Dietary Supplement Label Requirements (FDA Checklist)
Last updated · Written by the Supplement Facts Label Maker editorial team from FDA regulations (21 CFR 101.9, 101.36) and the FDA Dietary Supplement Labeling Guide.
A US dietary supplement label has five required statements: the statement of identity, the net quantity of contents, the Supplement Facts panel, the ingredient list (“Other ingredients”), and the name and place of business of the manufacturer, packer or distributor. Allergen and claim rules then add to these. Here is the checklist, with the regulation for each item.
The required elements
| Element | Where | Rule |
|---|---|---|
| Statement of identity: the words “dietary supplement” (or “herbal supplement” etc.) | Principal display panel | 21 CFR 101.3(g) |
| Net quantity of contents (count, weight or volume) | Bottom 30% of principal display panel | 21 CFR 101.105 |
| Supplement Facts panel | Information panel | 21 CFR 101.36 |
| “Other ingredients” list | Under the panel | 21 CFR 101.4(g) |
| Name and place of business | Information panel | 21 CFR 101.5 |
| “Contains:” allergen statement (9 major allergens) | After or next to ingredients | FD&C Act 403(w), FALCPA, FASTER Act |
| Domestic address or phone for adverse event reports | Label | FD&C Act 761 |
Inside the Supplement Facts panel
- Serving size and servings per container.
- Calories and macronutrients only when present in measurable amounts (101.36(b)(2)).
- Vitamins and minerals in the FDA order, in current units: mcg RAE for vitamin A, mcg DFE for folate, mg NE for niacin, mcg for vitamin D.
- %DV for each nutrient with a Daily Value; “†Daily Value not established” for the rest.
- Botanicals with the part of the plant used; proprietary blends with total weight and components in descending order.
The Supplement Facts label maker lays all of this out for you from the numbers you enter.
Claims: what changes the rules
- Structure/function claims (“supports immune function”) need the FDA disclaimer above and a notification to FDA within 30 days.
- Nutrient content claims (“high in vitamin C”, “excellent source”) must meet defined thresholds.
- Health claims about disease risk must be authorized or qualified by FDA. Disease claims are not allowed on supplements.
We do not generate claims of any kind. If you plan to use one, have it reviewed by a regulatory professional.
Pre-print checklist
- Amounts match your manufacturer’s specification or certificate of analysis.
- Units and Daily Values are current (post-2020 rule).
- Every ingredient in the panel or “Other ingredients”, with sources declared where required.
- Allergens declared, including sesame (added January 2023).
- Type size and contrast are legible at the printed size; ask your printer for a proof.
- Claims reviewed; disclaimer present if needed.
Sources: 21 CFR Part 101; FDA, Dietary Supplement Labeling Guide. This page is general information, not legal advice.
Frequently asked questions
Does the FDA approve supplement labels?
No. The FDA does not approve dietary supplements or their labels before they are sold. The company is responsible for making sure the product is safe and the label is truthful and compliant.
What is the required disclaimer for structure/function claims?
If the label makes a structure/function claim, it must carry the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” and the FDA must be notified within 30 days of first marketing. This tool does not write claims.
Where does the Supplement Facts panel go?
On the information panel, usually immediately to the right of the principal display panel, together with other ingredients and the manufacturer’s name and address, unless the package qualifies for an alternative placement.
What is the minimum type size?
Generally 1/16 inch (based on the lowercase “o”) for required statements, and at least 8 point for most of the Supplement Facts panel, with smaller sizes permitted on small packages. Check 21 CFR 101.36(i) for small-package options.