. US FTC Green Guides control (update pending); California SB 343 will restrict “recyclable” icons/claims from Oct 4, 2026; EU Directive (EU) 2024/825 bans generic environmental claims unless you prove recognised excellent environmental performance (applies 27 Sept 2026). UK CMA Green Claims Code + DMCC Act 2024 add teeth (up to 10% global turnover fines). [11, 12, 4, 5, 15]
Test market ≠ safe harbour. If your stimulus is publicly accessible, it’s advertising: you must have evidence before you run it. Keep early tests non-public and under NDA to avoid dissemination. [3, 16]
Build a claims ladder. Start with qualitative, non-public concept tests (no regulated terms), then controlled proof-of-concept under NDA, then limited publication with conservative wording once evidence meets regional rules.

Recommended actions (now)

Ring-fence experiments behind NDAs (research panels, prototype interviews, private apps).
Scrub high-risk words in stimuli (e.g., “treats acne,” “antibacterial,” “SPF,” “biodegradable,” “100% recyclable”) until evidence and pathways are cleared.
Stand up a Claims Substantiation File (CSF) per claim: protocol, data, stats, confounders, reproducibility.
Add a Green Claims gate: check CA SB 343, EU 2024/825, UK CMA before any “recyclable/compostable/carbon neutral” language.
Train teams on CAP 3.7 / FTC substantiation and US “intended use” triggers.

Key risks (12–24 months)

EU 2024/825 transposition and UK DMCC enforcement will raise penalties for weak environmental claims. [4, 15]
FTC Green Guides update likely tightens recyclability/offset/biodegradable guidance; state laws (e.g., CA SB 343) may bite first. [11, 13]

2. Definitions & Concepts

Advertising vs. research stimulus: Public dissemination inviting purchase or shaping demand vs. controlled exposure under NDA (non-public). Public tests require substantiation before dissemination. [3, 16]
Intended use (US FDA): Objective intent inferred from your claims, ads, and conduct; can reclassify a product as a drug/device. [1, 2]
Treated article (US EPA/EU BPR): Non-biocidal product treated with a biocide; only narrow claims allowed (protects the article itself). [4, 8]
Substantiation: Evidence you must hold before making objective claims (CAP 3.7; FTC “reasonable basis” / “competent and reliable scientific evidence”). [3, 16, 17]

Concept map (bullet)

Claim type → possible reclassification: medical/therapeutic → Drug/Device; antimicrobial/public health → Pesticide/Biocide; environmental → FTC/EU/UK consumer law; comparative/superlative → substantiation.
Experiment design: Public? evidence must exist. Non-public under NDA? safer, but still avoid regulated keywords.
Release gate: region rules (EU 655/2013; CAP 3.7; FTC Green Guides; CA SB 343; EU 2024/825; CMA/DMCC).

3. Standards, Regulations, and Governance

Authoritative overview (US/EU/UK)

US (FTC/FDA/EPA): Objective claims need reasonable basis before dissemination; health claims generally need human clinical evidence. FDA intended use doctrine can create drug/device status (21 CFR 201.128). EPA restricts antimicrobial/public-health claims; treated article claims are narrow. Green Guides (16 CFR 260) govern environmental claims. [16, 17, 1, 11]
EU: Cosmetics claims under Article 20 of 1223/2009 and Reg. (EU) 655/2013. Anti-greenwashing Directive (EU) 2024/825 bans generic environmental claims unless exceptional proof; applies 27 Sept 2026. Biocides: BPR Article 58 for treated articles. [7, 8, 4, 5]
UK: CAP Code 3.7 (hold evidence before publication), ASA environmental claims guidance; CMA Green Claims Code + DMCC Act 2024 add penalties up to 10% global turnover. [3, 18, 16, 15]

Topic	US	EU	UK
When must you have substantiation?	Before dissemination (FTC doctrine). [16]	Before marketing under UCPD + sector rules; cosmetics follow 655/2013. [8]	Before publication (CAP 3.7). [3]
Cosmetic → drug/device trigger	“Intended use” via claims (21 CFR 201.128). [1, 6]	Medicinal intent not allowed; Article 20/655/2013. [7, 8]	Mirrors EU; enforced by OPSS/Trading Standards. [20, 22]
Antimicrobial claims	EPA FIFRA; Treated Articles Exemption limits claims. [4]	BPR Article 58 treated articles. [10]	GB BPR via HSE; similar boundaries. [10]
Environmental claims	FTC Green Guides; CA SB 343 from Oct 4, 2026. [11, 12]	Directive (EU) 2024/825 bans generic environmental claims unless evidenced (from Sept 27, 2026). [4, 5]	CMA Code + DMCC fines up to 10% turnover. [15]

