Supplement Facts Label: Requirements and Rules

Direct answer

A compliant Supplement Facts label under 21 CFR 101.36 must include, in specific placement and formatting: statement of identity (“Dietary Supplement”), net quantity, the Supplement Facts panel (serving size, servings per container, dietary ingredients with %DV where applicable), other ingredients list in descending order by weight, allergen declaration, name and place of business, and the DSHEA disclaimer on any structure/function claim.

The most common compliance failures are missing DSHEA disclaimer, incorrect ingredient ordering, unsubstantiated structure/function claims, and missing allergen declarations. Any of these can trigger an FDA Warning Letter or an FTC advertising action. Commission a food-and-drug attorney or qualified regulatory consultant to review every label before print.

Supplement Facts vs. Nutrition Facts

A product cannot use both panels. Which panel you use depends on the regulatory classification (supplement vs. food), and that determines everything else about label compliance.

Required elements on a Supplement Facts label

1. Statement of identity

The principal display panel must include either “Dietary Supplement” or a description that substitutes the word “supplement” (such as “Herbal Supplement” or “Protein Supplement”). This is how FDA distinguishes dietary supplements from food products.

2. Net quantity of contents

Weight, volume, or numerical count of the contents. Example: “60 capsules” or “30 fluid ounces.”

3. Supplement Facts panel

The information box titled “Supplement Facts” listing serving size, servings per container, 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. Proprietary blends disclose the total weight of the blend, with individual ingredients listed in descending order by weight within the blend.

4. Other ingredients list

All ingredients not part of the dietary ingredient list, declared in descending order by weight. Includes excipients, fillers, binders, colors, flavors, and preservatives.

5. Allergen declaration

Required under the Food Allergen Labeling and Consumer Protection Act (FALCPA). Must identify the major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame as of 2023).

6. Name and place of business

Name and address of the manufacturer, packer, or distributor. If using a distributor address, include a phrase such as “Distributed by” to clarify role.

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 any label or promotional material making structure/function claims (such as “supports immune function” or “helps maintain healthy blood pressure”). Not required if the label makes no such claims. 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, providing the text of the claim and the ingredient supporting it. This is a filing, not an approval. FDA does not approve the claim.

Special labeling rules

Herbal supplements

When the ingredient is a botanical, the Supplement Facts panel must include the Latin scientific name of the plant, the part of the plant used (root, leaf, extract), and any standardization (such as “standardized to 5 percent curcuminoids”). Without these specifics, the label is not compliant for a botanical product.

Proprietary blends

Legal, but you must disclose the total blend weight. List ingredients within the blend in descending order by weight. You do not need to disclose individual ingredient weights within the blend (the blend protection is why manufacturers use this format).

Multivitamins

List each vitamin and mineral separately with individual %DV where established. You cannot aggregate multiple vitamins into a single line item.

Children's supplements

If marketed for children under 4, specific % Daily Value reference tables apply. This is specialized; consult a regulatory consultant before designing labels for children's products.

Common compliance failures

Missing DSHEA disclaimer on a structure/function claim. Most common finding in FDA Warning Letters on supplement labels. Add the disclaimer on any product making functional claims.

Unsubstantiated claims, especially disease-adjacent. “Cures insomnia,” “prevents heart disease,” “treats ADHD” are drug claims and are prohibited on supplement labels regardless of substantiation.

Ingredient ordering error. Dietary ingredients ordered by listed weight rather than descending by weight within the blend. FDA inspectors check this specifically.

Percent Daily Value errors. Miscalculating %DV against the wrong reference base, or using outdated Daily Value tables. 21 CFR 101.9 tables were updated in 2016; some older labels still use pre-2016 values.

Allergen declaration missing. Required under FALCPA. Missing allergen disclosure for products manufactured in shared facilities is a real recall trigger.

Net quantity inconsistency. “60 capsules” on the display panel with 59 capsules in the bottle is a consumer protection violation even if manufactured in good faith.

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.
7. Reserve the option to republish FDA-flagged labels within 30 days if FDA issues a corrective-action request.

Frequently asked questions