Component specifications

21 CFR 111.70(b) is one paragraph long: 'You must establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met.' The 2007 preamble (72 FR 34751) and the 2010 Small Entity Compliance Guide expand this into four required spec categories for every component lot, before that component is used in manufacturing:

1. An identity specification (the component is what it is claimed to be).
2. Component specifications for any purity, strength, and composition of the component you have determined are necessary for the dietary supplement to meet its established specifications.
3. Limits on those types of contamination that may adulterate or lead to the adulteration of the finished dietary supplement.
4. Component specifications for packaging or labels that come into direct contact with the dietary supplement.

21 CFR 111.3 defines 'component' broadly: 'any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement.' Operationally that bucket covers:

• Dietary ingredients (vitamins, minerals, herbs, amino acids, enzymes, probiotics — anything declared on the Supplement Facts panel).
• Other ingredients (excipients, binders, flow agents, capsule shells, coatings — listed below the boxed panel).
• Processing aids (release agents, anti-foaming agents) even if they do not appear in the finished batch.
• Water (when added as an ingredient or used in product contact).
• Primary packaging in contact with the supplement (bottles, blister film, capsule shells if separately sourced).
• Labels and label adhesives in contact with the supplement (rarely an issue, but in scope).

Note: secondary packaging (cartons, shipper boxes), pallets, and inks not in contact with the supplement are out of scope of 111.70(b) — though they may be in scope of other Part 111 sections (111.430 packaging requirements).

FDA does not publish a specification table for each ingredient. The manufacturer is responsible for setting numerically defensible limits. The hierarchy of evidence FDA expects you to draw on:

1. USP-NF / FCC monograph (preferred — compendial standard, presumed valid).
2. Other compendia (BP, EP, JP, ChP, AHP) where USP has no monograph.
3. Industry-association standards (AHPA, CRN, NPA) for botanicals without compendial coverage.
4. Supplier specification, audited and accepted by your QC unit, when no compendial standard exists.
5. Internally developed specification based on multiple lots, validated against the finished-product specification.

For contamination limits specifically, USP <2232> (elemental contaminants in dietary supplements) is the de-facto floor for heavy metals: 5 µg/g lead, 1.5 µg/g arsenic (inorganic), 0.5 µg/g cadmium, 1.5 µg/g mercury (methylmercury basis). Many brands target tighter limits — particularly for products marketed to pregnant women or children.

Setting the specification is only half the obligation. 21 CFR 111.75 requires the manufacturer to verify that each component lot meets the established spec BEFORE use:

• Identity — must be tested by the manufacturer on EVERY lot of EVERY dietary ingredient (111.75(a)(1)(i)). CoA does not substitute (without the rare 111.75(a)(1)(ii) petition).
• Other component specs (purity, strength, composition, contamination, packaging) — may be confirmed by CoA from a qualified supplier, provided the manufacturer has established the reliability of the supplier's CoA at least once per year via in-house confirmatory testing.
• 111.155 — components, packaging, and labels must be visually examined at receipt and either accepted, rejected, or quarantined pending QC disposition.

The component spec is a deliberately conservative input to the finished-product spec (111.70(e)). The arithmetic chain:

1. Component spec strength (e.g. ≥95 % curcuminoids) sets the potency_factor used in the MMR charge calculation.
2. Charge = (label_claim_per_serving × batch_size × overage_factor) ÷ potency_factor.
3. Component spec contamination limits (heavy metals, pesticides) compound through the formula to set the finished-product contamination limits (which must, conservatively, be ≤ the sum of all component contributions adjusted for inclusion rate).
4. Component identity confirms the Supplement Facts panel declaration (Latin binomial, plant part, chemical form).

A change to a component spec — supplier swap, new monograph adoption, tighter heavy-metals threshold — requires re-evaluation of the finished-product spec, and frequently triggers an MMR revision under 111.205. Build that linkage into change control or you will ship out-of-spec finished product without realising it.

1. Component specifications missing entirely for one or more components — automatic 111.70(b) finding.
2. Identity test relied on supplier CoA without an approved 111.75(a)(1)(ii) petition.
3. Heavy-metals specification absent from a botanical (especially clay-grown crops: turmeric, rice protein, kelp).
4. Specification 'as supplier-CoA states' — no numeric limits, no method, no acceptance criteria.
5. Supplier CoA reliance for purity/strength without documented in-house verification of the supplier's CoA at least annually.

• component_specs table with categories (identity, purity, strength, composition, contamination_metals, contamination_micro, contamination_pesticides, packaging).
• Each attribute has method, limit_lower, limit_upper, units, source_monograph (USP/BP/AHP/internal).
• Receiving (111.155) blocks accept if no approved spec exists for the material.
• Identity test workflow (111.75) gates lot release at receiving — CoA acceptance only with petition flag.
• CoA reliance has an annual re-verification clock; lapse triggers automatic NCR.
• Spec revisions cascade — changing a component spec auto-flags affected formulas/MMRs for re-review.