A staged checklist for dietary supplement label review

Stage 1 — Freeze the product facts

• Final formula, component ingredients, specifications, and supplier versions.
• Dosage form, serving size, directions, target users, and conditions of use.
• Package count, volume, or weight and the actual packaging configuration.
• Manufacturer, packer, distributor, importer, and brand-owner roles.
• Every proposed label, website, marketplace, advertising, and testimonial claim.

Stage 2 — Review the required label elements

• Statement of identity on the principal display panel.
• Net quantity wording, units, location, and prominence.
• Supplement Facts serving information, dietary ingredient rows, amounts, Daily Values, footnotes, and format.
• Other ingredients, sub-ingredients, allergens, colors, flavors, capsule materials, and relevant processing components.
• Name, qualifying role phrase, and place of business.
• Product-specific warnings, storage, tamper, and handling statements.

Stage 3 — Review claims and relationships

• Classify each exact statement in context; do not review isolated keywords only.
• Keep claims linked to asterisks, symbols, footnotes, qualifiers, and panel locations.
• Review the structure/function disclaimer and notification requirements when applicable.
• Confirm that substantiation supports the actual wording and conditions of use.
• Compare digital marketing with the label instead of assuming the label disclaimer covers external claims.

Stage 4 — Approve the finished artifact

• Inspect final-size proofs, package panels, folds, curves, overwraps, inserts, and contrast.
• Verify identifiers, version, date, source links, reviewer, open issues, and approval status.
• Compare production artwork with the approved file and retain the released version.
• Reopen review when formula, supplier, dose, package, claims, business details, evidence, or rules change.

Official starting points

• FDA Dietary Supplement Labeling Guide
• 21 CFR Part 101 — Food labeling
• FDA — Structure/Function Claims

Focused guides