Core Labeling Requirements for Dietary Supplements

Under U.S. regulations, dietary supplement labels must include several mandatory elements. These elements ensure that consumers receive transparent and standardized product information.

1. Statement of Identity

The label must clearly identify the product as a dietary supplement.

Examples:

• Vitamin D Dietary Supplement
• Magnesium Dietary Supplement
• Herbal Dietary Supplement

This statement must appear on the principal display panel (PDP) of the packaging.

2. Net Quantity of Contents

The label must indicate the total amount of product contained in the package.

Examples include:

• 60 Capsules
• 120 Tablets
• Net Weight 150 g

This information must be displayed clearly on the front label panel.

3. Supplement Facts Panel

The Supplement Facts panel is the most important part of dietary supplement labeling.

According to 21 CFR §101.36, the panel must include the following elements:

• Serving Size
• Servings Per Container
• Name of each dietary ingredient
• Amount of each ingredient per serving
• Percent Daily Value (%DV), when applicable

The heading “Supplement Facts” must appear prominently at the top of the box.

The panel must also follow standardized formatting rules, including typography, indentation, and boxed layout.

4. Declaration of Dietary Ingredients

Each dietary ingredient must be declared with its quantitative amount per serving.

For example:

Vitamin C (as ascorbic acid) — 500 mg
Magnesium (as magnesium citrate) — 200 mg

The declared amount refers to the actual amount of the nutrient or dietary ingredient, not the total weight of the raw material.

For example:

Magnesium citrate providing 200 mg elemental magnesium must be labeled as:

Magnesium — 200 mg

rather than listing the raw material weight.

5. Botanical Ingredient Identification

For botanical ingredients, the label must specify the plant part used.

Examples:

Milk Thistle Extract (seed)
Turmeric Extract (root)
Ginkgo Biloba Extract (leaf)

This helps ensure transparency regarding the botanical source.

6. Other Ingredients List

Ingredients that are not dietary ingredients must be listed under “Other Ingredients.”

Examples include:

• Capsule shell materials
• Flow agents
• Fillers
• Stabilizers

These ingredients must be listed in descending order by weight.

7. Name and Address of Responsible Party

The label must identify the manufacturer, packer, or distributor responsible for the product.

Typical format:

Manufactured for
Company Name
City, State, ZIP Code
Country (if imported)

This requirement allows traceability of the product.

8. Structure / Function Claims and Disclaimer

Dietary supplements may include structure/function claims, such as:

• Supports immune health
• Helps maintain bone health
• Supports normal energy metabolism

However, these claims must not imply disease treatment.

When such claims are used, the following disclaimer must appear on the label:

“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.”

This requirement originates from the Dietary Supplement Health and Education Act.

Common Labeling Compliance Risks

Companies entering the U.S. supplement market often encounter labeling issues due to misunderstanding regulatory requirements. The following are some common compliance risks.

Incorrect declaration of nutrient dosage

One of the most common mistakes is declaring the raw material weight instead of the actual nutrient amount.

Example:

Incorrect:
Magnesium Citrate — 1000 mg

Correct:
Magnesium — 200 mg (from Magnesium Citrate)

FDA labeling requires declaration of the nutrient amount, not simply the ingredient weight.

Missing plant part for botanical ingredients

Botanical ingredients must specify the plant part used.

Incorrect example:

Milk Thistle Extract — 300 mg

Correct example:

Milk Thistle Extract (seed) — 300 mg

Failure to identify the plant part may lead to labeling compliance issues.

Incorrect Supplement Facts formatting

The Supplement Facts panel must follow specific layout and formatting rules.

Common issues include:

• incorrect indentation
• missing serving size information
• incorrect placement of % Daily Value
• improper font hierarchy

Even small formatting errors may lead to regulatory concerns.

Unapproved disease claims

Supplements cannot claim to diagnose, treat, cure, or prevent diseases.

Examples of problematic claims include:

• Treats arthritis
• Prevents diabetes
• Cures liver disease

Such statements would classify the product as a drug under FDA regulations.

Missing FDA disclaimer

When structure/function claims appear on the label, the DSHEA disclaimer must be included.

Failure to include this statement may result in regulatory violations.

Regulatory References

For detailed regulatory language, the following official references can be consulted.

21 CFR §101.36 – Nutrition labeling of dietary supplements
https://www.ecfr.gov/current/title-21/section-101.36

FDA Dietary Supplement Labeling Guide
https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide

Electronic Code of Federal Regulations
https://www.ecfr.gov/current/title-21

Conclusion

Understanding the labeling requirements defined under 21 CFR is essential for companies developing or exporting dietary supplements to the United States.

Accurate ingredient declaration, correct Supplement Facts formatting, and compliant structure/function claims are key elements of regulatory compliance. Careful attention to these requirements can help reduce market entry risks and ensure smoother product commercialization.