Supplement Label Compliance Made Simple

When you make a supplement to sell in the United States, your label must follow specific rules set by the Food and Drug Administration (FDA). A label is more than pretty words on a bottle, it is a legal document that tells customers what is inside your product and how to use it safely.

This guide explains what must be on your label, how it should look, and what claims you can or cannot make, in simple language that anyone can understand.

Who makes the rules?

The FDA makes the rules for supplement labels in the United States. Supplements are treated as a type of food under the law, even though they are sold like vitamins and herbs.

The Federal Trade Commission (FTC) also makes rules about how supplements can be advertised so that companies do not make misleading promises. Both agencies work together to protect customers.

All 11 compliance requirements you need when designing a supplement label:

Table of contents

1. Product name and “dietary supplement”

Your product name must clearly show what the product is.
For a vitamin or herbal product, you must include the words “dietary supplement” near the product name so it is clear this is a supplement, not a food or medicine.

2. How much product is inside.

You must show how much product is inside, such as:

• 60 capsules
• 120 tablets
• 8 fluid ounces

This number must be on the front of the package so customers can easily see it.

3. Supplement facts panel requirements

The Supplement Facts panel is the black and white box on the label that tells customers exactly what is in your supplement and how much of each ingredient they get.

Think of it like the ingredient scoreboard for your product. If this panel is wrong, your label is not compliant.

The panel must say “Supplement Facts”

At the very top of the box, it must say:

Supplement Facts

This title must be:

• In bold
• Easy to read
• Larger than most of the other text inside the box

You cannot rename this panel. You cannot say “Nutrition Panel,” “Ingredient Facts,” or anything else.

It must say Supplement Facts.

Black and white format only

The Supplement Facts panel must be:

• Black text
• On a white background

No colors.
No gradients.
No patterns.

This helps make the panel easy to read and consistent across all supplements.

Thick black bar at the top

Directly under the words “Supplement Facts” there must be a thick black horizontal line.

This thick line separates the title from the information below and is part of FDA formatting expectations.

Serving size and servings per container

At the top of the panel, under the thick black line, you must list:

Serving Size
Servings Per Container

Example:

Serving Size: 2 Capsules
Servings Per Container: 60

Important rule:

Your serving size must match your directions for use.

If your directions say:
“Take two capsules daily”

Then your serving size must be:
2 Capsules

They must match.

Thin black line under serving information

After the serving size section, there is usually a thin black line to separate this area from the ingredient list.

This keeps the layout clean and organized.

Listing dietary ingredients

Each dietary ingredient must be listed on its own line.

For each ingredient, you must show:

• Ingredient name
• Amount per serving
• Percent Daily Value (when required)

Example:

Vitamin C (as Ascorbic Acid) 500 mg 556% DV

Rules:

• Vitamins and minerals are usually listed first
• Other dietary ingredients follow
• Ingredients must use their common or usual names

Heavy black bar near the bottom

Near the bottom of the Supplement Facts panel, there is usually another thick black horizontal bar.

This visually signals the end of the main nutrient section.

Footnotes at the bottom

Below the heavy black bar, you may need footnotes such as:

☨ Daily Value not established.

These must be inside the Supplement Facts box.

Proprietary blends (if used)

If your formula uses a proprietary blend, the panel must show:

• The blend name
• Total weight of the blend per serving
• Individual ingredients listed in descending order by weight inside the blend

You cannot hide what is inside a blend. The ingredients still must be listed.

Capsule shell or tablet coating disclosure

If your product is a capsule, the capsule shell ingredients must appear outside the Supplement Facts panel in the “Other Ingredients” list.

Example:

Other Ingredients: Vegetable cellulose (capsule), magnesium stearate, silicon dioxide.

They do not go inside Supplement Facts unless they are dietary ingredients.

Minimum font size and readability

The text inside the Supplement Facts panel must be:

• Easy to read
• Clear
• Not cramped
• Large enough to be legible

Very tiny text or decorative fonts increase compliance risk.

Simple, clean sans serif fonts are safest.

Ingredient list and other ingredients

There are two parts:

1. Dietary ingredients (shown in the Supplement Facts panel)
   
2. Other ingredients (shown outside the panel)
   

Other ingredients include things like capsule material, fillers, binders, and colors. They must be listed in order from most to least by weight.

Where the data for your supplement facts panel comes from

Your Supplement Facts panel is not guessed. It is built from manufacturing batch documents.

These usually come from your manufacturer and include:

• Master formula or batch sheet
• Ingredient weights per serving
• Serving size
• Capsule or tablet weight targets
• Potency of each raw material

This information is used to calculate:

• Amount per serving
• % Daily Value
• Final panel layout

4. Percent daily value (%DV)

Some ingredients require a percent Daily Value.
Some ingredients do not have an established Daily Value.

If an ingredient has no Daily Value, you must use a symbol (usually an asterisk *) and add this line at the bottom:

Daily Value not established.

