Which panel does your product need?
A Nutrition Facts panel (21 CFR 101.9) is for conventional food. A Supplement Facts panel (21 CFR 101.36) is for dietary supplements — products intended to supplement the diet that contain a dietary ingredient (a vitamin, mineral, herb, amino acid, and so on) and come in a form such as a capsule, tablet, softgel, gummy, powder, or liquid not represented as conventional food.
Classification follows how the product is marketed, not just what is in it. A protein bar is usually a conventional food (Nutrition Facts); a protein powder marketed as a dietary supplement uses Supplement Facts. Supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
How Supplement Facts differs
- Header — it reads 'Supplement Facts,' not 'Nutrition Facts.'
- Ingredients with a Daily Value — vitamins and minerals that have an established Daily Value are listed with their amount and %DV, much like on a food label.
- Ingredients without a Daily Value — botanicals, amino acids, and novel compounds with no established DV are listed (typically below a heavy rule) with a '†' symbol and the footnote 'Daily Value not established.'
- Botanical source — for a plant ingredient, the part of the plant must be identified (root, leaf, and so on).
- 'Other ingredients' — fillers, binders, and capsule materials that are not dietary ingredients are listed below the panel, in descending order by weight.
Proprietary blends
A proprietary blend lets a manufacturer group several dietary ingredients under one name without disclosing each one's amount. Under 21 CFR 101.36(c), the blend must be labeled a 'Proprietary Blend' (or a descriptive or fanciful name), show the total weight of the blend per serving, and list its ingredients in descending order by weight — but the individual amounts may be withheld. It is legal, though it means you cannot see how much of each ingredient you are getting.
Claims: structure/function and the DSHEA disclaimer
Supplements commonly carry structure/function claims — statements about how an ingredient affects the body's normal structure or function, such as 'supports immune health' or 'helps maintain healthy joints.' These are allowed without FDA pre-approval, but the manufacturer must hold substantiation, must notify the FDA within 30 days of marketing, and must print the DSHEA disclaimer:
'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.' The disclaimer requirement is 21 CFR 101.93; the FDA explains the claim rules here.
A supplement may not claim to diagnose, treat, cure, or prevent a disease — that would make it an unapproved drug. The line between a structure/function claim and a disease claim is exactly where many supplement labels get into trouble. Conventional-food claim rules are covered in the claims guide.
The rest of a supplement label
Like any packaged product, a supplement also needs a statement of identity (including the words 'dietary supplement'), a net quantity of contents, the Other Ingredients list, allergen information, and the manufacturer's name and address — the same non-panel elements covered in the label-requirements guide. Build a panel with the Supplement Facts generator.
The FDA does not approve dietary supplements before they go to market. The manufacturer is responsible for ensuring the product is safe and the label is truthful and compliant — so getting the panel and claims right is on you, not a reviewer.