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Selling it

What federal law requires on the label

Updated

On this page5

Supplement labeling is the most prescriptive small-manufacturer labeling in the United States, and most of the requirements are specific enough to fail on detail.

Five elements, plus the panel

A statement of identity including the words "dietary supplement" or an equivalent naming the dietary ingredient. A net quantity of contents. The Supplement Facts panel. An Other ingredients list. And the name and place of business of the manufacturer, packer or distributor.

Plus allergen declaration where applicable, and directions for use.

The Supplement Facts panel

Introduced by the heading "Supplement Facts", in a type size larger than any other print in the nutrition label.

Serving size, then servings per container beneath it, then the dietary ingredients with amounts per serving and percent Daily Value where one exists.

Serving size expressed in a term appropriate to the form. Servings per container may be omitted where the same information appears in the net quantity declaration, and the arithmetic between net weight, serving size and servings must actually work.

Other ingredients

Anything that is not a dietary ingredient goes below the panel rather than inside it: flow agents, anticaking agents, flavors, sweeteners, carriers.

Customers read this line specifically, so naming things plainly and explaining their function elsewhere is a stronger position than minimizing the list.

Claims and the disclaimer

A structure/function claim requires substantiation and the DSHEA disclaimer stating that the statement has not been evaluated by FDA and the product is not intended to diagnose, treat, cure or prevent any disease.

Missing that disclaimer on a claim is a common compliance failures in the category, and it is a sentence.

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.