US Compliance & Regulatory Documentation Software

No single federal agency controls US compliance — instead, a patchwork of regulators (FDA, EPA, FTC, SEC, CBP, CPSC) each govern their slice, while 50 states layer additional requirements on top. UFLPA enforcement at the border is managed by CBP. FSMA 204 food traceability falls under FDA. Proposition 65 is enforced through California private attorney general lawsuits. SEC climate disclosure applies to public companies. PFAS restrictions vary state by state. A single product sold nationwide may simultaneously trigger federal import controls, state-level chemical warnings, and sector-specific safety certifications.

This decentralisation means that compliance failures surface differently than in the EU. Instead of a single market surveillance authority, your exposure includes CBP detention at ports, FDA warning letters, California lawsuit notifications, state attorney general investigations, and retailer compliance audits that reference different subsets of these requirements. The cost of non-compliance ranges from $30 million in annual Prop 65 settlements to billions in UFLPA detained goods to existential reputational damage from an FSMA-triggered recall.

Sustalium organises US compliance by regulation rather than by agency, so your team sees the complete picture for each product across all applicable federal and state requirements. UFLPA supply chain traceability records sit alongside Prop 65 substance assessments and FSMA 204 lot-level documentation for the same product lines. When a new state adopts PFAS restrictions or the SEC adjusts climate disclosure timelines, the affected compliance records surface for review. For companies managing both US and EU obligations, shared underlying data — supplier evidence, substance testing, supply chain mapping — serves both regulatory environments without parallel data entry.