Upcoming changes & timelines

EU 2024/825: transpose by 27 Mar 2026; applies 27 Sept 2026. [4]
California SB 343: compliance date 4 Oct 2026 (post CalRecycle study). [12]
FTC Green Guides: revisions pending; keep using current Guides. [11, 19]

4. Evidence Base & Benchmarks

What counts as “competent and reliable” (health/efficacy claims)

US FTC: human clinical testing typically required for health-related benefit claims; lesser evidence must match expert consensus. [17, 20]
UK: CAP/ASA expects documentary evidence commensurate with the claim; testimonials alone are insufficient. [3]
EU cosmetics: meet the six criteria (655/2013); evidence should align with the PIF. [8]

Benchmarks (indicative)

“Clinically proven”: generally requires a controlled human study with objective endpoints and appropriate stats; avoid the phrase until your evidence meets expectations. [20, 3]
“Recyclable” (US): reflect availability of programs; CA SB 343 adds collection/sortation/end-market thresholds. [11, 12]
“Biodegradable”/“compostable”: require specified conditions and timeframes; avoid generic claims. [11]

Where data conflict (e.g., LCA methods), define functional unit, system boundaries, and allocation explicitly in CSFs.

5. Design & Production Implications

Rules of thumb for creative stimuli (safe language)

Cosmetics: use appearance/feel descriptors (“moisturizes,” “softens,” “improves the look of…”) when accurate; avoid therapeutic implications (“treats eczema,” “heals acne,” “SPF”). [6]
Antimicrobial: if making any claim, keep to “protects the product from odor‑causing bacteria” type statements only if a treated article and eligible; no public‑health claims. [4]
Environmental: specify what, where, and how (e.g., “widely recyclable in curbside programs covering 80% of CA households; check local rules”); validate against SB 343 and Green Guides; in EU/UK, avoid generic claims. [12, 11, 4]

Manufacturability flags

Child‑resistant (CR) claims trigger testing under 16 CFR 1700.20 (US) or ISO 8317 (EU). Do not test “child‑resistant” language publicly without certification.

Supplier perspective

Converters will ask for claim wording early to validate additives and icons vs. state/EU rules. Provide dielines with space for qualifiers.

6. Sustainability & Compliance Considerations

US: follow Green Guides closely; for “recyclable,” map municipal access and end‑market reality; track SB 343 for CA packs by 2026. [11, 12]
EU: from 2026, generic environmental claims generally prohibited unless exceptional proof per 2024/825. [21]
UK: CMA Green Claims Code applies now; DMCC 2024 adds direct fining powers; align to both CMA and ASA guidance. [16, 15]

Claims risk: words to avoid / safer alternatives

Avoid: “Treats acne/eczema,” “antibacterial packaging,” “SPF bottle label,” “biodegradable,” “100% recyclable,” “carbon neutral.”
Consider: “Helps reduce the appearance of blemishes,” “protects the product from microbial odour” (if treated‑article criteria met), “designed for recycling in [jurisdiction] curbside systems; check local rules,” “third‑party verified footprint for scope X.”

7. Workflow & Tooling

Checklists

Pre‑experiment (all claims)

Identify claim type (efficacy, environmental, comparative, sensory).
Map regulator & boundary (FDA/EPA vs EU/UK law).
Screen trigger words; rewrite to non‑therapeutic, non‑public‑health, non‑generic environmental phrasing.
Decide test mode: non‑public under NDA vs public (needs substantiation now).
Create Claim Substantiation File (CSF): protocol, endpoints, sample size rationale, analysis plan, storage.

Green claims gate (pre‑publication)

US: Green Guides test; CA SB 343 if sold in CA.
EU: 2024/825 generic claim ban check; vet label‑like icons.
UK: CMA Code 6 principles; ASA guidance; DMCC exposure analysis. [11, 12, 4, 16]

Decision trees (sketch)

Is your test public? → Yes → do you hold evidence commensurate with the claim? If no, do not publish. → No (NDA, closed panel) → proceed with neutral wording; record consent, prevent screenshots/indexing. [3, 16]
Does wording imply therapy/antimicrobial/public health? → Yes → regulatory pathway first (OTC/drug/device/EPA/BPR). → No → continue with cosmetics/consumer law checks.

