What is required on a supplement label? A comprehensive guide

January 9, 2026 •

3 min read

The US dietary supplement industry is a multi-billion dollar market, but it is heavily regulated by the Food and Drug Administration (FDA). For consumers, deciphering the information on a supplement label is crucial for making informed choices about the products they consume. Understanding the regulations for accurate and compliant labeling is essential for both manufacturers and users.

Quick Summary

Mandatory elements for a supplement label include a statement of identity, net quantity, Supplement Facts panel, ingredient list, and manufacturer contact information. Different types of claims are governed by specific regulations, and strict formatting rules dictate how information must be displayed. Adherence is critical for consumer safety and legal compliance.

Key Points

Statement of Identity: Labels must clearly state the product's name and identify it as a "dietary supplement" on the main display panel.
Supplement Facts Panel: A detailed nutrition panel is mandatory, listing the serving size, servings per container, and dietary ingredients with their amounts.
Ingredient Declaration: All ingredients, both active and inactive, must be listed. For proprietary blends, the total weight and ingredients in descending order of weight must be shown.
Manufacturer Information: The label must provide the name and address of the manufacturer, packer, or distributor for consumer contact and adverse event reporting.
Specific Claims and Disclaimers: Certain claims (e.g., structure/function) are allowed but require a specific FDA disclaimer stating the product is not intended to treat, cure, or prevent any disease.
Warning Statements: Important caution notices, such as "Keep out of reach of children," are mandatory on the label.

Essential Elements of a Supplement Label

For a dietary supplement to be legally marketed in the United States, its label must include five key pieces of information, as mandated by the FDA. These elements are strategically placed across the principal display panel (PDP) and the information panel (IP).

Principal Display Panel (PDP) Requirements

The PDP must feature:

Statement of Identity: The name of the product, such as "Vitamin D Supplement," in a prominent font size.
Net Quantity of Contents: Located within the bottom 30% of the PDP, stating the amount of supplement in the package by weight, measure, or count.

Information Panel (IP) Requirements

The IP, typically to the right of the PDP, must contain the following if not on the front. Formatting must follow specific guidelines.

Supplement Facts Panel: This panel requires proper formatting and includes serving size, servings per container, dietary ingredients, amount per serving, and % Daily Value.
Ingredient List: Any ingredients not in the Supplement Facts panel must be listed below it.
Manufacturer, Packer, or Distributor Information: Name and place of business of the responsible party.

The Role of Regulatory Claims

Supplement labels can include claims, regulated by the FDA and FTC. There are three main types:

Health Claims: Describe links between a substance and disease, requiring specific FDA approval.
Nutrient Content Claims: Describe the level of a nutrient (e.g., "high," "low").
Structure/Function Claims: Describe a nutrient's role in body structure or function. No FDA approval needed, but substantiation is required, and a mandatory FDA disclaimer must be included.

Claims, Disclaimers, and Other Label Elements

Other mandatory statements include:

The FDA Disclaimer: Required for structure/function claims: "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".
Adverse Event Reporting: Must include a domestic address or phone number for reporting serious adverse events.
Warning Statements: Essential cautions like "Keep out of reach of children" or allergy warnings.

Comparison: FDA vs. EU Labeling Requirements

Comparing US to EU regulations highlights differences in approach while both prioritize consumer safety.


Feature	US (FDA) Requirements	EU (e.g., Directive 2002/46/EC) Requirements
Classification	Dietary supplements are a category of food.	Food supplements are considered foods.
Claims Regulation	Health claims need FDA approval; structure/function claims require a disclaimer.	Health claims are regulated under Regulation (EC) No 1924/2006 and must be authorized.
Pre-market Approval	Not required, but notification is needed for new dietary ingredients (NDIs).	No pre-market approval, but specific rules apply.
Disclaimer	Mandatory disclaimer for structure/function claims, stating product is not intended to "diagnose, treat, cure, or prevent any disease".	No explicit FDA-style disclaimer, but claims cannot be misleading or imply a cure/treatment.
Information Language	English is typically required.	Must be in the language of the country of sale.
Daily Dose Warning	Implicitly covered in directions; not a specific standalone warning requirement.	Must explicitly warn not to exceed the recommended daily dose.

Labeling for Proprietary Blends

Specific FDA rules apply to proprietary blends to protect unique formulas while informing consumers.

Identified as "Proprietary Blend" or similar.
Total weight of all ingredients in the blend is listed.
Ingredients listed in descending order by weight.
Individual ingredient amounts within the blend are not required if the total weight is provided.

Conclusion: The Importance of Compliance

Understanding what is required on a supplement label is vital for consumer safety, trust, and manufacturer compliance. FDA guidelines ensure accurate information on contents, potency, and risks. From identity to the Supplement Facts panel and disclaimers, each element prevents misleading claims and promotes transparency. Non-compliance can result in legal issues, including fines and recalls. Adhering to these guidelines protects businesses and empowers consumers to make informed health decisions.

Food and Drug Administration's Labeling Requirements for Dietary Supplements

Frequently Asked Questions

The 'Supplement Facts' panel is the mandatory nutrition label for dietary supplements, detailing the serving size, number of servings, and all dietary ingredients, along with their quantities and Daily Values.

A proprietary blend is a mix of dietary ingredients formulated by a manufacturer. On the label, the total weight of the blend and all individual ingredients in descending order of weight must be listed, though individual ingredient amounts are not required.

No, the FDA does not approve dietary supplements before they are marketed. However, manufacturers are responsible for ensuring their products are safe and that their claims are truthful and not misleading.

An FDA disclaimer is required on a supplement label when a manufacturer makes a structure/function claim about the product's effect on the body. The disclaimer states the FDA has not evaluated the claim and the product is not for disease treatment or prevention.

The principal display panel must contain the product's statement of identity (its name) and the net quantity of contents (the amount of product in the package).

A health claim describes the link between a substance and a disease, requiring FDA approval, while a structure/function claim describes the role of a nutrient in affecting body structure or function and requires an FDA disclaimer, but not pre-approval.

A dietary supplement label must include a domestic address or a domestic phone number for reporting serious adverse events.