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The label

What else has to be on it

Updated

On this page8
Beyond the panel and the disclaimer, a supplement carries everything a packaged food carries, plus a couple of things specific to the category.

The usual five

  • Statement of identity, which here includes the term "dietary supplement" or an equivalent naming the type.
  • Net quantity, from the bottle and the fill.
  • Ingredients, for anything not in the panel.
  • Allergens, declared as required.
  • Name and place of business of the responsible party.

The identity statement does real work here

Calling the product a dietary supplement is part of how it is classified, and a bottle of liquid with botanical names and a dropper but no such statement is a product whose category is ambiguous. Ambiguity in this category is not a good place to be.

Directions matter more than usual

A dropper product needs a usable instruction, and the serving size in the panel has to match it. A panel saying one teaspoon and a direction saying two droppers is a contradiction on the same label.

Warnings, where they apply

Some ingredients carry expected cautions, and some audiences, pregnancy and children in particular, are commonly addressed. These are not generically required and they are frequently expected, and a product aimed at a vulnerable group without any is conspicuous.

Batch and date

Not strictly a label element in the way the five above are, and they are what makes the manufacturing records usable. A bottle with no code cannot be traced to the batch record that proves how it was made.

Order the artwork last

Net quantity depends on the bottle, the panel on the formulation, the disclaimer on the claims and the allergen line on the equipment. All four settle late and labels ordered early are labels reprinted.

The responsible party has to be reachable

A name and a place of business, not a brand and a web address. It is the line that tells a buyer or a regulator who actually stands behind the product, and a label that obscures it reads as evasive in a category where that is costly.

References

21 CFR 101, Food Labeling, for the elements every packaged food carries: statement of identity, net quantity, ingredients, allergens and the responsible party. law.cornell.edu
21 CFR 101.36, Nutrition labeling of dietary supplements, which requires the “Supplement Facts” heading set larger than all other print, a serving size expressed in a term suited to the form, servings per container, and other dietary ingredients by common name. law.cornell.edu
21 CFR 101.93, Certain types of statements for dietary supplements, which carries the disclaimer word for word and the requirement to notify FDA within 30 days of first marketing a product bearing a structure/function statement. law.cornell.edu
Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.