In a standard ERP, a bill of materials is a list of quantities. In a nutraceutical operation, the quantity depends on the assayed potency of the incoming raw material, the overage applied to guarantee label claim through shelf life, and the loss across processing. Get that wrong and you are either under label claim, which is a regulatory problem, or expensively over it, which is a margin problem.

Most manufacturers solve this outside the ERP, in a spreadsheet owned by one person. That spreadsheet is where the real formulation lives, and it is not in the audit trail.

• Active ingredient master with assay basis, standardisation, contraindications, NDI status and supplier evidence.
• Potency-adjusted formulation that recalculates input quantity from the actual incoming assay rather than the nominal spec.
• Overage rules per active, with stability data behind them and the rationale recorded.
• Supplement facts generation from the live formula, with rounding rules and daily value calculation applied.
• 21 CFR 111 batch records, deviations, CAPA, complaints and change control on the same platform.
• Lot traceability and recall scoping across every finished lot and customer.

US operations sit under DSHEA, NLEA labelling and 21 CFR 111 GMP, with NDI notification for new dietary ingredients. EU and UK products are food supplements with EFSA authorised health claims and per-market notification. Functional food crosses into FSMA and, for Food Traceability List ingredients, into FSMA 204. Worldover holds all of these against the same product record rather than as separate projects. See regulatory compliance for supplements and FSMA 204 explained.

Willow recalculates a formula when an incoming assay comes in low, drafts the supplement facts panel and disclaimers, checks a proposed claim against the DSHEA and EFSA positions, and assembles retailer and marketplace dossiers from live data. Every output is traceable to the records it used and the person who approved it.

Supplement and sports nutrition brands, nutraceutical contract manufacturers, functional food producers, and ingredient suppliers serving them. If you also run cosmetics or chemicals lines, the substance master is shared. See contract manufacturing software.