Separate the ingredient statement from Supplement Facts

Start with a complete formula

Collect the finished product formula, sub-ingredient composition, capsule or coating composition, flavors, colors, carriers, processing aids, and supplier specifications. A short marketing formula or certificate of analysis may omit components needed for label review.

Review sequence

1. Classify each component: determine whether it is a dietary ingredient declared in Supplement Facts or belongs in the separate ingredient statement.
2. Resolve compound ingredients: obtain component details and apply the rules governing how sub-ingredients are declared.
3. Use appropriate names: verify common or usual names and any source disclosure required by the applicable provision.
4. Determine order: review descending order of predominance by weight for ingredients governed by that requirement.
5. Check placement: review the relationship between the ingredient statement and the nutrition label under 21 CFR 101.4(g).
6. Compare final artwork: confirm that punctuation, parentheticals, allergens, and line breaks did not change the meaning.

Common evidence gaps

• The capsule shell is listed as one trade name without its component ingredients.
• A flavor, coating, premix, or carrier is present in production records but absent from the label review file.
• An ingredient appears both in Supplement Facts and Other Ingredients without a documented basis.
• The supplier changes a sub-ingredient while the artwork and allergen review remain unchanged.
• OCR merges the bottom of Supplement Facts with the adjacent ingredient statement.

Official starting points

• 21 CFR 101.4 — Food designation of ingredients
• 21 CFR 101.36 — Nutrition labeling of dietary supplements
• FDA Dietary Supplement Labeling Guide

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