Supplement Facts Label: Requirements and Rules

Direct answer

A compliant dietary supplement label must include, in specific placement and formatting: statement of identity (“Dietary Supplement”), net quantity, the Supplement Facts panel under 21 CFR 101.36 (serving size, servings per container unless the net quantity statement already gives it, dietary ingredients with %DV where applicable), unless an exemption in 101.36(h) applies, an ingredient list in descending order of predominance by weight, and name and place of business. Two more elements depend on the product: an allergen declaration when it is made with a major food allergen, and the DSHEA disclaimer on any structure/function claim.

Failures to check for include a missing DSHEA disclaimer, ingredients out of their required order, and a missing allergen declaration. Commission a food-and-drug attorney or qualified regulatory consultant to review every label before print.

Supplement Facts vs. Nutrition Facts

A dietary supplement does not use a Nutrition Facts panel: 21 CFR 101.9(j)(6) exempts dietary supplements from that section and requires labeling under 101.36 instead. Which panel applies depends on the regulatory classification (supplement vs. food).

Required elements on a Supplement Facts label

1. Statement of identity

The principal display panel carries a statement of identity that includes the term “dietary supplement.” The word “dietary” may be replaced by the name of the dietary ingredients (such as “calcium supplement”) or a term describing their type (such as “herbal supplement with vitamins”).

2. Net quantity of contents

Stated on the principal display panel by weight, measure, or numerical count; a count may also be combined with a weight or measure. A weight or measure statement gives liquids in fluid measure and solids by weight; a numerical count also meets the rule. Example: “60 capsules.”

3. Supplement Facts panel

The information box titled “Supplement Facts” listing serving size, servings per container (not needed in the panel when the net quantity statement already gives it, 21 CFR 101.36(b)(1)(ii)), amount per serving of each dietary ingredient, percent Daily Value (%DV) for nutrients with established Daily Values (based on 21 CFR 101.9), and a footnote for ingredients without established Daily Values.

Nutrients with established Daily Values (vitamin A, vitamin C, vitamin D, calcium, iron, and others) must show %DV. A proprietary blend shows the total weight of its other dietary ingredients, which are listed under it in descending order of predominance by weight.

4. Other ingredients list

Ingredients not identified in the Supplement Facts panel, listed by common or usual name in descending order of predominance by weight. The list sits below the panel (or to its right when space is short) and is headed “Other ingredients” when source ingredients are named inside the panel. It includes excipients, fillers, artificial colors, artificial sweeteners, flavors, and binders.

5. Allergen declaration

Required for the nine major food allergens. The Food Allergen Labeling and Consumer Protection Act (FALCPA) named eight: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act added sesame as the ninth, effective January 1, 2023.

6. Name and place of business

Name and place of business of the manufacturer, packer, or distributor. If the firm named did not make the product, a phrase such as “Manufactured for” or “Distributed by” shows its connection to the product.

7. DSHEA disclaimer (if making structure/function claims)

Exact language: “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.”

Required on the label or labeling of a supplement that makes a structure/function claim (such as “calcium builds strong bones” or “fiber maintains bowel regularity”). Not required if neither the label nor the labeling makes such a claim. Rule text is at 21 CFR 101.93.

8. Notification to FDA (for new structure/function claims)

Manufacturers making structure/function claims must notify FDA within 30 days of first marketing. The notice includes the text of the claim, the dietary ingredient or supplement it is about, and the product name. A responsible person signs it and certifies that the firm has substantiation that the claim is truthful and not misleading. FDA does not pre-approve these claims; the notice tells FDA the claim is being made.

Special labeling rules

Herbal supplements

A botanical ingredient is listed by its standardized common name and the part of the plant it comes from (such as root or leaves). The Latin binomial name is also required unless the reference Herbs of Commerce gives it for the common name on the label. Constituents such as curcuminoids may be listed under the ingredient with their amount per serving.

Proprietary blends

Legal, but the blend line shows the total weight of the blend's other dietary ingredients, and those ingredients are listed beneath it in descending order of predominance by weight. Their individual weights do not have to be listed. Dietary ingredients in the blend that have a Daily Value, such as vitamins and minerals, are still declared with their own amounts and %DV.

Vitamins and minerals

Vitamins and minerals in the panel are listed by name, each with its amount per serving and %DV, in the order 21 CFR 101.36 sets: vitamin A, vitamin C and vitamin D first, through fluoride last.

Percent Daily Values are based on values for adults and children 4 years and older. A product represented for infants through 12 months, children 1 through 3 years, or pregnant or lactating women uses that group's values, and the column heading names the group. This is specialized; consult a regulatory consultant before designing labels for these products.

Common compliance failures

Missing DSHEA disclaimer on a structure/function claim. The law allows a structure/function statement only if it carries the disclaimer in boldface type. Add the disclaimer on any product making structure/function claims.

Disease claims and unsupported claims. “Cures insomnia” and “prevents heart disease” are disease claims. A supplement label bearing one makes the product subject to regulation as a drug unless it is an authorized health claim for which the product qualifies. A structure/function claim also needs substantiation that it is truthful and not misleading.

Ingredient order errors. Vitamins and minerals in the panel follow the order 21 CFR 101.36 sets. Blend ingredients without a Daily Value, and the ingredient list outside the panel, run in descending order of predominance by weight.

Percent Daily Value errors. Dividing by the wrong reference value, such as an adult Daily Value on a product for children 1 through 3 years, or using Daily Values from before FDA's 2016 update to 21 CFR 101.9.

Allergen declaration missing. Required under FALCPA, which FDA enforces for dietary supplements. FDA can treat a product whose label lacks required allergen information, or that contains a food allergen through cross-contact, as misbranded or adulterated, and such products are subject to enforcement actions such as recalls.

Net quantity inconsistency. The net quantity must be an accurate statement of what the package holds. 21 CFR 101.7(q) recognizes reasonable variations from moisture loss or gain or from unavoidable deviations in good manufacturing practice, but variations may not be unreasonably large.

How to validate a label before print

1. Use a professional label design service familiar with 21 CFR 101.36, not a generic graphic designer.
2. Commission a regulatory consultant or food-and-drug attorney review. Budget varies by attorney and scope; request quotes for current rates.
3. Cross-check ingredient ordering against the batch records.
4. Verify %DV calculations against current 21 CFR 101.9 tables.
5. Confirm DSHEA disclaimer placement if any structure/function claims appear.
6. Test-print a proof and check readability at actual bottle size.

Frequently asked questions