A Guide to Understanding What are the rules for dietary supplement labeling?

October 10, 2025 •

4 min read

Over half of U.S. adults take dietary supplements, making transparent labeling crucial for consumer safety. Understanding what are the rules for dietary supplement labeling is key to interpreting these products correctly and making informed health choices.

Quick Summary

This article details the strict FDA regulations for dietary supplement labels, outlining mandatory information like the Supplement Facts panel, ingredient lists, and specific claim requirements.

Key Points

Mandatory Information: Every dietary supplement label must include the product's identity, net quantity, a Supplement Facts panel, a full ingredient list, and the manufacturer's name and contact information.
Supplement Facts Panel: This section details serving size, servings per container, dietary ingredients, and their amounts and Daily Value percentages, where applicable.
Label Claims: Claims are categorized as structure/function (with FDA disclaimer), health (requires FDA approval), or nutrient content (regulated level descriptions).
Structure/Function Disclaimer: A required bolded, boxed statement must accompany structure/function claims, clarifying the claim is not FDA-evaluated and the product isn't for treating disease.
Post-Market Regulation: Unlike drugs, supplements are not pre-approved by the FDA for safety. Manufacturers bear the primary responsibility for ensuring their products are safe and accurately labeled under DSHEA.
Ingredient Transparency: Labels must list all dietary and non-dietary ingredients. Proprietary blends must list the total weight and ingredients in descending order of predominance.
Consumer Safety Warnings: Key safety information, including allergen warnings and specific cautionary statements for ingredients like iron, is also a mandatory part of the labeling.

The Foundation of Dietary Supplement Labeling: DSHEA

Labeling for dietary supplements in the United States is governed primarily by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Unlike pharmaceutical drugs, dietary supplements do not require pre-market FDA approval for safety and efficacy. Instead, the responsibility falls on manufacturers to ensure their products are safe and that all information on the label is truthful and not misleading. This regulatory framework makes accurate and compliant labeling paramount for consumer protection.

The Mandatory Elements of a Supplement Label

All dietary supplement labels must contain five mandatory statements, prominently displayed either on the principal display panel (PDP), the area most likely to be seen by the consumer, or the information panel (IP), typically located to the right of the PDP. These elements are the cornerstone of transparent labeling and include:

Statement of Identity: The product's name, which must include the term "dietary supplement" or a similar descriptor (e.g., "vitamin supplement").
Net Quantity of Contents: The amount of the product in the package, expressed as weight, measure, or count.
Supplement Facts Panel: A box containing detailed nutritional information.
Ingredient List: A complete list of all ingredients, both dietary and non-dietary.
Manufacturer, Packer, or Distributor Information: The name and full address of the company responsible for the product.

Decoding the 'Supplement Facts' Panel

This panel provides the most critical nutritional information in a structured format enclosed in a box.

Serving Size and Servings Per Container: The panel must clearly state the maximum recommended serving size and the total number of servings in the container. This helps consumers understand the dosage.
Dietary Ingredients: All ingredients must be listed, along with their quantitative amount per serving. For vitamins and minerals with established Daily Values (DVs), the percentage of the DV is also required.
Other Dietary Ingredients: Ingredients without established DVs must also be listed and marked with an asterisk referring to the footnote "Daily Value Not Established".
Proprietary Blends: For blended ingredients, the total weight of the blend must be listed, and the individual ingredients must be listed in descending order of predominance by weight.

Understanding Label Claims

Labeling rules are particularly strict regarding the claims manufacturers can make about their products. There are three main types of claims:

Structure/Function Claims: Describe the role of a nutrient or ingredient in affecting the structure or function of the human body (e.g., "Calcium builds strong bones"). These claims are not evaluated by the FDA and must be accompanied by a mandatory disclaimer.
Health Claims: State or imply a relationship between a substance and the reduced risk of a disease (e.g., "Omega-3s may reduce the risk of heart disease"). These claims require pre-market approval from the FDA, based on significant scientific agreement.
Nutrient Content Claims: Characterize the level of a nutrient in a product, such as "high in calcium" or "low in fat". These must meet specific regulatory criteria.

