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Supplement Facts Panel Requirements - FDA Labeling Rules for Dietary Supplements

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Supplement Facts Panel Requirements - FDA Labeling Rules for Dietary Supplements

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Supplement Facts Panel Requirements - FDA Labeling Rules for Dietary Supplements

Supplement Facts Panel Requirements - FDA Labeling Rules for Dietary Supplements

The Supplement Facts panel is a legal requirement on every dietary supplement sold in the United States — not just a best practice or a consumer expectation. The requirements are specific, technical, and enforced. Getting them wrong is a misbranding violation under 21 U.S.C. 343, and FDA warning letters cite Supplement Facts errors with notable frequency. Here's what 21 CFR 101.36 actually requires.

Michael Wu

| Co-founder at Truli

The Supplement Facts panel is governed by 21 CFR 101.36, which was finalized as part of the same rulemaking that established Nutrition Facts requirements for conventional foods. Supplement panels have specific requirements that differ from Nutrition Facts panels in important ways — format, component listing, serving size expression, and which nutrients are required vs. optional.

 

Required Components of the Supplement Facts Panel

Under 21 CFR 101.36(b), the following must appear in the Supplement Facts panel:

Header: "Supplement Facts" in bold, larger type, at the top of the panel.

Serving size: Stated in common household units (tablets, capsules, softgels, teaspoons, etc.) and metric units. The serving size must reflect how the product is actually consumed.

Servings per container: The number of servings in the entire container.

Dietary ingredients: All ingredients that are dietary ingredients (vitamins, minerals, herbs, amino acids, other dietary substances) must be listed with the quantity per serving. Quantity must be expressed in appropriate units (mg, mcg, IU for vitamins where applicable, CFU for probiotics).

% Daily Value: For nutrients with established Daily Values (DVs), the % DV must be listed in a column adjacent to the quantity. Under the updated DVs effective January 1, 2020 (21 CFR 101.9), DVs changed for several nutrients — brands must use the current DVs, not older values.

Ingredients without established DVs: Listed with a dagger (†) symbol in the % DV column, with the dagger footnote stating "Daily Value not established."

 

Proprietary Blends

Under 21 CFR 101.36(c), proprietary blends (blends of dietary ingredients that are listed as a single ingredient entry) must:

  • Identify the blend by a name

  • List the total weight of the blend

  • List each ingredient within the blend in descending order of predominance by weight

 

"Descending order of predominance" is a firm requirement. Listing blend ingredients alphabetically or in a non-weight-based order is a misbranding violation. FDA warning letters have cited proprietary blend ordering errors directly.

 

Other Ingredients

Non-dietary ingredients (excipients, binders, fillers, coatings, capsule shells) must be listed outside the Supplement Facts panel under the heading "Other Ingredients" in descending order of predominance by weight. This includes gelatin or vegetable cellulose capsule shells, rice flour, stearic acid, silicon dioxide, and similar processing agents.

 

Format Requirements

Under 21 CFR 101.36(e), the Supplement Facts panel must:

  • Use hairlines (thin rules) to separate components

  • Have a minimum type size of 6 point for most text

  • Present information on a white or neutral background with sufficient contrast

  • Use black text on white background unless the label uses a different color that provides equivalent legibility

 

Tabular format is required for most products. A linear (simplified) format is permitted only for products with limited space (21 CFR 101.36(i)).

 

Small Package Exemptions

Products with very limited label space (packages with less than 12 square inches of total label area) may use a simplified panel under 21 CFR 101.36(i). But "limited space" does not mean the requirement can be skipped — it means a different format may be used, and the full information must be available to consumers through other means (e.g., a toll-free number or website).

 

Common Supplement Facts Violations

  • Incorrect serving size (not reflecting actual recommended use)

  • Missing ingredients from the panel (particularly minor ingredients that are technically dietary ingredients)

  • Using outdated Daily Values (pre-2020 DVs)

  • Proprietary blend ingredients not listed in descending weight order

  • Missing % DV for nutrients with established values

  • Incorrect unit expression (IU vs. mcg for Vitamin D, which FDA updated to mcg)

  • "Other Ingredients" listed inside the panel instead of outside it

 

The Supplement Facts panel is technical and exacting — errors are misbranding violations

Truli scans Supplement Facts panels against 21 CFR 101.36's formatting and content requirements — flagging serving size inconsistencies, proprietary blend ordering errors, outdated Daily Values, and missing required disclosures before products reach retail buyers or regulatory reviewers who will find them on their own.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

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Truli is an AI compliance platform for food, beverage, and supplement brands. Automate FDA/FTC label reviews, claims validation, and post-market monitoring — 10x faster.

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Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

Truli Logo

The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.

Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

Truli Logo

The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.

Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

Truli Logo

The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.