How to Create an FDA-Compliant Supplement Facts Panel

What 21 CFR 101.36 Requires

The Supplement Facts panel is distinct from the Nutrition Facts panel used on conventional foods. Per 21 CFR 101.36, all dietary supplements must include:

• "Supplement Facts" as the heading (not "Nutrition Facts")
• Serving size and servings per container
• Each dietary ingredient listed by its common or proprietary name
• Quantitative amount per serving (by weight or International Units)
• Percent Daily Value (% DV) where a Daily Value has been established
• Dietary ingredients without an established DV must still be listed with their amount
• Proprietary blends: list total weight and listed ingredients in descending order

Serving Size Declaration

The serving size must be listed in both common household measure (e.g., "2 capsules") and metric measure (e.g., "1.5 g"). If the product is in tablet/capsule form, list the number of units per serving. For powders, use grams or milliliters.

Servings per container must also be declared — even if it is an approximate number (e.g., "about 30 servings"). Rounding errors here are less critical than getting the ingredient amounts right.

Listing Dietary Ingredients and Amounts

Active dietary ingredients must be listed in the Supplement Facts panel. Each ingredient must include its quantitative amount per serving. Vitamin and mineral names should use the names established by the FDA (e.g., "Vitamin D3 (as cholecalciferol)").

Ingredients that are not a source of nutrients (like fillers, binders, excipients) must appear in the "Other Ingredients" section below the bar — not in the Supplement Facts box. See GRAS ingredient listings to confirm whether your excipients have established regulatory status.

Percent Daily Value (% DV)

For nutrients with an established Daily Value, you must declare % DV. If no DV has been established for a dietary ingredient, list the quantitative amount and use an asterisk with a footnote: "Daily Value not established."

Vitamins A, C, D, E, K, the B vitamins, calcium, iron, and several minerals all have established DVs. Be aware the DVs were updated in 2020 — using outdated values is a common labeling error flagged in FDA warning letters.

The "Other Ingredients" Section

Below the heavy horizontal bar on the Supplement Facts panel, you must list all non-dietary ingredients in descending order of predominance. These include fillers, binders, color additives, flavorings, and excipients.

Every other ingredient must also comply with FDA regulations. Check whether your excipients are on the Prop 65 list or have GRAS status before including them in your formula.

Common Labeling Violations in FDA Warning Letters

• Wrong heading: Using "Nutrition Facts" instead of "Supplement Facts"
• Missing % DV: Omitting Percent Daily Value for nutrients with established DVs
• Undeclared allergens: Failing to declare major food allergens per the Food Allergen Labeling and Consumer Protection Act
• Proprietary blend opacity: Not listing individual ingredients within a proprietary blend below the bar
• Incorrect serving size: Using metric-only measures without household equivalents
• Missing disclaimer: Omitting the required structure/function claims disclaimer

Structure/Function Claims Disclaimer

If your product label makes any structure/function claim (e.g., "supports joint flexibility"), you must include the following disclaimer on the product label: "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." This disclaimer must be prominently displayed, typically on the same panel as the Supplement Facts box.

This guide is for informational purposes only and does not constitute legal or regulatory advice. FDA labeling regulations change; always review the current 21 CFR Part 101 and consult a qualified regulatory expert for your product. Not affiliated with the U.S. FDA. IngredientCompliance is an independent tool operated by Gerim-Sterling LLC.