NCQM — National Committee for Quality Management

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Industry reference

Dietary Supplements

A supplement review begins with ingredients, intended use and the claims made for the finished product. Manufacturing controls, specifications, labeling and ingredient status are connected subjects, but they require separate evidence.

A product-specific review

Move from scope to evidence

  1. Define the product and activity

    Record each ingredient, its intended function, the dosage form and the claims made for the product. Resolve the supplement category and any relevant ingredient pathway before using manufacturing evidence to support marketability. A compliant facility process does not authorize an otherwise impermissible ingredient or claim.

  2. Connect requirements to evidence

    Connect component identity, specifications, production controls and finished-product disposition. Review supplier evidence in relation to the material received and the intended specification. A supplier certificate should not be accepted without considering the verification and testing responsibilities of the receiving organization.

  3. Review interfaces and changes

    Review label content and claims against the actual formulation and supporting evidence. Establish change triggers for ingredients, sources, process and presentation. Keep adverse event and complaint responsibilities visible rather than treating the release test as the end of the quality review.

3 source profiles

Requirements and technical resources

Review the references relevant to your product and activity. This selected federal collection does not replace a separate review of applicable state, local or contractual requirements.

Federal regulationFDA

Dietary Supplement Manufacturing, Packaging, Labeling and Holding

21 CFR Part 111

Part 111 establishes a production and quality-control system for dietary supplements. Its requirements cover personnel, premises, equipment, components, specifications, manufacturing records, testing, packaging, labeling and complaints. The rule concerns the supplement’s identity, purity, strength, composition and contamination limits. CGMP compliance does not resolve whether an ingredient, label statement or therapeutic claim is legally permissible.

Dietary Supplements

Federal regulationFDA

Dietary Supplements: New Dietary Ingredient Notifications

21 CFR 190.6; FD&C Act section 413

A new dietary ingredient raises a safety-notification question separate from supplement manufacturing and labeling. The manufacturer or distributor must determine whether notification is required for the ingredient and its intended use. FDA receives information supporting a reasonable expectation of safety at least 75 days before the applicable introduction into interstate commerce. A notification response does not approve the supplement.

Dietary Supplements

Federal regulationFDA

Foreign Supplier Verification Programs for Food Importers

21 CFR Part 1, Subpart L

FSVP places risk-based verification responsibilities on the defined U.S. importer of food. The program links the food’s hazards, the foreign supplier’s performance, supplier approval, verification activities and corrective action. It is not satisfied simply by obtaining a certificate. Seafood, juice, low-acid canned food, dietary supplements and certain small-importer situations have specific regulatory treatment.

Food & BeveragesAnimal Food & Veterinary ProductsDietary Supplements

Build a defensible review record

Identify the product configuration, the controlling provision and edition, the evidence required and the person authorized to make the decision. Keep a reason for exclusions and unresolved questions alongside confirmed requirements.

Revisit the record when design, materials, suppliers, software, claims or the applicable source changes. An earlier report remains useful only to the extent that it supports the current configuration and requirement.

Practice guidance