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Everything that has to be on the label

Updated

On this page5

Supplement labeling is the most prescribed in this catalog, and three of the rules are specific enough that designers break them without noticing.

The checklist

Statement of identity including "dietary supplement" or an equivalent naming the ingredient.

Net quantity of contents.

Supplement Facts panel: serving size, servings per container, dietary ingredients with amounts per serving, percent Daily Value where established.

Other ingredients, beneath the panel.

Name and place of business of manufacturer, packer or distributor.

Plus allergens, directions for use, and the DSHEA disclaimer wherever a structure/function claim appears.

The panel rules that catch people

The heading must say "Supplement Facts", not "Nutrition Facts", and it must be in a type size larger than any other print in the nutrition label. Designers routinely set it to match.

Serving size must use a term appropriate to the form. The regulation's examples are tablets, capsules, packets, teaspoonfuls. For a powder, declare the weight.

Servings per container sits beneath serving size, and may be omitted only where the same information appears in the net quantity declaration.

The arithmetic check

Net weight divided by serving size must equal servings per container. This is the check most often skipped and it is the one a customer with a scale can perform.

Derive the panel amounts from the formula percentages arithmetically rather than typing them into artwork, and tie the label version to the formula version so a change forces a review.

Worth adding

A lot code on every unit, which makes a problem containable. A best-before based on stability rather than convention. Storage guidance, because keeping it sealed and dry is most of what protects the product. And a plain note about how to mix it, which prevents a common complaint in the category.

References

US Food and Drug Administration. Dietary Supplement Labeling Guide. fda.gov
21 CFR 101.36, Nutrition labeling of dietary supplements, the Supplement Facts panel. ecfr.gov
21 CFR 101.7, Declaration of net quantity of contents. ecfr.gov
Written from published regulation and peer-reviewed work, not from a laboratory of our own. Your own certificates of analysis, your blend uniformity results and your own written specifications override anything general said here. Nothing on this site is a substitute for the records 21 CFR 111 requires you to keep.