Supplement Label Requirements: How to Write a Supplement Facts Panel
Most label rejections we see are not about claims. They are about a missing statement of identity, a Supplement Facts panel in the wrong order, or a net quantity in the wrong units. Here is the whole label, element by element, as the FDA rules (21 CFR 101.36) lay it out — and what changes for the UK, EU and Japan.
The five mandatory elements
- Statement of identity — the words “dietary supplement” (or “herbal supplement”, “vitamin D3 supplement” etc.) on the principal display panel, prominent.
- Net quantity of contents — count for capsules and gummies (“60 gummies”), weight for powders (“269 g (9.5 oz)”), volume for liquids (“60 mL (2 fl oz)”). Metric and US customary both.
- Supplement Facts panel — the box, in the prescribed format (below).
- Ingredient list — “Other ingredients:” in descending order of weight, directly below the panel.
- Name and place of business — of the manufacturer, packer or distributor. For an imported product, “Distributed by [your brand], [city, state]” plus “Made in China” country-of-origin marking.
The Supplement Facts panel, line by line
| Line | Rule | Example |
|---|---|---|
| Title | “Supplement Facts” in bold, larger than other text | Supplement Facts |
| Serving size | Common household measure | Serving size: 2 gummies |
| Servings per container | Count ÷ serving size | Servings per container: 30 |
| Column headers | “Amount per serving” and “% Daily Value” | |
| Nutrients with a Daily Value | Listed first, in the FDA order (calories, fat, carbs, sugars… then vitamins A, C, D, E, K, B-vitamins, minerals) | Vitamin D3 (as cholecalciferol) 25 mcg (1,000 IU) · 125% |
| Ingredients without a DV | Below a line, with a dagger † and the footnote “Daily Value not established” | Lion’s mane extract (fruiting body) 500 mg † |
| Proprietary blends | Blend total weight required; individual amounts optional — we advise against blends | |
| Footnote | “† Daily Value not established.” |
Units matter: vitamin D in mcg (with IU in parentheses), vitamin A in mcg RAE, vitamin E in mg, folate in mcg DFE, niacin in mg NE. Gummies must declare calories and sugars in the panel when present in meaningful amounts.
“Other ingredients”
Everything that is not a dietary ingredient goes here, heaviest first: the gummy base (glucose syrup, sugar, pectin, citric acid, natural flavors, fruit and vegetable juice for color, coconut oil, carnauba wax), the capsule shell (hypromellose), flow agents (rice flour, silica). Source names in parentheses where relevant: “gelatin (bovine)”. Sub-ingredients of a compound ingredient are declared in parentheses.
Allergens and origin
- Allergens: the nine major allergens (milk, egg, fish, shellfish, tree nuts, peanuts, wheat, soy, sesame) must be declared — “Contains: fish (cod)” for fish-gelatin softgels, “Contains: milk” for whey, “Contains: tree nuts (coconut)” is not required (coconut is exempt in practice but many brands declare it).
- Country of origin: “Made in China” or “Manufactured in China for [brand]” — customs requires it; it can be in small type on the back.
- Lot number and expiry / best-by date: not strictly mandated by the supplement rule but expected by every marketplace and required for traceability under cGMP. Printed on the bottle at packing.
Claims and the disclaimer
Structure/function claims (“supports normal sleep”, “supports muscle recovery”) are allowed and must carry the disclaimer, verbatim, on the label: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Disease claims are not allowed anywhere — label, listing, or social post. Words that trigger platform review: cure, treat, anxiety, depression, detox, weight loss, boost immunity, testosterone.
Warnings and directions
Directions for use (“Take 2 gummies daily”), and cautions where applicable: “Keep out of reach of children”, “Consult a physician if pregnant, nursing or taking medication”, iron warning where iron is present, melatonin cautions. Kids’ products need a child-appropriate serving and an age statement.
Size, contrast and placement
Minimum type size is 1/16 inch (about 4.5 pt) for most text on small packages, with the Supplement Facts panel in a legible, high-contrast box. A 60 ml dropper bottle has very little room — this is why our liquid labels often use a wrap label with a peel-back layer for the panel.
Mistakes we correct most often
- “Dietary supplement” missing from the front.
- Net quantity in ml only, no fl oz.
- Vitamin D declared in IU only.
- Serving size “1 scoop” with no gram equivalent.
- Disclaimer on the listing but not on the label.
- Disease words in the product name (“Anxiety Gummies”).
- No lot / expiry space left in the artwork.
UK, EU and Japan in one paragraph each
UK / EU: the product is a “food supplement”; the panel is a nutrition declaration with the daily dose, amounts per dose and %NRV; mandatory statements (“Do not exceed the recommended daily dose”, “Food supplements should not be used as a substitute for a varied diet”, “Keep out of reach of young children”); an EU or UK responsible operator address; only authorised health claims. Country notification (BVL, DGCCRF, Ministero della Salute) is separate from the label.
Japan: Food Labeling Act — product name, ingredient list in Japanese, net content, best-before date, storage, importer name and address, nutrition facts (energy, protein, fat, carbohydrate, sodium as salt equivalent). Health claims are limited to the regulated categories (FFC, FOSHU); ordinary supplements make no function claims.
How the label process works with us
For every stock formula we supply a pre-filled Supplement Facts panel and the mandatory statements as an editable file. Your designer adds the brand; we check the final artwork against this list before print. See compliance for the template and the document pack.