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FDA Regulations on Environmental Claims such as Sustainable or Biodegradable

Environmental claims such as sustainably sourced or biodegradable, when used on labels, packaging, or advertising for food specialties sold in the American market, are subject to regulation by the FDA and other federal agencies.

Like all marketing claims, environmental claims must be truthful, substantiated, and not misleading for consumers. In the United States, the Federal Trade Commission (FTC) regulates environmental claims for FDA-regulated products, while the Food Safety and Inspection Service (FSIS) performs this function for meat and poultry products regulated by the U.S. Department of Agriculture (USDA).

Both these American federal agencies have published guidelines to assist manufacturers in formulating compliant environmental claims. The FTC guide provides advice on claims like recyclable, degradable, or ozone-safe, but does not specifically address sustainability claims. While there is no pre-approval system for labels, the FTC can take action against a manufacturer if a claim is found to be misleading or lacking adequate documentation.

FSIS, on the other hand, published the latest version of its guidelines in August 2024, classifying environmental claims as those that describe land management or improvement methods, as well as the adoption of environmentally sustainable agricultural practices. To approve such claims for products sold in America, producers must provide adequate supporting documentation, and given the inherent complexity of these claims, they are strongly encouraged to use independent third-party certification bodies.

Item FTC (FDA-regulated products) FSIS (USDA meat and poultry)
Jurisdiction Regulates environmental marketing claims in advertising and promotional materials; coordinates with FDA for regulated product labeling. Approves labels for meat and poultry products; covers claims on animal husbandry and environment reported on labels.
Pre-approval of claim No pre-approval: the FTC does not "approve" labels; however, it can take enforcement actions if the claim is misleading or unsupported. Yes: many label claims require FSIS review/approval. Supporting documentation is examined as part of the label approval process.
Truthfulness and substantiation standards Claims must be truthful, not misleading, and adequately substantiated according to the Green Guides principles (reasonable consumer interpretation; clear qualifications when necessary). Specific and traceable documentation is required to demonstrate the factual basis of the claim (e.g., agricultural/environmental practices adopted; metrics; management plans; audits).
“Sustainably sourced”/“sustainable” No single regulatory definition exists in the Green Guides; the declared meaning (scope, boundaries, methodology) must be supported, and unjustified implications should be avoided. Treated as an environment-related claim: describes practices that maintain/improve resources or the environment. FSIS requires detailed evidence consistent with the proposed label meaning.
Role of third parties Third-party certification is not mandatory but can strengthen claims; however, it must still be accurate and not misleading. FSIS strongly encourages the use of independent certification bodies for complex claims (husbandry/environment), while still requiring internal evidence.
Covered areas Advertising, websites, social media, promotional materials (for FDA products, the FTC coordinates with FDA on labeling issues) Labels and on-label claims for meat and poultry products (USDA), including husbandry and environmental statements.
Sanction risks FTC actions for deceptive practices; cease-and-desist orders, remedies, and settlements. Denial/withdrawal of label approval; misbranding; USDA/FSIS enforcement.
Best practices for “sustainably sourced” Define the scope (product, packaging, ingredients/suppliers), metrics, and standards; indicate limits/qualifications; maintain verifiable evidence.

The “Sustainably Sourced” Claim

Document Minimum Content / Operational Notes
Definition and limits of the claim Clear description of what sustainably sourced means for the product/ingredient/packaging; boundaries (e.g., % of the supply chain covered; included/excluded stages); any qualifications on labels or promotional materials.
Criteria and standards adopted References to standards/measures (e.g., resource management, water/energy consumption, biodiversity, soil); mapping between criteria and claims; justification of environmental relevance.
Measurement methodology Metrics, calculation factors, assumptions; frequency of measurement; IT tools and systems; declared methodological limits (to avoid unjustified implications).
Chain of custody / Traceability Traceability procedures (batch, supplier, production site); evidence of physical segregation or mass balance; records of receipts/dispatches; supplier control.
Environmental assessments and management plans Reports on agricultural or management practices (e.g., soil/water conservation, pasture management, chemical inputs); objectives, KPIs, baseline, targets, and progress reports.
Internal and external audits Audit plans, checklists, minutes, corrective actions; frequency and auditor competence; traceability of follow-ups and closure of non-conformities.
Third-party certifications (if present) Valid certificates, scope of certification, applied standards, accredited bodies; correspondence between the certification scope and the proposed claim.
Label and promotional materials Label mock-up, claim text, qualifications/limitations; advertising/digital materials; consistency between label and external communication.
Consumer understanding analysis Assessment of misunderstanding risk; comprehension tests (if available); justification of claim clarity and provided qualifications.
Decision-making chain Internal approvals; roles and responsibilities; dossier "freeze" date; versioning and document governance.
Response readiness Contact list for inspections/requests (FSIS/FTC); quick file index; signed statements; response plan for authority inquiries.

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