Regulatory compliance software for supplements.

Supplements sit under DSHEA in the US, which means they are neither food nor drugs and get a rulebook of their own. Structure/function claims must be substantiated and notified. Supplement facts panels follow NLEA formatting. New dietary ingredients (NDIs) need FDA notification 75 days before market. Facilities operate under 21 CFR 111, the supplement GMP rule. In the EU, health claims must sit on the EFSA authorised list or the product does not carry them, and national notifications apply per member state. On top of that, retailers and marketplaces run their own claim review.

The obligations are not exotic. The problem is that most brands manage them in twelve tabs of a Google Sheet.

• Ingredient master with NDI status, contraindications, allergen flags and supplier evidence.
• Formulation with regulatory limits and dose thresholds enforced at design time.
• Claims register covering DSHEA structure/function claims and EFSA authorised health claims, linked to the evidence.
• Label review generating supplement facts panels, allergen statements and required disclaimers from the live formula.
• 21 CFR 111 GMP records, batch records and quality events on the same platform.
• Retailer dossiers answered from live data instead of assembled from PDFs.

Willow drafts the label and disclaimer set from the live formula, checks a proposed claim against the DSHEA and EFSA lists, and flags formulations that combine ingredients above a regulator or retailer threshold. Every action produces an audit trail of what data Willow used and who approved the output.

Brands that run supplements alongside cosmetics or food benefit from a single substance master across all three. See AI ERP for cosmetics and formulation software for adjacent modules; they share the same data model.

Supplement brands, sports nutrition companies, nutraceutical formulators, and contract manufacturers of finished dose formats. Whether the product is a capsule, a powder, a gummy or a functional beverage, the object being regulated is the substance and its concentration.