Official reference for %DV values

• The FDA publishes Daily Values (DVs) that manufacturers must use to calculate %DV for vitamins and minerals. These are in the Daily Value on the Nutrition and Supplement Facts Labels resource on fda.gov. Daily Value on the Nutrition and Supplement Facts Labels (FDA)

• For a downloadable numeric table of DV numbers, use the Interactive Nutrition Facts Label vitamins & minerals chart (PDF) from the FDA. Interactive Nutrition Facts Label vitamins and minerals chart (PDF)

Daily value table for vitamins and minerals (adults)

The table below lists the Daily Value (DV) that FDA uses to compute %DV, based on a 2,000 calorie diet.

Vitamin daily values

Nutrient | Daily Value (DV)
Vitamin A | 900 mcg RAE
Vitamin C | 90 mg
Vitamin D | 20 mcg
Vitamin E | 15 mg
Vitamin K | 120 mcg
Thiamin (B1) | 1.2 mg
Riboflavin (B2) | 1.3 mg
Niacin (B3) | 16 mg
Vitamin B6 | 1.7 mg
Folate (B9) | 400 mcg DFE
Vitamin B12 | 2.4 mcg
Biotin | 30 mcg
Pantothenic acid | 5 mg

Mineral daily values

Nutrient | Daily Value (DV)
Calcium | 1300 mg
Iron | 18 mg
Magnesium | 420 mg
Zinc | 11 mg
Selenium | 55 mcg
Copper | 0.9 mg
Manganese | 2.3 mg
Chromium | 35 mcg
Iodine | 150 mcg
Phosphorus | 1250 mg
Molybdenum | 45 mcg
Potassium | 4700 mg
Sodium | 2300 mg
Chloride | 2300 mg

These are the standard DV numbers used for %DV calculations on U.S. Supplement Facts panels.

How to calculate %DV (simple formula)

To find %DV for any nutrient:

%DV = (Amount per serving ÷ Daily Value) × 100

Example for vitamin C:

If one serving contains 250 mg vitamin C:

250 ÷ 90 = 2.78
2.78 × 100 = 278 %DV

So the label would show 278% for vitamin C.

Rounding rules

FDA rounding rules influence how you report %DV values on labels:

• Below about 0.5 %DV → show 0% (unless rule exceptions apply)
• 0.5 %DV to 2 %DV → round to nearest whole percent
• Above ~2 %DV → round to nearest whole percent

These rounding guidelines are part of 21 CFR 101.9(c)(4) and label guidance.

Example math across nutrients

Let’s walk through two real examples:

Magnesium

Daily value = 420 mg (elemental)
Serving amount = 100 mg

100 ÷ 420 = 0.238
× 100 = 24% DV

Label entry = 24%

Vitamin D

Daily value = 20 mcg
Serving amount = 25 mcg

25 ÷ 20 = 1.25
× 100 = 125% DV

Label entry = 125%

%DV Calculator

5. Name and place of business

Your label must show the name of your company and where it is based. This is usually:

• Your company name
• City, state, and zip code

This helps people know who is responsible for the product.

6. Directions for use

You must tell customers how to use your product. This usually goes near the Supplement Facts panel and should match the serving size you used in the panel.

Example
“Take two tablets daily with water.”

7. Warnings and allergen information

If your product contains common allergens such as dairy, soy, gluten, or others required by law, you must declare them clearly on the label.

Warnings are also needed when the formula has specific safety concerns. For example:

• If a product contains iron, it may need a child safety warning
• If the product has ingredients that may interact with medications, appropriate caution language helps reduce risk

8. Text font size minimums

When the FDA says your label must be legible and easy to read, that is not just a suggestion; it is the law. Your label must use fonts and sizes that real people can read without squinting.

Here are the main rules you need to know:

1. General text on the label

Text that is required on the label — such as the product name, net quantity of contents, directions, warnings, and required disclaimers must be:

• Easy to read
• Prominent and conspicuous
• At least 1/16 of an inch tall based on the height of a lowercase letter “o” in the font you choose.

This rule applies to most required label information and helps ensure that consumers can easily see important facts.

2. Net quantity of contents

The net quantity statement (for example, “60 tablets” or “120 capsules”) must appear in a clear and readable type size that meets the same minimum height rules.

FDA sets the minimum type height based on the size of your principal display panel (the front of the bottle people see first):

• 1/16 inch (about 1.6 mm) for small panels (5 square inches or less)
• 1/8 inch (about 3.2 mm) for larger panels
• 3/16 inch (about 4.8 mm) for even bigger panels
• And bigger sizes for very large panels

This helps ensure that the net quantity information is easy to spot and read.

3. Supplement facts panel text

The Supplement Facts panel has its own layout and font expectations under 21 CFR 101.36, including that the title “Supplement Facts” must be set in a type size larger than all other text in the panel unless it is impractical to do so.

The actual numeric entries and ingredient names inside the panel do not have a single fixed number in the main FDA regulation, but they must be clear, consistent, and not so small that they are hard to read. The FDA guidance and industry practice generally aim for at least 6 point type or larger for most of the panel, with some flexibility for very small packages.

