FDA & Compliance

How to Create an FDA-Compliant Supplement Facts Panel

The Supplement Facts panel is the most regulated element on your product label. It is governed by 21 CFR 101.36 and has precise rules about layout, typography, content, and ordering. Getting it wrong is one of the most common reasons supplements receive FDA warning letters — and those letters are public, searchable, and devastating to brand credibility. Here is exactly how to build a compliant panel.

Anatomy of a Supplement Facts Panel

Every Supplement Facts panel must contain these elements, in this order:

1. "Supplement Facts" header: Must use this exact phrase (not "Nutrition Facts," not "Ingredients"). Set in a type size larger than all other text in the panel, in bold.
2. Serving size: Expressed in common household measures (e.g., "1 capsule," "2 tablets," "1 scoop (10g)"). Must be a single serving that is customarily consumed.
3. Servings per container: A whole number (round down if the last serving is less than a full serving).
4. Amount per serving: The header that introduces the nutrient listing section.
5. Nutrients with established Daily Values: Listed in the order specified by FDA regulation (calories first if applicable, then vitamins and minerals in a specific sequence).
6. Percent Daily Value (% DV): Based on the current Reference Daily Intakes (RDIs). Use a dagger symbol (†) and footnote "Daily Value not established" for ingredients without an established DV.
7. Other ingredients with no DV: Listed below nutrients with DVs, separated by a thick bar.
8. Footnote: "* Percent Daily Values are based on a 2,000 calorie diet" (if calories are declared) or the dagger footnote for ingredients without established DVs.

Formatting Rules That Trip Up Brands

The FDA is specific about visual formatting. These rules are frequently violated:

• Hairline rules: The panel must be enclosed in a box. Thick bars (7-point) separate the header from serving size info and separate nutrients with DVs from those without. Thinner bars (3-point and hairline) separate individual nutrients.
• Type size: Minimum 8-point type for all text within the panel (6-point allowed for packages with less than 12 square inches of available label space). The "Supplement Facts" header must be larger than 8-point.
• Columns: Nutrient name on the left, amount per serving in the middle, and % DV on the right, properly aligned.
• Bold text: Nutrient names for which DVs have been established must be in bold. Amounts and % DVs should not be bold.
• Indentation: Sub-components of a nutrient group (like individual B-vitamins under a B-complex heading) are indented.

Declaring Ingredients Correctly

How you name and quantify each ingredient matters for compliance:

• Vitamins and minerals: List by their common name (e.g., "Vitamin D") followed by the specific form in parentheses (e.g., "(as Cholecalciferol)"). The amount must reflect the nutrient itself, not the weight of the compound delivering it.
• Herbal and botanical ingredients: List the common name, the part of the plant used (root, leaf, flower, fruit), and the Latin binomial name in parentheses. For extracts, include standardization information (e.g., "Turmeric Root Extract (Curcuma longa) (standardized to 95% curcuminoids)").
• Proprietary blends: If you use a proprietary blend, list the total weight of the blend and each ingredient in descending order of predominance by weight. You are not required to list individual amounts within the blend, but note that many consumers and retailers now expect full ingredient transparency, and "prop blend" labels are increasingly viewed negatively.
• Amino acids: List by common name (e.g., "L-Glutamine") with the amount per serving.

Updated Daily Values

The FDA updated Reference Daily Intake values in 2020, and all supplement labels must now use the current values. Key changes that still catch brands off guard:

• Vitamin D: DV increased from 400 IU to 800 IU (20 mcg). Must be listed in mcg, with IU optional in parentheses.
• Folate: Must be declared in mcg DFE (Dietary Folate Equivalents). For folic acid, the conversion is 1 mcg folic acid = 1.7 mcg DFE.
• Vitamin E: Must be declared in mg, not IU. The conversion depends on the form used.
• Units: Vitamins A, D, and E must use metric units (mcg or mg), not IU. IU values may be listed in parentheses.

The "Other Ingredients" List

Below the Supplement Facts panel, you must list all other ingredients (excipients, fillers, binders, capsule materials, flavors, colors, preservatives) in descending order of predominance by weight. Use common or usual names. For example: "Other Ingredients: Hypromellose (vegetable capsule), Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide."

Allergen declarations (milk, soy, wheat, tree nuts, etc.) must appear immediately after or adjacent to the ingredient list in bold or contrasting type.

Common Mistakes That Trigger Warning Letters

• Using outdated Daily Values (pre-2020 IU-based units for vitamins A, D, E)
• Missing the dagger footnote for ingredients without established DVs
• Listing nutrients out of the FDA-required order
• Omitting the plant part for botanical ingredients
• Type size below the 8-point minimum
• Missing or improperly formatted bar rules
• Declaring folate without DFE conversion

Let CoreXponent Handle Your Label Compliance

At CoreXponent, we create FDA-compliant Supplement Facts panels and complete label designs as part of every brand engagement. Our compliance team reviews every label against current 21 CFR requirements before your product goes to print — so you launch with confidence, not risk.