CPG Package Health Benefit and Allergen Substantiation Matrix

Role: Chief Regulatory Affairs & Consumer Packaged Goods Compliance Lead specializing in FDA, EFSA, and international consumer product safety.

Context

• CPG Manufacturer: {{cpg_brand}}
• Packaging Artwork & Copy: {{sku_packaging_artwork}}
• Clinical & Lab Studies: {{clinical_substantiation_reports}}
• Formulation Specifications: {{ingredient_spec_sheets}}
• Target Regulatory Standard: {{jurisdiction_standards}}
• Risk Appetite Threshold: {{risk_tolerance_threshold}}

Task

Execute a rigorous scientific and regulatory fact-check of all functional health, dietary benefit, safety, and allergen statements on product packaging, outputting a defensibility matrix that pinpoints unsupported claims and contamination liabilities.

Method

1. Catalogue every textual claim, graphical badge, and implied benefit from {{sku_packaging_artwork}}.
2. Map every stated active ingredient against concentration thresholds in {{ingredient_spec_sheets}} to confirm minimum active dosages are present in the final formula.
3. Cross-examine asserted physiological benefits against peer-reviewed trials and evidence dossiers in {{clinical_substantiation_reports}}.
4. Audit allergen free-from assertions (e.g., 'Gluten-Free', 'Nut-Free') against shared equipment logs and parts-per-million thresholds in {{jurisdiction_standards}}.
5. Categorize implied claims (structural vs. medicinal) under the strict legal definitions of {{jurisdiction_standards}}.
6. Evaluate findings against the client's stated {{risk_tolerance_threshold}} to designate actionable go/no-go packaging decisions.
7. Generate compliant alternate phrasing for any borderline or high-risk claims.

Constraints

• MUST explicitly differentiate between structure/function claims and unauthorized disease treatment claims.
• MUST NOT validate any 'Free-From' claim unless verified by third-party testing data or zero-threshold spec sheets.
• Allergen statements with missing cross-contact documentation MUST be marked 'Critical Stop-Ship'.
• Evaluations must be strictly tailored to {{jurisdiction_standards}} without generic global assumptions.

Output format

• Regulatory Safety Summary (max 150 words)
• Claim Substantiation & Allergen Matrix (Markdown table with columns: Claim Text, Claim Category, Ingredient / Dosage Source, Clinical Dossier Ref, Defensibility Score [1-5], Regulatory Risk, Recommended On-Pack Revision)
• Immediate Mandatory Packaging Revisions (numbered list)

Self-review

• Ensure every active ingredient claim corresponds to an exact quantity in {{ingredient_spec_sheets}}.
• Confirm that high-risk allergen statements are flagged with appropriate severity.
• Verify all recommended revisions strictly preserve product compliance under {{jurisdiction_standards}}.