4. Structure/function disclaimer font size

If you make a structure/function claim (like “supports immune health”), you must include the FDA required disclaimer:

“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.”

That disclaimer must be in boldface type and no smaller than 1/16 of an inch tall based on the height of a lowercase “o”.

9. Disclaimer requirements for structure-function claims

When you make a structure function claim on a supplement label, such as “supports immune health” or “supports metabolism,” you must include the required FDA disclaimer text.

Exact disclaimer text

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

How it must be connected to the claim

You have two compliant options:

Option 1, place the disclaimer right next to the claim
The disclaimer must be placed adjacent to the claim with no intervening material.

Option 2, link the claim to the disclaimer using a symbol
You can put a symbol, such as an asterisk, at the end of each claim and place the same symbol next to the disclaimer. This is specifically allowed by regulation.

Important placement rule most brands miss

The disclaimer must appear on each panel or page where there is a structure function claim.

Box requirement

If the disclaimer is not adjacent to the claim, it must be set off in a box. In plain terms, it needs a visible border around it so it looks like its own section.

Minimum size and bold requirement

The disclaimer must be in boldface type and the letter height must be no smaller than one sixteenth of an inch, measured using the lowercase letter “o.”

Does it have to be black and white?

The DSHEA disclaimer itself is not required to be black and white the way the Supplement Facts panel is. What matters is that it is bold, meets the minimum type size, and is prominent and easy to read.

Simple designer checklist for the disclaimer block

• Use the exact wording
• Make it bold
• Make sure the font is at least 1/16 inch letter height
• Place it next to the claim, or use an asterisk linking method
• If it is not right next to the claim, put the disclaimer inside a boxed border
• Make sure the disclaimer appears on every label panel where a claim appears

10. Any claims must be allowed

Allowed claims

Some statements are allowed when they describe how a nutrient supports normal body functions. These are called structure/function claims.

Examples
• “Supports immune health”
• “Helps maintain energy”

But when you make these statements, you also must include a small mandatory FDA disclaimer:

“* 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 helps the label stay within FDA rules.

Not allowed

You cannot make claims that say the product will:

• Treat a disease
• Cure a health condition
• Prevent a disease

Examples not allowed
• “Treats diabetes”
• “Cures joint pain”
• “Prevents heart disease”
Claims like these make the product a drug in the eyes of the law, which requires entirely different testing and approval.

11. Extra label information that matters

Country of origin (Made in USA claims)

If you want to say your product is Made in the USA, you must be able to truthfully support that claim based on where the product is made. If some ingredients come from other countries, the claim must still be accurate.

Organic claims

Using the word “organic” usually means the product has been certified organic by USDA standards. You should only use this if you have the actual certification.

Gluten-free, vegan, and similar claims

These claims can be used as long as they are truthful and you have documentation to back them up. Marketplaces often ask for proof even if FDA does not require it.

Final label compliance checklist

Before you print your label or launch your product, confirm the following:

Front of label

☐ Product name clearly states what the product is
☐ The words “Dietary Supplement” appear near the product name
☐ Net quantity of contents is shown (60 capsules, 120 tablets, etc.)
☐ Net quantity text is large enough and easy to read

Supplement Facts panel

☐ Panel title says “Supplement Facts”
☐ Panel is black text on a white background
☐ Thick black line under “Supplement Facts”
☐ Serving size is listed and matches directions for use
☐ Servings per container is listed
☐ Each dietary ingredient listed with amount per serving
☐ Percent Daily Value shown when required
☐ Footnote included for ingredients with no Daily Value
☐ Heavy black bar near bottom of panel
☐ Clean, readable font used

Other ingredients

☐ Capsule shell or tablet coating listed
☐ Excipients and processing aids listed
☐ Ingredients listed by common or usual name
☐ Listed in descending order by weight

Company and usage information

☐ Company name listed
☐ City, state, and zip code listed
☐ Directions for use included and clear
☐ Warnings included when appropriate
☐ Allergen information declared when applicable

Claims and disclaimer

☐ Only structure/function type claims used
☐ No disease treatment, cure, or prevention claims
☐ DSHEA disclaimer included with exact wording
☐ Disclaimer is bold
☐ Disclaimer font size is at least 1/16 inch
☐ Claims linked to disclaimer with asterisk or placed next to it
☐ Disclaimer appears on each panel where claims appear

General design

☐ All required text is easy to read
☐ Good contrast between text and background
☐ No required information hidden or crowded

Conclusion

Supplement label compliance is not about guessing or copying another brand. It is about following clear rules so customers know exactly what they are buying and how to use it safely.

If you build your label using verified manufacturing data, follow FDA formatting rules, and keep claims conservative and truthful, you dramatically reduce the risk of reprints, delays, and marketplace problems.

Educational use and liability disclaimer

This article is provided for educational and informational purposes only. It does not constitute legal or regulatory advice.

Labeling requirements may change and can vary by product type and circumstance. Brands are solely responsible for ensuring their labels comply with all applicable laws and regulations. NutraSeller is not responsible for label errors, regulatory actions, or marketplace enforcement decisions.