Comparison of Labeling for Supplements vs. Conventional Foods

While both dietary supplements and conventional foods are regulated by the FDA, their labeling rules differ significantly due to their distinct legal classifications.


Feature	Dietary Supplement Labeling	Conventional Food Labeling
Regulatory Framework	Governed by DSHEA, focused on post-market enforcement.	Governed by the Nutrition Labeling and Education Act (NLEA), requiring pre-market approval for certain aspects.
Nutrition Information Panel	Uses a "Supplement Facts" panel, with specific rules for dietary ingredients and proprietary blends.	Uses a "Nutrition Facts" panel, with standardized formatting and requirements.
Pre-Market Approval	Generally not required, except for new dietary ingredients.	Required for new food additives and some health claims.
Ingredient Sourcing	Can specify the source or part of a plant used for an ingredient (e.g., "ginger root").	Cannot list specific plant parts or animal-sourced descriptors on the nutrition panel.
Claims	Allows for structure/function claims with a mandatory disclaimer.	Does not permit structure/function claims with the same disclaimer requirements.

The All-Important FDA Disclaimer

One of the most recognizable elements of a supplement label is the disclaimer required for structure/function claims. It must be bolded, enclosed in a box, and state: "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 text clarifies that the product's function is not FDA-approved and serves as a critical warning that it should not be confused with a drug.

Other Crucial Labeling Information and Safety

In addition to the core components, supplement labels must include other information to protect consumers:

Allergen Warnings: Labels must clearly state the presence of any major food allergens, such as milk, eggs, or soy.
Cautionary Statements: Certain ingredients, like iron, require specific warning statements to prevent accidental overdose.
Domestic Contact Information: A domestic phone number or address is required for consumers to report serious adverse events.
New Dietary Ingredient (NDI) Notification: Manufacturers must notify the FDA at least 75 days in advance if a product contains a new dietary ingredient not previously marketed in the U.S..

Conclusion

The extensive regulations governing dietary supplement labeling, primarily rooted in DSHEA, exist to ensure a minimum level of transparency for consumers. While manufacturers have the responsibility for product safety, the labels themselves are a crucial communication tool, required to disclose everything from the ingredient list to specific health claim caveats. For consumers, understanding these complex rules, from the mandatory elements to the types of claims allowed, is vital for navigating the market safely and effectively. To stay fully informed, consumers and manufacturers alike should refer directly to the FDA's detailed guidance on supplement labeling.

Food and Drug Administration (FDA) Dietary Supplement Labeling Guide

Frequently Asked Questions

The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the primary federal law governing dietary supplement regulations in the United States. It requires manufacturers to ensure their products are safe and properly labeled but does not mandate pre-market FDA approval.

No, the FDA does not approve dietary supplements for safety or efficacy before they are marketed. The burden of proof for a product's safety and the accuracy of its claims rests with the manufacturer.

A "Supplement Facts" panel is used for dietary supplements, while a "Nutrition Facts" panel is for conventional foods. The supplement panel has specific rules for listing dietary ingredients, proprietary blends, and botanical sources that differ from the food panel.

A structure/function claim describes the intended role of a dietary ingredient in affecting the normal structure or function of the body, such as "Calcium builds strong bones." These claims do not need pre-approval but must be accompanied by a specific FDA disclaimer.

The ingredient list must contain all active and inactive ingredients by their common or usual names. In a proprietary blend, the total weight and a list of all ingredients in descending order of predominance must be provided.

The mandatory disclaimer, required for structure/function claims, is a boxed statement that reads: "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.".

Yes, supplement labels are required to clearly disclose the presence of any major food allergens, such as milk, eggs, soy, wheat, and tree nuts.