Calculator blueprints (to‑be)

US recyclability eligibility (SB 343 pre‑check): inputs = % population curbside access, % MRF sortation to target bale, % end‑market utilization → Pass/Fail for claim/icon in CA. [12]
Evidence gap tracker: per claim, track required evidence level, current dossier strength, and region‑specific thresholds.

Templates (to‑be)

CSF outline: Claim → Regions → Risk class (Green/Amber/Red) → Protocol → Data → Stats → Limitations → Final approved wording → Date/owner.
Stimulus labels for research only (non‑public): neutral description, no regulated icons, confidential metadata, unique participant code.

8. Category‑Specific Guidance (examples)

Beauty/Personal Care

Avoid therapy words; use appearance claims. SPF/antiperspirant/acne control → drug/OTC territory (US). EU/UK: comply with 655/2013 + Article 20. [6, 7]

Household/Surface

“Antibacterial” triggers EPA/BPR. If using antimicrobial additives for odour control in packaging, limit claims to protection of the product; ensure registration/treated‑article conditions. [4]

Food & Beverage

US health claims require FDA/FTC‑compatible evidence; dietary supplements have specific rules (structure/function statements, 21 CFR 101.93 notice/disclaimer). Do not A/B test disease‑reduction claims publicly without approvals. [22]

9. Case Studies (concise, anonymised)

1) “Deo bar that ‘stops sweat’”

Problem: concept said “stops sweat all day.” → Re‑phrase to “keeps underarms feeling dry” for NDA‑gated panel; build lab data first; move to public OTC‑compliant claims only after pathway clears. Result: avoided drug reclassification during discovery. [1]

2) “Antibacterial packaging insert”

Problem: creative said “reduces germs on hands.” → Counsel flagged EPA scope. Shifted to “helps protect the packaging from odour‑causing bacteria,” checked treated‑article eligibility, kept tests non‑public until dossier verified. Result: no pesticide registration triggered. [4]

3) “Recyclable in CA”

Problem: early mockups used chasing arrows; access data weak. → Run SB 343 gate; remove icon in CA until thresholds met; add geo‑specific QR to local guidance. Result: avoided mislabeling risk ahead of Oct 4, 2026 deadline. [12]

10. Common Pitfalls & Red Flags

Treating test ads as exempt — they aren’t; evidence first. [3, 16]
Assuming a disclaimer cures a regulated claim — it doesn’t if the overall impression implies therapy/public health. [1]
Using “clinically proven” loosely — needs rigorous human data. [20]
“Antibacterial” on non‑registered items — likely EPA/BPR violation. [4, 10]
Generic green claims (EU from 2026) — prohibited without exceptional proof. [4]
“Recyclable” or chasing arrows in CA without meeting SB 343 criteria. [12]

11. Designer tips / Compliance watch

Designer tip: Build copy variants that ladder up evidence. Keep a regional “Red words” list (treats, cures, antibacterial, SPF, biodegradable, carbon neutral).
Compliance watch: EU 2024/825 and CA SB 343 will force icon/term changes on global packaging by late 2026—plan artwork cycles now. [4, 12]
Manufacturing note: If you plan any CR claim, engage test labs (16 CFR 1700.20 / ISO 8317) before even testing the words publicly.

12. Evidence gaps (to resolve next)

Add EU Nutrition & Health Claims Regulation (EC) 1924/2006 practical thresholds and examples for F&B copy.
Map member‑state implementations of 2024/825 as transposition progresses.
Track FTC Green Guides revision outcomes (recyclability, offsets, degradability).

13. Quick reference — Safe experimentation playbook

Non‑public only for early copy tests (NDAs, closed panels, watermark assets, no indexing).
Write neutral: no therapy/public‑health/generic green terms.
Build CSFs as you go; don’t publish until the weakest link passes regional gates.
Geo‑gate environmental icons/claims (CA, EU from 2026, UK) in your artwork system.
Escalation rule: if you need a regulated claim to compete, open the regulatory pathway rather than “testing it live.”